Category Archives: surgery

topic is largely or exclusively about surgical products, technologies, markets and/or companies

Rising and fading technologies in the global market for wound closure

Technologies emerge, gain clinical acceptance, grow in caseload and become the standard of care. Then new technologies emerge, developed to improve on or eclipse established technologies. They gain acceptance and the cycle continues.

The pace of technology and market development in the products used in wound closure — sealants, glues, hemostats, sutures/staples, tape, and vascular closure devices — follow this path as characteristically as any medtech market. However, the pace of adoption varies both by technology type and geographic location. Consequently, there is a pretty wide range of compound annual growth rates in the sales of these product globally, regionally and by country.

Below illustrates the highest growth segment-geography combinations in the wound closure market. This frequently illustrates that novel technologies more rapidly penetrate well developed economies, which can sustain the initial high premium pricing of novel technologies, then progressively migrate to less well developed economies.  (For the sake of direct comparison, the high and low growth graphics are shown on the same scale.)

High Growth Segment-Geographies in Wound Closure

Screen Shot 2014-10-23 at 2.07.43 PMSource: MedMarket Diligence, LLC; Report #S192.

Low Growth Segment-Geographies in Wound Closure

Screen Shot 2014-10-23 at 2.07.52 PMSource: MedMarket Diligence, LLC; Report #S192.

Surgical Sealants and Glues in Wound Closure

Wound closure is a critical element of the overall wound management process. Indeed it is the most critical step in the sense that, if not accomplished promptly and effectively, can result in adverse outcomes ranging from chronic wound formation, infection and, unfortunately, death.

Sealants and glues have become an entrenched, though not dominant, aspect of routine clinical practice in wound closure. These technologies have demonstrated efficacy that has warranted their use independent of other closure technologies, such as traditional sutures and staples, or as adjuncts to them, and some of these products also are being employed as general hemostatic agents to control bleeding in the surgical field. Manufacturers have also developed surgical sealants and glues that are designed for specific procedures – particularly those in which staples and sutures are difficult to employ or where additional reinforcement of the internal suture/staple line provides an important safety advantage.

Surgical sealants are made of synthetic or naturally occurring materials and are commonly used with staples or sutures to help completely seal internal and external incisions after surgery. In this capacity, they are particularly important for lung, spinal, and gastrointestinal operations, where leaks of air, cerebrospinal fluid, or blood through the anastomosis can cause numerous complications. Limiting these leaks results in reduced mortality rates, less post-operative pain, shorter hospital stays for patients, and decreased health care costs.

Although some form of suturing wounds has been used for thousands of years, sutures and staples can be troublesome. There are procedures in which sutures are too large or clumsy to place effectively, and locations in which it is difficult for the surgeon to suture. Moreover, sutures can lead to complications, such as intimal hyperplasia, in which cells respond to the trauma of the needle and thread by proliferating on the inside wall of the blood vessel, causing it to narrow at that point. This increases the risk of a blood clot forming and obstructing blood flow. In addition, sutures and staples may trigger an immune response, leading to inflamed tissue that also increases the risk of a blockage. Finally, as mentioned above, sutured and stapled internal incisions may leak, leading to dangerous post-surgical complications.

These are some of the reasons why surgical adhesives are becoming increasingly popular, both for use in conjunction with suture and staples and on a stand-alone basis. As a logical derivative, surgeons want a sealant product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. In reality, it is difficult for manufacturers to meet all of these requirements, particularly with biologically active sealants, which tend to be pricey. Thus, for physicians, there is usually a trade-off to consider when deciding whether or not to employ these products.

It is useful to categorize surgical sealants, glues, and hemostats on the basis of their primary components and/or their intended use. The market for these products can be broken down (and has been done so in report #S192) by composition into products containing biologically active agents, products made from natural and synthetic (nonactive) components, and nonactive scaffolds, patches, sponges, putties, powders, and matrices used as surgical hemostats.

Global Market

The global market for products in wound closure is comprised of large, well established, and relatively low growth segments like sutures/staples; the low volume, low growth segments like surgical tapes; and the smaller, higher growth segments like vascular closure, hemostats, and surgical sealants/glues:

Growth and Size of Major Wound Closure Market Segments

 

s192-growth-size-bubbles

 

Sales ($millions) are 2014; Growth is CAGR 2013-2018.

Source: MedMarket Diligence, LLC; Report #S192 (published October 2014).

 

The MedMarket Diligence report #S192, “Worldwide Market for Surgical Sealants, Glues, and Wound Closure, 2013-2018: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”, details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, including tapes, sutures/staples, vascular closure, hemostats, fibrin sealants/glues and medical adhesives. The report details current clinical and technology developments, with data on products in development (detailing market status) and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. The Report provides full year actual data from 2013 and, for available companies, quarterly data from 2014. The report provides a worldwide forecast to 2018 of the markets for these technologies, with particular emphasis on the market impact of new technologies through the forecast period. The report provides specific forecasts and shares of the worldwide market by segment for Americas (detail for U.S., Rest of North America and Latin America), Europe (detail for United Kingdom, German, France, Italy, Spain, Rest of Europe), Asia/Pacific (detail for Japan, Korea, Rest of Asia/Pacific) and Rest of World.

