The future of medtech demands more and better imagination

I frequently see conclusions about the the future of medtech derived by analysts who are walking backward looking at their feet — living by the tenet of “past is prologue”. This type of “foresight” presumes an unchanging set of forces, leading (at best) to a conclusion that the future will hold more of the same.

Yet, the future of medtech is dictated far more significantly not by what has already happened, or as a result of past trends continuing as future trends, but by what has not happened yet. The major thrust of any significant growth (and isn’t growth what interests us?) comes primarily from events that do not as clearly follow from past events:

  • Surgical device sales forecasts are uprooted by introduction of laparoscopy
  • Tissue engineering preempts conventional treatments in wound, orthopedics, cardiology…
  • Success in type 1 diabetes treatment will be determined by device advances as well as cell therapy advances
  • Systems biology reveals risks and opportunities previously unseen

If you view your markets myopically, then you consider your competitors to be limited to those whose products most resemble your own. If you have a long view, you consider what might be possible based on available/emerging technology to tap into untapped demand or simply create latent demand that no company has yet been sufficiently visionary or innovative to seize. What patient populations, clinical practice patterns and their trends are the pulse that you monitor (or are you even monitoring these)?  There is a gap between what is available and a whole set of patients virtually untreated, physicians unsatisfied, and third party payers struggling.  Are you an angioplasty catheter manufacturer — or a coronary artery disease solution?  Do you make devices — or outcomes?

Source: Yann Girard https://www.linkedin.com/pulse/life-explained-through-technology-yann-girard

Look at staid “device” companies like Baxter International and see that they have “biosurgery” divisions.  Look at Medtronic and appreciate that they are as sensitive to developments in glucose monitoring and insulin pump technologies as they are to the litany of cell therapy approaches under pursuit. (These companies are fundamentally aware of technology “S-curves” — see graphic at right.)

Virtually every area of current clinical practice is subject to change when considering drug/device hybrids, biomaterials, nanotechnology/MEMs devices and coatings, biotechnology, pharmaceutical (and its growing sophistication in drug development), western medicine and eastern medicine, healthcare reform, cost containment, RFIDs, 3D printing, information technology  — it is imperative to see the upside and downside of these.

These are some of the forces that less characteristic of the past that are leading to startling new success in medtech developments:

  • Materials technologies are redefining the nature and functional limits of medical devices
  • Technologies more closely aligned with cure than symptomatic treatment gain rapid acceptance
  • The practice of considering outcomes measures of highly diverse technology solutions to disease has ascended to prominence in the mindsets of healthcare systems and payers
  • The use of information technologies and cross-medical discipline initiatives enables rapid determination of likely success and failures in whole new ways

Aside from the demands for operational efficiency and managing cash flows, the success or failure of medical technology companies has become a reflection of how well these companies position themselves now and in the future with an imaginative long view. Companies must consider the revenue streams in Year 1, Year 5 and Year 10.

 

Bioactive Agents in Wound Sealing and Closure

See updated analysis in Report #S290, “Sealants, Glues, Hemostats to 2022”.

Screen Shot 2015-03-30 at 10.14.59 AMBiologically active sealants typically contain various formulations of fibrin and/or thrombin, either of human or animal origin, which mimic or facilitate the final stages of the coagulation cascade. The most common consist of a liquid fibrin sealant product in which fibrinogen and thrombin are stored separately as a frozen liquid or lyophilized powder. Before use, both components need to be reconstituted or thawed and loaded into a two-compartment applicator device that allows mixing of the two components just prior to delivery to the wound. Because of the laborious preparation process, these products are not easy to use. However, manufacturers have been developing some new formulations designed to make the process more user friendly.

