Category Archives: medtech

topic is about medical technology of different types, describing specific products under development, the market for them or their impact on healthcare

Wound care market analysis shows challenges for acceptance of even the best medtech advances

The clinical practice and business of wound management encompasses virtually every type of surgery as well as trauma and disease.  Therefore, any advances in wound management — those resulting in faster healing of wounds; reduction in infections, scarring and other complications; and reduced cost in general — have the potential to impact big numbers in annual caseload. Were the markets to only operate on a correlation linking new medtech with direct clinical/economic benefit, the hurdles for medical product innovators would be far less challenging to surmount.

Market restraints to new medtech adoption, even for cost-reducing advances are often (ironically) represented by the high direct cost of the new technologies. Many countries’ have healthcare budgeting systems that are a real challenge for advanced wound care products, since such products may be proven to decrease healing times and hospital costs over the longer run, but in the short run the evidence may not be clear enough to warrant changes to existing expenditures. The development of substitute products threatens existing product categories and accepted clinical practices, while the need for definitive clinical and economic evidence backing new technology hinders growth and acceptance of some of the more advanced wound management technologies. In addition, improved wound prevention and a lack of regulation on tissue engineering in the EU are also expected to hold back the development of new technologies.

In addition to market restraints, there are a number of drivers which are expected to shape this market in the years to come. One of the primary drivers is the aging of the global population. Chronic diseases, such as circulatory conditions, anemias and autoimmune diseases influence the healing process as a result of their influence on a number of bodily functions. Illnesses that cause the most significant problems include diabetes, chronic obstructive pulmonary disease (COPD), arteriosclerosis, peripheral vascular disease (PVD), heart disease, and any conditions leading to hypotension, hypovolemia, edema, and anemia. While chronic diseases are more frequent in the elderly, wound healing will be delayed in any patient with underlying illness. Fortunately, most wounds heal without delay or complication. However, chronic wounds, such as those exacerbated by disease like diabetes, limited patient mobility and other problems, may take months or years to fully close, or may never close. Chronic wounds adversely affect the individual’s quality of life, and are a leading cause of burgeoning healthcare costs.

Advances in wound management technology that are leading to improved economic and clinical outcomes include:

  • “interactive” wound healing products that accommodate or respond to changes in the wound environment (e.g., via oxygen permeability or extraction of wound exudate)
  • “bioactive” wound healing products that capitalize on biological properties of wound product components to remove exudate, reduce infection and otherwise improve wound healing
  • physical systems such as NPWT, hyperbaric oxygen and others that more aggressively change the wound environment to respond to more problematic wound types
  • tissue replacement and substitution approaches to provide clinical solutions for wound types that, due to the wound severity and/or extent, cannot simply be addressed by conventional wound care products.

Wound care products are the subject of the new report from MedMarket Diligence entitled, “Worldwide Wound Management, Forecast to 2020: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”, report #S249.

Track medtech financings in January 2013

Fundings for medical technology companies for the month currently stand at $281 million.  Top fundings for the month include:

  • $85 million for Insulet Corp. (insulin pump)
  • $45 million for LipoScience, Inc. (NMR diagnostics)
  • $23.8 million for Ocular Therapeutix (ophthalmic drug delivery)
  • $22.3 million for Tryton Medical (stent for bifurcated coronary lesions)

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

Please see our prior post on medtech financing trends 2009-2012. Fundings for medtech in 2012 came in at $5,014 million, just 2% off from the $5,121 million raised in 2011.

Size and Growth of Global Wound Care Segments, 2012-2020

The global market for wound care is, in the aggregate, growing at modest pace of just under 6% through 2020.  However, there is widely variable growth among the product segments contributing to the total, with well established wound care markets essentially flat and novel wound care technologies growing at much more robust rates.

