Category Archives: biomaterials

Clinical utility of advanced wound closure and securement products

Products for the advanced securement of wounds — stopping bleeding, sealing the wound, tightly closing the wound and preventing post-surgical adhesions — will be accepted by clinicians (and paid for by healthcare systems) to the extent that the provide very specific clinical utility compared to traditional alternatives, many of which (like sutures and tapes) are simple to use, cost little and otherwise are readily accepted in the business of wound management.

Clinicians (and healthcare systems) will accept and adopt for routine use those new products for hemostasis, closure, sealing and anti-adhesion of wounds, whether chronic or acute, based on the level of clinical utility they provide compared to those traditional products, and the extent to which those new products provide utility is based on the types of utility provided (from “critical” to “perceived”), a metric that varies by clinical specialty.  For example, a new product that prevents bleeding and dramatically reduces morbidity is much more likely to be adopted than a product that yields merely aesthetic (e.g., reduced scarring) or perceived benefits that have no impact on morbidity.

Advanced products offer different degrees of utility from, on the high end, the value of enabling procedures otherwise not possible or highly impractical to, on the low end, perceived benefits with no significant positive impact on morbidity.  Further, the impact of advanced products varies by clinical specialty, with some expected differences between, for example, cardiology procedures and cosmetic procedures. The four main categories of benefit from advanced products include:

  • Important and Enabling: Important to prevent excessive bleeding and transfusion, to ensure safe procedure, and to avoid mortality and to avoid complications associated with excessive bleeding and loss of blood.
  • Improved Clinical Outcome: Reduces morbidity due to improved procedure, reduced surgery time, and prevention of complications such as fibrosis, post-surgical adhesion formation, and infection (includes adjunct to minimally invasive surgery).
  • Cost-Effective and Time-Saving: Immediate reduction in surgical treatment time and follow-up treatments.
  • Aesthetic and Perceived Benefits: Selection is driven by aesthetic and perceived benefits, resulting in one product being favored over a number of medically equivalent treatments.

Below is illustrated the distribution — by clinical category — of the kind of utility provided by advanced wound securement products (fibrin and other sealants, high strength adhesives, hemostatic products and anti-adhesion products):

cardio

 Total: 51.4 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

cosmetic

Total: 12.7 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 digestive

Total: 20.9 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 

general

Total: 27.4 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 

neuro

Total: 16 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

ortho

Total: 10.8 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 

 

Medtech technologies that are gaining traction (funding, other commitment)

Developments in medical technology span a stunningly diverse set of applications enabled by an equally diverse range of technologies.  To hone in on the developments that “matter”, it is worth considering those that have garnered, at a minimum, a level of financial or other commitment to move them toward commercialization.  Here, we highlight technologies under development at companies that have recently (Feb. 2013) received fundings as well as technologies under development at startups recently identified.

Several common themes underly the companies gaining funding, stemming from advances with versatile applications (cell/tissue, info tech), technologies that succeed in providing clinical advantage (minimal invasiveness) or otherwise increase the efficacy of existing treatments (imaging, diagnostics):

  • Tissue/cell-based technologies
  • Minimally invasive or less-invasive approaches to treatments
  • Neural based treatments (e.g., neurological stimulation, denervation)
  • Wireless technology and information technology embedded in device function
  • Imaging, diagnostic or other procedural enhancement to surgery or other treatment

Technologies at companies funding in February 2013:

  • Ocular surface interferometry and thermal pulsation system for diagnosis and treatment of evaporative dry eye
  • Sinus treatment implants
  • Regenerative medicine therapies for orthopedics and wound care
  • Satiety device for the treatment of obesity
  • Microstent for treatment of glaucoma
  • Catheter-based treatment of heart failure
  • Minimally invasive treatment for uterine fibroids
  • Wireless vital signs monitoring
  • Neuroscience-based device company focusing on obesity and metabolic disease
  • Wireless, transdermal continuous glucose monitoring system
  • Magnetic resonance imaging guidance of surgical and interventional procedures
  • Nonsurgical interstitial laser therapy for treatment of breast cancer
  • Ophthalmic drug delivery
  • Lung denervation
  • Deep brain stimulation.
  • Intra-ocular implants (glaucoma, severe infection) and intra-articular implant osteoarthritis)
  • Technology providing real-time, high resolution imaging of cancer cells
  • Targeted drug delivery in ophthalmology
  • Surgical adhesives
  • Device technology for treatment of respiratory disease
  • Neurological cooling to reduce the impact of trauma
  • Minimally invasive treatment for mitral valve regurgitation
  • Devices for use in cardiac and vascular markets
  • Supersaturated oxygen therapy to reduce myocardial necrosis following heart attack
  • Left ventricular access and closure devices
  • Intravascular continuous glucose monitoring
  • Amniotic membrane-based biomaterial technology
  • Needleless intramuscular drug injection device
  • Binocular device for ophthalmology diagnostics
  • Stem cells for use in regenerative medicine
  • Intraoperative ophthalmology diagnostics using wavefront aberrometry
  • Devices for the diagnosis and treatment of arrhythmias
  • Neurostimulation for treatment of chronic pain
  • Collagen-based implants
  • Needleless drug injection technology
  • Endoscopic vein harvesting
  • Undisclosed technology in ophthalmology
  • Nanotechnology-based, injectable wound healing scaffold for treatment of diabetic foot ulcers
  • Surgical robotic technologies integrated to digital 3D imaging for applications in spine, brain, and musculoskeletal procedures

