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Regenerative Medicine: The Next Medical Revolution - Episode 3 of HealthPadTalks is out now!

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2023 HealthPad Commentaries

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The HealthPad Team would like to extend our thanks for your continued support. As we celebrate another year together, we sincerely hope you've found our Commentaries interesting and helpful and we look forward sharing more thought-provoking content with you in 2024.

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The Future Of Regenerative Medicine

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The field of regenerative medicine is experiencing significant advancements and has the potential to transform healthcare by offering novel treatments, repairing damaged tissues and organs, and improving patients' quality of life
Key technologies shaping its future include stem cell research, tissue engineering, electro-stimulation, gene therapy, organ regeneration, 3D bioprinting, and nanotechnology
The progress of these technologies varies, raising the question of which will dominate the field in the next decade
Convergence of these technologies will play a pivotal role in transforming regenerative medicine
Advantages and challenges exist for each technology, and dominance will depend on scientific breakthroughs, clinical success, regulations, and patient acceptance
MedTech companies must intensify their R&D efforts in regenerative medicine to remain relevant
Collaboration between disciplines, institutions, and industry partners is crucial
Staying informed about emerging trends and breakthroughs is essential
Proactively identifying synergies and areas of collaboration can accelerate progress
MedTechs can actively shape the future of regenerative medicine by exploring and integrating evolving technologies

The Future of Regenerative Medicine
Navigating Evolving Technologies and the Imperative for MedTech Companies

In the rapidly evolving realm of modern medicine, regenerative medicine has emerged as a transformative and powerful force. With several innovative developments at its core, it has the potential to change our approach to healing and restoration. The long-awaited promise of personalized, curative, and transformative therapies appears to be within reach, giving hope to patients who have been waiting for breakthroughs.

Over the past decade, this broad field of medicine has witnessed significant developments, with various technologies emerging as promising avenues for medical innovation. Stem cell research, tissue engineering, electro-stimulation, gene therapy, organ regeneration, 3D bioprinting, and nanotechnology have all demonstrated their potential in addressing complex medical conditions. However, these technologies are progressing at different rates, and are often used complementarily, giving rise to a key strategic question for MedTechs investing in regenerative medicine research and development (R&D): Which technology or combination of regenerative medicine technologies will ultimately dominate the field in the next decade?

As this market segment gains momentum, it seems reasonable to suggest that many MedTechs have yet to fully grasp the magnitude and pace of these technological developments. To establish a presence or expand their footprint in this arena, companies must intensify their R&D efforts and monitor developments across the full range of these technologies to ensure they are not caught off guard. Time is of the essence, and those who fail to recognize this, risk being left behind.

Regenerative medicine

Regenerative medicine encompasses a broad range of approaches aimed at repairing, replacing, or regenerating damaged or diseased tissues and organs in the body. It draws upon principles from biology, engineering, and other scientific disciplines to restore both the structure and function of compromised tissues and organs. The concept underlying regenerative medicine involves utilizing the body's innate healing mechanisms to facilitate tissue repair and regeneration. This incorporates various techniques used either independently or together, and include stem cell therapy, tissue engineering, electro-stimulation, gene therapy, organ regeneration, 3D bioprinting, and nanotechnology, which either stimulate the body's natural regenerative processes or provide external support for tissue regeneration.

Brief history

Regenerative medicine has a rich history, driven by humanity's quest to heal and restore damaged tissues and organs. From ancient civilizations to modern times, medical science has continually evolved, seeking solutions to overcome the limitations of conventional treatments. This pursuit has given rise to the field of regenerative medicine. Early healers in ancient civilizations explored various remedies and techniques to promote tissue repair, ranging from herbal medicines to primitive surgical interventions. These practices laid the groundwork for our understanding of the body's inherent regenerative capacity.

In the 20th century, scientific advancements began unlocking new possibilities. The discovery of stem cells in the 1960s marked a breakthrough, revealing a versatile cell population capable of self-renewal and differentiation into specialized cell types. This discovery represented a paradigm shift in medical research and served as the foundation for modern regenerative medicine. The isolation and cultivation of human embryonic stem cells in the early 2000s was a significant milestone, offering potential for regenerative therapies. However, ethical concerns surrounding their use prompted scientists to search for alternative approaches. This led to the discovery of induced pluripotent stem cells (iPSCs) in 2006, which could be derived from adult cells and reprogrammed to resemble embryonic stem cells, thus bypassing the ethical concerns.

In recent years, regenerative medicine has experienced a surge of new and rapidly evolving medical technologies. Tissue engineering, biomaterials, gene editing techniques [a method for making specific changes to the DNA of a cell or organism], and advanced imaging modalities have impacted the field, enabling the creation of 3D tissue constructs, the bioengineering of organs, and direct tissue regeneration within the body. Regenerative medicine has expanded beyond traditional approaches, encompassing a wide range of therapeutic strategies, including cell-based therapies, gene therapies, electro-stimulation, and the utilization of growth factors and biomaterials. This multidisciplinary approach, leveraging the expertise of scientists, bioengineers, and clinicians, aims to develop transformative therapies for previously untreatable conditions.

In this Commentary

This Commentary explores the rapidly evolving technologies that have propelled regenerative medicine to the forefront of medical research and their potential implications for the future of healthcare. We describe the contributions to regenerative medicine of stem cell research, tissue engineering, electro-stimulation, gene therapy, organ regeneration, 3D bio printing, and nanotechnology. The Commentary discusses some of the challenges and ethical considerations facing the field and draws attention to governments actively pursuing regenerative medicine R&D. We stress that technologies, which contribute to this field are progressing at different rates and are often used complementarily. This raises a strategic question for MedTechs investing in regenerative medicine R&D: “Which technology or combination of regenerative technologies will ultimately dominate the field in the next decade?”. Answering this question should provide MedTechs, either contemplating entering this market segment or with established regenerative medicine franchises, with insights to guide their strategic decision-making and to assist in their long-term success in this rapidly evolving field.

Stem cell research

Stem cell research has changed regenerative medicine, opening new possibilities for tissue repair and disease treatment. One significant advancement is the development of Induced Pluripotent Stem Cells (iPSCs). These are created by reprogramming adult cells and can differentiate into any cell type, making them invaluable for personalized therapies. Unlike embryonic stem cells, iPSCs alleviate ethical concerns. However, ethical issues related to human cloning persist (see below). Nonetheless, iPSCs serve as a crucial tool, offering safer and more efficient techniques for studying diseases, screening drugs, and developing personalized therapies. They also enable the replacement of damaged cells and the creation of functional tissues and organs, providing opportunities for organ transplantation and personalized tissue replacement treatments. Researchers have also achieved success in transdifferentiation, rapidly generating desired cell types for regenerative and transplantation therapies. The gene-editing tool CRISPR-Cas9, (see below), further enhances stem cell research by allowing precise modifications for disease correction and improved traits. Clinical trials have demonstrated the potential of stem cell-based therapies in various areas, including spinal cord injuries, neurodegenerative disorders, heart disease, blood disorders, and diabetes. Advancements in bioengineering and microfluidics have further improved stem cell growth and differentiation, bringing us closer to fully harnessing the power of stem cell-based regenerative medicine.

Several companies and research institutions have made contributions to stem cell R&D. Mesoblast, an Australian biopharmaceutical company founded in 2004, focuses on developing cellular medicines based on mesenchymal lineage adult stem cells. They are actively involved in creating regenerative therapies for cardiovascular diseases, orthopedic disorders, and immune-mediated inflammatory diseases. Novartis, a Swiss pharmaceutical company, has made substantial investments in stem cell research and is dedicated to developing treatments for conditions such as macular degeneration and heart failure. Cellular Dynamics International (CDI), a biotech based in Japan and a subsidiary of Fujifilm, specializes in producing human iPSCs for use in drug discovery, toxicity testing, and disease modeling. Athersys, a biotech based in Cleveland, Ohio, US, focuses on developing innovative stem cell-based therapies. Their leading offering, MultiStem®, is a patented, adult-derived stem cell therapy platform designed to treat various disease states, including neurological disorders, cardiovascular diseases, and inflammatory conditions. Athersys has received Fast Track designations from the US Food and Drug Administration (FDA) for acute respiratory distress syndrome (ARDS), stroke, and transplant support. In 2022, Vertex Pharmaceuticals, based in Boston, US, acquired ViaCyte, a US biotech, for US$320m in cash. ViaCyte specializes in delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D). This acquisition provides Vertex with additional human stem cell lines, intellectual property related to stem cell differentiation, and manufacturing facilities for cell-based therapies, which can accelerate the company's T1D programmes. ReNeuron, a UK-based biotech focuses on developing cell-based therapies, for conditions like stroke disability, retinal diseases, and peripheral limb ischemia. Osiris Therapeutics, founded in 1993, developed Grafix®, a cryopreserved placental membrane used for wound healing and tissue repair. In 2019, the company was acquired by Smith & Nephew plc, a global medical technology business, for US$660m.

Tissue Engineering

Tissue engineering is a field that combines biology, engineering, and medicine to create functional tissues and organs. It has made advancements recently, such as the development of organoids used for studying diseases and personalized medicine. Biomaterials, like hydrogels, nanofibers, and 3D-printed scaffolds, play a role by providing support for cell growth. One challenge tissue engineering faces is creating blood vessels to ensure the tissues receive enough nutrients and oxygen. Researchers are using techniques like 3D bioprinting (see below), to create networks of tiny blood vessels within engineered tissues. 3D bioprinting allows for precise placement of cells and materials to create complex tissue structures. Decellularization, which removes cellular components from donor organs and replaces them with patient-specific cells, has also been successful in organ regeneration. Microfluidics and organs-on-a-chip platforms are used to mimic organ functions for studying diseases and testing drugs. Gene editing technologies like CRISPR-Cas9 (see below) show promise for modifying cells, enhancing tissue regeneration, and correcting genetic disorders.

