Medtech and biotech investment is driven by an expectation of returns, but rapid advances in technology simultaneously drive excitement for their application while increasing the uncertainty in what is needed to bring those applications in the market.
MedMarket Diligence has tracked technology developments and trends in advanced medical technologies, inclusive of medical devices and the range of other technologies — in biotech, pharma, others — that impact, drive, limit, or otherwise affect markets for the management of disease and trauma. This broader perspective on new developments and a deeper understanding of their limitations is important for a couple of reasons:
Healthcare systems and payers are demanding competitive cost and outcomes for specific patient populations, irrespective of technology type — it’s the endpoint that matters. This forces medical devices into de facto competition with biotech, pharma, and others.
Medical devices are becoming increasingly intelligent medical devices, combining “smart” components, human-device interfaces, integration of AI in product development and products.
Medical devices are rarely just “medical devices” anymore, often integrating embedded drugs, bioresorable materials, cell therapy components, etc.
Many new technologies have dramatically pushed the boundaries on what medicine can potentially accomplish, from the personalized medicine enabled by genomics, these advances have served to create bigger gaps between scientific advance and commercial reality, demanding deeper understanding of the science.
The rapid pace of technology development across all these sectors and the increasing complexity of the underlying science are factors complicating the development, regulatory approval, and market introduction of advanced technologies. The unexpected size and number of the hurdles to bring these complex technologies to the market have been responsible for investment failures, such as:
Theranos. Investors were too ready to believe the disruptive ideas of its founder, Elizabeth Holmes. When it became clear that data did not support the technology, the value of the company plummeted.
Juno Therapeutics. The Seattle-based gene therapy company lost substantial share value after three patients died on a clinical trial for the company’s cell therapy treatments that were just months away from receiving regulatory approval in the US.
A ZS Associates study in 2016 showed that 81% of medtech companies struggle to receive an adequate return on investment
As a result, investment in biotech took a correctional hit in 2016 to deflate overblown expectations. Medtech, for its part, has seen declining investment, especially at early stages, reflecting an aversion to uncertainty in commercialization.
Below are clinical and technology areas that we see demonstrating growth and investment opportunity, but still represent challenges for executives to navigate their remaining development and commercialization obstacles:
Type I diabetes
Non-invasive blood glucose measurement
Tissue engineering and regeneration
3D printed organs
Brain-computer and other nervous system interfaces
Interfaces for patients with locked-in syndrome to communicate
Interfaces to enable (e.g., Stentrode) paralyzed patients to control devices
Robotics in surgery (advancing, despite costs)
Optogenetics: light modulated nerve cells and neural circuits
Localized drug delivery
Further accelerated by genomics and computational approaches
Computational approaches to accelerate the evaluation of drug candidates
Organ-on-a-chip technologies to decrease the cost of drug testing
Impact on investment
Seed stage and Series A investment in med tech is down, reflecting an aversion to early stage uncertainty.
Acquisitions of early stage companies, by contrast, are up, reflecting acquiring companies to gain more control over the uncertainty
Need for critical insight and data to ensure patient outcomes at best costs
Costs of development, combined with uncertainty, demand that if the idea’s upside potential is only $10 million, then it’s time to find another idea
While better analysis of the hurdles to commercialization of advanced innovations will support investment, many medtech and biotech companies may opt instead for growth of established technologies into emerging markets, where the uncertainty is not science-based
Below is illustrated the fundings by category in 2015 and 2016, which showed a consistent drop from 2015 to 2016, driven by a widely acknowledged correction in biotech investment in 2016.
*For the sake of comparing other segments, the wound fundings above exclude the $1.8 billion IPO of Convatec in 2016.
Due to the uncertainty in the development, clinical testing, and regulatory approval of both biotech and medical technologies, which increasingly have to be viewed with the same competitive lens, investors have over the past few years shied away from seed stage or Series A stage company investment in favor of those nearer to market introduction. However, with the advent of a great number of new technologies and advances in the underlying science, there is enormous opportunity to identify companies and emerging sectors arising from these advances. The problem in identifying realistically promising companies is that it must be done so without falling prey to the bad investment practices in the past that ensued from a poor understanding of the technologies and their remaining commercial hurdles. Without careful consideration of remaining scientific development needed, the product’s target market, its competitors, and the sum total of the company’s capabilities to commercialize these technologies, investment in these areas will fall short of investment objectives or fail them outright.
While any of these considerations have the capacity to preempt a successful market introduction, a failure to understand the science behind the product and its remaining development hurdles to commercialization is likely to be the biggest cause of failure.
“We’ve already had one glaring example of a company, and its investors, learning the hard way that health and science advisors are important: Theranos.” (link)
Venture Capital has backed away from early stage investment
Earlier stage investment, with its higher risk, has higher potential reward, so there is a big need for more effective evaluation of potential early stage investments in order to (1) seize these opportunities that will otherwise potentially be lost with the shift to later stage fundings, (2) sort out those companies/technologies with overwhelming commercialization hurdles from those that will profitably tap an opportunity, and (3) gain the value of these opportunities before the innovation appreciates in value, driving up the price of the investment.