Technologies at recently identified startups (recent additions to startups database):

  • Tissue regeneration technologies for non-invasive skin care.
  • Biomaterials supplied to medical device and pharma manufacturers
  • Trans-reflective fetal EKG.
  • Surgical instrumentation.
  • Undisclosed medical technology.
  • Technologies for autologous tissue collection.
  • Stem cell therapy.
  • Novel, implantable ring to prevent parastomal hernia in abdominal surgery.
  • Transcatheter repair of mitral valve regurgitation.
  • Synthetic cartilage implant for treatment of osteoarthritis or cartilage damage.
  • Device-based treatment of congestive heart failure.
  • Clamping device to control bleeding in trauma.
  • Tissue matrix composition for tissue regeneration and wound care.
  • Spinal pain relief devices.
  • Wireless remote arrhythmia monitoring and diagnosis.
  • Undisclosed medical technology.
  • Surgical tools for arthroscopic procedures.
  • Fractional flow reserve guidewire method to obtain FFR measurements during coronary catheterization procedures.
  • Technology to ensure accurate intraoperative placement of hip and knee implants.
  • Neurological diagnostics to measure biomarkers, regulate drug dosage, others.
  • Respiratory monitoring devices, such as a “sleep sensors” shirt to enable less invasive monitoring for apnea or other respiratory conditions.
  • Endoscopic, minimally-invasive harvesting of veins used for coronary artery bypass grafting.
  • Ophthalmology diagnostics; binocular device for eye exams.
  • Device-based treatment for respiratory disease.
 Companies represented by these technologies are:
AFcell Medical, ArthroCAD, BAROnova, BeneChill, Bioject Medical Technologies, BioSig Technologies, Blaze Bioscience, CardioKinetix, Cartiva, Ceterix Orthopaedics, Clearside Biomedical, Cohera Biomedical, Cotera, Cytomedix, Diagnostic Biochips, Echo Therapeutics, Enteourage Medical Technologies, EnteroMedics, Envision DIagnostics, Evolus, Excelsius Surgical, First Pulse Medical, GluMetrics, Guided Interventions, Gynesonics, H & M Innovations, Handsome Ltd., HighLife SAS, Holaira, InfoBionic, Innocoll, Innovative Trauma Care, Insight Surgical Instruments, Intersect ENT, IsoStem, Ivantis, Kala Pharmaceuticals, Koring GmbH, Magenta Medical, Mardil, MRI Interventions, MxBiodevices, Neuros Medical, Novian Health, Parios Regenerative Sciences, PharmaJet, PLC Systems, PolyActiva, Rest Devices, Saphena Medial, Sapiens BV, Sotera Wireless, StemBioSys, TearScience, TELA BIO, TherOx, Uro Lasers, Ventec Life Systems, Vornia, Wavetech Vision Systems

Dominated by a few companies, advanced wound closure still has upside for new players

The global market for products in “wound securement”, or the aggregate of products that are related to the closure and healing of wounds, is dominated by traditional products — sutures and the more recent clips and staples.  However, as simple and effective as these are, particularly since their use is engrained in the skillsets of practicing surgeons, advances in wound closure, hemostasis and even anti-adhesion are challenging the entrenched positions of suture, staple and clip suppliers.  Fibrin and other sealants have found acceptance in use by surgeons seeking tighter wound sealing, faster healing, less scarring and other benefits.  Hemostatic agents have proven highly versatile (in a range of clinical settings from the OR to the battlefield) in rapidly stopping bleeds in a way that traditional wound closure cannot. The end result of surgery also demands that the surgery itself cause a minimum of complications, and products in anti-adhesion (many actually being sealant products that are actually effective in what one might consider the “opposite” role) have proved effective in this capacity.