Tissue engineering has achieved successes in various areas. Bladder tissues, tracheal replacements, skin substitutes, cartilage constructs, and liver models are some examples. In 1999, scientists successfully engineered and implanted bladder tissues in patients with bladder disease. In 2008, a tissue-engineered trachea was successfully implanted in a patient with a damaged airway. Tissue-engineered skin is commonly used for treating burn injuries, and advanced skin substitutes that closely resemble natural skin. Cartilage constructs show promise for repairing joints, and miniaturized liver models mimic liver function for drug testing. While these developments are promising, further research and clinical trials are needed to refine and expand the applications of tissue engineering in medical practice.

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Tissue Regenix, a UK-based company, that was spun out of the University of Leeds in 2006, employs decellularization and extracellular matrix technologies to create a range of products for wound care and orthopedic applications. Vericel, a Nasdaq traded US biotech based in Cambridge, Massachusetts, is focused on the development and commercialization of cell-based therapies. Its products include MACI [autologous cultured chondrocytes on porcine collagen membrane] for the repair of cartilage defects in the knee and Epicel [cultured epidermal autografts] for the treatment of severe burns. Medtronic, a giant American MedTech, has moved into regenerative medicine with the acquisition of MiroSurge AG, a Swiss company working on tissue engineering. Medtronic aims to develop regenerative therapies for the treatment of conditions like degenerative disc disease. Stryker, an American MedTech involved in orthopedics and tissue engineering, has a presence in the regenerative medicine through its subsidiary, Sage Products, which focuses on the development of advanced wound care and regenerative products.

Electro-stimulation

Electro-stimulation, also known as electrical stimulation or electrotherapy, offers a non-invasive and safe method to enhance tissue regeneration and repair. It involves the use of specialized devices that deliver controlled electrical impulses to specific areas of the body. While electro-stimulation has a range of applications in medicine, one area where it shows promise is in tissue regeneration and enhancing the body's ability to heal itself. A common application is for the stimulation of nerves and muscles. Applying electrical currents to these tissues can restore or improve their function. For instance, in patients with nerve damage or muscle weakness, the technology can help to reactivate the nerves or strengthen the muscles, leading to improved mobility and functionality. Electrotherapy also promotes tissue healing and regeneration by enhancing cellular activity. Electrical currents can stimulate the production of growth factors, which are substances that promote cell growth and tissue repair. Additionally, the therapy can increase blood flow to a treated area, bringing oxygen and nutrients that are essential for tissue healing. In some cases, electro-stimulation is used in combination with other regenerative therapies, such as stem cell treatments. Electrical currents can help guide and enhance the differentiation and integration of stem cells into damaged tissues thereby accelerating the healing process. While further research is still needed to fully understand its mechanisms and optimize its use, electro-stimulation holds potential for improving outcomes in regenerative medicine and helping patients recover from various injuries and conditions.

Several MedTechs are involved in electro-stimulation R&D for regenerative medicine. Medtronic has developed neurostimulation systems to manage chronic pain and improve neurological functions, which also can be used in regenerative medicine applications, such as nerve and muscle regeneration. Abbott Laboratories have made contributions to electro-stimulation devices for regenerative medicine. Their product portfolio includes implantable neurostimulation systems to manage chronic pain, movement disorders, and other neurological conditions and can aid in the regeneration of damaged nerves and muscles. Boston Scientific has developed a range of electrical stimulation systems for various applications, including chronic pain management, deep brain stimulation for movement disorders, and spinal cord stimulation, and can potentially contribute to regenerative medicine by stimulating tissue healing and facilitating the regeneration process. Nevro Corp specializes in the development of high-frequency spinal cord stimulation systems for chronic pain management. Their devices deliver electrical pulses to the spinal cord, modulating pain signals and providing relief to patients, and have the potential to aid in regenerative medicine by promoting tissue healing. Bioventus, established in 2012 and based Durham, North Carolina, US, is focused on ortho-biologic solutions for musculoskeletal healing. The company has developed a portable electro-stimulation device called the Exogen Ultrasound Bone Healing System, which has shown efficacy in promoting bone regeneration and is used in various clinical settings.

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Gene therapies

Gene Editing

Gene editing is a field of research that holds potential to change regenerative medicine. At its forefront is CRISPR-Cas9, a powerful tool that allows scientists to make precise modifications to our genetic material. By combining gene editing with gene therapy, new avenues for treating genetic disorders and diseases can be explored. CRISPR-Cas9, derived from bacteria, acts like molecular scissors, enabling researchers to modify specific genes efficiently and cost-effectively, which means they can introduce beneficial changes, remove, or replace faulty genes, and correct genetic mutations.

Gene therapy, a key component of regenerative medicine, involves introducing functional genes into a patient's cells to compensate for defective or absent genes that cause specific disorders. There are two primary approaches to gene therapy: in vivo, which delivers therapeutic genes directly into the patient's body, and ex vivo, which modifies the patient's cells outside the body before reintroducing them.

Gene therapy has shown success in treating Leber Congenital Amaurosis (LCA), a rare disorder causing vision loss in children. Luxturna, the first FDA approved gene therapy for LCA, delivers a functional copy of the RPE65 gene into retinal cells, restoring vision in patients. Another example is gene therapy for Severe Combined Immunodeficiency (SCID), also known as "bubble boy disease". By using a modified retrovirus, this treatment restores immune function in infants with SCID caused by a deficiency in the enzyme adenosine deaminase. Promising results have also been observed in the treatment of inherited blood disorders such as Beta-Thalassemia and sickle cell disease, both caused by mutations in the hemoglobin genes. Clinical trials are focused on editing patients' own hematopoietic stem cells to correct these genetic mutations. Despite successes, there are still challenges to overcome, which include improving delivery methods, ensuring long-term safety, managing immune responses, and increasing treatment accessibility.

Several companies are engaged in gene therapy R&D. Novartis developed Kymriah, the first FDA-approved gene therapy product. Kymriah utilizes the body's own T cells to fight certain types of leukemia. bluebird bio, another prominent company, focuses on developing gene therapies for severe genetic diseases and cancer. They obtained FDA approval for Zynteglo, a gene therapy used to treat transfusion-dependent beta-thalassemia patients. Spark Therapeutics, known for Luxturna, mentioned above, continues to operate as an independent subsidiary after being acquired by Hoffmann-La Roche. They are actively pursuing gene therapy treatments for inherited retinal diseases and other disorders. uniQure, a Dutch-based company, is a pioneer in gene therapy for rare genetic diseases and has developed Glybera, the first approved gene therapy in Europe. Pfizer, a global pharmaceutical company, has also made substantial investments in gene therapy, acquiring Bamboo Therapeutics, which is focussed on rare diseases related to neuromuscular conditions and the central nervous system. Sangamo Therapeutics, a biotech company based in California, US, specializes in gene editing and gene regulation technologies, with ongoing research in therapies for hemophilia and lysosomal storage disorders.

Organ Regeneration

Organ regeneration is a field in regenerative medicine that offers hope for patients in need of new organs. For instance, in the US, currently, there are ~114,000 people waiting for organ transplants, ~60% (70,000) will not receive the organ they need, and each day ~20 people die due to the lack of available organs. Through advancements in bioengineering and organ transplantation techniques, functional organs can now be developed to restore health and enhance quality of life. Stem cells and tissue engineering play a role in creating organs that mimic the structure and function of natural ones. Additionally, innovations in 3D printing and biomaterials have provided solutions for successful organ transplantation.

The liver has shown regenerative capabilities, and surgeons can transplant a portion of a healthy liver into a recipient, enabling regeneration and restoring the organ's function. Researchers have explored approaches to stimulate cardiac regeneration, such as using stem cells and biomaterial scaffolds to repair damaged heart tissue. While these techniques are still in development, they hold promise for treating heart diseases and reducing the burden of heart failure.

In the pursuit of overcoming the limitations of traditional organ transplantation, several companies are engaged in organ regeneration R&D. For instance, Miromatrix Medical utilizes decellularization techniques to create fully functional organs and tissues by removing cellular material from donor organs while preserving the extracellular matrix. United Therapeutics and its subsidiary Lung Biotechnology focus on bioengineering lungs using technologies like tissue engineering, stem cell therapy, and gene editing. CellSeed Inc., a Japanese biotech, has developed a technology called "cell sheet engineering" that uses patient-derived cells to promote tissue repair and regeneration.

3D Bioprinting

3D bioprinting is a technology in regenerative medicine that facilitates the creation of complex tissue structures with precision and customization. Significant progress in the filed has been made in the past decade, including the development of advanced bio-inks that consist of biocompatible materials and living cells. These bio-inks can be deposited layer by layer, resulting in 3D tissue constructs that closely resemble natural tissues in complexity and functionality. The resolution and speed of 3D printers have also improved, enabling the production of detailed structures at a faster pace. By integrating imaging technologies like MRI and CT scans, patient-specific models can be created, optimizing the design and production of customized implants and prosthetics. One of the key advantages of 3D bioprinting is its ability to recreate intricate tissue structures with vascular networks that ensure nutrient supply and waste removal, which are vital for the survival and functionality of larger constructs. This technology has created new possibilities in personalized medicine, particularly in the development of customized implants and prosthetics. By utilizing patient-specific data, such as medical images, 3D bioprinting can fabricate implants and prosthetics that perfectly fit an individual's anatomy, leading to improved comfort and functionality. Further, biologically active substances like growth factors can be incorporated into the printed structures, allowing for localized and controlled release. This targeted therapy promotes tissue regeneration at the site of implantation.

