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

Requirements for effective surgical sealants

Tourniquet, pressure and sutures have been used for controlling excessive bleeding during surgical procedures for many hundreds of years. Fibrin sealants represented a revolution in local hemostatic measures for both bleeding and nonbleeding disorders. Fibrin sealant has the potential to provide life-saving control of excessive bleeding in many critical surgical operations and during a number of elective procedures. The terms “sealant” and “glue” are frequently used interchangeably in the surgical context, but there is actually a difference in adhesive strength between sealants, pioneered by fibrin products (sometimes homemade) and the later, stronger glues of which cyanoacrylate-based products were the leaders.

In order for a sealant to be effective, the product should meet several parameters, depending upon the application. Among these are:

  • Ability to close the wound
  • Strength of bond
  • Speed of curing
  • Protection of the wound from infection
  • Low surface friction
  • Breathability in order to aid healing
  • Lack of adverse side effects to skin and internal tissues
  • Cost-effectiveness
  • Ease of handling

Fibrin and other sealant products have been approved and used outside the United States for many years and their use has created strong awareness of their surgical and economic benefits in Europe, Latin America and Asia. As a result, many such products have been marketed in these regions for 20 years or more, and have been developed for a variety of surgical uses. In the U.S., these products were initially approved as hemostatic adjuncts to suturing. They are increasingly being used for sealing of tissues, but their use beyond hemostasis (i.e., as sealants and low-strength glues) lags that of markets outside the U.S.

There are more than 30 companies worldwide developing fibrin sealants and driving a market that will exceed $2.2 billion by 2017.

sealants-regional-forecast

 Source: MedMarket Diligence, LLC; Report #S190.

For complete analysis of the global market for fibrin sealants, see the MedMarket Diligence Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017.”

High and low growth wound care sales by country

Wound care product sales are growing at wildly variable rates around the world, with extremes spanning from the emergence of new technologies in rapidly growing economies to the technologies with low innovation in sluggish economies.

MedMarket Diligence’s global analysis of wound care products, technologies, companies and markets reveals the full spectrum of growth rates for well established to rapidly emerging products.

Below is illustrated the high growth country/product segments in wound management, reflecting the rapid adoption of new technologies such as growth factors and bioengineered skin, as well as older products such as alginates that are gaining sales in rapidly developing economies.

wound-country-high

Source: MedMarket Diligence, LLC; 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.”

At the other end of the extreme are those very well established products growing at less than anemic rates in countries where the economy is not as robust and/or where the growth has been superseded by sales of more novel products. Conventional dressings and bandages offer considerably less demand than do growth factors, bioengineered skin and skin substitutes and similar new products.

wound-country-low

Source: MedMarket Diligence, LLC; Report #S249

Of course, growth of sales in wound management products (and any product) is defined as the percentage change in sales volume over time. Smaller markets (typically soon after they have formed as a result of their initial commercialization) tend to grow on a percentage basis much faster. Indeed, a $1 dollar sale in year 1 followed by a $2 sale in year 2 represents a 100% growth rate, while a $1 increase in sales from year 1 to year 2 for a $100 million market represents virtually zero growth. Conversely, a 1% increase in a $1.75 billion market is a $17.5 million increase. This is indeed obvious, but must be kept in mind when considering the growth rates discussed above.

Technologies at startups identified in 2013 (through April)

Below is a list of the technologies at startup companies identified thus far in 2013 and included in the Medtech Startups Database:

  • Surgical tools for arthroscopic procedures.
  • Fractional flow reserve guidewire method to obtain FFR measurements during coronary catheterization procedures.
  • Technology to ensure accurate intraoperative placement of hip and knee implants.
  • Neurological diagnostics to measure biomarkers, regulate drug dosage, others.
  • Respiratory monitoring devices, such as a “sleep sensors” shirt to enable less invasive monitoring for apnea or other respiratory conditions.
  • Endoscopic, minimally-invasive harvesting of veins used for coronary artery bypass grafting.
  • Ophthalmology diagnostics; binocular device for eye exams.
  • Device-based treatment for respiratory disease.
  • Undisclosed ophthalmology technology.
  • Catheter-based medical devices for the treatment of cardiovascular disease
  • Extracorporeal rotary blood pump system designed to increase eligibility for the arteriovenous fistula (AVF) vascular access site for hemodialysis and to increase AVF maturation success.
  • Organ-specific stem and progenitor cells for use in research and therapeutic application, including stem cell transplants for lymphoma and leukemia.
  • Egg precursor cells for the treatment of infertility.
  • Polymer-based adhesive tissue tape for use as a surgical sealant.
  • Devices that are visible yet safe in radiofrequency and magnetic resonance fields.
  • Tissue removal device for removal of soft and hard tissue in orthopedics.
  • 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.

