Medical technology definitions and markets get blurry

Time was when a device was a device, a drug was a drug and biotech was . . . well, still in R&D.  When is a device a device? When is a duck a duck?  If it walks like a duck, sounds like a duck and looks like a duck, it’s a duck — or is it? You have to make certain that you carefully define your assumption of what defines a "duck" versus what is like a duck in appearance or what has duck-like qualities or what has aquatic grazing tendencies similar to ducks but in fact is a quite unrelated waterfowl.

Over the recent past (say, five years), the steady rate of development to make products do more, perform at higher standards, and to play more roles in achieving a more aggressive goal in clinical outcomes is seriously complicating any effort to categorize a technology into such previously neat niches. And it isn’t just at these higher levels of definition (of course, devices like stents are coated to impede restenosis, others in tissue engineering are made of materials designed to stimulate cellular in-growth and then just dissolve); it’s the subtle distinctions between otherwise similar products that make some issues more blurry. Issues like trying to assess market potential. So, when is a fibrin sealant a glue and when is it a hemostatic agent? When does a device compete with a similarly designed device and when does it in fact compete with a lifestyle change? It’s not simple enough anymore to be able to distinguish equipment from reusables. We no have to be able to separately measure usage of disposables, reusables and (I abhor this term) reposables. Perhaps most importantly, at least in the eyes of the weary medtech manufactuters, is the idea that competition has long since been changed from being defined as those products performing a similar, albeit narrowly-defined function, like when the angioplasty manufacturer could reasonable consider his/her competitors to be all other manufacturers of devices that produce catheter-based recanalization of the atherosclerotic lumen. Oh, woe the angioplasty manufacturer who does not now also consider atherectomy, transmyocardial laser revascularization, bare metal stents, drug-eluting stents, traditional/open, MIDCAB (and similar) or and even percutaneous coronary artery bypass graft, let alone the classes of drugs and other non-device approaches to produce non-surgical reversal of atherosclerosis. But any analysis of an established market and/or technology sector (see MedMarket Diligence Reports), must find a way to wrap up the data and weigh it in specific "market segment" bundles. As carefully as any such effort is handled, with assumptions laid out carefully, rarely is it any guarantee (trust us on this score) that all clients will see any particular market the same way, and they will be all too ready to challenge the notion of a hemostat, calling it instead a sealant, or a glue or some other moiety of their choosing, or insisting that a <5% market share does not make a company a "minor" player. To argue this is, of course, their perogative. So, bear with those like us when, however tedious it may seem, we methodically define a duck in excruciatingly explicit term so we can ensure that we gotten all "ducks" in a row and counted.

See a selection of our reports here.

 

Tags: medtech, device, implant, biotech, drug.

 

Bone and Other Allografts Worldwide

Worldwide Allograft MarketAllografts are the main “traditional” orthopaedic biomaterials. This market segment includes bone allografts (fresh, or freeze-dried bone; also demineralized bone) and soft-tissue allografts, including cartilage, tendons and meniscus.

The global market for all allografts was $1.5 billion in 2006, with bone allografts contributing half of that, soft-tissue allografts $500 million, and demineralized bone the remaining $250 million. The ligament and cartilage segments are expected to double from 2006 to 2011, and there will be even greater growth in the meniscus segment, but relatively slow growth in bone allografts. The reason for the anticipated surge in soft-tissue allografts is the increasing demand for repair procedures related to growth in more active lifestyles among affluent younger people. Bone allografts, by contrast, face increasing competition from synthetic bone substitutes and there is a continuing shortage of donor material.

(From “Emerging Trends, Technologies and Opportunities in the Markets for Orthopedic Biomaterials, Worldwide,” Report #G625.  Published December 2006.  See link.)

Tags: medtech, orthopedic, biomaterial, allograft

Medical/Surgical Sealants; Worldwide Growth

Sealants GrowthSurgical sealants and fibrin glues are biologically-based products designed to aid in the process of clot formation. Clotting is the first naturally occurring process in wound repair, and affects many subsequent biochemical processes in the wound healing cascade.