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Several companies have recognized the potential of 3D bioprinting and invested in R&D programmes to advance the field. Organovo, EnvisionTEC, the BICO Group, Aspect Biosystems, RegenHU, and Poietis are among enterprises driving innovation in 3D bioprinting. They all develop technologies and platforms to create functional human tissues, print biomaterials, offer standardized bio-inks, and provide advanced bio fabrication solutions. Their efforts aim to change regenerative medicine and contribute to the development of functional tissue constructs for therapeutic applications.

Nanotechnology

Nanotechnology has influenced regenerative medicine by enabling precise manipulation of matter at the nanoscale. This technology has led to breakthroughs in targeted drug delivery systems and the development of innovative nanomaterials for tissue regeneration and wound healing. Nanoparticles and nano-carriers, designed through nanotechnology, can encapsulate drugs, and deliver them directly to affected tissues or cells, improving treatment efficacy while minimizing side effects. These targeted drug delivery systems have reduced the required dosages, making treatments more effective and less toxic. The technology has also facilitated the development of advanced nanomaterials like nanostructured scaffolds, which mimic the natural extracellular matrix of tissues, and provide a supportive framework for cell growth and tissue regeneration. With high surface area-to-volume ratio and tunable mechanical properties, nanostructured scaffolds release bioactive compounds or growth factors in a controlled manner, promoting tissue regeneration in various areas like bone, cartilage, nerve, and skin. Additionally, nanotechnology has contributed to the creation of smart wound dressings that actively enhance the wound healing process by exhibiting antimicrobial properties, moisture management, and controlled release of therapeutics.

Several companies are involved in nanotechnology R&D for regenerative medicine. Nanobiotix focuses on nanoparticle-based solutions for cancer therapy, while Arrowhead Pharmaceuticals uses a nanoparticle-based delivery system to transport RNA interference (RNAi) therapeutics into target cells. Athersys [a biotech mentioned in the stem cell section above] incorporates nanotechnology-based methods in their allogeneic stem cell product, MultiStem. Capsulution Pharma AG offers customized nanoparticle-based solutions for targeted drug delivery, including applications in tissue engineering and wound healing. Capsulation’s nano capsules are invisible to the human eye. A pin head, which is ~1.5mm across, could contain ~3bn capsules. NanoMedical Systems specializes in implantable drug delivery systems with potential applications in regenerative medicine.

Challenges and ethical considerations

It is important to acknowledge the challenges and ethical issues, which accompany the field of regenerative medicine. One of its primary challenges is the complex and intricate nature of the human body. Developing therapies that can effectively repair and regenerate damaged tissues and organs is a daunting task that requires extensive scientific knowledge and technological expertise. The limited understanding of cellular behaviour, tissue interactions, and the intricacies of organ development present significant hurdles in translating regenerative medicine from the laboratory to clinical applications. In addition, regenerative medicine faces ethical considerations. One concern revolves around the use of embryonic stem cells, which are derived from human embryos. The destruction of embryos in the process raises ethical concerns, as it involves the termination of potential human life, which necessitates balancing the pursuit of medical advancements and respecting the moral value attributed to embryos. iPSCs have overcome ethical concerns associated with embryonic stem cells but raise ethical concerns of their own that are associated with their ability to clone humans, which we highlighted in the stem cell section above. Similarly, gene editing technologies like CRISPR-Cas9 have introduced new possibilities for manipulating genes and altering the genetic makeup of organisms, including humans. While gene editing presents significant opportunities for treating genetic diseases, it raises ethical questions about the modification of the germline, hereditary traits, and the potential for unintended consequences. International ethical frameworks need to be established to guide the responsible use of gene editing techniques and ensure that the potential benefits outweigh the associated risks.

Regulatory issues play a role in shaping the future of regenerative medicine. As the field progresses and new therapies emerge, regulatory bodies must establish clear guidelines and frameworks to evaluate the safety and efficacy of these treatments. Striking the right balance between fostering innovation and protecting patients' wellbeing is important for the development and implementation of regenerative medicine approaches. Public acceptance and understanding are paramount for the widespread adoption of these technologies. Educating the public about the science, potential benefits, and ethical considerations is essential to foster informed discussions and garner support. Building trust between the scientific community, regulatory agencies, and the public is essential to navigate the challenges and dilemmas inherent to regenerative medicine. Only with careful deliberation, collaboration, and responsible stewardship, will regenerative medicine contribute its full potential for solutions that improve health and wellbeing.

A role for governments

Government support for regenerative medicine is important for the development of innovative therapies for disabilities and diseases with limited treatment options. Administrations investing in R&D can result in therapies that address unmet medical needs and offer hope to patients. Many disabilities and diseases severely impact individuals' quality of life, hindering their daily activities and overall wellbeing. Governments have a public health obligation to foster the development of regenerative medicine, as it has the potential to restore or regenerate damaged tissues and organs, ultimately improving the lives of millions. In addition to the health benefits, regenerative medicine is a rapidly growing sector with significant economic potential. Appropriate support for R&D in this field can stimulate economic growth by creating high-skilled jobs and attracting investment from biotech and pharmaceutical companies. The successful development and commercialization of regenerative medicine therapies can also reduce healthcare costs, as they offer more effective treatments and alleviate the burden on healthcare systems.

Governments that prioritize R&D in regenerative medicine contribute to scientific advancements and potentially help to establish their countries as leaders in this emerging field. R&D facilitates collaboration between academia, industry, and healthcare institutions, driving innovation. This support aligns with principles of equity, access to healthcare, and the pursuit of scientific progress, demonstrating an administration's social and ethical responsibility to promote health and wellbeing among its citizens. Aging populations and increasing rates of chronic diseases and disabilities pose significant challenges to healthcare systems worldwide. Continuous treatments, hospitalizations, and long-term care result in substantial healthcare costs. By investing in R&D for regenerative medicine, governments can develop therapies that offer long-term solutions, reducing the need for costly and continuous interventions. This can lead to significant healthcare savings over time.

An international perspective

Countries worldwide are actively supporting R&D in regenerative medicine. The US is a leader in the area, with significant investment in R&D through organizations like the National Institutes of Health (NIH). Japan has established itself as a global leader with substantial funding, and supportive regulation with a streamlined approval process for regenerative medicine therapies. South Korea has also emerged as a prominent player, establishing dedicated centres and institutes to promote regenerative medicine and foster collaboration between academia and industry. The UK is committed to supporting R&D in the field and encouraging collaboration between various stakeholders. Germany invests in regenerative medicine R&D through research centres and institutes, while China has launched initiatives, established research centres, and has a rapidly growing regenerative medicine industry. These countries, and others, are actively engaged in advancing the field through funding, regulations, and collaboration, which aim to accelerate the development and commercialization of regenerative therapies.

Takeaways

We have presented a range of regenerative medicine technologies and described their advantages and challenges. We also mentioned that these technologies are developing at different rates and are often used together to create one therapy. So, what can MedTechs do to answer the question we posed at the beginning of this Commentary: Which technology or combination of regenerative medicine technologies will ultimately dominate in the next decade? While it is difficult to predict the future, it seems reasonable to suggest that the convergence of these evolving technologies will play a pivotal role in the transformation of regenerative medicine. Each technology brings both advantages and challenges, and their ultimate dominance will depend on several factors, including scientific breakthroughs, clinical success, regulatory considerations, and patient acceptance. To remain relevant and succeed in this arena, companies must recognize the urgency of intensifying their R&D efforts in regenerative medicine. This requires not only investing in cutting-edge technologies but also fostering collaboration between disciplines, institutions, and industry partners. By cultivating a comprehensive understanding of the evolving landscape, MedTechs can position themselves to either establish a significant presence or expand their footprints in regenerative medicine. It is important for them to closely monitor advancements across a range of relevant technologies. With the rapid pace of innovation, staying informed about emerging trends, breakthroughs, and disruptive technologies is essential to avoid being caught off guard. By proactively identifying potential synergies and areas of collaboration, enterprises can leverage their expertise and resources to accelerate progress.

Over the next decade, regenerative medicine has the potential to transform healthcare by offering novel treatments, repairing damaged tissues and organs, and improving patients' quality of life. MedTechs have an opportunity to help drive this transformation, but they must embrace the challenge of exploring and integrating various rapidly evolving and complex technologies. Will they be brave and agile enough to do this?

#stemcellresearch #tissueengineering #electro-stimulation #genetherapy #organregeneration #3Dbioprinting #nanotechnology

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3D bioprinting and the advanced wound care market

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Advanced wound care is a large and fast-growing global market currently dominated by North America and Europe
In the next decade, Asia-Pacific, the Middle East and Africa and South America regions are expected to become significant wound care markets
Price sensitive Western MedTechs with wound care franchises might be challenged to penetrate these under-served rapidly growing emerging regional markets
Innovative technologies that currently contribute to advanced wound care include growth factors and cytokines, stem cells, tissue engineering, regenerative medicine approaches, and 3D bioprinting
Each has technical and clinical challenges likely to present obstacles for their future growth
3D bioprinting however appears well positioned to eclipse competing technologies and disrupt the global advanced wound reconstruction market in the next decade

3D bioprinting and the advanced wound care market

3D bioprinting is a relatively new and innovative medical technology. Although in its infancy, it has established a market presence of ~US$1.3bn, and, over the next four years, its market value is projected to increase at a compound annual growth rate (CAGR) of ~21% and reach >US$3bn by 2027. An earlier Commentary drew attention to the technology’s likelihood to impact several aspects of healthcare. Here we assess 3D bioprinting’s potential near-term influence on the advanced wound care market compared with competing technologies.