But old habits die hard, so very high caseload of wound closure is still addressed via sutures, staples and clips.  Consequently, the global market for wound closure and related products has companies like Ethicon (J&J) holding big pieces of the pies.

sealants-all-shares

Legend:

A: Ethicon/J&J
B: Covidien
C: B. Braun
D: Others
E: 3M
F: CSL Behring
G: Pfizer
H: Equimedical BV
I: Baxter
J: Cryolife
K: AdMedSol
L: Genzyme Biosurgery

Source: “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2012-2017″, MedMarket Diligence Report #S190.

Wound management market remains fragmented

One of the key aspects to the global wound management market that is often overlooked is the actual diversity of products and technologies in use and in development.  Despite the fact that wound management is arguably the oldest area of medicine, an incredibly wide range of approaches have been developed to optimize conditions for wound healing or otherwise facilitate the healing of wounds that range from acute, surgically created to chronic, disease-linked wounds.

With a wide range of active competitors exhibiting a correspondingly wide range of strengths in different wound care product areas, the distribution of the market varies widely by product type.

Below is illustrated the market shares of companies in wound management by product segment. As is clear from an overview, there are a few segments in which select competitors dominate, but the general rule is that each segment is dominated or distributed across a varying list of competitors.

all-wound-shares

Legend:

A: JNJ
B: 3M
C: Beiersdorf
D: Smith & Nephew
E: Others
F: B. Braun
G: Systagenix
H: Mölnlycke
I: Covidien
J: ConvaTec
K: Hartmann
L: Coloplast
M: Lohmann
N: UDL Laboratories
O: Argentum
P: Integra LifeSciences
Q: Sanofi Biosurgery
R: Organogenesis
S: Shire Regenerative Medicine
T: KCI

Source: MedMarket Diligence, LLC; Report #S249: “Wound Management, Worldwide Market and Forecast to 2020: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.”

See also “Worldwide Surgical Sealants, Glues, Hemostats, Other Wound Closure and Anti-Adhesion,” Report #S190.

Remora, mussels, geckos, crab shells, Australian burrowing frogs, spider webs, porcupine quills, sandcastle worms

It may not be obvious what links all of these creatures, but it is their all-natural adhesiveness.

We have for some time been tracking the very wide range of naturally occurring “bio-glues” or other adhesives (or adhesive mechanisms) that are being evaluated to either be used directly as medical/surgical adhesives or be used as models to create bio-inspired med/surg adhesives.

We add another (shown first) in the remora fish, which has long demonstrated a remarkable ability to adhere to sharks and other marine animals without causing apparent damage to their tissues and has joined the ranks of the other bio-glues under study — at least to consider their possible development as commercial products, including for medical/surgical adhesion.

Most of these have simply been preliminarily investigated as to why they have such high strength, why they adhere under certain challenging conditions and other reasons.

MedMarket Diligence tracks the actual medical/surgical markets for fibrin and other sealants, glues, hemostats, tapes, staples/sutures/clips and anti-adhesion products in Report #S190.

Technologies at recently identified medtech startups

Below is a list of the technologies under development at startups that MedMarket Diligence recently identified and added to the Medtech Startups Database.

  • Tissue regeneration technologies for non-invasive skin care.
  • Biomaterials supplied to medical device and pharma manufacturers
  • Trans-reflective fetal EKG.
  • Surgical instrumentation.
  • Undisclosed medical technology.
  • Technologies for autologous tissue collection.
  • Stem cell therapy.
  • Novel, implantable ring to prevent parastomal hernia in abdominal surgery.
  • Transcatheter repair of mitral valve regurgitation.
  • Synthetic cartilage implant for treatment of osteoarthritis or cartilage damage.
  • Device-based treatment of congestive heart failure.
  • Clamping device to control bleeding in trauma.
  • Tissue matrix composition for tissue regeneration and wound care.
  • Spinal pain relief devices.
  • Wireless remote arrhythmia monitoring and diagnosis.
  • Undisclosed medical technology.
  • Surgical tools for arthroscopic procedures.
  • Fractional flow reserve guidewire method to obtain FFR measurements during coronary catheterization procedures.
  • Technology to ensure accurate intraoperative placement of hip and knee implants.
  • Neurological diagnostics to measure biomarkers, regulate drug dosage, others.
  • Respiratory monitoring devices, such as a “sleep sensors” shirt to enable less invasive monitoring for apnea or other respiratory conditions.
  • Endoscopic, minimally-invasive harvesting of veins used for coronary artery bypass grafting.
  • Ophthalmology diagnostics; binocular device for eye exams.
  • Device-based treatment for respiratory disease.

