Medical technology feeds

The “© 2018, MedMarket Diligence, LLC -- advanced medical technologies” blog draws from the research, publications and other content of MedMarket Diligence as well as from my own readings, insights and perspectives.  While I am not wont to be stingy, I am not always inclined to give up valuable sources, but in the interest of quid pro quo, perhaps, I’d like to offer a few salient tips, sources and resources that I find useful.  I’ll get the self-promotion out of the way — a good source is a good source — and follow it with those I find invaluable (most, but not all, are rss/xml links):

In addition to these resources, one of the most useful tools available in this era of information overload is software called WebSite-Watcher, which I have found to have more varied uses than I ever anticipated.  (Think “staying aware”.)  Another highly valuable resource is Google Alerts, which has been in beta seemingly forever, but has long since proven its worth.

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The Uses of Adjunctive Surgical Closure and Securement Products

From MedMarket Diligence report #S145, “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007-2011.”  See link.

  • The use of products such as tapes and sutures for wound closure and securement leads to faster wound healing with less risk of contamination by debris and infectious agents, and with improved cosmetic outcomes. Failure to use these products can lead to significant complications, infections, significant delays to healing, and potentially loss of life through infection of the tissue leading to septicemia.
  • Hemostats, sealants and glues have been shown to aid recovery and rehabilitation after invasive surgical procedures, to reduce morbidity associated with infection rates and post-surgical adhesions, and to reduce morbidity associated with specific procedures. For example these products may be used to reduce the risk of deep vein thromboses resulting from tourniquet application to reduce bleeding during total knee replacements.
  • Hemostats and sealants have been demonstrated to have substantial cost-effective benefits during many surgical operations and the cost of these products are increasingly seen as minor in comparison with the time saved during the surgical procedure alone, even without taking into account rehabilitation. These products have been shown to be highly cost effective for topical wound closure and there are also many potential internal applications for these products.
  • Use of cyanoacrylate glues for closure has established a considerable following in all regions of the world. Conservative accident and emergency costs for closure of a small bleeding trauma laceration with sutures, local anaesthetic, antibiotic cream and suture removal kit are approximately $75 (before labor and time are included). Cyanoacrylate products can be used without anaesthetic, without sutures, and since cyanoacrylate sloughs off the skin surface, without a removal kit. The FDA has approved cyanoacrylate products as having an anti-microbial outcome, which further reduces the cost of using them to approximately 30% of using sutures. Once labor and time are added this falls to 5%.
  • Effective haemostasis also demonstrates attractive cost attributes; hemostats can be used for rapid and effective control of bleeding during surgery, thus avoiding an element of the hourly cost of an operating room ($2000 to $10000 per hour). For example, a $115 haemostat needs to shave 4 minutes off the operating time to ‘pay its way’. Often, these materials can save from five minutes to two hours depending on procedure.
  • Sealants also have attractive health economic attributes. The most obvious cases come from specific procedures which have become the lead indications and focus for development programs in many companies. For example, air leaks during lung surgery lead to the need for extended hospitalization (up to 28 days) and more intensive care, as well as additional surgical procedures. Sealants are also commonly applied to avoid cerebrospinal fluid leakage during neurological and spine surgery; leakage of cerebrospinal fluid would otherwise result in infection (including meningitis), debilitating headaches and other problems. In addition, the surgeon uses significant direct time to achieve meticulously leak-proof closure of the dura. This can be avoided by expert and experienced application of appropriate sealant products.
  • Significant cost-effectiveness arguments can be made for products that avoid blood transfusions or reduce the quantities of blood transfusion products required. Approximately 8 million patients worldwide would benefit directly from increased usage of hemostats, sealants and glue products to reduce bleeding during cardiovascular, orthopaedic, urologic, and other general surgical procedures. Units of blood cost approximately $180 each; however the benefit of reducing transfusion requirement goes beyond this simple saving. Often, the real benefit is that appropriate haemostasis reduces the risk of mortality. For example, reducing blood loss during cardiovascular procedures in particular not only prevents the use of large volumes of donated blood (e.g. 5-10 units for dissection of aortic aneurysms) but significantly reduces mortality rates (which can be as high as 30% for aortic aneurysm procedures).
  • Adhesion-prevention products have been shown to significantly reduce post-surgical adhesions associated with gynaecological, spinal, cardiovascular and orthopedic procedures. Post-operative adhesions can severely complicate subsequent interventions by making re-entry hazardous, and impeding orientation and visibility, which can lead to damaging the surrounding tissues or vessels. There may also be increased blood loss, and significantly longer operating time required to cut through the adhesions.

