Incremental advances and game-changing innovation in medtech

Medical technology development is driven by a variety of factors. The most common drivers are to extend or improve the capabilities of existing technologies:

    • Addressing under-served clinical need
      • enabling treatment of “untreatable” patient types
      • enabling shift of procedures to outpatient or doctors’ offices
    • Reducing cost
      • less expensive device
      • faster healing time
    • Improving performance
      • reducing operating time
      • lowering the rate of complications

These drivers underscore much activity in medical technology development, since they typically focus on designing products that are improvements upon existing, FDA-approved or CE-Mark technologies. The hurdles to these developments are (relatively) few, requiring little more than being able to construct an argument that a newly developed medical product provides a feature that is “better” than available technologies. (This, of course, represents the putative reason for high healthcare costs, with only nominally “new” technologies commanding price premiums over established ones, but that is the focus of a different discussion.)

In reviewing the formation of new medtech companies that we have recorded in our data over the past three years, there are a number of very common drivers:

  • Intraoperative imaging, monitoring, disease detection

– gas spectroscopy of electrosurgery smoke (e.g., “iKnife”)
– real-time imaging (ultrasound, MRI)
– intraoperative microscopy

        • Polymers, biomaterials, biologics and cell or tissue regeneration to replace diseased or traumatic tissue

– biomaterials
– growth factors
– extracellular matrices
– synthetics (e.g., cartilage)

        • “Back-filling” in endoscopic surgery

– development of surgical instrumentation for use in laparoscopic surgery, single-incision (or single-port) laparoscopy, NOTES (arguably, NOTES is not a radically new approach but the embodiment of what “minimally invasive” endoscopy is when pushed to its logical limits) and other endoscopy .

– endoscopic and surgical instrumentation to allow/facilitate office-based procedures

        • “generic” medical devices
        • biodegradable implants
        • transcatheter technologies

Among the less common of these technologies are those that emerge from the application of a fundamentally different approach to healthcare (call it “paradigm shift” or “game-changing” or whatever your preferred buzz-term).  These technologies consider treatment from a very different perspective that fundamentally change the rules of the game. To some degree, radical change stems simply from the emergence of a new technology that enables radically different treatment, such as the use of stem cells to restore pancreatic function in diabetes. In other cases, medtech manufacturers have recognized the law of diminishing returns in pursuing incremental innovation of established technologies and have instead forged entirely new paths to treatment, as in the use of neuromodulation for pain management (and other clinical end-points) or transcatheter procedures to replace invasive cardiovascular surgery.

Examples of game-changing technologies:

  • Transcatheter alternatives to surgery
  • Treatment of hypertension via ablation of sympathetic nerve
  • Neuromodulation or neurostimulation for relief of chronic pain or treatment of hypertension and other conditions
  • Intraoperative pathology detection (ultrasound, iKnife mass spectrometry, optical coherence tomography)
  • Stem cell or induced pluripotent stem cells applied to treatment of diabetes, other diseases

In the end, the bulk of medtech developments arise from innovative improvements on existing technologies to create competitive advantage, but the mistake for any current market participant is to not remain vigilant in considering the developments of current or potential competitors pursuing radical alternatives to more effectively satisfy clinical (and economic) need.


MedMarket Diligence maintains a dynamic database of Medtech Startup Companies that details very new, highly innovative companies focused on current and emerging medtech markets.

 

Active wound healing technologies

Interactive and bioactive wound dressings reflect the major thrust in advanced wound management developments — effective (i.e., complete and timely) wound healing demands active intervention to not just protect wounds from the elements, so to speak, but to drive processes that accelerate wound healing.

A wound is a dynamic setting in which a great number of activities are taking place and, if not actively managed, can go decidedly awry.  Many factors influence the rate of wound healing and, in some cases, may actually turn acute wounds into chronic, non-healing wounds. These factors include mechanical stress, debris, temperature, dessication and macerations, infection, chemical stress, medication, and other extrinsic factors (e.g., alcohol abuse, smoking, radiation therapy and other) as well as the patient’s existing condition (e.g., health, age, body build, nutritional status, etc.).

