- In catheterization, a doctor can poke a hole in your leg and fix your heart.
- Radiosurgery can destroy a tumor and leave adjacent tissue untouched, touching the body only with energy.
- A doctor thousands of miles away can do surgery on you via telepresence and robotic instrumentation.
- Medical device implants like stents have been developed to simply dissolve over time.
- Doctors can see cancer via live imaging during operations to ensure that they excise it all.
- Type 1 diabetics may soon be able to so easily manage their condition, via combined insulin pump / glucometer that they may almost forget they have diabetes (or cell therapy may cure them!), while Type 2 diabetics will grow in number and cost to manage.
- Organs are already being printed, as are other tissue implants.
- Neuroprosthetics, exoskeletons and related technologies are enabling wheelchair-bound and other physically challenged people to walk upright, allowing amputees to control prosthetics with their mind,
- Almost two-thirds of the 7,000 medical device firms in the United States have fewer than 20 employees — Medtronic employs all the rest. (OK, that’s an exaggeration.)
- Science fiction continues to drive the imagination of medtech innovators. Decentralized diagnostics — very small, efficient devices in the hands of a doctor that will rapidly assist in diagnoses and expedite the process of intervention — are becoming pervasive, ideally embodied in the fictional “tricorder” in Star Trek.
Below is a table with a list of the market segments demonstrating greater than 10% compound annual growth rate for the associated region through 2022, drawn from our reports on tissue engineering & cell therapy, wound management, ablation technologies, stroke, peripheral stents, and sealants/glues/hemostats. Products with over 10% CAGR in sales are shown in descending order of CAGR.
|1||General, gastrointestinal, ob/gyn, other||tissue/cell||WW|
|3||Organ Replacement/ Repair||tissue/cell||WW|
|8||Bioengineered skin and skin substitutes||wound||Rest of A/P|
|9||Peripheral drug-eluting stents (A/P)||peripheral interventional||A/P|
|10||Peripheral drug eluting stents||peripheral interventional||RoW|
|11||Peripheral drug-eluting stents (US)||peripheral interventional||US|
|12||Negative pressure wound therapy||wound||Germany|
|13||Hydrocolloid dressings||wound||Rest of A/P|
|15||Foam dressings||wound||Rest of A/P|
|16||Growth factors||wound||Rest of A/P|
|17||Alginate dressings||wound||Rest of A/P|
|19||Bioengineered skin and skin substitutes||wound||Japan|
|20||Hemostats||sealants, glues, hemostats||A/P|
|22||Bioengineered skin and skin substitutes||sealants, glues, hemostats||US|
|23||Bioengineered skin and skin substitutes||sealants, glues, hemostats||WW|
|24||Film dressings||wound||Rest of A/P|
|25||Surgical sealants||sealants, glues, hemostats||A/P|
|26||Hydrogel dressings||wound||Rest of A/P|
|27||TAA Stent grafts||peripheral interventional||A/P|
|28||Negative pressure wound therapy||wound||RoW|
|29||Biological glues||sealants, glues, hemostats||A/P|
|32||AAA Stent grafts||peripheral interventional||A/P|
|33||Cerebral thrombectomy systems||stroke||A/P|
|34||High-strength medical glues||sealants, glues, hemostats||A/P|
|35||Carotid artery stenting systems||stroke||A/P|
|36||Cardiac RF ablation products||ablation||A/P|
|38||Peripheral venous stents||peripheral interventional||A/P|
|39||Cerebral thrombectomy systems||stroke||US|
|40||Left atrial appendage closure systems||stroke||A/P|
|41||Cyanoacrylate glues||sealants, glues, hemostats||A/P|
|42||Foam dressings||wound||Rest of EU|
|44||Cryoablation cardiac & vascular products||ablation||A/P|
|45||Bioengineered skin and skin substitutes||wound||Germany|
|46||Thrombin, collagen & gelatin-based sealants||sealants, glues, hemostats||A/P|
|47||Cardiac RF ablation products||ablation||RoW|
|48||Bioengineered skin and skin substitutes||wound||RoW|
|49||Microwave oncologic ablation products||ablation||A/P|
Source: MedMarket Diligence Reports
An important determinant of “where medicine will be” in 2035 is the set of dynamics and forces behind healthcare delivery systems, including primarily the payment method, especially regarding reimbursement. It is clear that some form of reform in healthcare will result in a consolidation of the infrastructure paying for and managing patient populations. The infrastructure is bloated and expensive, unnecessarily adding to costs that neither the federal government nor individuals can sustain. This is not to say that I predict movement to a single payer system — that is just one perceived solution to the problem. There are far too many costs in healthcare that offer no benefits in terms of quality; indeed, such costs are a true impediment to quality. Funds that go to infrastructure (insurance companies and other intermediaries) and the demands they put on healthcare delivery work directly against quality of care. So, in the U.S., whether Obamacare persists (most likely) or is replaced with a single payer system, state administered healthcare (exchanges) or some other as-yet-unidentified form, there will be change in how healthcare is delivered from a cost/management perspective.
