- 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.”
Below, after the categories of cardiovascular procedures, are the comprehensive listings of the surgical and interventional procedures in the management of cardiovascular disease represented in the MedMarket Diligence Report #C500, which also analyzes the clinical practice patterns, trends, and the impact on medical device sales and the impact of new medical device introductions during the forecast period, addressing each major area of surgical and interventional cardiovascular medicine:
Surgical and Interventional Procedures Covered:
- Coronary artery bypass graft (CABG) surgery
- Coronary angioplasty and stenting
- Lower extremity arterial bypass surgery
- Percutaneous transluminal angioplasty (PTA) with and without bare metal and drug-eluting stenting
- Peripheral drug-coated balloon angioplasty
- Peripheral atherectomy
- Surgical and endovascular aortic aneurysm repair
- Vena cava filter placement
- Endovenous ablation
- Mechanical venous thrombectomy
- Venous angioplasty and stenting
- Carotid endarterectomy
- Carotid artery stenting
- Cerebral thrombectomy
- Cerebral aneurysm and AVM surgical clipping
- Cerebral aneurysm and AVM coiling & flow diversion
- Left Atrial Appendage closure
- Heart valve repair and replacement surgery
- Transcatheter valve repair and replacement
- Congenital heart defect repair
- Percutaneous and surgical placement of temporary and permanent mechanical cardiac support devices
- Pacemaker implantation
- Implantable cardioverter defibrillator placement
- Cardiac resynchronization therapy device placement
- Standard SVT & VT ablation
- Transcatheter AFib ablation
We have sorted procedures first by growth (CAGR) to 2022, then by volume in 2022.
Source: MedMarket Diligence, LLC; Report #C500.
Source: MedMarket Diligence, LLC; Report #C500.
Compared to the use of cellular based technologies, gene editing, nanotech, and even more promising technologies ahead, the technology of ablation — the use of simple energy at various wavelengths, at various temperatures, intensities, methods desigend to be effective, accurate, and precise — is not as sexy, but these technologies really are medtech old school.
Indeed, ablation technologies may not be able to compete effectively against cell therapy, gene therapy, or other advanced medical technologies, especially where “cure” is a reality, but they really do stand at the forefront of surgery today (and in some sense as the likely peak of device technologies). They are not concepts or potential technologies, but are treating myriad diseases today, offering better outcomes and improving quality of lives and saving lives.
Growth rates in sales of devices, equipment, and supplies in most ablation types are at least respectable in an era of cost containment, while other ablation modalities are strong enough in tapping unmet patient demand that they are investment-attractive. Just as these technologies have emerged and developed alongside other MIS technologies, they will continue to track surgeries (or interventions, sorry cardio guys) and be there until surgery, interventional medicine, or whatever its moniker, is made obsolete.
See the Smithers Apex report, “The Future of Ablation Products to 2020,” described at link.
Source: Smithers Apex
Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022. See Report #C500.
Publishing July 2016
This report covers surgical and interventional therapeutic procedures commonly used in the management of acute and chronic conditions affecting myocardium and vascular system. The latter include ischemic heart disease (and its life threatening manifestations like AMI, cardiogenic shock, etc.); heart failure; structural heart disorders (valvular abnormalities and congenital heart defects); peripheral artery disease (and limb and life threatening critical limb ischemia); aortic disorders (AAA, TAA and aortic dissections); acute and chronic venous conditions (such as deep venous thrombosis, pulmonary embolism and chronic venous insufficiency); neurovascular pathologies associated with high risk of hemorrhagic and ischemic stroke (such as cerebral aneurysms and AVMs, and high-grade carotid/intracranial stenosis); and cardiac rhythm disorders (requiring correction with implantable pulse generators/IPG or arrhythmia ablation).
The report offers current assessment and projected procedural dynamics (2015 to 2022) for primary market geographies (e.g., United States, Largest Western European Countries, and Major Asian States) as well as the rest-of-the-world.
See the complete table of contents at Report C500.
We see three key forces underlying investment trends in medical technology:
- The spectrum of competition has been broadened and sometimes isn’t even obvious.
