Medical devices versus nature

If one is in the position of needing to look to the future of medical technology to identify opportunities or predict challenges in the market (and who in this industry is not?), then it is hard to not factor into the analysis two very different current trends and play them out toward the resulting future market impact. One trend is the biotech-driven trend of elucidating natural processes of health, disease and healing in order to exploit understanding of the natural sciences to solve medical problems. The other trend is the technology-centric trend of developing hardware, largely surgical or at least interventional technology, that may dramatically achieve better surgical/interventional endpoints. To (over)simplify, one could say this is the biotech versus device polemic, but that really does simplify the dynamics too far, suggesting there is ultimately an either/or conclusion, which is false.

A group at Harvard-MIT earlier this year reported in the Proceedings of the National Academy of Sciences on a flexible, waterproof and even biodegradable bandage based on the sticky feet of the gecko. The lesson of the gecko is that the gecko’s stickiness comes from nanoscale fibers or "pillars" that increase the surface adhesion, which the Harvard-MIT team mimicked in the construction of the tape with nanostructures in the surface. Now, while this does not really represent a biological solution (such as the protein-based glue used by mussels to attach to surfaces; see also Report #S175), the study of natural processes revealed a solution that could be modeled in medical technology. This points up the huge number of opportunities that reside in nature directly (e.g., mussel glue) or indirectly (nanostructured adhesive based on the gecko). After millions and millions of years of evolution that has produced survival advantage for the natural world, it would almost be viewed as foolish to pursue solutions to medical problems without considering that those problems have already been solved, somewhere, in nature. Some scientists are convinced, for example, that the biological diversity resident in the Amazon rain forest holds cures for cancer and many other diseases.

At the other end of the spectrum is technology like the Da Vinci (Intuitive Surgical, Inc.), a four-arm, flexible wrist robot on which are mounted miniaturized tools and cameras controlled by a surgeon, at a cost of $1.4 million, not including the cost of parts, maintenance and training. The system enhance the precision of surgeons performing prostate surgery and is also being adapted to the performance of hysterectomies, fibroid removal (and other gyn procedures), heart valve replacement and kidney surgery. The system enable a level of control that is simply not possible by the freehand surgeon, which enables much more challenging procedures, ones that may heretofore have been inoperable or simply not possible without causing unacceptably high complications. Intuitive’s Da Vinci is not alone in this trend. Accuray has developed its CyberKnife for its ability to precisely attack tumors without surgery. There are also complex systems under development by Hansen Medical and Stereotaxis.

Certainly, the emergence of medical/surgical robotics can be viewed analogously, albeit simplistically, to the advent of laparoscopy, with its technology-intensive approach that minimizes trauma to the patient. But, the several-thousand dollar investment of laparoscopy hardly compares to $1.4 million (plus) for Da Vinci. Nonetheless, the facts of Da Vinci’s market success to date have been clear, since Intuitive has been exceeding Wall Street’s expectations for sales, revenues, etc., all of which is nothing less than remarkable in this era of cost containment.

What do these trends say for future market opportunities? The "biotech" trend tells us that there are many opportunities yet to be discovered based on the amount of disease (and even trauma) in the world and the lack of cures for them that are not "perfect" — reversing the disease condition and restoring health without the smallest complication. Of course, there also remain a huge number of "nearly perfect" solutions, or even less perfect ones that hold potential due to the fact that they provide even the most marginal advantage over existing therapies, if such exist at all for the treatment of specific diseases.

The "technology-intensive" trend suggests that the limitation of what we can achieve is not dictated by our knowledge of natural systems but is determined only by the apparent limits of our imagination and technology development well outside of healthcare (e.g., robotics are not inherently medical), which will include materials sciences, information technology and the stunning array of technology hybrids that can be constructed to achieve specific outcomes (RFID-embedded surgical instruments, ingestible "pillcams", etc.).

The two schools of thought are not mutually exclusive, by any stretch of the imagination. In fact, there are are enormous opportunities in the marriage of the two. The mandate for medtech manufacturers seems to be then that they should, on the one hand, come to as thorough an understanding possible of the natural biological processes associated with the disease or disorder of interest and, on the other hand, imagine and apply any and all technology, regardless of scientific discipline, that will result in an improved outcome for the patient. With the rapid growth in our understanding of the complex etiologies of disease and with the spectrum of technologies that can be constructed to serve specific functions, the only limitations appear to be imagination and reimbursement, and with Intuitive Surgical’s market success, one would wonder if the latter is even a problem.