From the clinical practice and technology side, there will be enormous changes to healthcare. Here are examples of what I see from tracking trends in clinical practice and medical technology development:
- Cancer 5 year survival rates will, for many cancers, be well over 90%. Cancer will largely be transformed in most cases to chronic disease that can be effectively managed by surgery, immunology, chemotherapy and other interventions. Cancer and genomics, in particular, has been a lucrative study (see The Cancer Genome Atlas). Immunotherapy developments are also expected to be part of many oncology solutions. Cancer has been a tenacious foe, and remains one we will be fighting for a long time, but the fight will have changed from virtually incapacitating the patient to following protocols that keep cancer in check, if not cure/prevent it.
- Diabetes Type 1 (juvenile onset) will be managed in most patients by an “artificial pancreas”, a closed loop glucometer and insulin pump that will self-regulate blood glucose levels. OR, stem cell or other cell therapies may well achieve success in restoring normal insulin production and glucose metabolism in Type 1 patients. The odds are better that a practical, affordable artificial pancreas will developed than stem or other cell therapy, but both technologies are moving aggressively and will gain dramatic successes within 20 years.
Developments in the field of the “artificial pancreas” have recently gathered considerable pace, such that, by 2035, type 1 blood glucose management may be no more onerous than a house thermostat due to the sophistication and ease-of-use made possible with the closed loop, biofeedback capabilities of the integrated glucometer, insulin pump and the algorithms that drive it, but that will not be the end of the development of better options for type 1 diabetics. Cell therapy for type 1 diabetes, which may be readily achieved by one or more of a wide variety of cellular approaches and product forms (including cell/device hybrids) may well have progressed by 2035 to become another viable alternative for type 1 diabetics.
- Diabetes Type 2 (adult onset) will be a significant problem governed by different dynamics than Type 1. A large body of evidence will exist that shows dramatically reduced incidence of Type 2 associated with obesity management (gastric bypass, satiety drugs, etc.) that will mitigate the growing prevalence of Type 2, but research into pharmacologic or other therapies may at best achieve only modest advances. The problem will reside in the complexity of different Type 2 manifestation, the late onset of the condition in patients who are resistant to the necessary changes in lifestyle and the global epidemic that will challenge dissemination of new technologies and clinical practices to third world populations.
Despite increasing levels of attention being raised to the burden of type 2 worldwide, including all its sequellae (vascular, retinal, kidney and other diseases), the pace of growth globally in type 2 is still such that it will represent a problem and target for pharma, biotech, medical device, and other disciplines.
- Cell therapy and tissue engineering will offer an enormous number of solutions for conditions currently treated inadequately, if at all. Below is an illustration of the range of applications currently available or in development, a list that will expand (along with successes in each) over the next 20 years.
Cell therapy will have deeply penetrated virtually every medical specialty by 2035. Most advanced will be those that target less complex tissues: bone, muscle, skin, and select internal organ tissues (e.g., bioengineered bladder, others). However, development will have also followed the money. Currently, development and use of conventional technologies in areas like cardiology, vascular, and neurology entails high expenditure that creates enormous investment incentive that will drive steady development of cell therapy and tissue engineering over the next 20 years, with the goal of better, long-term and/or less costly solutions.
- Gene therapy will be an option for a majority of genetically-based diseases (especially inherited diseases) and will offer clinical options for non-inherited conditions. Advances in the analysis of inheritance and expression of genes will also enable advanced interventions to either ameliorate or actually preempt the onset of genetic disease.
As the human genome is the engineering plans for the human body, it is a potential mother lode for the future of medicine, but it remains a complex set of plans to elucidate and exploit for the development of therapies. While genetically-based diseases may readily be addressed by gene therapies in 2035, the host of other diseases that do not have obvious genetic components will resist giving up easy gene therapy solutions. Then again, within 20 years a number of reasonable advances in understanding and intervention could open the gate to widespread “gene therapy” (in some sense) for a breadth of diseases and conditions –> Case in point, the recent emergence of the gene-editing technology, CRISPR, has set the stage for practical applications to correct genetically-based conditions.