The major segments of the wound care market include the following:

  • Traditional Adhesive Bandages
  • Traditional Gauze Bandages
  • Non-Adherent Bandages
  • Film Dressings
  • Foam Dressings
  • Hydrogels
  • Hydrocolloids
  • Alginate Dressings
  • Antimicrobial Dressings
  • Negative Pressure Wound Therapy
  • Bioengineered Skin & Skin Substitutes

Below is illustrated the global wound care market comprised of segments, with the “bubble” sizes and position on the vertical representing the current (2012) sales and the position on the horizontal axis representing the compound annual growth rate for each segment from 2012 to 2020.

s249-size-growthSource: MedMarket Diligence, LLC; Report #S249

 

Medtech Financing Trend — Put Simply, Up

Medtech financing has been volatile over the past few years, but our review of the month-by-month financings (tallied from ongoing efforts at tracking each and every medtech financing) shows that the trend is decidedly upward.  Below illustrates the trend from early March 2009 to December 2012, with the data smoothed by calculating rolling three month averages and a calculate trendline inserted.

financing_mar09-dec12

Source: Compiled by MedMarket Diligence, LLC

The individual monthly financings are tallied and detailed at link.

For reference, we track medtech fundings by SEC filings, company press releases, brokerage reports and other sources, with the definition of “medtech” as follows:

We view medical technology (medtech) as principally 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.

 

New Global Wound Management Market Report from MedMarket Diligence

Global Wound Management Market to Reach Nearly $13 Billion, New Report from MedMarket Diligence

Considering a wide range of dressing types and the more novel negative pressure wound therapy and bioengineered skin/substitutes, global wound product sales will reach nearly $13 billion in 2013, according to a new MedMarket Diligence report.

PRLog (Press Release) – Jan. 9, 2013 – Despite limitations to growth of wound care products stemming from reimbursement and regulatory approval of more advanced products, the global wound management market is growing steadily as a result of improved, cost-effective products addressing the upward trending caseload of otherwise costly slow-healing wounds. The result is that sales of wound management products have grown and will continue to grow at a sustainable rate for the next decade.

“Wound care is a medtech market that focuses the attention of manufacturers on continually applying insights in wound etiology to products that exploit the body’s natural healing processes to accelerate wound healing,” says Patrick Driscoll of MedMarket Diligence, publisher of a new global report on wound management. “This has driven the development of a wide range of dressing types with novel materials, advanced physical wound healing technologies and bioengineered skin.”

Underlying most wound care growth is the demographics of an aging population and the growing incidences of chronic diseases, which impede the healing process due to their involvement in a number of bodily functions. Illnesses that cause the most significant problems include diabetes, chronic obstructive pulmonary disease (COPD), arteriosclerosis, peripheral vascular disease (PVD), heart disease, and any conditions leading to hypotension, hypovolemia, edema, and anemia. While chronic diseases are more frequent in the elderly, wound healing will be delayed in any patient with underlying illness. While most wounds heal without any problems, chronic wounds may take months or years to fully close, or may never close. Chronic wounds adversely affect the individual’s quality of life, and are a leading cause of burgeoning healthcare costs.

The new MedMarket Diligence report is entitled, “Worldwide Wound Management, Forecast to 2020: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”. The report details the complete range of products and technologies used in wound management and wound care, from dressings, bandages, hydrogels, skin and skin substitutes, negative pressure wound therapy (NPWT) and others. The report details the current clinical and technology developments in the worldwide market providing a current assessment of products in development and on the market; market size and forecast; competitor market shares; 52 key competitor profiles; and an assessment of the market opportunity for current and hopeful competitors. The report provides full year (actual) 2011 market size and share data, with forecast market data to 2020, for the Americas (with detail for U.S., Rest of North America and Latin America), Europe (with detail for United Kingdom, Germany, France, Spain, Italy, and Rest of Europe), Asia/Pacific (with detail for Japan, Korea and Rest of Asia/Pacific) and Rest of World.

This report’s emphasis is on advanced and leading edge developments (i.e., those approaching wound management from novel perspective) such as growth factors, stem cells, gene therapy and other approaches, while baseline data (current and forecast market size and current competitor market shares) is provided for established segments — multiple dressings types (film, foam, alginate, antibacterial, non-adherent), hydrogels, hydrocolloids, and NPWT. The report details the clinical and technology developments underlying the clinical practice and market development in wound care market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. Separate size, growth and competitor data are presented for the U.S., leading western European countries, Japan and the Rest of World category. The report’s company profiles assess key companies regarding current/projected products, technologies and positions in the advanced wound care market.

The wound care market is dominated by Johnson and Johnson, 3M, Smith & Nephew, and Systagenix, but is also driven by a large number of mid-size and smaller companies effectively pursuing niches in the market.

The report is described in detail at http://www.mediligence.com/rpt/rpt-s249.htm.