The securement market may be subdivided into Sutures and Staples, Tapes, Haemostats, Sealants, High Strength Glues, and Adhesion Prevention Products. The total securement market is forecast to grow from almost $7 billion in 2006 to reach $10 billion in 2011 at a CAGR of 7.5%.

   


The complete report on “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007-2011” is described with complete table of contents and list of exhibits here.

Medical Technology Market Analysis, MedMarkets (April 2008)

Below is the coverage in the April 2008 issue of MedMarkets.

Ablation:  An Energized Market

Demand for Hip and Knee Implants Expected to Increase

MedMarket Outlook: Beyond Technology Innovation: Current and Future Market Forces and Trends

Early Stage Companies: Evalve, ES Vascular, Cardiorobotics, TriVascular

Early Stage Company Financings: Alure Medical, Arbel Medical, Breathe Technologies, CoAxia, IDev Technologies, IlluminOss Medical, Lanx, Pathway Medical Technologies, Tryton Medical

Recent Medtech Startups

Biotechnology Update: Self-Assembling Nanofibers Show Promise for Spinal Cord Injury

Drivers: Sluggish Economy Slows Venture Capital Market

Leading Clinical Edge
Nanovalve Useful for Drug Delivery
Molecular Machine Serves as Remote Control
Progress Made on Biosensing Nanodevice
Mutant Proteins Stimulate Heart Cell Growth
Specialized MRI Identifies Brain Cancer Early
New Therapy for Pediatric Retinoblastoma
Eye Drops Monitor Brain Tissue Repair
Nanoengineered Gel for Spinal Cord Injury
Cell-Sorting System May Detect Cancer

Developments
FDA Approves OrNim’s Monitoring Device
Study Challenges Aspect Medical’s Device
Kinetic Concepts to Acquire LifeCell
Promising Results for Evalve’s MitraClip
U.S. Patient Receives CardioKinetix Heart Implant
Medtronic Improves Talent Stent Graft
FDA Reports Medtronic AneuRx Deaths
Medtronic CRT Clinical Trial Fails
Positive Results for Echo Therapeutics’ Symphony
Abbott’s Glucose Monitor Approved
Datascope to Sell Business to Mindray
Philips Completes Respironics Acquisition
ArthroCare’s Ablation Device Successful
Benefits from Genzyme’s Carticel Sustained
J&J Considers Design Changes for Charité
LifeNet Health Launches Cervical Implant
BioMimetic Refutes FDA Comments
AngioDynamics to Buy Diomed

Complete content available to subscribers only.  For coverage in all past issue of MedMarkets, see link.

See Reports from MedMarket Diligence.

Nucleus Replacements, Kyphoplasties Up; Spine Fusions (Way) Down

The balance of patient caseload distributed among alternative spine surgery technologies will demonstrate marked shifts from 2009 to 2017 as technologies/techniques like kyphoplasty and nucleus replacement gain greater presence at the expense of traditional approaches like spine fusion.  This is apparent in the shares of the markets each technology will represent in 2009 versus 2017.

Shares of Worldwide Spine Surgery Market by Segment, 2009 & 2017

Spine market segment shares, 2009 and 2017

Source:  MedMarket Diligence, LLC;  Report #M510, Worldwide Spine Surgery 2008-2017.

These figures apply to a market growing at a compound annual growth rate of over 14%, making the shifts of caseload to newer technologies represent significant shifts in sales for competing companies.


Data drawn from MedMarket Diligence report #M510, Worldwide Spine Surgery, 2008-2017.