A silent epidemic

Chronic wounds have become a large and fast-growing silent epidemic. They are difficult to heal because of aggravated underlying causes such as diabetes, obesity, and an aging population. Such wounds increase morbidity and mortality and inflict substantial medical, economic, and social burdens on healthcare systems globally. For instance, the mortality rate of neuropathic foot ulcers, the commonest wound associated with diabetes, is comparable to that of cancer (~30%), and cost more to treat. In the US, ~10% of the population (~30m) have diabetes, and $1 out of every $4 in healthcare costs is spent on caring for people with the condition, and the total annual cost of diabetes ~US$327bn. Further, each year, ~2m people living with the condition develop a diabetic foot ulcer (DFU) or other difficult to heal wounds. The US National Institutes of Health (NIH) estimate the annual cost of treating DFUs to be between ~US$9bn and US$13bn, which is in addition to the cost of treating diabetes and excluding the huge costs associated with treating venous leg ulcers and pressure ulcers each year. The US government has increased its effort to introduce new and advanced products for chronic wounds, with the aim to offer effective and affordable treatment to a large and growing pool of elderly patients. By 2060, the nation’s geriatric population is projected to be >77m, suggesting an increase in the 2% of Americans currently suffering chronic wounds. Similarly in England, where >11m people, (~19% of the population) are ≥65 years. A 2017 study estimated that the annual cost of managing chronic wounds and associated comorbidities for seniors by the country's National Health Service (NHS) was £5.3bn.

Rapidly developing therapies

Without appropriate care chronic wounds may not heal properly, leading to pain, decreased mobility, other long-term complications, and death. Wound healing is a dynamic and complex process of repairing or replacing damaged or lost tissue and its goal is to restore the structure and function of an affected tissue as closely as possible to its pre-injury state. Over the past two decades there have been significant advances in technologies to treat chronic wounds, some of which are reviewed in this Commentary. Today, >3000 products have been developed to treat different types of wounds by targeting various aspects of the healing process. There are several approaches to wound repair, including the use of advanced wound dressings, skin substitutes, growth factors, and regenerative medicine techniques.

However, despite decades of R&D and advances in the management of chronic wounds, they remain an under-served, yet fast growing, therapeutic area. This is partly due to the lack of comprehensive assessment and diagnostic tools and the significant time and medical resources that their management consume. However, artificial intelligence (AI) techniques are beginning to be used to help medical professionals and institutions automate wound care assessment and thereby save valuable resources. For example, KroniKare, a start-up based in Singapore, has developed the KroniKare Wound Scanner, a handheld tool that employs multi-spectral scanning techniques that can assess a chronic wound in ~30 seconds, which enables quick and accurate treatment. The scanner has been clinically validated by the Singapore government’s Health Sciences Authority as a Class-B registered diagnostic AI device.

In this Commentary

This Commentary provides a brief history of the wound reconstruction market. North America and Europe represent the largest share of the advanced wound care market, which is currently valued at ~US$11bn, growing at a CAGR of ~5.7%, and projected to reach ~US$16bn by 2028. We draw attention to the fact that the market is changing with a growing presence of the Asia-Pacific, the Middle East, and Africa and South America regions: all with vast and rapidly growing populations, expanding middle-class segments demanding enhanced wound care and governments committed to increasing their expenditures on wound healing. Traditional US MedTechs, which currently dominate the wound care market, may struggle to increase their franchises in these emerging markets due to a range of factors including regulatory complexities, unique healthcare challenges, price sensitivity, and logistical challenges. The Commentary describes several innovative wound care products and the leading corporations developing and marketing them. These offerings include growth factors and cytokines, stem cells, tissue engineering, regenerative medicine approaches, and 3D bioprinting. For each we briefly describe the main technical and clinical obstacles they need to overcome to increase their impact on the chronic wound care market. The Commentary concludes by summarising the limitations of several advanced wound care offerings and suggests reasons why, in the next decade, 3D bioprinting is likely to eclipse competing technologies and disrupt the global wound reconstruction market.

Brief history

Complex wound reconstruction is a relatively new field that has emerged over the last few decades. Advances in medical devices and clinical techniques have allowed for the successful treatment of wounds that were previously considered untreatable. In the early 1990s, the concept of wound bed preparation was introduced, which emphasized the need to prepare a wound before applying any kind of dressing or treatment. This involved removing dead tissue, and controlling infection, to promote healthy tissue growth. In the late 1990s and early 2000s, tissue engineering and regenerative medicine emerged as promising fields for complex wound healing. These focused on using biological materials, such as stem cells and growth factors, to stimulate tissue growth and regeneration.

In 1996, the US Food and Drug Administration (FDA) approved the Integra Dermal Regeneration Template, a manufactured collagen matrix with a claim of regenerative dermal tissue designed as a skin replacement, and initially used in patients with extensive burns with insufficient donor tissue for coverage. In 1998, Apligraf became the first commercially available, FDA approved, product containing living cells, to treat venous ulcers that failed to respond to conventional treatments. It is a synthetic skin created from harvested infant foreskins and produced and marketed by Organogenesis, a US corporation based in Massachusetts. In 2000, the product obtained further approval for the treatment of diabetic foot ulcers. In the years since, other products containing living cells for wound healing have gained regulatory approval and are used to treat a range of complex wounds.

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In addition to advances in technology and treatment options, there has also been a growing recognition of the importance of a multidisciplinary approach to complex wound reconstruction. This involves teams of healthcare professionals, including wound care specialists, plastic surgeons, and rehabilitation professionals, working together to develop comprehensive personal treatment plans for individual patients.

Despite these advances, the clinical assessment and management of chronic wounds remain challenging owing to their long-term treatment regimens and complex wound healing mechanism. Various conventional approaches including cell therapy, gene therapy, growth factor delivery, wound dressings, and skin grafts are being utilized to promote healing in different types of wounds. However, such therapies are not satisfactory for all wound types, which creates a need to develop newer and innovative treatments. In recent years, innovative wound healing technologies have made progress and continue to evolve. These include stem cell therapies, bioengineered skin grafts, and 3D bioprinting, which all focus on skin regeneration with minimal side effects. According to a 2023 report by Tracxn, a MedTech research platform, globally there are ~580 companies producing wound care offerings.

A fast-growing global market

Wound reconstruction is a large and rapidly growing segment of the medical technology industry. According to a 2022 Fortune Business Insights report, the global advanced wound care market is projected to grow from ~US$11bn in 2021 to ~US$16bn in 2028 at a CAGR of ~5.7% in forecast period. Its expansion is driven by several factors, including: (i) an aging global population: ~10% of the world’s ~8bn people are ≥65 years and this age group is expected to increase to ~17% by 2050. Older adults are more prone to chronic wounds due to decreased skin elasticity, poor circulation, and other factors, (ii) increasing worldwide prevalence of chronic wounds such as diabetic foot ulcers, venous leg ulcers, and pressure ulcers, (iii) advances in wound care technologies, including growth factors, stem cell therapies, biomaterials, and regenerative medicine approaches, (iv) increasing healthcare spending: governments and healthcare systems throughout the world are investing more in advanced wound care, and (v) increased public awareness of the importance of wound healing.

Significant regional markets

Advanced wound reconstruction markets vary in different regions of the world. Currently, North America is the largest, and expected to be valued at ~US$5bn by 2027, followed by Europe, which is currently valued >US$3bn with a projected 4.2% CAGR over the next four years. Here we draw attention to emerging markets of the Asia Pacific, Middle East and Africa (MEA) and South America regions.

The Asia-Pacific region has substantial growth potential particularly in India, China, and Southeast Asia. These regions have vast, aging populations, governments increasing healthcare expenditure, high incidence of chronic diseases, and a rising awareness of the importance of wound care among large and rapidly growing middle classes. In China (population >1.4bn), for instance, the wound reconstruction market is expected to grow significantly driven by: (i) an aging population - by 2040, ~402m people, (28% of the population) are expected to be >60 years, (ii) national efforts to improve healthcare infrastructure, (iii) increasing investment in medical research, and (iv) rising incidence of chronic diseases that require wound management. India (population ~1.4bn), is also a substantial potential market with a growing demand for advanced wound care solutions, increasing healthcare expenditure, and a rising number of government initiatives to improve healthcare services. Southeast Asia, which includes Indonesia (population ~280m), Malaysia (population >32m), Thailand (population >70m) and Vietnam(population ~100m), also represent significant growth potential for the wound reconstruction market.

The Middle East and Africa (MEA) region is expected to have substantial growth potential for wound healing due to increasing medical management expenditure, improving healthcare infrastructure, and a rising number of government initiatives to improve wound care. Although this region is a diverse and complex healthcare market, there are several countries within it with significant growth potential for wound care. For instance, in the Middle East, the United Arab Emirates (population ~9.5m) is a wealthy market with a rapidly developing healthcare infrastructure, increasing demand for advanced wound healing solutions, and a high prevalence of diabetes-related wounds. Saudi Arabia too is a substantial potential market, driven by a large and growing population (~36m), increasing healthcare expenditure, and rising awareness of the importance of wound care management. In Africa, South Africa (population >61m) has a large and advanced healthcare system, increasing demand for complex wound care solutions, and a high prevalence of diabetes-related wounds.