 

The Spine Market: Big, Growing and Persistently Device-Intensive

[Having covered a very wide range of medical technology markets, spanning cardiology to gastroenterology, biotechs to devices and disposables/reusables/"reposables" to capital equipment, I have to note that the spine surgery market is really unique among all of them — resistant to cost containment, persistently device-oriented, and subject to tremendous innovation all the same. In some ways, spine surgery may be the last bastion of medical device development, clinging as it does to its inherent need for products that are structural in nature and therefore keeping at bay the wholesale intrusion of biotechs and pharmaceuticals. – P. Driscoll]


The global spine market is large, active and growing rapidly in revenues. Several dynamic forces, in addition to the aging of the population, are expected to affect the market and treatments during the next several years. While spinal fusion will always have a place, its share of the treatment market is expected to decline. Newer treatments such as total disc replacement and nuclear arthroplasty will erode the spinal fusion market, as these and other treatments which preserve spinal motion gain favor over the invasive and traumatic fusion of two or more spine segments.  

The total global spine surgery market includes includes devices for spinal fusion, bone graft substitutes, total disc replacement, nuclear arthroplasty (also known as nucleus replacement) vertebroplasty, kyphoplasty, interspinous process spacers and devices for image guided surgery.  The combined market will have a compound annual growth rate (CAGR) of over 14% through 2017. 

As has been the historical precedent, many devices are first launched outside of the US, primarily in the European Union, where the product approval process is less strenuous than in the US. Therefore, a number of new products, such as nucleus replacement, have sales outside of the US but no sales here, or very modest US sales due to use as an investigational or humanitarian device.

Worldwide, spinal fusion is expected to always be a tool for the orthopedic surgeon, but as a procedure it is starting to yield market share to other, more motion-preserving devices and procedures. In addition, motion-preserving technologies are filling the treatment gap between lumbar back pain treated with non-surgical means, and multi-segment spinal fusion. Motion-preserving devices also leave the option of fusion open as more of a last resort treatment, if needed. As technology advances, populations age and surgeons gain experience with new treatments, these trends are expected to continue.

In dollar terms, spine fusion revenues are expected to be flat as bone graft substitutes, total disc replacement and vertebroplasty/kyphoplasty begin to replace some spinal fusion procedures. Nucleus replacement, a market in its infancy, will also be increasing during the period covered in this study, but will remain a relatively modest sub-segment of the entire market.

Global Spine Surgery Market by Percentage and Segments, 2008-2017

Source: Report #M510, "Spine Surgery: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017."

The exhibit above shows the percent shares (by USD) of the product segments. This graph shows more dramatically the predicted shift from spinal fusion towards other technologies. One of the drivers of this trend is the desire by Baby Boomers to remain active into their later years. This means that they will be more likely to opt for a total disc replacement, for example, in order to keep spinal fusion as a more drastic, final solution if all else fails.

Another factor behind the growth of the global spine market is the increasing prevalence of obesity, especially in developed countries. Obesity puts added strains on the vertebrae and increases the rate of normal wear. While the rate of obesity seems now to be slowing in some countries, it is expected to remain a significant factor through at least 2017.
Innovation as a factor refers both to the plethora of new designs and devices being patented and produced, and the new materials under development which go into some of those devices. Critics suggest that some of these devices are a technology looking for a market. Years are usually required to conduct the testing and to obtain market approval through the FDA or other regulatory approvals such as the CE mark in the EU, or approval by the Japanese medical device authorities. Further years of surgeon experience using the new devices with patients will determine which devices are winners in the race, and which fall out of usage. Nevertheless, there are a number of start-up companies in the US and outside of the US which are working to develop devices in hopes of meeting a significant need and reaping the rewards. Patients are frequently the beneficiaries of this research and development, and hence innovation is a powerful driver of the global market.
Baby boomers, in addition to requesting spinal treatments which will allow them to return to their normal, active lifestyle, are also increasingly requesting minimally invasive or minimal access surgery. MIS device revenues are expected to increase due to this growing demand.

 

 

 

 

Consolidation, competition on the rise in sealant, glue, anti-adhesion market

The market for surgical closure and securement — sealants, glues, sutures, tapes, and anti-adhesion — has entered a phase in which major driving forces are the introduction of new procedures and techniques by the surgical profession, the development by the medical device industry of new wound closure devices and biomaterials, and the growing willingness of surgical specialists to use these devices in appropriate circumstances.

There is now a continuum between simple closure using sutures and the use of specially designed devices and delivery systems with new bioresorbable securement materials either as supplements to conventional closure methodology or as stand-alone replacements.

Worldwide expenditures on all medical devices is estimated to have surpassed $173 billion in 2006. In the field of tissue repair and surgical securement, the total market reached almost $7 billion, underpinned by product advances reflecting improved understanding of the underlying mechanisms of tissue repair, patient demographic pressures creating an increasing caseload of procedures, and a rapidly expanding number of new products (see below).