During the wounding event, blood from capillaries at the damaged tissue site seeps out and reacts with tissue proteins and air to cause platelets and complement factors to trigger the cleavage of pro-thrombin into thrombin which then changes fibrinogen into fibrin, the main insoluble component of a blood clot.

It was natural for practitioners, looking for effective haemostasis, to look at fibrin as a source of effective haemostatic activity. In the 19th century, physicians used fibrin powder to stop bleeding. During the period from 1940 to 1960, understanding of blood fractionation and the development of processes for preparing blood fractions, meant that a pure form of fibrin could be prepared and manufactured in a stable format.

Fibrin sealants represent the most useful of surgical hemostats. These products can be used to clot blood but are also used to seal around suture lines for organ transplants, mastectomies, and various resection procedures, to prevent leakage of fluids and gases. A number of companies have developed devices capable of preparing autologous fibrin and platelet formulations that can be used as sealants, and active mixes of growth factors to aid repair. Harvest Technologies, Plasmaseal, Thermogenesis, Biocoral Inc, and Interpore Cross Medical (Autologous Growth Factors product) are four companies with products designed to address this need.

Because sealants are often available as multicomponent systems that need to be mixed immediately prior to surgical application, several innovative devices have been developed to facilitate application. During product manufacture, the thrombin component and the Factor XIII/fibrinogen components are kept separate until required. Addition of fibrin product to a bleeding surface primed with the other component results in accelerated hemostasis and a sealing effect on the bleeding surface.

(From “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007-2011.” Published February 2007, MedMarket Diligence, LLC. For more information see report description, table of contents.)

Tags: medtech, sealants, fibrin, cyanoacrylate

Selected Medical/Surgical Sealant Product Companies and Their Strategies

Exhibit ES-8:  Selected Sealant Product Companies and Their Strategies

Company

Products and Prices

Strategy

Focal
division of Genzyme
Biosurgery

Focal
Seal L $30 per ml

Available for lung resections in Europe and as an adjunct for non-hemostasis
sealing in the USA. Focal exploiting light activated hydrogel IP.
Focal is strategically focused on exploiting unique sealant
capability of its products in neurological, cardiovascular,
gastrointestinal, and thoracic applications.

Angiotech

CoStasis
(Dynastat) $50 per ml

A sprayable liquid hemostat adjunct for use in surgical procedures to
control bleeding in specific clinical applications. Five year
agreement with Tyco for a broad range of indications in the USA,
Europe, Latin America, Middle East, Australia, New Zealand, and India.
Cohesion provides unique products for sealing and hemostasis
targeted at the full range of surgical procedures.

Fusion
Medical

Acquired by Baxter

Floseal
$28 per ml

Non-sealant hemostat for all hemostasis as an adjunct, including problematic
bleeding. Strategy is to develop patented products which combine
technologies incorporating a number of processed mammalian
biomaterials and have hemostatic benefits for surgery in demanding
actively bleeding procedures, and lead to rehabilitation and
re-operation benefits by reducing adhesion formation.

Baxter
Healthcare

Tisseel
$65 per ml

Homologous pooled fibrin, human thrombin, and bovine aprotinin. Adjunct for
hemostasis in an expanding range of indications. Baxter focuses on
biopharmaceuticals, vaccines, biosurgery and transfusion products and
provides products for medication delivery and dialysis. The bioscience
division of Baxter provides innovative solutions for biosurgery,
tissue regeneration and surgical hemostasis.

CryoLife

Bioglue
$45 per ml

Haemostatic adjunct for aortic dissection during surgery and may also be used
during lung procedures; contains proprietary mixture of bovine albumin
and glutaraldehyde. CryoLife focuses on providing donated human
tissue for surgical procedures. Recently has focused on developing
synthetic and engineered products as replacements for donated tissue.
CryoLife will continue to target Bioglue at procedures which require a
strong hemostatic tissue sealant, and compete on product benefits with
Tisseel etc.