South America is expected to experience significant growth in the wound reconstruction market, driven by increasing awareness of its importance, rising demand for advanced wound recovery solutions, and a growing number of government initiatives. Several countries in the region have substantial market growth potential, including: (i) Brazil, the largest economy in the region, with a population of ~217m and high incident rates of chronic wounds, (ii) Argentina (population >46m), which has a large healthcare sector and a growing demand for advanced wound care products and services, and (iii) Colombia, with a growing economy and a large population (>52m), is emerging as a key regional player in wound care solutions and services.

Leveraging opportunities in emerging markets

Many Western MedTechs are ill equipped to leverage the opportunities in emerging regions of the world with underserved, growing advanced wound care markets. North America and Europe account for ~55% of the global medical technology market and provide the largest share of MedTechs’ revenues. It is in these wealthy regions that most company executives have spent most of their professional careers and therefore have had little or no in-country experience of emerging economies. For decades, North American and European healthcare systems rewarded medical activity rather than patient outcomes and this drove high growth rates, significant profit margins, and industry expansion without much risk or in-depth strategic thinking. Such conditions, complemented by substantial periods of low interest rates and cheap money, encouraged the financialization of the medical technology industry: companies used mergers and acquisitions (M&A) to pursue scale and consequently became bigger but not necessarily better. Today, the ten largest medical device corporations account for >40% of the sales in a global market of ~US$490bn. The market has become an oligopoly, which emphasizes size and tends to blunt competition. Although such conditions are changing and having international experience, a global mindset, and R&D knowhow are increasingly valued, there is still a significant reliance on legacy products marketed predominantly in wealthy Western nations. Even now, relatively few company leaders have had in-depth experience of emerging regions of the world, where differences in language, competition, regulations, and culture create barriers to their ability to understand and navigate the nuances of these markets.

Wound healing technologies

The development of new wound healing technologies is an area of active R&D in the medical device industry, which aim to accelerate the healing process and improve outcomes for patients. Here we provide a flavour of these.

(i) Growth factors and cytokines

A promising area of research to stimulate wound healing is the use of growth factors and cytokines. These are naturally occurring proteins in the body that play a key role in the healing process. Researchers are exploring ways to use these proteins in wound care products to promote tissue regeneration and accelerate wound repair.

There are several MedTechs with offerings in this area. UK based Smith & Nephew markets a range of wound healing products, including biologic agents that contain growth factors and cytokines. The company’s REGRANEX Gel, which contains recombinant platelet-derived growth factor s (PDGF), received FDA approval in 1997, and is used to treat diabetic neuropathic foot ulcers. Acelity, a Texas-based privately held company founded in 1976, manufactures and markets several advanced wound care products, including biologic agents that contain growth factors and cytokines. The company’s VAC VeraFlo Therapy with Prontosan, received CE Mark in 2017 and combines negative pressure wound therapy [a method of drawing out fluid and infection from a wound to help it heal] with a solution that contains cytokines and growth factors to help promote wound healing. Nasdaq traded Integra LifeSciences develops and markets wound healing products. The Integra Flowable Wound Matrix contains growth factors and is used to treat chronic wounds. Osiris Therapeutics, founded in 1993 and based in Maryland, USA, specializes in regenerative medicine and has a range of products to promote wound healing, including Grafix, a human placental membrane that contains growth factors and cytokines. NYSE traded MedTech, Stryker markets numerous advanced wound care products, including biologic agents that contain growth factors and cytokines. Its key product in this area is MIST Therapy, which is a painless, non-contact, low-frequency ultrasound treatment delivered through a saline mist containing cytokines and growth factors to promote wound healing.

Challenges
Growth factors and cytokines are proteins that are produced naturally by the body. Replicating their production in a laboratory setting can be challenging and result in high production costs and thereby limit their accessibility and affordability. Also, these molecules are quickly broken down and cleared from wound sites, which limits their effectiveness to promote healing. Developing methods to increase their stability and longevity is crucial to improving their efficacy.

While growth factors and cytokines have shown promise in preclinical studies, clinical trials have not always demonstrated consistent benefits in wound healing, and this raises some concerns about their potential for adverse effects such as allergic reactions or immune system activation. The success of these molecules in promoting wound healing depends on their ability to effectively interact with a complex network of cells in a precise and targeted manner, which can be challenging to achieve.

(ii) Stem Cells

In recent years, stem cell-based therapies for wound healing and skin regeneration have garnered much interest owing to their potential to morph into different types of cells that promote tissue regeneration and accelerate wound healing. Researchers are exploring the use of various types, such as mesenchymal stem cells (MSCs) [multipotent stem cells found in bone marrow]; adipose (body fat)-derived stem cells (ASCs), [a subset of MSCs, which can be obtained easily from adipose tissues and possess many of the same regenerative properties as other MSCs], and pluripotent stem cells (iPSCs) [cells that can develop into many different types of cells or tissues in the body]. These present the main sources of stem cells that are utilized for wound healing and skin regeneration.

While there are many products on the market, the leading MedTechs using stem cells for wound healing include Acelity, whose flagship offering is the RECELL Autologous Cell Harvesting Device, which uses patients’ skin cells to promote healing in chronic wounds and burn injuries. Organogenesis’s Apligraf, mentioned above, contains stem cells. Integra LifeSciences’s Dermal Regeneration Template, also mentioned above, is a matrix of bovine collagen and glycosaminoglycan molecules that contains autologous stem cells [stem cells removed from a person, stored, and later given back to the same person] to promote tissue regeneration. And Smith & Nephew’s PICO Single Use Negative Pressure Wound Therapy System, which uses a proprietary dressing with stem cells to promote healing in chronic wounds.

Challenges
Despite stem cell-based therapies being common and effective for the promotion of wound healing, there are challenges associated with their source, genetic instability, potential immunogenicity, risks of infection and carcinogenesis and high processing costs. Stem cells are a complex and heterogeneous population of cells that are sensitive to their environment, and replicating their production in a laboratory can be technically demanding and costly. They have the potential to differentiate into various cell types and promote tissue regeneration, but if not appropriately controlled, they can form tumours. Developing methods to ensure the safety and efficacy of stem cell-based therapies and minimising the risk of tumour formation are crucial to their future impact on the wound care market.

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(iii) Tissue engineering

Tissue engineering is another approach being explored for wound healing. This involves a combination of cells, engineering, materials, methods, and suitable biochemical and physicochemical factors to restore, maintain, improve, or replace different types of biological tissue. Researchers have developed tissue-engineered skin substitutes that can be used to promote wound healing and tissue regeneration in patients with chronic wounds. Leading MedTechs with advanced products in this area include Acelity, Organogenesis, Integra LifeSciences and Smith and Nephew.

Challenges
There are non-trivial challenges associated with the production and maintenance of functional and viable tissue engineered constructs in a laboratory setting. The technology requires the growth of cells on scaffolds or matrices that mimic the extracellular matrix of the target tissue. The process of creating these involves multiple steps, including cell isolation, seeding, differentiation, and integration with the host tissue. Ensuring the quality and functionality of these constructs is demanding, and replicating such processes in a large-scale production setting is time consuming and costly. Another technical challenge is the need for a vascular network to support the growth and survival of the engineered tissue. The lack of blood vessels can limit the delivery of oxygen and nutrients to the cells within the tissue construct, which can result in cell death and impaired tissue function. Developing methods to vascularize tissue constructs and integrate them with the host vascular system is crucial to the success of tissue engineering in wound reconstruction. Clinical success depends on offerings not being rejected by a patient’s immune system and being able to integrate with a complex network of cells in a precise and targeted manner, which can be difficult to achieve.

(iv) Regenerative medicine approaches

Regenerative medicine approaches such as platelet-rich plasma (PRP) and extracellular matrix (ECM) are being developed for their potential to promote wound healing. The former is an autologous biological product containing higher amounts of platelets [small cells that circulate within your blood and bind together when they recognize damaged blood vessels]. Compared to circulating blood, PRP contains an increased concentration of growth factors, which is a prerequisite for wound healing. The approach involves isolating platelets from a patient's blood, which, when introduced into a wound has the potential to stimulate and accelerate tissue healing. In recent years, PRP has attracted a lot of research attention.

ECM is an extensive three-dimensional scaffold made from natural or synthetic materials that provides structural integrity and can be used to promote tissue regeneration and accelerate wound healing. Because of the nature of chronic wounds, recovery is reduced by a lack of functional ECM in the dermal matrix, which is responsible for stimulating healing. The restoration of functional ECM in wounds contributes to their reconstruction and closure. Both PRP and ECM technologies show promise in promoting tissue regeneration.

MedTech leaders in this field include Osiris, Terumo, Stryker and Zimmer Biomet. Osiris Therapeutics specializes in regenerative medicine approaches for wound healing, including ECM products. Grafix, the company’s key offering, is a cryopreserved placental membrane product that is designed to promote tissue regeneration in chronic wounds. Terumo, a Japanese corporation founded in 1921, opened its first overseas office in the US in 1971 and subsequently became a global player. The company is now a leader in blood management technologies and offers a range of products specializing in wound healing, including PRP systems. Its main offering, the Terumo BCT COBE Spectra Apheresis System, is used to collect and process blood components, including platelets, for use in wound healing. Stryker’s flagship ECM product is the MatriStem UBM Wound Matrix, which is derived from porcine urinary bladder tissue and is designed to promote tissue regeneration in chronic wounds. Zimmer Biomet is a global leader in musculoskeletal healthcare and offers a range of products for wound healing, including PRP systems. Its principal product is the EBI Bone Healing System, which is used to promote healing in fractures and other musculoskeletal injuries.