Therefore, even if one only considers the products in the traditional category of wound care products — wound dressings — there is a considerable number of product types that have been developed to control these processes:

  • film dressings — allow the passage of oxygen and moisture
  • foam dressings — facilitate care of delicate wounds through less frequent changes
  • hydrogels — provide benefits of moist wound healing and absorption of exudate, support autolytic debridement
  • hydrocolloids — very absorbent for wounds with high exudate, support autolytic debridement
  • alginates — conformable, provide high absorbency and support autolytic debridement
  • anti-microbial dressings — provide moist wound healing without simultaneously stimulating growth of microbes

These products operate at the low end of the intervention scale by playing the projective role of traditional wound dressings, but in a dynamic way to facilitate and/or accelerate wound healing.

A step beyond wound dressings is the growing practice of effectively replacing the damaged tissues through homograft, allograft and other skin replacements and skin substitutes.  These products may be used with or without cellular and tissue growth factors.

At the more extreme end of the scale are involved devices and equipment that aggressively alter the wound environment to accelerate healing — negative pressure wound therapy, therapeutic ultrasound, electrical stimulation and others.


Wound care is the subject of the 2013 MedMarket Diligence Report #S249, “Wound Management, Worldwide Market and Forecast to 2021: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”, described in full at link.

Medtech from incremental to quantum leap advances

Advanced medical technologies become advanced by the application of innovation that results in more effective, less costly or otherwise arguably better outcomes (including reduced risk of complications or disease recurrence) for patients, including in some cases enabling treatment when none was previously possible. It is intrinsic to every entrepreneur that the idea he/she is pursuing accomplishes this.

Manufacturers of products on the market have an imperative to either improve upon those products or make them obsolete. This imperative is manifested in a spectrum of planned innovation from simple incremental innovations to the quantum leap of a radically new approach.

There is an enormous amount of technology development, often applicable to multiple different clinical applications, that will be realized in product markets in the future. For the moment, though, I would like to look beyond “incremental improvements” or “product line extensions” or other marginal advances that serve little more than superficially addressing shortcomings of existing products on the market. I would like to look at waves of innovation coming in the short to long term that are expected to impact medtech in ways that are increasingly “radical” or represent varying orders of magnitude of improvement in results.

Three categories spanning short, mid, and long reflect what I see in medtech development. Below, I outline the nature of each and the specific examples that are or will be emerging.

Short term. With change encompassing technologies that are just sufficiently different so that they cannot simply be called incremental innovations, some short term advances often combine two or more complementary and/or synergistic technologies in new ways to advance healthcare. Examples include:

  • Image-guided surgeries to augment the surgeon’s ability to navigate complex anatomy or discern the margins of healthy versus disease tissue.
  • Natural orifice endoscopic surgery (and shift in general from invasive to interventional and intraductal procedures) to either drastically reduce or eliminate the trauma of surgical access
  • Non-invasive therapeutics (like lithotripsy, gamma knife, others) to treat disease without trauma to collateral tissues.
  • Genome-driven treatment profiling (prescreening to determine ideal patients with high probable response).
  • Personalized (custom) implants. These already exist in orthopedics, but the potential for customized implants in gastroenterology, cardiology, and many other clinical areas is wholly untapped.
  • Regenerative technologies (bone, skin, other). These technologies represent introductory markets with lowered challenge compared to more complex functional anatomy (e.g., vital organs).
  • Smart devices (implantable sensors, RFID-tagged implants, etc.) to provide data to clinicians on implant location and status or, in the extreme respond diagnostically or therapeutically to changes in the implant’s immediate environment.

Mid-term. These are new therapeutic options that are fundamentally different than those in current use for a given treatment option. These are technologies that have demonstrated high probability of being feasible in large scale use, but have not yet accumulated enough clinical data to warrant full regulatory approval.

  • Nanotech surface technologies for biocompatibility, localized treatment delivery or other advantages at the interface between patient and product.
  • Materials that adapt to changes in implant environment, to maintain pH, to release drugs, to change shape.
  • Artificial heart. A vital organ replacement that currently has demonstrated the capacity to be a bridge to transplant but has also advanced sufficiently to open the possibility of permanent replacement in the not-too-distant future.
  • Cell/device hybrids. These are organ replacements (e.g., kidney, lung, liver) performing routine function or natural organs, but configured in a device to address unresolved issues of long term function, immune response and others.
  • Artificial organs (other than heart) — closed loop glucometer/insulin pump (artificial pancreas). These are not even partial biological representations of the natural organ, but completely synthetic “organs” that intelligently regulate and maintain a steady state (e.g., blood glucose levels) by combining the necessary functions through combined, closed-loop mechanical means (an insulin pump and glucometer with the necessary algorithms or program to independently respond to changes in order to otherwise maintain a steady state.