Introduction (through early 2007) of New Securement Technologies to the U.S. Market 

Product

Company

Description

Interceed

Johnson & Johnson

Fabric adhesion prevention

Seprafilm

Genzyme

Hyaluronic acid adhesion prevention

Fibrin sealant

Baxter/Haemacure

Fibrin based sealant/hemostats

FocalSeal L

Focal

Protein sealant

FloSeal

Fusion

Polymer sealant

Costasis

Cohesion

Collagen hemostat

Lubricoat

Lifecore, J&J

Hyaluronic acid adhesion prevention

Glushield

Glustitch

Cyanoacrylate glue

CoSeal

Angiotech

Synthetic sealant

VitaGel

Angiotech

Autologous blood sealant

DuraSeal

Confluent Surgical

Dural sealant

BioGlue

CryoLife

Bovine serum albumin-based surgical adhesive

Arista

Medafor

Absorbable hemostat

Indermil

Syneture (US Surgical)

Cyanoacrylate tissue adhesive

 Source:  Report #S145, to be updated in Report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2009-2013".  December 2008.

The tissue closure and securement market can be regarded as a benchmark indicator for overall expansion of medical device usage. This is because surgical closure and securement products are becoming components of all surgical procedures. These products are used for rapid and efficient closure of surgical wounds, and internal securement of tissues to reduce pain and accelerate rehabilitation. Appropriate use of these products can reduce risk of infection, and can optimize the repair process to enhance the speed and strength of tissue repair, as well as reducing complications such as those resulting from post-surgical adhesions.

Overall industry spending in the health care system has a major impact on this segment. Consolidation in health care purchasing organizations (particularly in the United States) creates a pressure for cost-effectiveness arguments and supporting clinical efficacy data, and may also limit pricing potential, often when the overall cost in a category appears to be growing uncontrollably. The shift to outpatient and community-based treatment sites and practices affects the way that products are designed, marketed and distributed. In the securement segment, hospital administrators are involved in purchasing more routine and generic surgical securement and closure products, with surgeons selecting newer, more advanced technologies. In addition, the case for cost-effectiveness involves professional preferences and adoption of new procedures, as well as the potential to reduce surgical theater time and costs.

Many new surgical procedures have been established over the last 10 years as products and procedures have been modified to accommodate increased patient awareness and to support practitioner-based competencies. These procedures are often linked to new technologies. For example, minimally invasive procedures that were comparatively rare 10 years ago are now routine; more than 70% of gall bladder surgeries are performed laparoscopically and more than 60% of patients with angina pectoris receive image-guided PTCA (percutaneous transluminal coronary angioplasty) instead of open heart surgery. These procedures depend on new devices and instruments, including improved means of internal and external closures and securement. In addition, aging of the population adds progressively to the surgical caseload. For example, in the United States, Medicare beneficiaries are forecast to increase from 34 million to 70 million between 2000 and 2030. Products targeted at this primarily elderly population would be expected to reflect this trend by compound annual sales growth of 2%–3%. In other regions of the world, this trend is also seen as a major market growth rate determinant.

Clinical Caseload

The market potential for surgical securement products is driven by a combination of new technologies coming to market and expanding caseload for which these technologies are applicable. The potential for these products continues to grow as surgical practices improve and the benefits of new products address the requirement for fast and effective closure.

 Source:  Report #S145, to be updated in Report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2009-2013".  December 2008.

 

We forecast that approximately 70 million procedures worldwide might benefit from products in this category and, due to demographic trends and evolving surgical capabilities, this number is forecast to increase at an annualized rate of 3%–5% (see chart, “Potential Procedure Volume for Surgical Sealants, Glues and Wound Closure”).

Of the 70 million surgical and procedure-based wounds created each year in surgeries worldwide, 23 million are created during surgical procedures in the United States. Although it is possible that healing all these wounds could be improved through use of adjunctive products for surgical closure and securement, use of the most advanced of these products has been limited to a fraction of these procedures. For example, there are approximately 3 million procedures worldwide that receive sealant products, generating $1 billion in sales. We forecast much greater usage of sealants once clinical efficacy is proven in a broad range of procedures and as new sealant products are launched. In addition to improvements in adjunctive treatment of bleeding, new procedure-enabling devices for soft tissue repair and securement have been introduced. These products have expanded the total market for securement and closure of soft tissues with bioresorbable materials.

This field is expanding rapidly as new devices allow the surgeon to perform closure more quickly and with improved outcomes for patients. A significant premium is possible when new products and devices enable complex securement procedures to be performed under minimally invasive protocols with significant time savings in the operating room. New technologies and new biomaterials allow improved tissue repair, and it is possible to revalue segments of this market based on significant improvements in clinical practice. We expect this market segment to triple in value over the next decade.

Driven by procedure volumes, the total market potential for currently available products is in excess of $3 billion for hemostats and sealants, and over $1 billion for skin wound closure using high-strength glues. The introduction of a high-strength, nontoxic elastic glue would revolutionize the market further and lead to even higher sales potential. 

