Medtech fundings for February 2017 stand at $500.4 million, led by the $75 million credit facility secured by BioDelivery Sciences, the $45 million private placement by Corindus Vascular Robotics, the $41 million funding of Rhythm, Inc., the $37.2 million funding of Entellus Medical, and the $33 million funding of startup Surrozen.
Below are the top fundings for the month. For a complete list of fundings, see link.
Source: Compiled by MedMarket Diligence, LLC
For a historical listing of fundings in medtech, see link.
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 old Chinese saying, “May you live in interesting times”, is often used as a curse (and likely originated as such), since interesting is oft synonymous with challenging, uncertain, stressful or otherwise difficult. Insult or blessing, we are entering interesting times.
The coming era of development in medical technology may be the most interesting in history. Let’s get to it.
Consider the near term:
Cost pressures, demands for improved outcomes, and need for better access to healthcare have been rising to the fore as forces overhauling markets for medical technologies.
Chronic disease has always represented a major cost challenge, given the expense of ongoing care, but as cost and quality become more demanding, while prevalence of type 2 diabetes, obesity, and associated co-morbidities increase (and compounded by higher prevalence of type 2 in an increasingly older population), driven by persistent sedentary lifestyles, diet, and other health choices, it becomes clear that chronic disease will command much attention, representing real opportunities in medtech.
Never before have so many technologies, alone or in combination, been poised to change the nature of intervention:
information-intensive device, drug, and biotech product development
information-intensive medical devices
genetically-influenced drug development
In the medium term (next 5-10 years):
Type 1 diabetes gradually becomes less burdensome, with fewer complications, and improved quality of life for patients.
Type 2 diabetes continues to plague Western markets in particular, despite advances in diagnosis, treatment, and monitoring due to challenges in patient compliance.
Cancer five year survival rates will dramatically increase for many cancers. The number of hits on Google searches for “cure AND cancer” will reflect this.
Multifaceted approaches available for treatment of traumatic brain injury and spinal cord injury – encompassing exoskeletons to help retrain/rehabilitate and increase functional mobility, nerve grafting, cell/tissue therapy, and others.
Organ/device hybrids will proliferate and become viable alternatives to transplant, or bridge-to-transplant, for pulmonary assist, kidney, liver, heart, pancreas and other organ.
The use of stem cells for therapeutics is a radically different type of medicine, and while stem cells can be powerfully therapeutic, their use has also shown the potential to cause new cancer, graft-versus-host disease, organ damage, infection, and other direct and indirect complications. Nonetheless, the excitement around stem and other pluripotent cells creates a climate not far removed from the wild west – the potential of such open territory being up for grabs has drawn hordes of activity, not all in the best interests of patients or shareholders. The stem cell industry and others will continue to press the FDA to approve more therapies, with the pressure easing up only after a scarcity of patient deaths, complications, or just lackluster results.
Beyond 10 years, many things might happen, but which one actually happens (or the degree of its success) will be dictated by timing.
Will the big success in diabetes as we approach 2030 be cell-based — as in autogeneic pancreatic cells induced from stem cells — or will the state of the art at that time still be the “pump/meter closed loop artificial pancreas” (expected to be the case well before 2030?
Will tissue engineering allow us to preempt death?
The potential for us to preempt an enormous amount of disease is already before us, yet we studiously avoid it. At what point do we take advantage of this?
Consider what will be the case beyond 2026.
Research gaps will have narrowed drastically. The gap between basic science and clinical application will be very small. Our medical diagnostics will be extremely richly detailed, near-instantaneous, and widely accessible (e.g., there will be variants or embodiments of IBM Watson and similar intelligent diagnostic systems), which will of course optimize the potential for therapeutics. But the impact on research will be dramatic, because we will be able to much more rapidly and efficiently learn from an obvious integration of routine clinical data and research data via meta-analysis-esque (for lack of a less clumsy term) capacity to derive data from disparate local and remote systems.
Our nearly complete knowledge of the full spectrum of pathogenic factors (from environmental to genetic) and their correlation with specific patient populations will have pierced the veil that has concealed the etiologies of a large number of diseases, opening the door wide to the development of therapies.
We will understand, predict, and manage the development of genetic disease.
All political denial to the side, some of the most significant threats to our health in the future will ensue from our relentless campaign to ravage the planet’s resources – air, water, food – driven by overpopulation and happily capitalized upon by what we are seeing is a growing horde of lethal, many well evolved but otherwise persistent pathogens (from tuberculosis, MRSA, Ebola, Marburg, and many others as yet unidentified), already made more threatening due to antibiotic resistance we have knowingly facilitated.