Challenges
Regenerative medicine approaches for wound healing require an in-depth understanding of the underlying mechanisms of tissue regeneration, which is complex. A precise understanding of multiple signaling pathways, cell types, and extracellular matrix components are crucial, and how these interact is fundamental to the development of effective therapies. For regenerative medicine treatments to be successful they need appropriate delivery of cells, growth factors, and other biological molecules to the site of injury. Achieving this requires a careful consideration of the biological and physical factors at play, which can be challenging.

(v) Three dimensional (3D) bioprinting

In recent years, three dimensional (3D) bioprinting has emerged as a rapid and high throughput automated technology that significantly reduces the limitations of other wound healing and regenerative medicine technologies that depend on manual processes and are hindered by the time it takes for them to reconstruct large chronic wounds. 3D bioprinting is an automated process that allows for the creation of three-dimensional structures using living cells and biomaterials. It involves the layer-by-layer deposition of bio-inks, which contain living cells and other biological components, using a specialized printer. The resulting structures can then be implanted into the body to promote tissue regeneration and wound healing. Advances in the technology have led to the development of more complex tissue constructs, such as skin, bone, and cartilage. In the near to medium term, 3D bioprinting has the potential to eclipse established and evolving wound healing technologies and disrupt the advanced wound care market.

Centres of excellence

There are several scientists, institutions, and start-ups, which have made significant contributions to the field of complex wound reconstruction using bioprinting. Here we mention a few. A pioneer in the area is Anthony Atala, founding Director of the Wake Forest Institute for Regenerative Medicine, which is part of the Wake Forest School of Medicine in North Carolina, USA. The Institute is a world-renowned centre of excellence for research in 3D bioprinting and wound healing. Professor Atala, a bioengineer, urologist, and pediatric surgeon, is recognized for his work in the area. One of Atala’s most notable contributions is the development of the first 3D bio printed human bladder, which he created using a combination of patient cells and biomaterials and then successfully implanted the constructs into several patients with bladder disease. Atala’s pioneering work in 3D bioprinting has paved the way for new treatments and therapies for patients suffering from complex wounds and tissue damage.

The Advanced Regenerative Manufacturing Institute (ARMI) located in Manchester, New Hampshire, USA, is a public-private partnership with a specific focus on 3D bioprinting research and has developed innovative techniques to create living tissues and organs. ARMI collaborates with academic institutions, government agencies, and industry partners to accelerate the translation of 3D bioprinting research into clinical applications. Another leading institution is the Tissue Engineering and Regenerative Medicine International Society (TERMIS), which is a global organisation that aims to promote research, education, and clinical translation in the field of tissue engineering and regenerative medicine. It has >50 chapters worldwide and organises annual conferences to bring together experts in the field. TERMIS plays a significant role in advancing 3D bioprinting research by providing a platform for collaboration and knowledge exchange.

One example of a start-up specializing in advanced wound care that is using 3D bioprinting is Pandorum Technologies, founded in 2011 and based in Bengaluru, India. Its flagship offering CorneaGen, is a 3D-bioprinted cornea that can be used to replace damaged or diseased corneas in patients. The cornea is made up of a bio ink composed of corneal cells and hydrogels that mimic the natural extracellular matrix of the cornea. The company has also developed a bio printed skin that can be used for wound healing research and drug development. It is composed of layers of living cells that mimic the structure and function of human skin. Pandorum has R&D initiatives in India and in the US located in the Medical University of South Carolina (MUSC) at Charleston and MBC BioLabs, in the San Francisco Bay Area, USA.

Challenges
The success of 3D bioprinting depends on its ability to create structures that can support the growth and differentiation of cells into functional tissue. Identifying and developing biomaterials that can mimic the extracellular matrix of the target tissue, while providing the necessary mechanical and biological cues to support cell growth is technically demanding. The process of 3D bioprinting involves the deposition of multiple layers of cells and biomaterials to create a three-dimensional structure. Achieving the desired geometry and spatial organisation of these layers can be challenging and requires precise control over the printing process. A challenge for the technology regarding wound healing is the time it takes to obtain autologous cells to fabricate skin constructs for patients with extensive burn wounds, which require rapid treatment.

Can 3D bioprinting disrupt the advanced wound care market?

Although it is difficult to predict the future of any technology with certainty, it seems reasonable to suggest that 3D bioprinting could become the dominant technology in the field of advanced wound reconstruction in the next decade. Bioprinting has several advantages over other technologies, briefly described in this Commentary, and currently used in wound reconstruction. Traditional methods such as skin grafting and tissue engineering using scaffolds, have limitations in terms of their ability to produce complex tissue structures and patient-specific treatments. 3D bioprinting, on the other hand, allows for precise control over the placement of cells and biomaterials, and can produce highly complex and customized tissue constructs. The technology is rapidly advancing, and new developments are being made at an unprecedented rate. Researchers are continuously developing new biomaterials, improving the resolution and speed of bioprinters, and exploring new applications. 3D bioprinting appears to have the potential to meet the large and growing demand for advanced wound reconstruction by allowing for the creation of customized tissue constructs tailored to the specific needs of individual patients. Further, it can reduce the need for multiple surgeries and treatments, improve patient outcomes and reduce healthcare costs.

Takeaways

Over the next decade, advanced wound care markets are expected to grow and change due to the increasing influence of the purchasing power in emerging regions of the world and advances in technology. While wealthy North America and Europe, with ~14% of the global population, will continue to be commercially significant for the medical device industry, the Asia-Pacific, MEA, and South America regions, where >80% of the world’s population live, are likely to become important wound care markets because of the growing incident rates of chronic conditions and related wounds requiring treatment, expanding middle classes demanding improved care and governments’ commitment to enhancing their healthcare systems.

While it is unlikely that non-bioprinting technologies will disappear from the field of complex wound reconstruction, there are several reasons, which we have briefly described, why they are likely to have a reduced influence on the market as it evolves over the next decade. By contrast, the advantages offered by 3D bioprinting, combined with the rapid pace of its R&D, the growing demand for personalized affordable treatments in emerging economies, and the universal need to reduce healthcare costs, suggest that the technology is well positioned to disrupt the advanced wound care market in the next decade.

Will traditional MedTechs with wound care franchises be agile enough to benefit from these new market and technology opportunities?

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Healthcare disrupters

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MedTech growth strategies have taken advantage of low interest rates and cheap money to debt finance acquisitions of near adjacent companies with existing tried and tested products
This allowed companies to expand their product portfolios, geographic reach, and customer bases
Many MedTechs preferred such a growth strategy to investing in R&D to develop disruptive technologies that maybe outside their immediate field of interest
These technologies include 3D bioprinting, robotics, virtual reality, biometric devices and wearables, digital therapeutics, and telemedicine
All are patient-centric software driven technologies rather than hardware devices that serve the needs of hospitals
All are positioned to influence the shape of healthcare systems over the next decade
Many MedTech R&D investments are devoted to making small improvements to legacy products that prioritize the interests of large healthcare organizations over the needs of patients
Traditional MedTech M&A-driven growth strategies that have benefitted from an era of low interest rates and cheap money may now be challenged in the current period of higher interest rates, stagnate growth and rapidly evolving disruptive healthcare technologies.

Healthcare disrupters

On March 10, 2023, the Silicon Valley Bank (SVB) collapsed after a series of ill-fated investment decisions triggered a run on its assets. It was the largest bank failure since the 2008 financial crisis and the second largest in US history. The demise of SVB triggered a subsequent free fall in the shares of the Silvergate Bank, the Signature Bank, and the First Republic Bank. Then, on March 17, Credit Suisse shares crashed. Despite a US$54bn lifeline from theSwiss National Bankon March 19, the bank collapsed and was ‘acquired’ by UBS for ~US$3bn. This banking crisis could create a weakness in corporate balance sheets more generally. Especially in MedTechs that have borrowed heavily in an era of low interest rates and cheap money, and now might be challenged by higher rates, economic stagnation, and rapidly advancing software driven healthcare technologies. These include, 3D bioprinting, robotics, virtual reality (VR), biometric devices and wearables, digital therapeutics, and telemedicine. All are positioned to influence the shape of healthcare over the next decade by: (i) changing the way healthcare is delivered, (ii) improving patient outcomes, (iii) lowering healthcare costs, (iv) increasing access to care, and (v) creating new business models as value shifts from hardware to software. Should the banking collapse be a warning to traditional MedTechs whose preferred growth strategies have been debt financed acquisitions of near adjacent companies with physical product offerings optimised for hospitals?

In this Commentary

This Commentary explores the potential vulnerability of some MedTechs that have taken advantage of the recent period of low interest rates and cheap money to pursue growth strategies dominated by the acquisition of near adjacent companies, and have not balanced this with investments in innovative technologies. These may not fit neatly into their existing product portfolios and business models but are positioned to have a significant influence on the medical technology industry and healthcare systems over the next decade. Such technologies include: 3D bioprinting, robotics, virtual reality (VR), biometric devices and wearables, digital therapeutics, and telemedicine. Before describing these, we briefly outline the causes of the recent banking crisis and suggest how it might signal a weakness in corporate balance sheets more generally.

