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.

 

Trend and distribution in clinical/technology focus of medtech startups

MedMarket Diligence has been tracking the formation of medtech startups for over a dozen years. For the sake of definition (since not everyone has the same view of “medtech” or “startup”), we view “medtech startups” as: Medtech companies are those principally developing and/or marketing medical devices and equipment, but also all technologies that are directly competitive with or complementary to technologies represented by therapeutic or diagnostic medical devices/equipment. Startups are companies typically founded within the two preceding years and often much sooner (months or weeks preceding).

Below is illustrated the clinical/technology distribution of medtech startups identified by MedMarket Diligence and included in the Medtech Startups Database:

startups-summary-may-2013

Note: Medtech startups may be categorized multiple ways (e.g., surgery and minimally invasive and spine).

Source: Medtech Startups Database.

The number of companies identified over time is illustrated below, with detail on the clinical and technology categories of each, with the overall shape of the curve reflecting both our ramp-up in the process of identifying companies and the rate of companies being formed (note, given the number of categories tracked, it is best to simply observe the overall distribution rather than the detail on specific categories, and for this reason the above graph shows the numbers by descending order of categories):

startups-summary-category-year-may-2013

Note: Medtech startups may be categorized multiple ways (e.g., surgery and minimally invasive and spine).

Source: Medtech Startups Database.

The decline in numbers of startups subsequent to 2007 reflects the global recession and its harsh impact on the availability of capital to support new company formation.

Medtech fundings for May 2013

Fundings for medtech companies in May 2013 came in at $703 million. Top fundings for the month were:

  • $175 million for Ophthotech Corp. (treatment for wet AMD)
  • $78 million for Tornier, N.V. (joint replacement and soft tissue repair)
  • $62.5 million for Proteus Digital Health (wearable and ingestible sensors)
  • $54.6 million for Natera (prenatal diagnostics)
  • $40.3 million for Rockwell Medical (products for ESRD and chronic kidney disease)
  • $38.23 million for Silk Road Medical (endovascular treatment of neurovascular disease)
  • $35.17 million for Emisphere Technologies (drug delivery technologies for large molecule oral delivery)
  • $24.9 million for Cardio3 BioSciences (regenerative therapies for damaged myocardium)
  • $22.24 million (€17 million) for STAT-Diagnostica (rapid, comprehensive diagnostic device)
  • $20 million for BPL Medical Technologies (defibrillators other patient management/monitoring)

The complete list of medtech fundings for May 2013 are detailed at link.

See below for the trend in fundings from 2009 through 2013 thus far (with trendline).

Fundings-2009-May-2013

Source: Compiled by MedMarket Diligence, LLC (see detail at link)

 

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.

Advanced wound technologies penetrating, expanding markets

Advanced medical technologies gain footing in medical technology markets by a combination of displacing caseload previously served by older, established technologies, and tapping into previously unserved (or underserved) caseload by offering new product benefits. In other words, new technologies gain sales by both penetrating existing markets and actually expanding the current market.

The global wound care market is characterized by such a shift toward advanced technologies, where the overall gain in sales of new technologies is accounted for by both the displacement of traditional product sales and the added caseload of patients previously untreated or under-treated.

Below is illustrated the shift in share of the total market arising from each of the multiple different wound management technologies. Growth in the market (and resulting decline of traditional technologies) is arising from growth factors, bio-engineered skin & skin substitutes, as well as growth in some older but still advancing technologies driving growth in foam and alginate dressings.

adv-wound-share

Source: Report #S249, “Worldwide Wound Management, 2012-2021.”