Technologies Under Development at Medtech Startups, November 2016

Below is a list of the technologies under development at medical startups recently identified by MedMarket Diligence and included in the Medtech Startups Database.

  • Intravenous light therapy.
  • Post-op drainage device.
  • Devices for vascular access during hemodialysis.
  • Implantable, localized drug delivery for cancer.
  • Technology to facilitate ureter placement.
  • Tools to improve safety of surgery.
  • Technologies for improved tendon repair.
  • Needle guidance and analytics to facilitate spinal tap.
  • Closed-loop catheter for localized liver cancer treatment.
  • Cancer detection
  • Improved vascular access for dialysis.
  • Developing an artificial pancreas.
  • Nasogastric feeding system.

For a complete list of technologies in development at medtech startups identified since 2008, see link.

The future of cardiovascular medicine

The MedMarket Diligence has published a global analysis and forecast of cardiovascular procedures, designed to be a resource for active participants or others with interest in the future of cardiovascular medicine and cardiovascular technologies.

See the press release on Medgadget.

Where will medicine be in 2035?

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.”

Growth in wound management from trends in prevalence, technology

Worldwide, an enormous number of wounds are driving a $15 billion market that will soon pass $20 billion. What is driving wound sales is the continued growth and prevalence of different wound types targeted by medical technologies ranging from bandages to bioengineered skin, physical systems like negative pressure wound therapy, biological growth factors, and others.

Most attention in wound management is focused on improving conventional wound healing in difficult clinical situations, especially for chronic wounds, in the expansion of wound management technologies to global markets, and in the application of advanced technologies to improve healing of acute wounds, especially surgical wounds.

Global Prevalence of Wound Types, 2015

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Source: MedMarket Diligence LLC; Report #S251. Request excerpts from this report.

Total Wound Care Market as Percent of Entire Market, 2024

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Source: MedMarket Diligence LLC; Report #S251. Request excerpts from this report.


 

Three Key Forces Behind Startups and Investment in Medical Technology

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.

Technologies in Development at Medtech Startups, October 2015

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.

Medtech Startups, 2010-2015

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.

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Source: Medtech Startups Database

Below is a graphic on the companies by country. The U.S. (not shown) led with 327 companies.

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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:

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Source: Medtech Startups Database

 

New Medical Technologies at Startups, May 2015

Below is the list of technologies under development at medical technology companies identified in May 2015 and included in the Medtech Startups Database.

  • Nanotechnology-based diagnostic
  • Bone fixation devices, including for post-sternotomy closure
  • Devices and materials for bone lengthening
  • Nanopolymer drug delivery
  • Developing an artificial pancreas; combined blood glucose monitor and insulin pump
  • Terahertz radiation-based measurement of blood glucose
  • Patient-specific orthopedic implants
  • Undisclosed medical technology
  • Novel energy delivery-based medical technology
  • Device for early detection of cardiovascular disease based on endothelial dysfunction
  • Facet joint surgical instruments
  • Neuromodulation technology
  • Electric stimulation in wound healing
  • Mesenchymal stem cell treatment in cardiology, transplantation, and autoimmunity
  • Integrated blood glucose monitor, insulin dosing
  • Surgical instrumentation

For a historical listing of technologies at medtech startups, see link.

 

New Technologies Under Development at Medtech Startups, August 2014

Below is a list of the technologies under development at newly identified medtech startups and included in the Medtech Startups Database.

  • Technology for the repair of rotator cuff tears.
  • Technologies for intravenous cannulation and phlebotomy, and an otorhinoscope.
  • Implant for the treatment of urinary incontinence.
  • LED (light) treatment of acute, dry macular degeneration.
  • Esophageal cooling device to manage patient temperature.
  • Surgical robotics.
  • Patient positioning system for orthopedic surgery.
  • Device to treat macular degeneration by delivering microcurrent to the eye.

For a historical listing of medtech startup technologies included in the database, see link.

Glucose monitoring research drives more promises than answers

If I had a nickel for every headline like this that ultimately failed, like the technology, to actually achieve the promise, I would be on a tropical beach sipping pina coladas:

“Glucose monitoring for diabetes made easy with a blood-less method” (link)

Technologies in development for less-invasive or non-invasive glucose monitoring are legion, and many are very promising, but you can’t fill out a deposit slip with these promises. Frequently, such alternatives are based on the premise of quantifying blood glucose by sensitively detecting glucose in other fluids (interstitial fluid, tears, saliva, urine, etc.) that do not require the use of lancets to draw blood. However, despite their sensitivity and other sophistication in detecting minute quantities of glucose, their “arm’s length” to actual blood glucose compounds the challenge by requiring that the test reproducibly correlate the sample values with actual, current blood glucose levels.

The challenge stands unanswered, while the burgeoning population of endlessly finger-pricked diabetics remains painfully unsatisfied.

As a practical reality, continuous blood glucose monitors like those from Dexcom and Medtronic offer far more to the diabetic population, not only by avoiding finger pricks but also by revealing the patterns in blood glucose levels over time as a result of activity, carbohydrate intake, insulin bolus, insulin basal rate, stress and countless other patient-specific determinants.