The Biotech Bubble
Biotech in the 1980s was enamored with companies pursuing “magic bullets” — technologies that had the potential to cure cancer or heart disease or other conditions with large, untapped or under-treated populations. With few exceptions, these all-in-one-basket efforts were only able achieve a measure of humility in the VCs who had poured volumes of money into them.
Here was evidenced a fundamental problem with biotech at a time when true scientific milestones were being reached, including successes in mapping the human genome: Landmark scientific milestones do not equate with commercial success.
As a result, money fled from biotech as few products could make it to market due to persistent development and FDA hurdles. By the late 1980s, many biotechs saw three quarters of their value disappear.
A Renewed Bubble?
The status of biomedical science and technology, with multiple synergistic developments, will lead to wild speculation and investment, potentially leading to yet another investment bubble. However, there will be advances that can point to real timelines for market introduction that will support investment.
Recent advances, developments and trends supporting emerging therapeutics
Stem cells. A double-edged sword in that these do represent some the biggest therapeutics that will emerge, yet caution is advised since the mechanisms to control stem cells are not always sufficient to prevent their nasty tendency to become carcinogenic.
Drug discovery models, such as using human “organoids” and other cell-based models to test or screen new drugs.
Systems to accelerate the rapid evaluation of hundreds, perhaps, thousands of potential drugs before moving to animal models or preclinicals.
Meta-analysis, the practice of analyzing multiple, independently produced clinical data to draw conclusions from the broader dataset.
cell biologists, immunologists, molecular biologists and others have a better understanding of pathology and therapeutics as a result of information sharing; plus BIG DATA (e.g., as part of the “Cancer Moonshot”). Thought leaders have called for collection and harnessing of patient data on a large scale and centralized for use in evaluating treatments for specific patients and cancer types.
Artificial intelligence applied to diagnosis and prescribed therapeutics (e.g., IBM Watson).
Examples of resulting therapies, at a minimum, include multimodal treatment – e.g., radiotherapy and immunotherapy – but more often may be represented in considerably more backend research and testing to identify and develop products with greater specificity, greater efficacy, and lowered risk of complications.
In reviewing patents, fundings, technology development trends, market development, and other hard data sources, we feel these are some of the strongest areas for investment in not only the medical device side of medtech, but also the broader biomedical technology arena:
Cancer probes (e.g., fluorescent or optical coherence tomography, frozen section, cytologic imprint analysis, ultrasound, micro-computed tomography, near-infrared imaging, and spectroscopy)
neurostimulation and neuromodulation
In addition, there are many areas in healthcare in which there is much untapped demand with problems that, so far, seem to have eluded medtech solutions. These include infection control (Zika, MRSA, TB, nosocomial infections, etc.), chronic wound treatment (including decubitus/stasis/diabetic ulcers), type 2 diabetes and obesity.
Fundings for medtech in January 2017 stand at over $700 million, led thus far by the $55 million funding of Intuity Medical, the $54 million for Apollo Endosurgery, $50 million debt funding of ConforMIS, and the $50 million funding of Neuropace. Below are the top fundings for the month. For a complete list of fundings (to be updated during the month), see link.
Source: Compiled by MedMarket Diligence, LLC
For a historical list of fundings since 2009, see link.
Medtech fundings for December 2016 stand at $905 million, led by the $397 million funding of Microbot Medical as part of its merger with StemCells and followed by the $206 million Series EE funding of Intarcia Therapeutics. Other key fundings include Astute Medical’s $43 million, and Femasys’ $37 million.
Below is a list of the top fundings for the month. For a complete list of fundings for the month, see link.
Source: Compiled by MedMarket Diligence, LLC
For a historical listing of fundings per month since 2009, see link.
Global Dynamics of Cardiovascular Surgical and Interventional Procedures, 2015–2022. details
Fundings for August 2016 were led by the $93 million funding of CVRx, followed by the $49 million funding of Auris Surgical Robots, and the $30 million funding of VytronUS. See link for the complete list.
For a comprehensive list of medtech fundings since 2009, see link.
Medtech fundings for July 2016 stand at $612 million, led by the $183 million IPO of Bioventus, followed by the $49 million Series C funding of VytronUS, the $32 million funding of Endotronix and the $30 million funding of Senseonics.
Below are the top fundings for the month thus far. Check back before month end to see updates.
For a complete list of fundings in July 2016, see link.
Medtech fundings for June 2016 stand at $607 million, led by the $172.5 million post-IPO sale of Nevro’s convertible notes, the $75 million IPO (to happen in June) of OrthoPediatrics, and the $50 million funding of Clearside Biomedical.
Below are fundings for the month, thus far. Please revisit this post (and refresh your browser) for updates by month-end.