The report may be purchased online for immediate download from https://www.mediligence.com/store/page44.html.

For other MedMarket Diligence reports and other content, see http://www.mediligence.com.

[MedMarket Diligence Reports are produced through primary and secondary research. Data is gathered from published sources on products and technologies on the market and under development. Clinicians and industry representatives are interviewed for their knowledge and insights on product development, market development, clinical practice and trends associated with the evolving use of technologies. Secondary data is used to corroborate and support assessments and projections. Reports are written and researched by industry insiders, whose familiarity with the companies, industry dynamics and other marketplace specifics facilitate the research process and ensure high quality and thorough reports.]

2013 Medtech Outlook

The 2013 Medtech Industry — Some General Predictions

In 2012, much has been made of the Affordable Care Act or, more precisely, the 2.3% excise tax on medical devices used to fund the addition of 30 million new patients to the U.S. healthcare system. Despite a chorus of voices for a repeal of the tax, with repeal arguments that range from credible to absurd, the tax is likely to stay in place.  With the influx of new patients in 2013 and beyond, the cost versus benefit will become clear, but we forecast that the debate on the excise tax will linger well into the new year.

The U.S. and global economy have been recovering with growing momentum following several stagnant years.  Just as a rising tide floats all boats, the stronger economy in 2013 will help drive medtech though more available capital leading to increased spending by healthcare systems for increased inventories and investment in new technologies.

Investment in medtech will likely show modest increase as money that has been previously stored in the “safe harbor” of medtech investment will shift back to non-medtech investment targets that have now been made more attractive by the stronger economy. In the recessionary economy of post 2008, medtech investment has favored later stage (i.e., “less risky”) technologies — those already in or about to enter the market.  Now, with hunger for larger returns in the stronger economy, the money that will flow into medtech in 2013 will be more inclined to fund earlier stage products and companies.

Physicians and companies will not part ways, but in 2013 they will not be so cozy, given the Sunshine Act’s intention to reveal how cozy they actually are in order to eliminate financial bias in physician endorsement of new technology. Even before the Sunshine Act, the writing has been on the wall that the links between physicians and companies have been too close. Greater scrutiny of these links will create challenges for medtech to ensure that clinical validation of new technologies will be unbiased.

Trends associated with the FDA include steady progress in reducing review times, closer scrutiny of off-label uses, more stringent attention to false or misleading claims and, in general, an uptick in enforcement. We forecast that the regulation of medical devices will become increasingly complex as the FDA seeks to address deficiencies in the 510(k) process and, in general, complete reviews more efficiently to satisfy the needs of industry and needy patients without compromising device safety.

The regulatory process will also become further challenged as it faces new definitions (or lack thereof) for “medical devices”, since the marriage of drugs and devices (i.e., hybrids), the growth of resorbable implants and other innovation trends blur the previously distinct boundaries between drug, device, biotech and other products.

2013 will also see the emergence and/or expansion of multiple medtech markets.

  • Expect a growing number of developments in neurology-focused therapeutics such as neuromodulation, the expanded use of hybrid devices in cardiology (including bioresorbable stents).
  • The press for minimal invasiveness and the capacity of medtech to respond through innovation will drive development and adoption of new technologies paradigms such as NOTES (natural orifice transluminal endoscopic surgery) technologies; transcatheter technologies and other medical/surgical technologies that dramatically reduce the need for surgical incisions or other invasiveness; non-invasive diagnostics such as glucose meters in diabetes
  • Surgical and interventional procedures are increasingly being integrated with more sophisticated pre-operative and intraoperative (“real time”) imaging systems that enhance the physician’s ability to direct therapy more effectively at pathologies with less collateral damage, reducing complications, accelerating recovery and otherwise improving patient outcomes.  Some of these systems, such as intraoperative MRI, are very sophisticated and accordingly expensive, so benefit/cost may limit adoption but for the most at risk caseload.
  • The blessing in disguise that was the Bush administration’s ban on federal funding of embryonic stem cell research led to a burst of research in adult stem cells that bypassed the embryonic stem-cell ethical dilemma. With the Obama administration’s subsequent lifting of the federal ban, both embryonic and adult stem cell research is proceeding at breakneck pace.  2013 is therefore likely to see an equally powerful burst of advances leading to practical therapies based on stem (or pluripotent) cell technology.
  • Driven by research indicating important, patient-specific differences in physiology that impact the effectiveness of medical devices and other medtech, 2013 will show an increase in customized or personalized medicine.  The diagnostic component will include genetics-driven predictors of disease while the therapeutic will include a wide range of product types, from the development of autologously cultured tissues or stem cell-derived tissues, and custom-fitted implants in cardiology, orthopedics, general surgery and other specialties.
  • 3D printing is being applied to medtech in both prototype development and in such seemingly far-fetched ideas as organ printing, which is actually in active development.
  • Biomaterials, or materials technology in general, increasingly expand the number of possibilities of what can be achieved with medical devices and other medtech products. Drug-coated devices, drug-delivery devices, extracellular matrices, bioresorbable implants, nanotechnology-based and other coatings and a wide range of other materials technologies are enabling medtech products to be more disease-specific, less toxic, less prone to biocompatibility issues, less likely to be associated with procedure-specific collateral damage and otherwise more effective in achieving high quality outcomes at lower overall cost.