Selected Biologically Active Sealants, Glues, and Hemostats 

CompanyProduct NameDescription/
(Status*)
Asahi Kasei MedicalCryoSeal FS SystemFibrin sealant system comprising an automated device and sterile blood processing disposables that enable autologous fibrin sealant to be prepared from a patient's own blood plasma in about an hour.
BaxterArtissFibrin sealant spray
BaxterTisseelBiodegradable fibrin sealant made of human fibrinogen and human thrombin. For oozing and diffuse bleeding.
BaxterFloSealHemostatic bioresorbable sealant/glue containing human thrombin and bovine-derived, glutaraldehyde-crosslinked proprietary gelatin matrix. For moderate to severe bleeding.
BaxterGelFoam PlusHemostatic sponge comprising Pfizer's Gelfoam hemostatic sponge, made of porcine skin and gelatin, packaged with human plasma-derived thrombin powder.
Behring/NycomedTachoCombFleece-type collagen hemostat coated with fibrin glue components.
Bristol-Myers Squibb/ZymoGenetics (Sold by The Medicines Company in the US and Canada)RecothromFirst recombinant, plasma-free thrombin hemostat.
CSL BehringBeriplast P/Beriplast P Combi-SetFreeze dried fibrin sealant. Comprised of human fibrinogen-factor XIII and thrombin in aprotinin and calcium chloride solution.
CSL BehringHaemocomplettan P, RiaSTAPFreeze-dried human fibrinogen concentrate. Haemocomplettan (US) and RiaSTAP (Europe).
J&J/EthiconEvicelEvicel is a new formulation of the previously available fibrin sealant Quixil (EU)/Crosseal (US). Does not contain the antifibrinolytic agent tranexamic acid, which is potentially neurotoxic, nor does it contain synthetic or bovine aprotinin, which reduces potential for hypersensitivity reactions.
J&J/EthiconEvarrestAbsorbable fibrin sealant patch comprised of flexible matrix of oxidized, regenerated cellulose backing under a layer of polyglactin 910 non-woven fibers and coated on one side with human fibrinogen and thrombin.
J&J/EthiconBIOSEAL Fibrin SealantLow-cost porcine-derived surgical sealant manufactured in China by J&J company Bioseal Biotechnology and targeted to emerging markets.
J&J/EthiconEvithromHuman thrombin for topical use as hemostat. Made of pooled human blood.
Pfizer/King PharmaceuticalsThrombin JMIBovine-derived topical thrombin hemostat.
Stryker/OrthovitaVitagel SurgicalBovine collagen and thrombin hemostat.
Takeda/NycomedTachoSilAbsorbable surgical patch made of collagen sponge matrix combined with human fibrinogen and thrombin.
Teijin Pharma Ltd/Teijin Group (Tokyo, Japan)KTF-374Company is working with Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN) to develop a sheet-type surgical fibrin sealant. Product combines KAKETSUKEN's recombinant thrombin and fibrinogen technology with Teijin's high-performance fiber technology to create the world's first recombinant fibrin sealant on a bioabsorbable, flexible, nonwoven electrospun fiber sheet.
The Medicines Company (TMC)Raplixa (formerly Fibrocaps)Sprayable dry-powder formulation of fibrinogen and thrombin to aid in hemostasis during surgery to control mild or moderate bleeding.
The Medicines Company (TMC)In development: Fibropad patchFDA accepted company's BLA application for Fibrocaps in April 2014 and set an action date (PDUFA) in 2015. In November 2013, the European Medicines Agency agreed to review the firm's EU marketing authorization application. Status update in report #S192.
Vascular SolutionsD-Stat FlowableThick, but flowable, thrombin-based mixture to prevent bleeding in the subcutaneous pectoral pockets created during pacemaker and ICD implantations.

Source: MedMarket Diligence, LLC

Note: Status of products detailed in Report S192. See UPDATED analysis in 2016 report #S290. Available online.

 

Orthopedic biomaterials worldwide market

Definitions

Biomaterial is an abbreviated form of the term biocompatible material, which can be defined as “a synthetic or natural material used to replace part of a living system or to function in intimate contact with living tissue” . Biomaterials are intended to interface with biological systems; they may be viable or non-viable. Artificial hips, vascular stents, artificial pacemakers and catheters are all made from different biomaterials.

The category of biomaterials now generally includes biomimetic materials – synthetic constructs with compositions and properties similar to biological materials. Calcium hydroxyapatite, used as a coating on artificial hips, is a typical example; it is used as a bone replacement and facilitates attachment of an implant to living bone. The term “orthopaedic biomaterials” applies, clearly, to biomaterials used to replace, augment, heal or otherwise enhance the function of bone which is damaged or deficient as a result of disease or trauma.