However, fear not, my 2.3% excise tax refugees. The future is bright for you, if you care to recognize your place in it.
But first, here’s a blunt reality: Medical devices, at least as we know them, will simply become irrelevant. Medical devices, no matter how sophisticated, are clunky mechanical tools for amelioration of symptoms for diseases about which know too little to solve with near-zero cost permanent cures (think of the vaccine, an unbelievable idea in the mind of those fearing polio) but only when drugs or other interventions are not also possible.
Let there be no doubt — medical technology will thrive. Disease is persistent. Conditions are worsening for the human population. But, more importantly, at least from the sense of an industry with a big financial stake in the situation, nature does not give up her secrets easily and there remain many obstacles to overcome (not least of which is wanton and persistent human ignorance) before we are able to utterly avoid or cheaply cure all diseases.
MedMarket Diligence is hours away from publishing its 2015 report on the worldwide wound management market.
The report is entitled, “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”. The report is described in detail at link.
The very diverse field that is wound management encompasses technologies from gauze to bioengineered skin and skin substitutes and many in between. Growth rates range from flat to over 15% annually through 2024.
The highest growth segments in medical technology sectors typically derive their high growth from modest absolute changes on very small volume and therefore rarely can sustain that growth over time. However, in wound management, the use of bioengineered skin and skin substitutes will result in the highest cumulative sales compared to all segments from 2015 to 2024 — excluding, that is, the high volume segments of traditional adhesives, gauzes, and non-adherent dressings. Also noteworthy is the second highest cumulative sales over this period was for antimicrobial dressings, despite this segment having relatively modest growth on a percentage basis, but proceeding from significant sales in 2015 (already at over $1.5 billion).
During the forecast period, the most significant change evident in sales is the jump in the share of the market represented by bioengineered and other skin replacements, as noted above. But with compound annual growth rates (to 2024) in sales in the different wound segments ranging from near 1% to nearly 20% — for segments with 2015 sales at a low of $300 million and a high of $15 billion — there is considerable shifting of shares of the global wound market.
On a geographic basis, wound care technology migration, efforts to secure underserved patient caseload, and other forces result in growth rates that vary by country or region. The well-developed USA market therefore does not compare in uptake of both old and new technologies within growth markets like China and others in the Asia/Pacific region.
Wound management is an old medical practice, and wounds have not changed in nature other than the mix prevalence of different wound types. Yet, the volume of all wounds, and the need to improve they may be managed, support development of many new technology and changes in clinical practice. In turn, this drives and sustains an unusually large number of competitors.
Below is a list, drawn from the forthcoming December 2015 report (#S251) from MedMarket Diligence global wound management market, of companies that are sufficiently large or active or noteworthy for us to have specifically profiled in our report. The true number of companies in wound (and detailed but not “profiled” in our report) is in the hundreds.
The MedMarket Diligence Report #S251, “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World” (see link for details), provides a current and forecast assessment (to 2024) of the worldwide market for wound management.
I frequently see conclusions about the the future of medtech derived by analysts who are walking backward looking at their feet — living by the tenet of “past is prologue”. This type of “foresight” presumes an unchanging set of forces, leading (at best) to a conclusion that the future will hold more of the same.
Yet, the future of medtech is dictated far more significantly not by what has already happened, or as a result of past trends continuing as future trends, but by what has not happened yet. The major thrust of any significant growth (and isn’t growth what interests us?) comes primarily from events that do not as clearly follow from past events:
Surgical device sales forecasts are uprooted by introduction of laparoscopy
Tissue engineering preempts conventional treatments in wound, orthopedics, cardiology…
Success in type 1 diabetes treatment will be determined by device advances as well as cell therapy advances
Systems biology reveals risks and opportunities previously unseen
If you view your markets myopically, then you consider your competitors to be limited to those whose products most resemble your own. If you have a long view, you consider what might be possible based on available/emerging technology to tap into untapped demand or simply create latent demand that no company has yet been sufficiently visionary or innovative to seize. What patient populations, clinical practice patterns and their trends are the pulse that you monitor (or are you even monitoring these)? There is a gap between what is available and a whole set of patients virtually untreated, physicians unsatisfied, and third party payers struggling. Are you an angioplasty catheter manufacturer — or a coronary artery disease solution? Do you make devices — or outcomes?
Look at staid “device” companies like Baxter International and see that they have “biosurgery” divisions. Look at Medtronic and appreciate that they are as sensitive to developments in glucose monitoring and insulin pump technologies as they are to the litany of cell therapy approaches under pursuit. (These companies are fundamentally aware of technology “S-curves” — see graphic at right.)