Long-term. Orders of magnitude, quantum shift, paradigm shift or otherwise fundamentally different means to serve clinical need.

  • 3D implant printing. In a recent example, in an emergency situation a 3D implant for repair of a infant’s trachea was approved by the FDA. These implants, as in the case of the trachea repair, will most often be customized for specific patients, matching their specific anatomy and may even include their (autologous) cells. They may also be made of other materials including extracellular matrices that will stimulate natural cell migration followed eventually by bioabsorption of the original material. Depending upon type of material and complexity of the anatomy, these technologies may emerge in the near or distant future.
  • Gene therapies. Given the root cause of many diseases has a genetic component or is entirely due to a genetic defect, gene therapies will be “permanent corrections” of those defects. An enormous number of hurdles remain to be crossed before gene therapies are largely realized. These deal with delivery and permanent induction of the corrected genes into patients.
  • Stem cell therapies. The potential applications are many and the impact enormous of stem cell therapies, but while stem cell technology (whether for adult or embryonic) has made enormous strides, many challenges remain in solving the cascade of differentiation while avoiding the potential for aberrant development of these cells, sometimes to proliferative (cancerous) states.
  • “Rational” therapeutics. Whether by stem cell therapies, gene therapies or other biochemical or biological approach, “rational” therapeutics represent the consummate target for medical technology. Such therapeutics are “rational” in the sense that they perfectly address disease states (i.e., effect cures) without complication or need for recurrent intervention.

There are certainly more holes than fabric in this tapestry of short-, mid- and long-term technology innovation, but this should serve to illustrate the correlation between the sophistication of the potential medtech solution and the level of technical challenge in order to achieve each.

 

Reference reports in Ophthalmology, Coronary Stents and Tissue Engineering

MedMarket Diligence has added three previously published, comprehensive analyses of  medtech markets to its Reference Reports listings. The markets covered in the three reports are:

  • Ophthalmology Diagnostics, Devices and Drugs (see link)
  • Coronary Stents: Drug-Eluting, Bare, Bioresorbable and Others (see link)
  • Tissue Engineering, Cell Therapy and Transplantation (see link)

Termed “Reference Reports”, these detailed studies were initially completed typically within the past five years. They now serve as exceptional references to those markets, since fundamental data about each of these markets has remained largely unchanged. Such data includes:

  • Disease prevalence, incidence and trends (including credible forecasts to the present)
  • Clinical practices and trends in the management of the disease(s)
  • Industry structure including competitors (most still active today)
  • Detailed appendices on procedure data, company directories, etc.

Arguably, a least one quarter of every NEW medtech report contains background data encompassing the data listed above.  Therefore, the MedMarket Diligence reports have been priced in the single user editions at $950 each, which is roughly one quarter the price of a full report.

See links above for detailed report descriptions, tables of contents, lists of exhibits and ordering. If you have further questions, feel free to contact Patrick Driscoll at (949) 859-3401 or (toll free US) 1-866-820-1357.

See the comprehensive list of MedMarket Diligence reports at link.

 

Advice to forward-looking medtech manufacturers (and their competitors)

trainWill Rogers said, “Even if you are on the right track, you’ll get run over if you just sit there.” The current challenge for medtech manufacturers is that, as a result of a wide range of forces, trends and developments, the train that threatens to run them over has gotten a whole lot faster. Below is a short list of perspectives that is needed by medtech manufacturers and their competitors in order to stay ahead of the train.