In the field of postoperative adhesion control, newly developed products improve on early prototypes and have substantial clinical efficacy data to allow for a significant premium cost. Over $500 million in revenues were generated in 2006 in this market segment, and we expect that this market will grow to over $1 billion within the next five years.

Market Consolidation, Competition on the Rise

A number of market leaders have consolidated their positions within the surgical closure and securement markets through successful internal development programs and through technology partnerships with innovative vendors of next-generation technologies. For example, U.S. Surgical (a Tyco company) and Ethicon (Johnson & Johnson) are major suppliers of cyanoacrylate products in the United States; with dominant sales resources to sell these products, these companies lead the market, even though they face competition from the Canadian company Glustitch, the U.K.-based MedLogic and others. Synovis (formally Biovascular Inc.) has targeted cardiovascular and other procedures, and has a range of closure products; it has recently partnered with GEM to develop and exploit GEM’s internal high-strength glue product (Glubran) in the United States.

Companies in the sealant market are highly competitive, and acquisitions and mergers have also played a significant role in shaping both this market and the individual companies with their products and underlying strategic focus. For example, Baxter launched fibrin sealant technology (acquired when it bought Immuno) in the United States. In addition, its purchase of Immuno in 1998 forced Baxter to relinquish a monopoly position by forming a partnership with Haemacure, thus allowing it to market fibrin products in the United States. Baxter has also acquired rights to Fusion Inc. technology, giving Baxter a portfolio of sealant products. Separately, CryoLife has demonstrated the potential to compete within the rapidly evolving sealants market in the United States by developing superior products.


MedMarket Diligence is completing the 2008 report, publishing December 2008, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-adhesion, 2009-2013."  See Report #S175.

 

Top New Medical Technologies and/or Platforms

While this is separately a White Paper that I wrote and periodically re-write to reflect new stuff being developed (or progressing in that development), it is worthwhile to occasionally revisit the list of technologies that have real promise, especially if that promise is getting closer to reality, or only if the demand is simply getting greater.

  • Ablation and other high energy technologies.  What used to be handled by scalpel when my father did general surgery, is now increasingly being accomplished using energy-driven modalities that provide other tissue effects that a sharp metal blade alone could never do.  These technologies are therefore growing in both the penetration of traditional surgical procedures and the expansion to clinical applications.
     
  • Nanotech and microelectromechanical systems (MEMS).  It is actually a gross oversimplification to use a word like "nanotech" and imply that you are talking about one type of technology.  The only thing common to nanotech is size; every manner of material, construction, function and clinical benefit is part of this area.  The pace of development is striking.
     
  • Drug-device hybrids.  Just a few of the applications of combining drugs and devices in a single device include localized drug-delivery that avoids toxic, systemic dosages and vastly improved biocompatibility of existing devices. These two options alone represent multiple enormous markets.  Now, naked metal (or other) implants seem almost barbaric.
     
  • Bioresorbable materials.   Polymer and other materials technologies are enabling the development of implants and other devices that conveniently go away when they are no longer needed.  Already a significant market force in areas like bone growth in orthopedics, bioresorbable stents and other implants are proving their worth in cardiology and urology. 
     
  • Atherosclerotic plaque-reversing drugs.  When Pfizer divested itself of Esperion Therapeutics, it did not bode the end of this striking new drug approach to atherosclerosis, it simply illustrated the persistent challenge of drug development.  Here, it should be kept in mind that, the bigger the potential payout, based on huge clinical need (e.g., drug solution to the device intensive treatment of coronary artery disease), the more likely it is only a matter of time before the product reaches the market.  The jury is out on the "when" part, not the "if".
     
  • Rational therapeutics.  This is the holy grail thinking behind the development of many, many biotech products.  If one can develop a cure — a direct resolution of the underlying biological defect or deficiency in disease — and not just the symptoms, then one has changed the market in paradigm ways.  The hurdle and the payoffs are huge.
     
  • Tissue engineering technologies.  We have begun to be able to develop tissue engineered organs of increasing complexity — skin, bladders and rudimentary pancreases — and the benefits of these are huge.
     
  • RFID.  There is little, really, that is sophisticated about radiofrequency identification devices,  but their rapid integration into medical technologies of a wide range (tagging surgical instruments so they don’t get left behind, implants that enable external identification or even status, other types) will extend the utility and value of medical devices.
     
  • Noninvasive glucose monitoring.  Optimizing care for diabetes means, at a minimum, very frequent (5-10) checks per day of blood glucose.  This many finger pricks per year by the total number of diabetics globally (a rapidly growing number at that) who clearly would benefit from noninvasive monitoring reveals the value of this opportunity.  Capturing that opportunity means the combined success of both technology and cost.
     
  • Infection control.  This area is a top area, not for the sigificant technologies that have been developed, but the enormous demand for them.  Between rapidly emerging problems like methicillin-resistant staph aureus (MRSA), the resurgence of tuberculosis, the enormous costs of nosocomial infections and other infection-related challenges, infection control is an enormous, global opportunity.
     