Virtually every area of current clinical practice is subject to change when considering drug/device hybrids, biomaterials, nanotechnology/MEMs devices and coatings, biotechnology, pharmaceutical (and its growing sophistication in drug development), western medicine and eastern medicine, healthcare reform, cost containment, RFIDs, 3D printing, information technology — it is imperative to see the upside and downside of these.
These are some of the forces that less characteristic of the past that are leading to startling new success in medtech developments:
Materials technologies are redefining the nature and functional limits of medical devices
Technologies more closely aligned with cure than symptomatic treatment gain rapid acceptance
The practice of considering outcomes measures of highly diverse technology solutions to disease has ascended to prominence in the mindsets of healthcare systems and payers
The use of information technologies and cross-medical discipline initiatives enables rapid determination of likely success and failures in whole new ways
Aside from the demands for operational efficiency and managing cash flows, the success or failure of medical technology companies has become a reflection of how well these companies position themselves now and in the future with an imaginative long view. Companies must consider the revenue streams in Year 1, Year 5 and Year 10.
Manufacturers, clinicians and others focusing on technology advancement in spine surgery are not developing radical innovations, but are making enough incremental improvements in a number of ways that result in growth in the industry. Most improvements fall into a number of categories:
New materials technologies: Historically, spinal fusion instrumentation was fabricated from metallic biomaterials, including stainless steel and titanium alloy, because of their strength and fatigue resistance. However, one key drawback of these metallic implants is incompatibility with diagnostic imaging, including MRI and CT scans, which are crucial for visualizing changes to the spinal cord and vital soft tissue structures of the spine. To overcome these issues a variety of new materials such as biocompatible carbon fiber-reinforced (CFR) thermoplastic materials and implantable polyetheretherketone (PEEK) polymers were examined as an alternative to the traditional materials. In addition to biocompatibility, biostability and compatibility with diagnostic imaging, these advanced thermoplastic polymers provide a range of mechanical properties that are well suited to the demanding environment of spinal implants.
Implantable PEEK polymers are available today in an array of formulations, ranging from unfilled grades with varying molecular weight, to image-contrast and carbon fiber-reinforced grades. The first implantable unfilled PEEK polymer–PEEK-OPTIMA was pioneered in 1999 by United Kingdom-based Invibio Biomaterial Solutions. Introduced by Invibio in 2007 to provide controlled visibility through X-ray, CT and MRI technologies, image-contrast grades offer tailored opacity that allows for easier post-operative device placement verification by surgeons and clear assessment of the healing site. Also launched by Invibio in 2007, carbon fiber-reinforced (CFR) grades provide significantly increased strength and stiffness as well as a modulus similar to that of cortical bone.
The CD HORIZON LEGACY PEEK Rod from Medtronic Sofamor Danek and the EXPEDIUM™ PEEK Rod System from DePuy Spine, Inc., are examples, in which these polyetheretherketone (PEEK) polymers are radiolucent and have the ability to reduce scatter and artifact from CT and MRI images. [Picture source: MRI scan via Shutterstock]
Computer aided fixation of spinal implants: A number of proprietary techniques are being developed that provide computer or robotic alignment for the placement of spinal implants. Current research ensures that further developments will occur resulting in more extensive use of computer aided fixation. [Picture source: NIH]
Minimally invasive spine surgery: Manufacturers have development technologies in percutaneous and endoscopic approaches to spine surgery that are having (and will continue to have) a significant impact on patients, clinical practice and the market for spine products. It is producing all the expected benefits of less invasiveness — less traumatic surgery results in shorter recovery times and better outcomes and opens up spine surgery to more elderly, infirm and other patients for whom traditional spine surgery would be contraindicated. [Image: Handbook of Minimally Invasive and Percutaneous Spine Surgery; allamericanspeakers.com]
Variable axis screw systems: A variable axis screw system is a pedicular screw system that features a variable-axis head, which offers a ±25 degrees of angulation. The system also offers a pre-contoured rod. The contoured rod, along with the angulation available in the screw head, alleviates the need for rod contouring. The screw also features a pre-assembled head and double lead thread. The pre-assembled head reduces the steps required for construct assembly and the double lead thread increase the speed of screw insertion and construct assembly so that the overall operative time can be shortened. [Picture source: DePuy Synthes]
Products, technologies, markets, companies and opportunities in the spine surgery industry are the focus of the MedMarket Diligence Report #M540, “Global Market for Medical Device Technologies in Spine Surgery, 2014-2021: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.” The next five purchasers of this report (any option) will receive a 25% discount off the published price online by entering the coupon code “spinepricectomy”.