Medtech trends, current and future

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Medtech Trends map.
We are working on a long range view of medical technology developments.  Since one tool to conceptualize ideas with priorities, subsets and linkages is “mind mapping”, we have used mindmapping software to construct a map of medtech trends involving the main elements of current trends, future trends and drivers.

The map is illustrated below in a Flash version. You may resize (zoom in/out) of the map and otherwise navigate it via the controls below right (and just above the map on the right).  You may also move about the map it in all directions by clicking on the map and moving it in the desired direction with your mouse/touchpad.

Elements of the map that contain embedded notes with additional information show a text box icon on the side, so that if you move your cursor over it, the text will display.

We welcome your feedback.


Much of technology development over the course of the medtech industry’s history has been of the “product line extension” variety in which incremental improvements are made in devices and their composite materials in order to refine or otherwise increase their performance. Periodically, development has taken larger, more sudden leaps when re-examination of the fundamentals underlying medical technology generated new concepts that precipitated wholly new technologies. For example, surgery took a sudden leap forward in the late ’80s and ’90s when a recognition took place that (1) open abdominal surgery has inherent disadvantages stemming from trauma, risk of infection and other adversities and (2) endoscopic technology merely lacked the surgical instrumentation and design of a procedural format (e.g., via the use of insufflation) necessary to convert laparotomy to laparoscopy. The recognition that new technology obviated the need for trauma of laparotomy coincided with the obsolescence of virtually hundreds of years of traditional surgery. This development was only possible due to the emergence of a brand new paradigm called laparoscopic surgery, in which a host of abdominal procedures could be performed that avoid the trauma inherent in open abdominal surgery.

(And now, another leap is taking place by replacing laparoscopy with NOTES procedures in access is provided by existing orifices rather than any kind of incision or surgically-created port.)

Incremental improvements continue to enable manufacturers to sustain market shares and price premiums, but the nature of economic forces demanding better outcomes for every dollar spent and the proliferation of opportunities arising from technology advances on multiple fronts (with those fronts often combining synergistically) are precipitating leaps in medtech development beyond incremental improvement.

Below is illustrated an overall outline and map of the developments and drivers we see in medtech.

Get the Flash Player to see this player.

Source: MedMarket Diligence, LLC

The changing landscape for surgical sealants, glues, hemostats, other wound closure and anti-adhesion

Products that provide hemostasis, closure, sealing and anti-adhesion of wounds comprised long established products (e.g., tapes, sutures, etc.) as well as a variety of advanced products such as fibrin and other surgical sealants, surgical glues, hemostats and products to prevent post-surgical adhesion.  While traditional products are being innovated to keep pace with advanced products (for example, through the development of absorbable sutures), the shift of caseload and product sales away from traditional products appears unrelenting.

As a result, the balance of the competitive landscape is forecast to shift over the next few years toward advanced sealing, hemostasis, closure and anti-adhesion products.  Below is illustrated, in a combined “donut” chart, this shift from 2012 to 2017 in the share of the global market for these products.

sealants_donut_2012-2017

Source: MedMarket Diligence Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017.”

These percentage shifts may not seem significant unless one considers that the global market for these products is over $5 billion.

Highly variable shares of wound management manufacturers by product type

Products on the market and under development for the treatment of wounds reflect a diversity created by the wide range of technologies that have been developed to optimize wound healing by controlling specific conditions at the wound site.  These include moisture, adherence of the wound dressing to the wound, resistance to bacterial or other infections, presence of exudate and others.  Moreover, the volume of wound caseload (in annual incidence and cumulative prevalence), across a range of wound types, provides sufficient demand to support the marketing and development of a large number of wound care products.

Consequently, even focusing an analysis of the global wound management market on a narrow range of applications, namely wound dressings, bandages and related wound coverings, yields a large and diverse number of product types and competitors.

Below are illustrated the market shares (by percentage) for major manufacturers of wound management products in each of the major wound product categories.

Wound-Mkt-Share-Pct

 

Source: “Wound Management Worldwide Market and Forecast to 2020: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”, Report #S249; MedMarket Diligence.

 

Advanced medtech is shifting the balance in wound management

Global markets for sales of wound management products are projected to evolve through 2020, with advanced wound management technologies progressively tapping into previously underserved (or unserved) clinical need or displacing caseload treated via traditional wound management products.  The result is a shift in the balance of traditional/advanced product revenue shares of the total market, as illustrated below:

Shift-wound-segments

Source: MedMarket Diligence, LLC; Report #S249.

The need for medtech products to provide reduced risk of infection, faster healing, fewer complications and lowered cost (especially for chronic wounds) is resulting in growth for advanced products, despite their upfront higher costs, at the expense of traditional wound dressings and bandages.