  • Spine surgery.   The nature of the human spine, constructed of bone that needs to be both flexible and strong, demands device-intensive solutions.  The growing patient population of active, older adults is ratcheting the pressure on technologies to be less invasive, provide greater range of motion, last longer, cost less — all of which drives innovation in spine surgical technologies.
     
  • Obesity treatment technologies.  Technology solutions to the increasingly prevalant problem of obesity are imperfect, but still are frequently better solutions for the obese than an alternative that may ultimately also encompass heart disease, diabetes, stroke and other problems.  Diverse drug and device alternatives have been developed and the trend in obesity incidence will simply drive their continued development. 

Other forces are at work driving the above technologieis including, of course, cost containment, the integration of information technologies in both medical product and development process and the globalized economy.


The above topics are covered in various MedMarket Diligence reports.  See our list of titles.

Companies active in surgical glues, sealants, wound closure and anti-adhesion

The companies involved in the marketing and development of surgical sealants, glues, and other wound closure and anti-adhesion products are a robust group.  The number of competitors and the breadth and depth of their offerings are testimony to the size of the active market as well as its considerable potential.  Below is the list of companies preliminarily profiled in the pending, December 2008, report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-adhesion, 2009-2013."  The report is described here.
 
SECTION 4:    COMPANY PROFILES
 
4.1      3DM, Inc. (3D-Matrix, Ltd.)
4.2      Abbott Vascular
4.3      AccessClosure, Inc.
4.4      Adhezion Biomedical, LLC 
4.5      Advanced Medical Solutions 
4.6      Angiotech Pharmaceuticals, Inc.
4.7      Anika Therapeutics, Inc.
4.8      ARC Pharmaceuticals Inc.
4.9      Arch Therapeutics (formerly Clear Nano Solutions)
4.10    ArthroCare Corporation
4.11    B. Braun Melsungen AG
4.12    Bard Medical Division, CR Bard
4.13    Baxter International Inc.
4.14    Bayer Schering Pharma
4.15    BD (Becton Dickinson and Company)
4.16    Biiosyntech Inc.
4.17    Biocoral Inc
4.18    Biogentis, Inc.
4.19    BIOSTER a.s.
4.20    Cardiovascular Sciences, Inc.
4.21    Cardiva Medical, Inc.
4.22    Ceremed, Inc.
4.23    Chemence Ltd.
4.24    Cohera Medical, Inc.
4.25    Collagen Matrix, Inc.
4.26    Covidien
4.27    CryoLife, Inc.
4.28    CSIRO PhotoMedical Technologies
4.29    CSL Behring
4.30    CSMG, Inc.
4.31    CuraMedical BV
4.32    DePuy, Inc.
4.33    Entegrion
4.34    Ethicon, Inc., Johnson & Johnson
4.35    FibroGen, Inc.
4.36    Fidia Advanced Biopolymers SpA
4.37    Flamel Technologies SA
4.38    Focal, Inc.
4.39    Forticell Bioscience
4.40    FzioMed, Inc.
4.41    GEM s.r.l.
4.42    Genzyme Biosurgery
4.43    GluStitch, Inc.
4.44    Haemacure Corporation
4.45    Harvest Technologies Corporation
4.46    HemCon, Inc.
4.47    Hemostasis LLC
4.48    Henkel Loctite Corp.
4.49    HyperBranch Medical Technology, Inc.
4.50    Innovasa Corporation
4.51    Integra Lifesciences Corporation
4.52    Interpore Cross International
4.53    Isto Technologies, Inc.
4.54    I-Therapeutix, Inc.
4.55    Kaketsuken (Chemo-Sero-Therapeutic Research Institute)
4.56    Kensey Nash Corporation
4.57    Kimberly-Clark Health Care
4.58    King Pharmaceuticals, Inc.
4.59    LifeBond, Ltd.
4.60    Lifecore Biomedical Inc.
4.61    Marine Polymer Technologies
4.62    Medafor, Inc.
4.63    MedTrade Products
4.64    Meyer-Haake GmbH Medical Innovations
4.65    Morris Innovative
4.66    Neose Technologies
4.67    Nycomed Pharma AS
4.68    Omrix Biopharmaceuticals Inc.
4.69    Organogenesis, Inc.
4.70    Pharming Group NV
4.71    Plasma Technologies, Inc.
4.72    PlasmaSeal LLC
4.73    Pluromed, Inc.
4.74    Polyganics, BV
4.75    ProFibrix BV
4.76    Protein Polymer Technologies, Inc.
4.77    Radi Medical Systems AB
4.78    Scion Cardio-Vascular, Inc.
4.79    Sea Run Holdings
4.80    Smith & Nephew Plc 
4.81    Sutura Inc.
4.82    Synovis Life Technologies, Inc.
4.83    Teleflex Medical
4.84    ThermoGenesis Corp.
4.85    Therus Corporation
4.86    Thrombotargets Corp.
4.87    Tissuemed Ltd.
4.88    TraumaCure, Inc.
4.89    TyRx Pharma, Inc. 
4.90    Vascular Solutions, Inc. 
4.91    Vectura Group plc 
4.92    Vivostat A/S
4.93    Z-Medica Corp.
 