“High Growth Medical Technologies” 2008

We have just updated our “High Growth Medical Technologies” white paper, as we expect to continually do in the immediate future, since the areas with growth keep changing, and new areas keep appearing.

As all white papers should be, it’s free.  Here’s the link so you can download it.

Patent (Reform) Pending?

Among the many critical events in the life of a new medical technology, the awarding of a patent is arguably at the top of the list in terms of commercial significance.  It is a seminal event that validates both the uniqueness and the practicality of the innovation.  Alongside demonstrable management expertise, at least some preliminary market research and the right VC phone numbers, a patent can start the whole funding and development ball rolling.

But now, the Patent Reform Act of 2007 (H.R. 1908, S. 1145)  is gaining momentum and may become reality.  And that may change the ball game considerably.

Some of the key elements of the legislation are below (drawn in part from Wikipedia):

  • Switch from first-to-invent to first-to-file
  • Defining “inventor” to include a joint inventor and coinventor.
  • Revising procedures for patent interference disputes.
  • Revising requirements for an inventor’s oath or declaration to allow substitute statements in specified circumstances (e.g., death or disability) and supplemental and corrected statements.
  • Allowing a third party assignee (other than the inventor) or a person with a proprietary interest to file a patent application.
  • Modifing provisions relating to damages for patent infringement to:
    1. require a court to conduct an analysis of a patent’s specific contribution over prior art;
    2. allow increased damages for willfull patent infringement; and
    3. expand the prior user defense.
  • Renaming the Board of Patent Appeals as the Patent Trial and Appeal Board. (Also, revising provisions relating to the Board’s composition, duties, and authorities).
  • Allowing a person who is not the patent owner to file a petition with the Board to cancel a patent as invalid (post-grant review). Would also set forth procedures for the consideration of such petitions, including provisions to prevent harassment of patent owners and abuse of process.
  • Allowing third parties to submit documents relevant to the examination of a patent application.
  • Revising venue requirements for civil patent actions against individuals and corporations to allow actions to be brought in the judicial district where either party resides (currently, where the defendant resides) or where the corporation has its principal place of business or was incorporated.
  • Banning tax planning patents.
  • Allow financial institutions to infringe patents on check collection systems.

The biggest concern I have, as I begin to preliminarily review this, is that the general thrust of the reform, while focusing on resolving specific deficiencies, has the definite potential to squeeze innovation.  For example, the switch from “first to invent” to “first to file” will give a distinct advantage to those inventors who have well-oiled patent filing capabilities.  Viewed simply (sometimes this is how one must do things), an inventor comes first, then the apparatus to file patents, pursue venture capital, hire management, etc.  So, the “first to file” change has implicitly deemphasized the value of the inventor.  Am I missing something?

Admittedly, I have an inherent bias toward small startup medtech innovators.  I simply believe that they are the source of an enormous number of ideas.  To restrict them in any way will do harm to medtech development.  And forcing inventors to file first and invent later not only puts the cart before the horse, but also requires the inventor to dilute his/her focus on inventing as the singlemost important activity.

The rest of the legislation strikes me as the net effect of too many cooks in the kitchen and a lot of tinkering with a system that has stood for some time as the lynchpin supporting the creation and protection of ideas not just for U.S. inventors, but worldwide, since U.S. patents carry so much weight outside the U.S.

The answers are not simple when it comes to legislation of this sort, since there are many competing stakeholders, and the whole patent/innovation/commercialization process has so many interdependencies that determine success and failure.  I don’t claim to have all the answers (beware of anyone who says they do), but in the interest of enacting “reform”, in an election year no less, we may seriously underestimate the implications of the legislation on those interdependencies.  I recognize the need for reform, but I am frankly sick of the incessant drumbeat, of demanding change for change’s sake.

See this additional perspective from ZDNet’s Dana Blankenhorn:

Big patent law reform on the way? by ZDNet‘s Dana Blankenhorn — Crouch writes that the court is asking some basic questions, including whether the State Street decision, which allowed business methods patents, should be overturned. That case is also used to justify software patents.

Stay tuned . . .