- Drug development will be dramatically more sophisticated, reducing the development time and cost while resulting in drugs that are far more clinically effective (and less prone to side effects). This arises from drug candidates being evaluated via distributed processing systems (or quantum computer systems) that can predict efficacy and side effect without need of expensive and exhaustive animal or human testing.The development of effective drugs will have been accelerated by both modeling systems and increases in our understanding of disease and trauma, including pharmacogenomics to predict drug response. It may not as readily follow that the costs will be reduced, something that may only happen as a result of policy decisions.
- Most surgical procedures will achieve the ability to be virtually non-invasive. Natural orifice transluminal endoscopic surgery (NOTES) will enable highly sophisticated surgery without ever making an abdominal or other (external) incision. Technologies like “gamma knife” and similar will have the ability to destroy tumors or ablate pathological tissue via completely external, energy-based systems.
By 2035, technologies such as these will measurably reduce inpatient stays, on a per capita basis, since a significant reason for overnight stays is the trauma requiring recovery, and eliminating trauma is a major goal and advantage of minimally invasive technologies (e.g., especially the NOTES technology platform). A wide range of other technologies (e.g., gamma knife, minimally invasive surgery/intervention, etc.) across multiple categories (device, biotech, pharma) will also have emerged and succeeded in the market by producing therapeutic benefit while minimizing or eliminating collateral damage.
Information technology will radically improve patient management. Very sophisticated electronic patient records will dramatically improve patient care via reduction of contraindications, predictive systems to proactively manage disease and disease risk, and greatly improve the decision-making of physicians tasked with diagnosing and treating patients.There are few technical hurdles to the advancement of information technology in medicine, but even in 2035, infotech is very likely to still be facing real hurdles in its use as a result of the reluctance in healthcare to give up legacy systems and the inertia against change, despite the benefits.
- Personalized medicine. Perfect matches between a condition and its treatment are the goal of personalized medicine, since patient-to-patient variation can reduce the efficacy of off-the-shelf treatment. The thinking behind gender-specific joint replacement has led to custom-printed 3D implants. The use of personalized medicine will also be manifested by testing to reveal potential emerging diseases or conditions, whose symptoms may be ameliorated or prevented by intervention before onset.
- Systems biology will underlie the biology of most future medical advances in the next 20 years. Systems biology is a discipline focused on an integrated understanding of cell biology, physiology, genetics, chemistry, and a wide range of other individual medical and scientific disciplines. It represents an implicit recognition of an organism as an embodiment of multiple, interdependent organ systems and its processes, such that both pathology and wellness are understood from the perspective of the sum total of both the problem and the impact of possible solutions.This orientation will be intrinsic to the development of medical technologies, and will increasingly be represented by clinical trials that throw a much wider and longer-term net around relevant data, staff expertise encompassing more medical/scientific disciplines, and unforeseen solutions that present themselves as a result of this approach.Other technologies being developed aggressively now will have an impact over the next twenty years, including medical/surgical robots (or even biobots), neurotechnologies to diagnose, monitor, and treat a wide range of conditions (e.g., spinal cord injury, Alzheimer’s, Parkinson’s etc.).
The breadth and depth of advances in medicine over the next 20 years will be extraordinary, since many doors have been recently opened as a result of advances in genetics, cell biology, materials science, systems biology and others — with the collective advances further stimulating both learning and new product development.
See the 2016 report #290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.”
The following is drawn from “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.” Report #S290.
The need for surgical sealants, glues and hemostats is directly related to the clinical caseload and procedure volumes, as well as to the adoption of these products for multiple uses, such as the use of one product for sealing, hemostasis and anti-adhesion. It is fair to say that use of these products has become routine in the surgical suite and in other clinical locations. Procedure volumes are in turn driven by demographic forces, including global aging populations, while regulatory changes will continue to influence uptake of these products.
Source: MedMarket Diligence, LLC; Report #S290.
Fibrin sealants are made of a combination of thrombin and fibrinogen. These sealants may be sprayed on the bleeding surface, or applied using a patch. Surgical sealants might be made of glutaraldehyde and bovine serum albumin, polyethylene glycol polymers, and cyanoacrylates.
Sealants are most often used to stop bleeding over a large area. If the surgeon wishes to fasten down a flap without using sutures, or in addition to using sutures, then the product used is usually a medical glue.