  • Focus on your competitors’ solutions, not their products. Stent manufacturers (and this is just an example) are not competing only against stent manufacturers; they are also competing against drug-eluting balloon angioplasty, atherectomy, percutaneous myocardial revascularization, atherosclerotic plaque-reducing drugs, myocardial stem cell therapy and other device, drug, biotech and other options.  The focus is on the disease and all the alternative ways to treat it (even preventing it). And it bears reminding that a duty of your market intelligence is to keep a watchful eye on the broadest possible definition of potential competitors — gene therapy, holistic medicine, eastern medicines.
  • Be careful where you draw the line on your product’s features. There are many choices to be made in designing and engineering a medical product. The more you build into the product (being resorbable, being intelligent, having biocompatibility coating, having embedded drug(s), etc.), the more benefits you can potentially claim, but the more arduous the engineering, testing and regulatory approval will be.  The traditional advantage medical devices have over drugs has been that devices are “inert”, accomplishing their therapeutic endpoint without the large scale side effects possible with systemically active drugs.  The more devices are imbued with drugs, made of resorbable material or have any kind of interactive capability with the tissue around them, the more likely will be occurrence of adverse effects.
  • Directly or indirectly, your product must be viewed as lowering healthcare cost. In real terms, a product that demonstrably lowers costs compared to alternatives has a decided advantage. However, your product has only to give the appearance of saving money, or at least clearly suggests that it will not raise healthcare costs. Directly, if you can point to units per patient and average selling price and you can point to explicit cost saving compared to currently used products, you’ve gained an advantage. Short of that, you can gain advantage if you can make a defensible cast that your product leads to indirect cost savings such as in less trauma, less collateral damage, faster healing times and similar.
  • “Zero invasiveness” is the target. Expect increasing numbers of percutaneous and “natural orifice” procedures at the expense of not only open surgical procedures but also laparoscopic procedures. Too many surgical and interventional formats, and support systems for them, have been developed that signal the end of the need for invasive procedures.  And whether the procedure is done laparoscopically, endoscopically, percutaneously, or even radiosurgically, the need to cut, resect/excise or otherwise physically alter anatomy or morphology to address pathology will be obviated by, and be less attractive than, effective non-surgical/non-interventional approaches.
  • “Personalized medicine” may be largely theoretical, or at least largely unrealized, BUT the potential to be able to predetermine when therapies will or will not work is too significant in its implications to ignore. (Looking at this another way, I recently spoke with a pharmaceutical colleague who noted that blood markers in patients with a particular condition could help them screen out 97% of the diagnosed patients for whom their therapy would be ineffective.  Their conclusion was not that the drug was 97% ineffective but that, for 3% of the diagnosed population, the drug would be highly effective and therefore highly profitable.)
  • The pace of change is accelerating. Developments in material sciences, the growth in applied understanding of basic life sciences, the emergence of “paradigm-shifting” industries like stem cell and tissue regeneration, the rewards being reaped by genome sequencing, the integration of advanced information technologies in drug discovery, simulated device prototype testing and other advances are dramatically shortening the gap between idea and market introduction, reducing product life cycles (accelerating obsolescence) and increasing the intensity of competition for all manufacturers.

The advice for any medtech manufacturer — or, for that matter, any manufacturer of a product competing against a “medtech” product — is that they must continually address the view of their competitive landscape to recognize and be prepared to respond to real and perceived competition, trends, forces and opportunities.

Medical technology being redefined by forces, innovation

One of the significant challenges in current markets for medical technology is the evolving definitions that dictate the nature of the competitive landscape. The unrelenting economic forces underpinning medtech — to drive down the cost of healthcare — have forced manufacturers to respond to competition that is broader, more aggressive and centered considerably less on “features” than on “benefits”, with benefits under intense scrutiny. Healthcare systems have limited the number of contracted vendors and the lower prices have reduced manufacturers’ margins, which has shaken out those unable to compete on cost and resulted in a market increasingly characterized by a much smaller number of competitors who must compete against all therapeutic alternatives, regardless of the nature of the technology approach.

In a very real sense, medical technology has in fact enabled these forces as manufacturers have responded to the market forces by developing products that compete, cost effectively, on a broader therapeutic scale. Innovators have been steadily stretching the boundaries of possibility through advanced materials technologies development (polymers, hybrids and embedded drugs, nanomaterial and other coatings, etc.). Researchers in basic and applied sciences are combining understanding from multiple disciplines impacting medtech performance — the benefits of understanding in cell biology, molecular biology, biochemistry, chemistry, flow dynamics, computer science, statistics, physics, and others are increasing the performance in vivo of new medical technologies.

As a result, the nature of medical technology has changed, particularly relative to competition. Below is a THEN and NOW view of medical technology.

medtech-defs1

Source: MedMarket Diligence, LLC

 

Growth in posterior pedicle screw fusion systems in spine surgery

Posterior pedicle screw fusion systems are used extensively in spine surgery; eight or more screws may be used in a single procedure.

The posterior pedicle screw fusion system will continue to be used in spine surgery for the foreseeable future. Industry managers believe that, even as new treatments come on to the market, spinal fusion will continue to be the gold standard treatment for degenerative disc disease unresponsive to conservative measures.