Source: MedMarket Diligence, LLC

Wound prevalence by types, worldwide

The bulk of wound types driving the use of products for wound sealing, closure, hemostasis and anti-adhesion are surgical incisions made for the purpose of treating disease. While this figure is over 100 million annually on a global basis, its significance as a force for the use of wound closure and related technologies must be tempered by the fact that surgical incisions are intentionally made and therefore are made by surgeons and other clinicians with advanced expectation of how the wound will be closed.  By contrast, wounds of other types offer a degree of complexity and unpredictability that, even in their lower numbers, represent a markedly bigger challenge for clinicians to manage.  Indeed, the most significant costs in wound management ensue from chronic wounds, which arise as a result of inadequate circulation, excess pressure, infection, complicating disease or conditions (e.g., diabetes, obesity) and other factors.

Below is illustrated the global distribution of wound prevalence by type of wound (2011).

wound-prevalence-pie

Source: MedMarket Diligence, LLC; Report #S190 and Report #S249.

Types and Uses of Wound Care Products

Wound care products take many forms based on the type of function provided by the product, the wound type and its severity.  Excluding for the moment the emerging array of physical wound healing systems (e.g., NPWT, hyperbaric oxygen, etc.), there are quite a number of combinations, and as new materials emerge, such as types of media or means to deliver wound care, the combinations are expected to multiply.

Below is illustrated a representation of wound product types, forms and applications.  This now includes the rapidly growing field of growth factors in wound care, which may be delivered by many different methods, including carrier or media types.

Types and Uses of Wound Care Products

woundcare-product-types

Sources: Murphy, P.S. et al. Plastic Surgery International Volume 2012 (2012), Article ID 190436, 8 pagesdoi:10.1155/2012/190436; MedMarket Diligence, LLC, Report #S249.

Medtech fundings for April 2013

Fundings for medical technology during April 2013 totaled $422 million. Top fundings included:

  • $40 million for electroCore Medical, LLC (non-invasive vagal nerve stimulation therapeutic devices)
  • $39.3 million for Celator Pharmaceuticals (nanoparticle-based drug delivery in cancer)
  • $33 million for Esperion Therapeutics (LDL-lowering therapies)
  • $32.2 million for Watermark Medical, Inc. (sleep apnea diagnostics)
  • $29 million for Vaportherm (treatment for COPD, other respiratory)
  • $25.5 million for Solta Medical (medical aesthetics)
  • $25 million for Topera, Inc. (electrophysiology mapping systems)
  • $22.6 million in an IPO for InspireMD (vascular stents)
  • $20 million for Avinger (intravascular imaging)

For the complete list of fundings for April 2013 see link.

Growth versus current share in global wound management products

Sales of products in global markets for wound management are in a fairly dynamic state of flux, especially for the very large, well established market that it is.  Traditional wound management products — dressings and bandages that do little more than keep debris out of wounds — are being challenged aggressively by products playing a considerably more active role in accelerating wound healing and preventing the complications and costs inherent in chronic wounds.

The market for even commodity-like dressings products continues to grow, driven by increased prevalence of many wound types and supported by these products’ ease of use and low cost.  However, the markets for more advanced products are growing at substantially higher rates as a result of the ability of these products (or the perception) to provide faster, less costly or otherwise better wound healing.  The net effect is that all segments of wound management product sales are growing (see Exhibit 1), although a variable rates, resulting in considerable shifts in each segment’s share of the total wound market (see Exhibit 2).

Exhibit 1

3013-03-27-CAGRs

Source: MedMarket Diligence, LLC; Report #S249.

Exhibit 2

3013-03-27-wound

Source: MedMarket Diligence, LLC; Report #S249.

Consequently, the rapid growth in sales of advanced products is shifting the balance of sales away from traditional products.

As rapid as the growth of advanced wound product sales is, there is still a long competitive battle to wrest control of a large share of wound management from traditional bandages and dressings (see Exhibit 3).

Exhibit 3

3013 03 27 wound pie

Source: MedMarket Diligence, LLC; Report #S249.