See Report #S175 for more detail.

 

Surgical sealants, glues, wound closure, anti-adhesion, worldwide

[Publisher’s note:  The report #S175 described below is the most recent in a highly regarding industry series tracking this huge med/surg market, with its implication for devices, biologics, biomaterials and other products across a wide range of clinical application sectors. The report is pending publication in early December 2008.]


Report #S175, entitled, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2009-2013," (see link) 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 details current clinical and technology developments in 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.

The 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 2013 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.

The report offers key benefits: 

  • Worldwide scope enables comprehensive opportunity assessment
  • Geographic segmentation, based on ground-level analysis, reveals local potential
  • Detailed company profiles provide real awareness of competitive landscape
  • Forecasts to 2013 reveal insights of relative future market impact
  • Competitor market shares by segment give hard, actionable data

  The report is available for purchase on an advance discount at link.

Acquisition a growing focus in medtech

Yesterday, we commented on top 10 medical innovations reported at the Cleveland Clinic Innovation Summit.  

At the summit, Boston Scientific CEO Jim Tobin’s presentation underscored the other point we made recently, that acquisition is a routine part of medtech’s drive for innovation.  Boston Scientific has some $2 billion on hand and is looking for companies whose products can contribute to top line growth, underscoring that startups with a more future potential are less of interest.  The operative consideration is that revenues in the near term are important for Boston Scientific, as it recuperates from its expensive acquisition of Guidant.  Tobin’s presentation was well described here.

 

When Medical Devices are “Finished”

In last week’s Wall Street Journal, Stephen Oesterle, the vice president for medicine and technology at Medtronic was paraphrased for his startling conclusion that medical devices are “finished”. His point, “You can’t keep stuffing gizmos into people to treat end-stage disease… When biotechnology gets right, we’re finished. Because it’s restorative, not palliative as devices are.”

While subsequent to his statement other Medtronic representatives tried to put this in the context of something other than foretelling the death knell of Medtronic itself, his point is, IMHO, right on target.

Setting aside pharmaceuticals in its own category and addressing biotech and medical devices, there is a fundamental distinction between these two approaches to healthcare that defines the status quo and an inevitable future for both. Succinctly put though Dr. Oesterle’s comments are, I can endeavor to put it in other words: medical devices treat symptoms while biotech — if not now, then ultimately, treats underlying disease.

Therein lies a distinction that has turned the medical device industry into a major market worldwide, while the biotech industry has yet to reach a fraction of its commercial potential.  With a focus on symptoms, arguably a much lower technololgy hurdle than the myriad challenges faced by biotech as it seeks to effectively eliminate disease(s) at their source, the medical device industry produces limited, though very specific clinical endpoints that are arguably very incomplete, yet highly valuable.  (The coronary stent does not cure the patient of his/her atherosclerosis; it just maintains the crucial patency of coronary arteries to keep the patient alive.)

This is a topic i have addressed in the past, sometimes hammering the point endlessly to anyone who would listen.  Biotech is ideal. Devices are now. However, lest one think that there is a point at which we simply switch from devices to biotech (when Medtronic folds!), the reality is that devices, imperfect as the are, will continue to evolve. To this point, below please find the August 2006 edition of “MedMarket Outlook” from our discontinued “MedMarkets” publication. 

 


(August 2006)  MedMarket Outlook: Medical Devices in a Future Scenario

 

 

The future of medtech is proceeding along paths determined by technologies already developed, but also guided by the need to provide less invasive treatment of disease with better long-term outcomes. If these paths are followed to their logical endpoint, medical technologies of the future can be predicted. Concurrently, paths toward the development of treatments via biotechnology have their own logical endpoints. Many biotechnologies have the potential to preempt medical technologies, due to their intrinsic design as “rational therapeutics” — treatments of the root cause of disease rather than only its symptoms.

Here we consider the development in medical technology to have largely achieved its potential and we describe the devices and their characteristics as they would exist in such a future. We make no assertion that each and every technological hurdle that needs to be crossed can indeed be crossed (we imply the possibility); we simply give the benefit of doubt to the technologies that may be developed in order to consider what benefits may ensue.

In short, the future of medtech will be such that two general categories of technologies exist; those that are focused on treating specific pathologies and symptoms and those that represent organs or organ systems. Lastly, it should be noted that we envision this “future scenario” not as one happening 25 years (or more) hence, but in some cases less than a decade.