The relentless proliferation of wound closure technologies

Sutures are not dead. They cling to the wound closure market as tenaciously as, well, non-resorbable sutures.

Though the mainstay in the management of acute and traumatic surgical wounds for literally hundreds of years, sutures have been giving up some of their hold on the market, as a result of a robust rate of development, introduction and clinical acceptance of a wide array of biologically-based, chemically-based or combination of chem/bio products that stop bleeding, seal wound edges to varying degrees (adjunctively and independently) and otherwise close and heal wounds. The value of these products ranges from the critical, such as in new hemostat products with the potential to revolutionize treatment of battlefield wounds, to the aesthetic, with sealants that can dramatically reduce or eliminate scarring.

As the ancient Greek philosopher Heraclitus recognized, however, you cannot put your finger in the same river twice. The surgical arena continues to change dramatically and it challenges and creates enormous incentives for manufacturers to keep pace by developing novel wound closure technologies. Laparo-endoscopic innovations from conventional laparoscopy through single port laparoscopy to natural orifice transluminal endoscopic surgery established new requirements for the manipulation of tissue and manufacturers responded with a wide range of endoscopic sutures, staples, clips and appliers to facilitate MIS procedures.  Even sutures themselves have been reengineered to dissolve in controlled ways to enhance the end result of wound closure.

But where sutures were once THE universally accepted manner to bring wound margins together, they are now challenged on all sides by fibrin and other surgical sealants, hemostatic agents, vascular closure devices, cyanoacrylate and other high strength surgical glues and even sophisticated tapes. For now, sutures hold the slim margin of dominance in this aggregate market, but by 2018, the overall market for wound closure will be represented in the majority, by products other than surgical sutures and staples:

Worldwide Surgical Wound Closure Products Market, by Device Segment, 2018

closure-shares-2018

Source: MedMarket Diligence, LLC; Report #S192

 

New Medical Technologies at Startups, September 2014

Below is a list of new technologies under development at medtech startups recently identified and included in the Medtech Startups Database:

  • Robotics for ophthalmic surgery.
  • Dynamic force generation for bone repair.
  • Neursurgical brain simulation system.
  • Orthopedic technologies including pedicle screw that does not require a guide wire.
  • Synthetic bone graft materials.
  • Minimally invasive mitral valve replacement.

For a historical listing of the technologies under development 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.

Effective technologies for wound hemostasis, sealing and closure

See the pending 2014 Report #S192, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2013-2020″.

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 are the most common.

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 simple hemostasis (i.e., as sealants and low-strength glues) lags that of markets outside the U.S.

Despite the development of novel sutures (e.g., resorbable), endoscopically applied clips and other innovations, fibrin sealants will remain a versatile option available to surgeons to achieve hemostasis and sealing of wounds (alone or adjunctively with sutures/staples). Their clinical track record, biocompatibility and ready availability match high demand. Their limitation in adhesive strength, however, does put some limit on their sales potential, since significant demand exists for tight sealing and strong bonding of tissues under stress, such as in lung and bowel resections, cardiovascular and other anastomoses and adhesion of muscle, that go beyond what fibrin sealants can achieve. For this reason, other naturally-occuring “bioglues” are under development that will achieve tighter tissue bonds than fibrin sealants, but without the toxic effects of cyanoacrylates (“superglues”).

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. (This report is being updated by the pending 2014 Report #S192.)

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.”

Wound technologies being adopted at varying rates globally

The success of specific wound management products in the market ensues from their ability to produce clinical outcome in environments where there are clinical, economic and other incentives for that success.  The different technologies are used in different healthcare systems/countries/markets with different patient demographics, practice patterns and other variables, resulting in widely variable levels of market success.

Gauze dressings, bioengineered skin, alginates, negative pressure devices, cellular growth factors, hydrogels, antimicrobial dressings — all of these products (and more) represent the practice of wound management for the entire spectrum of wound types and severities.

Practice patterns, regulatory requirements, price pressures, healthcare delivery system gatekeepers, demographics, cultural sensitivities — the net effect of these forces and others dictate the size and outlook of the markets for different wound management products in global markets.

Screen Shot 2014-05-13 at 9.20.35 AM

It’s no surprise, then, that product sales are growing (or declining) at different rates in different regions of the world, but the data is clear on this. MedMarket Diligence researched and published this data in its global wound management market Report #S249, which details the clinical practice of wound management, the products on the market and in development, the current and forecast markets for each worldwide and regionally and the competitors vying for market presence now and in the future.  Research from primary and secondary sources, the global wound market data illustrated above (which is also detailed by country) and presented in Report #S249 is a compelling read for market participants.