The global market for posterior pedicle screw fusion systems was nearly $3 billion 2012, and is forecast to reach a value of almost $6 billion by 2020. The average selling price (ASP) is expected to drop over this period, due largely to strong competition and the sheer number of companies manufacturing and selling these devices.

pedicle-screw

Source: MedMarket Diligence, LLC: Report #M520.

A variable number of pedicles screws are used in each procedure but this number on average will remain the same through 2020.  Consequently, with prices being squeezed, unit growth will outpace dollar volume sales growth.

The global leader for posterior pedicle screw fusion systems is Zimmer, followed by Medtronic, with the two companies controlling almost 75% of the market. There are many smaller companies in this market, and all of these are targeting the same customers, creating intense pricing pressure for devices that are generally ‘me-too’ and leading to consolidation as manufacturers hit their lowest limits on cost.

 

Opportunities, drivers and growth platforms in medtech

horizon_00364590The medical technology industry is characterized by its steady focus on finding and developing innovative solutions on the horizon that will meet the demands of clinicians and healthcare systems to more rapidly and effectively solve problems in the management of disease and trauma.

Given the state of the art in healthcare regarding the performance of current and potential medical technologies, there are a number of key opportunities in medtech that are driven by specific forces and are likely to be solved by one or more high value platform technologies.  These opportunities, drivers and high value platforms are listed below.

The biggest opportunities in medtech:

  • Non-toxic, high strength closure and sealing of internal wounds (GI, pulmonary, cardio, etc.)
  • Closed-loop “artificial pancreas” comprising integrated glucometer and insulin pump
  • Versatile chronic wound management to accelerate healing of multiple chronic wound types
  • Non-invasive blood glucose testing (infrared, interstitial fluid or other approach)
  • Non-invasive large molecule drug delivery (transdermal, inhaled, encapsulated, etc.)
  • Interventional surgery (catheter or natural orifice) instrumentation
  • Infection control for nosocomial vectors
  • Organ replacement and transplant (preservation, bridge-to-transplant, etc.)

Drivers

  • Untreated or underserved, growing patient population
  • Cost containment
  • Eliminating lost productivity
  • Less invasiveness for lower cost, faster healing
  • Point-of-care (home, physician office, bedside) diagnostics for comprehensive screening and detection
  • Increasing demands for devices to be specific, be clinically effective and have small or non-existent long-term footprint

High Value Platform Technologies

  • Materials technologies incorporating one or more features of biocompatibility, adaptation, cell migration, drug elution, resorption, excretion or other easy removal
  • Adult, embryonic and other pluripotent stem cells
  • Gene therapy emerging from recent innovations (e.g., type 1 diabetes)
  • Interventional surgical technologies
  • Multi-parameter (MRI, CT, ultrasound, etc.) intraoperative imaging
  • Laparoscopic and natural orifice transluminal endoscopic surgery
  • Nanotechnology drug delivery, surface modification
  • Integration/fusion of information technologies with implants

We have identified these opportunities, drivers and platforms from research in a wide range of medtech markets, considering the state of the art in clinical practice, products/technologies on or nearing entry to the market, clinician and healthcare system perspectives, and the  current/forecast sales data for products in surgery, cardiology, spine/orthopedics, cell/tissue therapy, obesity, wound management, others.

See MedMarket Diligence Reports.

 

 

Technologies at recently identified medtech startups

Below is the list of technologies under development by medtech startups that were recently identified and included in the Medtech Startups Database.

  • Laser-based detection of metastatic cancer cells.
  • Ultrasound therapeutics.
  • Detection of concussion.
  • Orthopaedic implants.
  • Spine surgery implants including interspinous process spacers.
  • Technologies in ophthalmology.
  • Surgical implants including for hernia repair.
  • Stomal management solutions.
  • Ophthalmic drug delivery.
  • Device for the treatment of fecal impaction.
  • Developing low level light therapy for a variety of medical applications.
  • Device to prevent wound infections.
  • Targeted delivery of fluids including drugs and contrast media.
  • Implants for orthopedics, spine and trauma.
  • Various medical devices, including a device to assist laparoscopic surgery and pain management device.
  • Intraoperative nerve monitoring.
  • Treatment of peripheral artery disease.
  • Surgical instrumentation.
  • Minimally invasive device to treat collapsed nasal valves.
  • Minimally invasive treatment for venous reflux disease.

For a comprehensive listing of the technologies added to the Medtech Startups Database, see link.