The surgeon and the perioperative nurse have a variety of hemostats from which to choose, as they are not all alike in their applications and efficacy. Selection of the most appropriate hemostat requires training and experience, and can affect the clinical outcome, as well as decrease treatment costs. Some of the factors that enter into the decision-making process include the size of the wound, the amount of hemorrhaging, potential adverse effects, whether the procedure is MIS or open surgery, and others.
Active hemostats contain thrombin products which may be derived from several sources, such as bovine pooled plasma purification, human pooled plasma purification, or through human recombinant manufacturing processes. Flowable-type hemostats are made of a granular bovine or porcine gelatin that is combined with saline or reconstituted thrombin, forming a flowable putty that may be applied to the bleeding area.
Sealants and glues are terms which are often used interchangeably, which can be confusing. In this report, a medical glue is defined as a product used to bond two surfaces together securely. Surgeons are increasingly reaching for medical glues to either help secure a suture line, or to replace sutures entirely in the repair of soft tissues. Medical glues are also utilized in repairing bone fractures, especially for highly comminuted fractures that often involve many small fragments. This helps to spread out the force-bearing surface, rather than focusing weight-bearing on spots where a pin has been inserted.
Thus, the surgeon has a fairly wide array of products from which to choose. The choice of which surgical hemostat or sealant to use depends on several factors, including the procedure being conducted, the type of bleeding, severity of the hemorrhage, the surgeon’s experience with the products, the surgeon’s preference, the price of the product and availability at the time of surgery. For example, a product which has a long shelf life and does not require refrigeration or other special storage, and which requires no special preparation, usually holds advantages over a product which must be mixed before use, or held in a refrigerator during storage, then allowed to warm up to room temperature before use.
It was once quite convenient for manufacturers of deluxe medical widgets to worry only about other manufacturers of deluxe medical widgets. Manufacturers must now widen their perspective to consider current and future competition (and opportunity) from whatever direction it may come. –> Just thought I might chime in and suggest that, if you do make such widgets, it might be a good idea to maybe throw at least an occasional sidelong glance at biotech. (Most of you are, great, but some of you think biotech is too far away to compete…)
Organ Bioengineering is years away and poses little challenge to medical devices …FALSE. Urinary bladders have been engineered for pediatric applications. Bioengineered skin (the “integumentary” organ) is now routinely bioengineered for burns, chronic wounds, and other wound types. Across a wide range of tissue types (bone, cardiac, smooth muscle, dermal, etc.) scientists — clinicians — have rapidly developed technologies to direct the construction and reconstruction of these tissues and restore their structure and function.
Cell Biology. Of course cells are engineered into tissues as part of the science of tissue engineering, but combine this with advances in engineering not just between cells but between cells AND within cells and (…sound of my head exploding). With the sum of the understanding and capacity to control we have gained over cellular processes over the past few decades now rapidly accelerating, medical science is fast approaching the point at which it can dictate outcomes for cell, tissues, organs, organ systems, and humans (I am not frightened, but excited, with caution). Our understanding and proficiency gained in manipulating processes from cell division to pluripotency to differentiation to senescence to death OR NOT has profound consequences for fatal, debilitating, incurable, devastating, costly, and nearly every other negative superlative you can conceive.
CRISPR*: This is a new, relatively simple, but extraordinary tool allowing researchers or, more importantly, physicians to potentially swap out defective genes with healthy ones. See Nature.
(* clustered regularly interspersed short palindromic repeats)
Biotech has, over its history, often succeeded in getting attention, but has had less success justifying it, leaving investors rudely awakened to its complexities. It has continued, however, to achieve legitimately exciting medical therapeutic advances, if only as stepping stones in the right direction, like mapping the human genome, the development of polymerase chain reaction (“PCR”), and biotech-driven advances in molecular biology, immunology, gene therapy, and others, with applications ripe for exploitation in many clinical specialties, Sadly, the agonizing delay between advanced and “available now” has typically disappointed manufacturers, investors, clinicians and patients alike. CRISPR and other tools already available (see Genetic Engineering News and others) are poised to increase the expectations – and the pace toward commercialization – in biotechnology.
Vaccines and Infectious Disease: Anyone reading this who has been under a rock for lo these many years, blissfully ignorant of SARS, Ebola, Marburg, MRSA, and many other frightening acronyms besides HIV/AIDS (more than enough for us already) should emerge and witness the plethora of risks we face (and self-inflict through neglect), any one of which might ultimately overwhelm us if not medically then economically in their impacts. But capitalists (many altruistic) and others have come to the rescue with vaccines such as for malaria and dengue-fever and, even, one for HIV that is in clinicals.