There will also be secondary forces impacting medical technologies. By this, we mean forces in the innovation of non-medical technologies or other forces that are changing the use and/or implementation of medical devices. First among these is forces for the integration of information technologies in medical devices encompassing infusion pumps and other “smart” devices, radiofrequency identification systems, wireless telemetry and others.

While we are more focused on medical technologies than on technologies like information systems that affect more of the logistics than the clinical delivery of healthcare, it should not be overlooked that healthcare in 2013 will also be characterized by steady growth in the application of information technology.  At its simplest level, information technology in healthcare is the management of healthcare information — electronic medical records, healthcare information systems, picture archiving and retrieval, etc. But to a much greater degree, information technology is impacting healthcare through several key areas:

  • Computer aided design and prototype development. Conventional use of computer aided design in the development of medical devices is already common, but increasingly sophisticated programs and systems are being developed to optimize device design to reflect a more comprehensive understanding of the forces, dynamics and anatomy of patients, as well as the more thorough understanding of pathology. With the use of CAD and 3D printing, prototypes can be quickly produced that, if not functional, can facilitate the development of ideas toward functional prototypes. In cardiology, flow dynamics have been recognized as a critical aspect effectively applied through computer aided design of vascular stents, catheters, embolic protection, aneurysm repair and many others. In orthopedics, the use of CAD is facilitating customized implants.
  • Systems biology and the demand for multivariate analysis. One of the most significant long term objectives of medical device (or medtech) development is the innovation of products that more comprehensively address disease states (or wellness) by integrating understanding of anatomy, physiology, chemistry, genetics, physics and all other possible disciplines having potential impact on the long term efficacy of a medical product.  While there is fundamental science to be learned to achieve such a multivariate understanding/solution, and this is a long-term goal well beyond 2013, the increasing recognition of diverse factors impacting product efficacy is incrementally improving each new product embodiment — and such work is a part of product development already.  The concurrent interplay of alternative device (or other medtech product) configurations with myriad biological, physical and other forces demands information technologies that are able to predict downstream effects of each possible innovation.

[Please note we are continuing to review new medtech development efforts and analyze their potential impacts so that we may update our 2013 forecast here.]

 

Mussel adhesive finds potential cardiovascular application

In a further advance leveraging the adhesive qualities of “bioglues, or naturally-derived materials used in nature — such as the adhesive that allows mussels to hold fast to rocks despite the churning waters around them — a University of British Columbia scientist has developed a gel modeled after the mussel peptide that might be used to prevent the rupture of atherosclerotic plaque in blood vessels.  The research is published in the Proceedings of the National Academy of Science’s current issue of the online journal, PNAS Early Edition (see also http://phys.org/news/2012-12-mussel-goo-blood-vessel.html#jCp).

A whole class of biologically-derived adhesives — “bioglues” — including those from mussels, geckos, crab shells, burrowing frogs, spider webs, porcupine quills and even bacteria, are under investigation for their potential human clinical applications. (See link.)

A wide range of materials are in use and in development for medical applications in adhesive, sealing, hemostasis and other wound management functions.  See the press release from MedMarket Diligence (3/5/2012).

Fibrin and other sealants and surgical glues are the subject of the 2012 MedMarket Diligence report #S190, “Sealants, Glues, Wound Closure and Anti-Adhesion Worldwide Markets, 2012-2017.”