Haemacure

Haemaseel
$65 per ml

Hemostat adjunct identical to Tisseel. Strategy to become a fully
integrated supplier of haemostatic and sealant products and to evolve
these into new uses such as drug delivery.

 

Source: MedMarket Diligence, LLC

From “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007-2011,” published February 2007. Click for details.

This report details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, from tapes, sutures and staples to hemostats, fibrin sealants/glues and medical adhesives. The report examines the clinical and technology developments underlying this huge and rapidly growing worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. This report is a market and technology assessment and forecast of products in wound closure. The report details the current and emerging products, technologies and markets involved in wound closure and sealing using sutures and staples, tapes, hemostats, fibrin and sealant products and medical adhesives. The report provides a worldwide current and annual forecast to 2011 of the markets for these technologies, with particular emphasis on the market impact of new technologies through the coming decade. The report provides specific forecasts and shares of the worldwide market by segment for the U.S., Europe (United Kingdom, German, France, Italy, BeNeLux), Latin America, Japan and Rest of World.

The report provides background data on the surgical, disease and traumatic wound patient populations targeted by current technologies and those under development, and the current clinical practices in the management of these patients, including the dynamics among the various clinical specialties or subspecialties vying for patient population and facilitating or limiting the growth of technologies. The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market over a ten-year forecast. The report also assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.

 

See http://mediligence.com/rpt/rpt-s145.htm.

Tags: sealant, fibrin, cyanoacrylate 

Medical product industry investment making a turn

Healthcare product (medical device and biotech) investment, like all investment in the past four years, has been pinched, but not so much as one might believe. The total investment has been relatively stable, and in fact has increased recently in the both the aggregate and for medical devices specifically. What is more the case with investment in the post-9/11 and post dotcom era is the conservative shift in that investment, notably a shift in investment from earlier or expansion stage of company development to later stage investments. We’ve talked about this before. (Perhaps the most telling aspect over the past four years has been that MedMarket Diligence experienced a big increase in information purchased from the investment community, apparently no longer satisfied solely with their own research.) The conservative shift is waning, however. We’ve read the tea leaves and see signs (numbers of deals, size of the deals, and numbers of startups forming) that opportunity-hungry investors are ready to take more chances.Expect the following to happen in 2006 – barring any unforeseen global event (let’s be safe, but let’s also live our lives!). Aggregate investment in healthcare products will take a healthy jump, with a measurably bigger share going to medical devices, and investment will shift back upstream in the development cycle. Many more deals, at bigger average investments (i.e., $10 million each).

Aggressive medtech development in lieu of perfect solutions

In reviewing a past report we produced on the management of obesity, which was addressed more recently in our October issue of MedMarkets, I was struck by the proliferation of companies pursuing surgical device solutions to obesity. These include variants of the gastric band approach, which simply reduces gastric capacity. The market for these devices has burgeoned in the past couple years, and is expected to grow aggressively. Why? For one, the stigma of obesity is fading as it is being viewed in the popular press more as the result of pathology than character flaw. This has opened the floodgates to people seeking a surgical solution. Reimbursement (not my forte) has at least not been an impediment. But why all the device development? This is a classic device-centric pathology; the stomach is a structure whose capacity can be readily reduced through gastric banding, it is a relatively simple surgical procedure and produces the immediate effect of reducing intake of food. This is, of course, also the rapid adoption phase of a market, and it is difficult (short of available long term data on approved devices – especially since most devices are not approved in the U.S., yet) to see the downside. It would be misguided of me to not acknowledge that devices are rarely (ever?) perfect solutions to pathology. But, I also recognize the tremendous potential for devices to achieve solutions that increasingly raise the barrier to the development of biotech/pharma/biopharm solutions to pathology, because devices, imperfect or limited in functional performance or fit with the premise of “rational therapeutics” though they may be, they are available now and are achieving solutions sine qua non.