Critical Mass, Synergies, and Info Tech. Biotechnology is succeeding in raising great gobs of capital (if someone has a recommended index/database on biotech funding, let me know?). Investors appear to be
forgetful increasingly confident (in the 1990s, I saw big layoffs in biotech because of ill-advised investments, but that was then…) that their money will result in approved products with protected intellectual property and adequate reimbursement and manageable costs in order to result in attractive financials. The advances in biological and medical science alone are not enough to account for this, but such advances are almost literally being catalyzed by information technologies that make important connections faster, yielding understanding and new opportunities. The net effect of individual medically-related disciplines (commercial or academic) advancing research more efficiently as a result of info tech and info sharing/synergies between disciplines is the expected burst of medical benefits ensuing from biotech. (Take a look also at Internet of DNA.)
Below are technologies under development at startups recently identified and included in the Medtech Startups Database.
- Breast cancer detection.
- Technologies in cardiac surgery, neuromodulation, and cardiac rhythm management.
- Technologies for minimally invasive laminoplasties, foraminoplasties, and implantables in spine surgery.
- Xenogenically-sourced tissue matrices for soft tissue, regenerative, and vascular applications.
- Device to clean trocar during laparoscopic procedures.
- Pressure sensors in catheterization/angiography.
For a comprehensive listing of the technologies under development at startups identified since 2008, see link.
In our flurry of activity in October, we overlooked summarizing the new medical technologies identified at startups and added to the Medtech Startups Database:
- Neodymium vaginal dilator for treatment of pelvic pain.
- Large bore, power injection vascular access
- Surgical instruments for use in bariatrics.
- Surgical oncology.
- Spine surgical technology including expandable intervertebral cage.
- Technologies to treat hearing loss.
- Device to determine blood vessel size.
- Cerebrospinal fluid shunt.
- Focused ultrasonic surgical devices for hemostasis, cauterization, and ablation.
- Collagen polymers to create 3D tissue systems for drug discovery, engineered tissue/organ, wound management, and 3D bioprinting.
- Regenerative medicine to treat brain injury or damage.
- Neuro-monitoring and neuro-critical care.
- Orthomusculoskeletal implants.
- Devices and methods for hip replacement
- Intraoperative image system.
- Exocentric medical device
- Electro-hydraulic generated shockwave for cosmetic, medical applications.
For a historical listing of technologies at medtech startups, see link.
From 2010 to present (Oct 2015), as included in the Medtech Startups Database, MedMarket Diligence identified 442 new (under one year old) medical technology startups whose businesses encompass, alone or in combination, medical devices, diagnostics, biomaterials, and the subset of both biotech and pharma that is in direct competition with medical devices, including tissue engineering and cell therapy. Of these, 74% were founded in the U.S., 5% were founded in Israel, and the rest were founded in 18 other countries.
Companies in the database have been categorized by clinical and/or technology area of focus, with multiple categories possible (e.g., minimally invasive and orthomusculoskeletal and surgery). Below is the composition of the companies identified from Jan. 2010 to Oct. 2015.
Source: Medtech Startups Database
Below is a graphic on the companies by country. The U.S. (not shown) led with 327 companies.
Source: Medtech Startups Database
In the U.S., the breakdown by state, other than California and its 466 companies (excluded only to show states with significantly lower numbers), is as follows:
Source: Medtech Startups Database
The growth in sales of a medical technology is dictated by a unique combination of a specific technology in a specific clinical application in a specific geographic market.
In the Smithers Apex report, “The Future of Tissue Ablation Products to 2020“, the markets for the different ablation technology types were assessed per application in each of the major world geographies. See the groupings, below:
Ablation Types and Clinical Applications:
- External Beam Radiation Therapy (EBRT)
- LINAC Systems
- Cardiac & Vascular
- Oncologic Surgery
- GYN Surgery
- Dermal/Cutaneous Surgical
- Ophthalmic (Cataract) Surgical
- Multipurpose Surgical
- Urologic Surgical
- Multipurpose High Intensity Focused Ultrasound (HIFU)
- United States & Other Americas
- Largest Western & European States
- Major Asian States
- Rest of World
The Smithers Apex report contains the detailed assessment of ablation technology sales in each combination of technology, geography and clinical application. Below is illustrated graphically, sorted by compound annual growth rate in sales, each of the combinations.
Growth of Ablation Technologies by Clinical Application and Geography, 2014-2020
Source: Smithers Apex