Disease- and Trauma-Specific Device Solutions
In the idealized future medtech industry, medical devices will have been optimized to facilitate the body’s own capacity to heal. Devices will be constructed to provide the function — e.g., maintaining the patency of a vessel lumen (stents), serving as a temporary or permanent lumen (AAA graft), be a fully functioning hip replacement, etc. — as long as (and no longer than) necessary for the body to complete all of the repairs of its own that are possible. In this sense, devices will be developed to help the body help itself, then get out of the way to not impede further healing. In particular, bioresorption will have become highly sensitive to timing (stents will dissolve or deconstruct to be excreted at the precise time needed). This will include extracellular matrices used for the regeneration of tissues of all types of tissue (muscle, bone, even nerve) with the matrix facilitating tissue ingrowth before being resorbed. Similarly, biocompatibility will become a more active feature of implanted devices such that they will go well beyond simply being inert or inducing no immunological or other response and will at a maximum, will elute drugs, proteins or other agents that will actively stimulate or facilitate the body’s normal healing process.

Devices will be highly intelligent, sensing the conditions in their environment and responding as necessary. Responses will include bioresorption, release of drugs, change in shape or other responses

Devices will be tracked wirelessly for status, providing patient and clinician with information about the status of healing, alerting each to changes requiring intervention long before adverse symptoms appear. This tracking will also include tracking of the device itself, revealing data on device integrity and alerting the patient/clinician to any change.

Increasingly complex devices will be implanted percutaneously, endoscopically or by other means to minimize any trauma. During implantation, the devices will have very low profiles to enable them to traverse to the target site through very small and/or sensitive (e.g., enervated) tissues.

Cost will have played a critical role in determining the effectiveness of device development, but not simply considering the device cost itself, which may be significant. The true cost of these devices will be determined thoroughly as a measure of their ability to achieve specific outcomes compared to the costs of any and all technologies or approaches that compete for similar outcomes.

These device technologies are based on the premise of technologies under development now. Advances in materials technologies, drug/device innovations and many others may produce opportunities for devices with benefits largely unforeseen at this time.

Biohybrid, artificial organs
In light of medtech’s general inability to compete directly with the premise of biotech — treatment of root disease rather than symptoms, medtech will have the potential nonetheless to provide solutions to disease and trauma, with the solutions being ones in which medtech devices or systems so thoroughly address the symptoms of diseases as to emulate cures of them.

In the future world we are envisioning, many organs and organ systems will be available to replace or augment the functions of organs that have been removed or are dysfunctional as a result of disease or trauma. The organs will be comprised of mechanical and biological components that will variously house reservoirs of therapeutics that will periodically and painlessly be replenished, contain bioreactors that will express patient-specific proteins, hormones and other naturally occurring substance, or provide other therapeutic intervention (as with defibrillators, pacemakers, etc.). Mechanical components will be made of materials producing no inflammatory response, inducing no clot formation or other effect and will otherwise be completely neutral to the body.

These organ systems, like the devices described above, will be intelligent, sensing multiple parameters and responding in real-time basis to maintain ideal homeostatic control specific to the patient’s dynamic needs (sleep, stress, exercise, metabolism, etc.). The “intelligence” of the systems will be represented in ways from the simple, including elution based on the concentration of substances (platelets, specific proteins, etc.) in the environment (such as to prevent restenosis), to the complex, including microprocessor-calculated basal or bolus infusion of drug or other substance based on biofeedback-mediated function (e.g., insulin pump and glucose monitor).

The status of the biohybrid organ/system will be monitored remotely by the patient and, in turn, by the physician through wireless communication to display current patient condition, trended functions and other status. Eventually, such external monitoring will become unnecessary other than for unusual events, such as extreme changes in patient condition that, even though the organ/system may be well prepared to respond to, warrants attention by the patient and/or clinician.

The biohybrid organ/system status will also be communicated wirelessly, displaying data on its sensor functions, reservoir levels or other parameters of its function, as well as the system’s integrity. As with monitoring the organ/system’s environment (noted in previous paragraph), the monitoring of the organ/system itself will eventually be silent other than for unusual or adverse events signalling a problem with the system itself.

The power sources employed by these systems will have evolved from being extremely long-term batteries that only infrequently require recharging (done remotely) to motion-activated power (or similar alternative energy sources) to potentially biological sources deriving power from the patient, such as (in a very advanced scenario) through exploitation of energy from adenosine triphosphate (ATP).

Examples of the organs or organ systems that may ultimately be developed (and are in process) include the following:

  • Pancreas – Glycemic control will be ensured through basal infusion of insulin and periodic bolus matching fluctuating needs.
     
  • Heart – Effective replacement of normal heart function will be achieved through designs and construction that will produce no hemolysis, and produce cardiac output precisely matching circulatory need.
     