The demise of SVB

Founded in 1983, headquartered in Santa Clara, California, USA, SVB was the preferred bank of the large and rapidly growing tech sector, and it quickly grew to become the 16^th largest bank in America. Tech companies used SVB to hold their cash for payroll and other business expenses, which resulted in a significant inflow of deposits. Banks only keep a portion of such deposits as cash and invest the rest. Like many other banks, SVB invested billions in long-dated US government bonds. [Bonds are debt obligations, where an investor loans a sum of money (the principal) to a government or company for a set period, and in return receives a series of interest payments (the yield). When the bond reaches its maturity, the principal is returned to the investor]. Bonds have an inverse relationship with interest rates; when rates rise, bond yields and prices fall. During the past decade of historically low interest rates, bonds became a preferred investment vehicle. SVB’s problem arose when central banks throughout the world increased rates to curb inflation, partly caused by the hike in energy prices following the Ukraine war. For instance, in 2022, the American Federal Reserve raised interest rates seven times; from ~0 to 4.5%. As interest rates rose, SVB’s large bond portfolio lost money and the bank was forced to sell its bonds at a loss. On March 8, SVB announced a US$1.75bn capital raise to plug the gap caused by the sale of its loss-making bonds. This alerted customers to SVB’s financial challenges. They started withdrawing their deposits, which triggered a run on the bank.

MedTech growth strategies

Sudden hikes in interest rates may sound alarm bells for some traditional MedTechs that have pursued debt financing to acquire near adjacent companies rather than invest in R&D to develop disruptive technologies and innovative offerings. While R&D is a critical component of the industry, it is a complex and costly process, which often takes years to yield a product that can be marketed and generate revenue. By contrast, M&A activity allows companies to acquire existing products and technologies that have already been developed and tested, which reduces the risk and uncertainty of R&D. Further, with the industry becoming increasingly competitive, MedTechs need to achieve scale and market share to remain relevant. This can be achieved by the acquisition of near adjacencies, which allows acquirers to quickly expand their product portfolios, geographic reach, and customer base.

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The recent era of low interest rates and cheap money reinforced debt financed acquisitions as a growth strategy. Between 2011 and 2021, there were 2,365 M&A deals in the MedTech industry globally. However, to the extent that MedTechs focussed their acquisitions on near adjacencies, they may have missed out on acquiring innovative technologies positioned to reshape the industry over the next decade. This is because disruptive technologies often come from outside a company's core business and may not be immediately obvious to its leaders. Further, indebted companies facing high interest rates, might feel obliged to increase their revenues, which could result in them doubling down on cost cutting and optimizing their legacy products rather than investing in innovative R&D to drive revenue growth. Companies that adopt such business models could be at risk of having a dearth of technologies to drive future growth in a significantly more competitive healthcare ecosystem and challenging financial markets.

Disruptive technologies

The disruptive technologies we mention above shift the needle from hardware to software, from the needs of organizations to the needs of patients. While most of these are in their infancy, they all have the potential to transform healthcare in the next decade by providing new treatments for a variety of diseases and injuries, advancing drug development, enabling personalized medicine, reducing healthcare costs and improving medical training and surgical procedures. Let us explore these in a little more detail.

3D bioprinting

Three dimensional (3D) bioprinting is a relatively new technology, which involves the creation of 3D structures using living cells and holds promise for the future of regenerative medicine. The technology is an additive manufacturing process like 3D printing, which uses a digital file as a design to print an object layer by layer. However, 3D bioprinters print with cells and biomaterials, creating organ-like structures that let living cells multiply.

In 1999, a group of scientists at the Wake Forest Institute for Regenerative Medicine led by Anthony Atala, a bioengineer, urologist, and pediatric surgeon, created the first artificial organ with the use of bioprinting. Soon afterwards, bioprinting companies like Cellink (Sweden), Allevi (Italy), Regemat (Spain), and RegenHU (Switzerland) evolved. In 2010, Organovo, a biotech company founded in 2007 and based in San Diego, California, USA, introduced the first commercial bioprinter capable of producing functional human tissues that mimic key aspects of human biology and disease. In 2014, the company was the first to successfully engineer commercially available 3D-bioprinted human livers and kidneys. In 2019, researchers at Rensselaer Polytechnic Institute, New York, USA developed a way to 3D bioprint living skin, complete with blood vessels. Also in 2019, researchers at Tel Aviv University in Israel announced the creation of a 3D bioprinted heart using a patient's own cells. Today, 3D bioprinting is used to create a wide range of tissues and organs, including skin, bone, cartilage, liver, and heart tissue.

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One of the most promising applications of 3D bioprinting is the creation of replacement organs using a patient's own cells. This could potentially eliminate the need for organ donors and reduce the risk of rejection. The technology also can be used to create complex tissues and structures, such as blood vessels, skin, and bone, which could be useful for patients with severe burns or injuries, as well as those with degenerative diseases. Further, 3D bioprinting can be used to create realistic models of human tissues for drug development and testing, which could help to reduce the cost and time associated with drug development, as well as reduce the need for animal testing. 3D bioprinting could enable the creation of customized implants and prosthetics that are tailored to a patient's unique anatomy.

According to findings of a 2023 report by MarketsandMarkets, in 2022, the global 3D bioprinting market was ~US$1.3bn, and expected to grow at a compound annual growth rate (CAGR) of ~21% and reach >US$3bn by 2027.

Robotics

Medical and surgical robotics have a relatively short history. The first robot-assisted surgical system, the PUMA 560, [Programmable Universal Machine for Assembly], was developed in 1985 by the engineering firm Unimation, and used to perform a neurosurgical biopsy. A decade later, in 1994, the FDA approved the first robotic system for laparoscopic surgery, the Automated Endoscopic System for Optimal Positioning (AESOP), which was superseded in 2001 by the ZEUS Robotic Surgical System. In the late 1990s and early 2000s, researchers began exploring miniature in vivo robots for minimally invasive procedures. In 2000, the first robotic system designed for spinal surgery, SpineAssist, was developed by Mazor Robotics, an Israeli company, which Medronic’s acquired in 2018. In the mid-2000s, researchers began developing robots for use in orthopaedic surgery. Perhaps the biggest influence on robotic surgery was made by Intuitive Surgical, an American company founded in 1995. Intuitive developed the da Vinci Surgical System, which was approved by the FDA in 2000 and quickly became the most widely used surgical robot in the world. It has been used in millions of procedures across a wide range of specialities. Today, Intuitive Surgical is a Nasdaq traded company with a market cap of >US$84bn, annual revenues >US$6bn and >12,000 employees.

Medical and surgical robotics continue to evolve, with new technologies and applications being developed all the time. Such technologies offer the potential for more precise, efficient, and less invasive procedures, reduced operating times, improved accuracy, and fewer surgical complications. Demand for surgical robotics is increasing as are investments in robotic surgery companies and an increasing number of hospitals around the world are investing in robots. In the US, >250 hospitals use surgical robots for complex operations. Europe has also seen an increase in the number of hospitals that utilize robots for medical purposes. In 2016, there were over 7,000 medical robots in use globally, today there are >20,000.

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According to a Verified Market Research report, in 2021 the global market for medical robots was ~US$11bn and is expected to reach ~US$35bn by 2030. Scientists are developing the next generation of microbots, which are small enough to seamlessly travel through the human body performing repairs.

Virtual reality

The use of virtual reality (VR) in healthcare has been growing rapidly in recent years, but its history only dates from the early 1990s, when the first VR applications in healthcare focused on pain management and distraction therapy. In the late 1990s and early 2000s, researchers began exploring the use of VR for a wider range of medical applications, including surgical simulation, medical education, and mental health therapy. In recent years, the technology has been used in pain management, physical therapy, treatment of phobias and anxiety disorders, and to improve quality of life for hospice patients. During the Covid-19 pandemic, VR was used to help healthcare workers train for and cope with the challenges of the pandemic, as well as to provide virtual healthcare visits to patients who were unable to receive in-person care.

VR healthcare start-ups have attracted attention from major players. For example, in February 2020, Medtronic acquired UK start-up Digital Surgery for >US$300m. Founded in 2013 by two former surgeons, Digital Surgery first made waves with an app to help train surgeons using a database of common procedures. It also developed VR software to train doctors as well as AI tools for surgeons in the operating room. OxfordVR is also a British VR start-up. Founded in 2017 by Daniel Freeman, Professor of Clinical Psychology at Oxford University, the company is focused on mental health applications and has successfully automated psychological therapy. Users are guided by a virtual coach instead of a real-life therapist, which allows the treatment to reach significantly more patients. Another notable VR start-up is Firsthand Technology, founded in 2016 and headquartered in California, USA. The company's flagship product is a VR distraction therapy (VRDT) that offers immersive experiences designed to distract patients from the discomfort and anxiety associated with medical procedures. The company's offerings demonstrate the importance of addressing the psychological and emotional factors that impact health and well-being. In January 2020, Pear Therapeutics, a leader in digital prescriptions acquired Firsthand.

Over the next decade, expect VR to improve medical/surgical training by providing immersive, realistic simulations for medical students and health professionals, allowing them to practice procedures and techniques in a safe and controlled environment. In addition to helping patients to reduce pain and anxiety during medical procedures, VR can help to overcome barriers to care, such as distance and mobility, by providing virtual healthcare visits and remote monitoring of patients. Also, the technology is positioned to improve surgical planning. By providing surgeons with 3D models of patients' anatomy, allowing for more precise surgical planning, and reducing the risk of complications. Further, it can be used in physical therapy to improve patient engagement and motivation, leading to faster recovery times.