The orthopaedic biomaterials field is like a cake that can be cut in various ways; for example by the types of materials used, the different structures involved, and by the clinical uses to which they are put. And of course the business of orthopaedic biomaterials can involve analysis of the market (actual and potential) and of the industry which supplies these materials and the devices of which they are made.

Worldwide Market

The total global value of the medical devices market is estimated to be more than $165 billion in 2006, with annual growth at 5.5%, led by the Americas with annual rates approaching 7%.

Orthopaedic devices are a major contributor to the global medical device market, accounting for almost $26 billion in 2006, and with a growth rate that reflects growth in the medical sector overall.

The current valuation of the orthopaedic biomaterials segment is around $7.4 billion, representing over 17% of the orthopaedic total. It is also estimated that this market segment will grow at over 13% per year, which is more than double the rate for the overall orthopaedics market. At this rate the biomaterials segment will achieve a value of $9.4 billion by 2011.

Growth in the U.S. market is expected to be somewhat faster than in Europe and significantly greater than in the developing world, partly because new biomaterials are relatively expensive and their uptake is related, in general terms, to GDP. Overall, the U.S. market for orthopaedic biomaterials is expected to grow by approximately 12% per annum over the next five years. Below is shown the segmentation of the global market by main regions and countries.

ortho-bio-ww

Source: MedMarket Diligence, Report #M625, "Emerging Trends, Technologies and Opportunities in the Markets for Orthopedic Biomaterials, Worldwide."

Any ranking of the major players in the orthopaedic biomaterials marketplace must take account of the fact that some companies have orthopaedic product offerings other than biomaterials, and/or they are subsidiaries of larger concerns which do not provide detailed breakdowns of revenues. For example, among industry leaders are Genzyme Biosurgery, DePuy and Medtronic Sofamor Danek all of which are subsidiaries, while Smith & Nephew has a range of orthopaedic product offerings not including biomaterials.

Biopolymers in orthopedics

Polymers for use as biomaterials in orthopedics, in addition to the demand for biocompatibility and non-toxicity, must have appropriate degrees of thermoplasticity, strength, crystallinity, degradation characteristics and hydrophilicity . Following are the main polymers used as biomaterials in orthopaedic and other applcations.

Poly-L-Lactic Acid (PLLA).  Polymer-based absorbable implants were first used in the early 1960s when American Cyanamid developed Dexon, a polyglycol material that was used as a resorbable suturing material. It was commercialized by Davis and Geck in 1970. When blended with polylactic acid (PLA), polyglycol forms a copolymer structure that breaks down gradually in the presence of bodily fluids through hydrolysis. The main resorbable medical grade polymer in current use is Poly-L-Lactic Acid (PLLA). It is more hydrophobic than PLA or PGA and maintains its structure in the body for longer; it is used in the manufacture of interference screws, soft tissue anchors, urological stents, tacks and staples.

Polymethylmethacrylate (PMMA).  This is the most commonly used orthopedic cement, used primarily to anchor hip stems in hip arthroplasty operations. It is also commonly used in the treatment vertebral compression fractures.

Polytetrafluoroethylene (PTFE).  PTFE was discovered in 1938 by chemists at DuPont, but was not marketed until after World War II. It is a fluorinated carbon with a high molecular, partly crystalline structure, resistant to virtually all chemicals. It offers an extremely wide working temperature range, from -200 to +300 °C. Its surface is adhesion-resistant due to shielding of the carbon chain by fluorine atoms.

A major use of PTFE is to make the prosthesis for the Anterior Cruciate Ligament (ACL) repair procedure. The ACL has considerable strength and modulus due to an aligned type I collagen network that bears great loads while undergoing little deformation. However, while the ACL’s mechanical properties increase during development, they begin to deteriorate with age and may therefore need to be augmented by prosthesis.

PTFE is also used in graft augmentation devices to protect biological grafts. Its intended use is to be a temporary load-bearing device and it does not require long-term performance capability. Apart from its use in graft augmentation, PTFE is also used in microporous hydrophobic membranes (MHM) that are used in products such as vented blood warmers, in-line suction filters and vented suction containers.