  • Lung – An artificial lung will largely be achieved through the development of highly effective materials that virtually mimic alveolar epithelium at the interface between lung and blood vessels, enabling efficient gaseous exchange.
     
  • Liver – The myriad functions of the liver will have made it one of the most difficult organs to replace, in effect demanding the development of a master organ with multiple separate organ components addressing the needs of homeostasis (proteins, fat/cholesterol, hormones, vitamins, glucose, etc.), synthesis (proteins, bile acids, cholesterol), storage, excretion, filtering and defensive barrier against bacteria in the gut. The development of biofeedback and control across such multiple areas will be a herculean accomplishment.
     
  • Kidney – Filtration and regulation of water and inorganic electrolytes in the artifical kidney, by comparison to the development of the artificial liver, will be considerably less challenging.
     
  • Skin/integumentary – As an organ system, the integumentary serves an extremely important one in its defense against infection. Artificial integumentary systems may well be developed, although tissue engineering technologies are likely to soon eclipse any artificial technologies.
     
  • Limbs – The necessary development of biomechanics and systems to enable autonomic and conscious neural control of limbs may ultimately only be limitated by the strength the patient’s healthy anatomy to which it is joined. Fine-motor skills will likely be indistinguishable from biological limbs. Sensitivity to heat and pressure may even be regulated to maximize tolerance of the environment such that performance will exceed that of normal limbs. Overall appearance and in detail will be indistinguishible from normal limbs.

In varying degrees, these developments are already on their way toward completion. And while, indeed, many hurdles remain before some of these scenarios will be possible, one must consider these hurdles in comparison to the hurdles faced by the biotechnology industry as it pursues solutions a variety of diseases and disorders. The “rational therapeutic” holy grail is one that has for biotech been a source of endless promise and endless solicitation of additional venture capital. But as “imperfect” as some of
the medtech solutions above may be, their potential as self-contained, cure-like solutions for disease make them eminently more promising for their near-term potential than do “perfect” biotech solutions.

Medtech startup formations economically immune?

There is certainly the possibility (despite my doubts) that the current economic slowdown in global markets will have major effects on the medical technology industry. One simply cannot deny that there is simply less VC or other cash floating around that might be put to medtech investment. And maybe, as has occurred in the past (e.g., in the post dotcom bubble era), investment that does take place will move further downstream, away from the speculative risk of very early startups. In hindsight, it is easy to see such trends and developments.

But looking forward, it is difficult to see significantly diminished demand for the promise of medical technology development. Companies continue to be founded at a strikingly active pace.

The Medtech Startups Database, from MedMarket Diligence, has over the past half dozen years accumulated the data on nearly 900 new medtech companies under two years old — a remarkable pace of entrepreneurship.  In the very recent activity in company formation, here are a samping of the technologies these companies are pursuing:

  • Laser devices to “weld” biological tissues together for wound closures.
  • Drug-coated urinary and other catheters and stents that are designed to prevent or treat scar tissue.
  • Artificial heart technologies.
  • Heart pumps.
  • Compliant balloon technologies.
  • Device for mitral valve repair without need for sternotomy.
  • Pharmaceutical treatments for ischemia and vascular disease, focused on peripheral artery disease.
  • Non-polymeric drug eluting stent
  • Device technology in diabetes management.
  • Medical device inflatables, including devices for biological navigation such as in support of colonoscopy and other endoscopy.
  • Minimally-invasive products for motion-preserving spine surgery.
  • Minimally invasive treatment of vertebral compression fractures.
  • Minimally invasive treatments for removing varicose veins.
  • Drug-coated angioplasty for coronary and peripheral applications

 


Medtech Startups Database described here. See pending and recent MedMarket Diligence reports: Sealants, Glues Wound Closure (coming in December), Ablation Technologies,  and Spine Surgery.

Economy catches up with biotech investing (no surprise)

If you simply compare the average development times of pharmaceuticals, biotech and medical devices, you will see that medical devices demonstrate the shortest time from conception to market (or rejection). Devices, by virtue of providing, in many cases, a simple mechanical function — flatten atherosclerotic plaque against the lumen (angioplasty), keep it there (stents), close wounds (sutures, staples), reduce stomach size (lapband), etc. — have fewer inherent possible downstream complications compared to pharmaceuticals, with their more powerful chemical effects, or biotech products, with their more power biochemical, genetic or other effects. 

So, it is not surprising that when recession hits the economy, forcing a more shortened view of investment returns, medical devices garner a relative edge in investment.  Hence, it was not surprising to see this article:  Economy catches up with biotech investing today.

It is a double-edged sword, indeed, that devices are more “blunt” in their effects, with reduced likelihood of the scope and degree of downstream affects of biotech and pharmaceutical products.  Shorter development cycle equates with faster routes to market, not larger market opportunity or, in the case of patients, better long term outcomes.