According to a 2021 Verified Market Research report, the VR healthcare market was valued at ~US$3bn in 2019, and is projected to reach ~US$57bn by 2030.

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Biometric devices and wearables

Biometric devices and wearable technologies aim to empower people with granular data that leads to actionable healthcare insights. It gives people the ability to collect their own health data and report them in a digital format to physicians, thus eliminating the need for in-person appointments for simple check-ups. Insurers and providers have also bought into wearable devices, relying on data collected from them to inform personalized health plans. Corporations too have adopted them to encourage healthy habits among employees working from home.

The use of biometric devices and wearables in healthcare has a relatively short, but influential history. In the early 2000s, the first commercial monitors were introduced, which allowed athletes to track their heart rates during exercise. The technology can provide a wealth of data about a patient's health, allowing healthcare providers to tailor treatment plans to individual patients, monitor chronic disorders, detect changes in real-time and intervene expeditiously. Biometric devices and wearables can help to detect early signs of illness or disease and can help patients to take a more active role in their own health and wellness. The technology has the potential to reduce the cost of care by enabling remote monitoring, preventing hospital readmissions, and reducing the need for in-person visits. Further, it can provide researchers with large amounts of patient data to facilitate AI-driven research into disease prevention and treatment.

One successful biometric device company is Fitbit, which was founded in 2007 and is headquartered in San Francisco, California, USA. Fitbit offers a range of wearable devices that track physical activity, heart rate, sleep patterns, and other biometric data. The company’s products include smartwatches, activity trackers, and wireless headphones that integrate with its mobile app and web-based platform to provide users with personalized health and fitness insights. The company has developed partnerships with insurers and healthcare providers to use its products as part of employee wellness programmes. Since its founding, the company has sold >120m devices. In 2019, Fitbit was acquired by Google for US$2.1bn, which is a testament to the value of biometric data and the potential of wearables to transform healthcare.

The Apple Watch is the other market leader. Its first edition, launched in 2010, included features for tracking physical activity, heart rate, and other health metrics. An upgraded version, released in April 2015, helped to establish the health tracking market, which led to the mass adoption of wearable technologies. From the outset, the Apple Watch was conceptualized as a device that would help people stay connected in less invasive ways than with smartphones. Each iteration since its inception has increased the watch’s focus on improving health and wellbeing. In 2018, it was approved by the FDA as a medical device capable of alerting users to abnormal heart rhythms. Today there are ~150m Apple Watch users.

Another leader in the wearable sensor market is Abbott Laboratories, which provides a range of services for diabetes and cardiology. In November 2018, the company received FDA clearance for its FreeStyle Libre, a glucose reader smartphone app. Oura Health, a Finnish company founded in 2013, has launched a health wearable product in the form of a small ring that tracks activity, heart rate, body temperature, respiratory rate, and sleep data. As the technology continues to evolve, biometric devices and wearables are likely to play an increasing role in healthcare by helping people to participate in their own health and wellness, improving medical outcomes, and reducing healthcare costs.

According to findings from a 2019 ResearchandMarkets report, the wearable health technology industry is projected to see a CAGR >25% between 2020-2027, and annual sales are expected to reach ~US$60bn by 2027.

Digital Therapeutics

Digital therapeutics (DTx) are software-based interventions that aim to prevent, manage, or treat medical conditions by modifying patients’ behaviours. The therapeutics are delivered through mobile apps, virtual reality, or digital platforms. Their use in healthcare is growing, and the history of DTx can be traced back to the late 1990s when the first digital intervention for substance abuse was developed. In the early 2000s, a few digital interventions were introduced to manage chronic conditions such as diabetes and hypertension. However, it was not until the 2010s when the use of DTx started to gain momentum, driven by technological advances, the growing prevalence of chronic diseases, and the need for more cost-effective healthcare solutions.

In the November 2020 edition of Scientific America, DTx were ranked in the top-10 emerging technologies, which have demonstrated an ability to prevent and treat a variety of chronic conditions. In September 2017, Pear Therapeutics’ digital software programme, reSET, became the first FDA-approved DTx for substance use disorders (SUD) involving alcohol, cocaine, marijuana, and stimulants. According to the US Centers for Disease Control and Prevention (CDC) >40m Americans, ≥12 years presented with SUDs in 2022. In 2020, Pear received FDA clearance for Somryst, an insomnia therapy app. The company has a pipeline of DTx offerings for a wide range of conditions, including multiple sclerosis, epilepsy, post-traumatic stress disorder and traumatic brain injury. In 2020, the FDA approved EndeavorRx, which is produced by Boston based Akili Inc and is the first DTx delivered as a video game for children with attention deficit hyperactivity disorder (ADHD). Omada Health, is another digital therapeutics start-up, founded in 2011 and headquartered in California, USA, which provides personalized coaching and support to individuals with chronic health conditions.

Given that DTx are evidence-based and personalized, they can be tailored to meet the unique needs of each patient. This individualized approach can lead to enhanced patient outcomes and improved quality of life. DTx are often more cost-effective than traditional therapies, as they eliminate the need for in-person visits and reduce the need for expensive medications. This could help to lower healthcare costs. Digital therapeutics can be accessed from anywhere, any time and on any device, making them particularly useful for patients in remote or underserved regions. This could help to improve access to healthcare for millions of people. DTx can be integrated with other healthcare technologies, such as wearables, mobile health apps, and electronic health records, to provide a comprehensive approach to healthcare. This could lead to improved coordination of care and better health outcomes. Further, DTx could bring about a shift in treatment paradigms and change the way we approach chronic diseases: instead of relying solely on medications, patients could use digital therapeutics to manage their conditions and improve their overall health.

The FDA has created a new classification for digital therapeutics, which is likely to make it easier for more DTx solutions and services to obtain regulatory approval. In a 2020 survey of MedTech leaders by Deloitte, a consulting firm, 63% of respondents agreed that DTx will have a significant impact on the industry over the next 10 years. A report by Grand View Research, suggested that the global digital therapeutics market was valued at US$4.20bn in 2021, and is estimated to grow at a CAGR of ~26% from 2022 to 2030.

Telemedicine

The practice of using telecommunications and information technologies to provide remote medical services, has a history dating back to the early 20^th century. In 1924, the first radiologic images were transmitted by telephone between two towns in West Virginia, USA. In the 1950s and 1960s, the technology began to advance, and the first video consultation between a patient and a physician was conducted. In the 1970s, NASA began using telemedicine to provide medical care to astronauts in space. In 2001, the Indian Space Research Organization successfully linked large city hospitals and healthcare centres in remote rural areas. With the development of the internet in 1990s, remote healthcare exchanges became more widespread, particularly in rural areas where access to medical services were limited. In 1993, the American Telemedicine Association (ATA) was founded to promote the use of the technology. Since then, telemedicine has continued to evolve and expand.

The Covid-19 pandemic led to a surge in telemedicine usage as healthcare providers looked for ways to provide care while minimizing in-person contact. Based on a survey by McKinsey, a consulting firm; before the pandemic in 2019, ~11% of US patients used telehealth services. After COVID, that number had grown to ~50%. Some estimates suggest that during the height of the pandemic, the number of telemedicine appointments increased by 5,000%. According to McKinsey’s, 76% of US consumers report that they are interested in using telehealth in the future as a way to complement in-person physician visits.In August 2020, digital health history was made with the merger of two of the largest publicly traded virtual care companies Teladoc and Livongo. The former, a multi-billion-dollar market leader in telemedicine founded in 2002, and the latter, a multi-billion-dollar market leader in remote patient monitoring. The deal created a US$38bn entity, which was the market’s first full-stack virtual health company. Today, virtual health is a rapidly growing field, and combines virtual physician visits, remote patient monitoring, chatbots, algorithms, and analytics.

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Over the next decade, AI-powered telemedicine tools are likely to become more prevalent, helping to streamline and automate many aspects of the care delivery process, such as triage, diagnosis, and treatment plans. Remote patient monitoring technologies are likely to become more advanced and widespread, allowing healthcare providers to monitor patients’ health and vital signs remotely, which can improve outcomes and reduce hospitalizations. Expect healthcare providers to increasingly work as part of virtual care teams, collaborating with other health professionals, including specialists, to deliver care to patients in real-time, regardless of location. Telemedicine will continue to improve access to care, particularly for underserved populations such as those in rural and remote areas, and those with limited mobility or poor transportation options. The technology will also facilitate more personalized and patient-centred care, as providers will be able to tailor care plans to the specific needs and preferences of individual patients.

According to a report by MarketResearchFuture, the current global telemedicine market size is valued at ~US$67bn and is expected to reach >US$405bn by 2030, exhibiting a compound annual growth rate of >22%.

Takeaways

We have described six evolving software driven technologies positioned to significantly influence healthcare systems in the next decade. Note that all are software driven and focused on patients to make care more personalized and sensitive to specific needs of individuals. Such technologies are in stark contrast to traditional medical devices, which overwhelmingly are physical devices designed to serve hospitals, rather than individual patients. Such a focus can lead to a lack of innovation, higher costs for patients, lower quality of care, and less personalized treatment options. A shift towards technology optimized to deliver patient-centered care is necessary to improve the quality of healthcare and ensure that patients receive the best possible outcomes. From our analysis it is not altogether clear whether traditional MedTechs are well positioned to achieve this.

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