Widely different technologies (as in treatment of coronary artery disease, see white paper) can address a clinical condition, with the solution to the problem being the focus of new investment.
New materials for devices, drug-device hybrids, biotech-driven solutions, and other innovations can create competition between very different technologies. As a result, the paradigms and truths that held true in the past, when devices only went head-to-head with devices, are no longer relevant, creating the need to better assess the competitive landscape.
Manufacturers must there develop good market awareness, as in being cognizant of all the potential source of competition, such as from companies in adjacent markets who might pivot and seize market share.
- Money flows to niches in medtech where the demand for clinical utility is high.
The biggest forces driving medtech are increasing patient populations or the cost of managing them. Niches that address the challenges of an older population with unsolved painful and or costly conditions (orthopedics, chronic wounds, diabetes, bariatrics) have prominent cost targets that stimulate investment.
Patient demographics, healthcare cost/utility demands and other forces make some medtech niches very attractive, even if only as a result of technology migration (e.g., to growth geo markets).
- Underserved patient populations command almost as much attention as the untapped patient populations.
There is much potential return on investment to be made in blockbuster treatments, but these can be financial sinkholes compared to less grandiose technology solutions. A motive force exists in medtech, centered around healthcare costs, that is relentlessly forcing medical technology innovators to find opportunity within existing markets, by eliminating cost (e.g., shifting care to outpatient as via minimally invasive technologies). Significant medical technology investment has already recognized the value in targeting conditions for which new technology, new clinical practices and/or simply new ways of thinking can improve the quality of life, patient costs or both.
Medtech investment is most serious when it is (1) in high dollar value, or (2) tied to the formation of companies. It reflects confidence in that sector to the degree set by the investment.
In the past five years, MedMarket Diligence has tracked the identification of over 600 companies in medtech. Below is the distribution of their focus across a large number of clinical and technology areas (multiple possible, as in “minimally invasive” and “orthomusculoskeletal”).
These companies have also been tracked through their specific investments (detailed historically at link).
Source: MedMarket Diligence, LLC; Medtech Startups Database.
Cardiology, orthopedics, and surgery are mainstay drivers of new technology development in medtech, as has been the push for minimally invasive therapies, but nanotechnology, interventional (e.g., transcatheter) technologies, biomaterials, wound management and other niches have a steady stream of new company formations.
See recent reports from MedMarket Diligence in the following clinical areas.
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.
Below is a list of the technologies under development at new medtech companies and recently added to the Medtech Startups Database.
- Devices to assist pulmonary function.
- Technologies to improve performance of orthopedic implantation.
- Treatments for conditions associated with spinal cord injury and disease.
- Technologies for the preservation and transport of organs and biologicals.
- Interventional technologies for the treatment of neurovascular technologies.
- Spinal fusion technologies
- Orthopedic implants, including a prosthetic meniscus for placement in the knee joint.
- Women’s health products including low risk device to measure cervical dilation.
- Medical device to rapidly and accurately diagnose otitis media.
- Bioabsorbable heart valve.
- Electro-hydraulic generated shockwave for cosmetic, medical applications.
For a historical listing of technologies at medtech startups, see link.
Ablation is not a new technology, nor is it a recent addition to the tools available to clinicians (electrosurgery dates back a hundred years or more), but is still evolving in both the practice of medicine and surgery and the medtech industry. New technology developments, changes in clinical practice and growth and migration of the technologies globally are characteristics of ablation as a worldwide market with significant change and opportunity.
New ablation technologies have arisen at different times over the past 50 years, accentuated by the emergence of sophisticated instrumentation and devices designed to very precisely apply their inherent energy toward specific clinical applications. This has been and will continue to be a pattern in the ablation market, as manufacturers develop new instruments and methods to refine the delivery of ablation toward specific clinical applications. Consequently, revenues will continue to shift from one modality to another in the pursuit of improved clinical outcomes.
Download a White Paper on tissue ablation at link.
See “The Future of Tissue Ablation Products to 2020″ at link.