Polyurethane The Polymer Technology Group produces polyurethane bionate, used in applications that have a potential mode of degradation such as pacemaker leads; also as base polymers for surface modification, known as surface modifying end groups (SMEs). SMEs can permanently modify surface properties, such as blood compatibility, abrasion resistance, coefficient of friction, and resistance to degradation in implants.

Polyvinyl chloride (PVC). Vinyl has proved to be one of the most successful modern synthetic materials; it is a polymer formed by chlorine (about 57 percent by weight), carbon and hydrogen. It is long-lasting and safe in production, use and disposal. Typical uses for vinyl in the healthcare field include blood and IV bags, dialysis tubing, catheters, labware, pressure monitoring tubing, breathing tubes and inhalation masks. Vinyl is durable, sterilizable, non-breakable and cost-effective.

Polydimethylsiloxane (PDMS or silicone).  Silicones are synthetic polymers with a linear repeating silicon-oxygen backbone. However, organic groups attached directly to the silicon atoms by carbon-silicon bonds prevent formation of the 3D network found in silica.. Silicone is used in a variety of fields such as medicines, food processing, and a wide range of medical devices as well as putty and sealants. Silicone oil is commonly used as a lubricant in syringes and blood giving sets. Silicones are used during surgery to repair retinal detachment. Silicones are also used for breast prosthesis and in topical applications.

Polyester.  Polyethylene terephthalate (PET)—linear and aromatic polyester—was first manufactured by DuPont in the late 1940s. It is still known by the original trade name of Dacron. Current medical applications of PET include implantable sutures, surgical mesh, vascular grafts, sewing cuffs for heart valves, and components for percutaneous access devices.

PET sutures have been used in the medical field for half a century and are especially valuable for critical procedures, where strength and stable performance over a long duration is necessary. Woven PET is used in surgical meshes for abdominal wall repair and in applications requiring surgical “patching.”

Synthetic vascular prostheses made of woven as well as knitted PET are used in the repair of the thoracic aorta, ruptured abdominal aortic aneurysms, and to replace iliac, femoral, and popliteal vessels. PET is also used as a sewing cuff around the circumference of the heart valves to promote tissue ingrowth and to provide a surface to suture the valve to the surrounding tissue. Percutaneous tunneled catheters also use PET cuff to stabilize catheter location and minimize bacterial migration through the skin.

Polymer Biomaterials Used in Orthopaedics

 

Polymer Type

Orthopaedic Application

PLLA, PGA, PLA

Soft Tissue Anchors, Screws, Staples

PMMA

Bone Cement

Polyurethane

Facial Prostheses

PDMS

Bones and Joints

Nylons

Joints

 

Source: MedMarket Diligence, LLC; Report #M625, "Emerging Trends, Technologies and Opportunities in the Markets for Orthopedic Biomaterials, Worldwide."

 

Bioresorbable Polymers

There is an increasing demand for biodegradable or bioresorbable fixation implants for use in procedures such as shoulder reconstruction, small joint fixation, meniscal repair and cruciate ligament fixation . The total number of such procedures in the USA is estimated to be more than 250,000 each year. The biodegradable polymers used to meet this demand include polyglycolide (PGA), polyglycolide-co-lactide, polylactic acid (PLA), and poly-L-lactic acid (PLLA).
 

Orthopedic Biomaterials, Worldwide Market Segmentation

Biomaterial is an abbreviated form of the term biocompatible material, which can be defined as “a synthetic or natural material used to replace part of a living system or to function in intimate contact with living tissue”. Biomaterials are intended to interface with biological systems; they may be viable or non-viable. Artificial hips, vascular stents, artificial pacemakers and catheters are all made from different biomaterials.

The category of biomaterials now generally includes biomimetic materials – synthetic constructs with compositions and properties similar to biological materials. Calcium hydroxyapatite, used as a coating on artificial hips, is a typical example; it is used as a bone replacement and facilitates attachment of an implant to living bone. The term “orthopaedic biomaterials” applies, clearly, to biomaterials used to replace, augment, heal or otherwise enhance the function of bone which is damaged or deficient as a result of disease or trauma.

The orthopaedic biomaterials field is like a cake that can be cut in various ways; for example by the types of materials used, the different structures involved, and by the clinical uses to which they are put. And of course the business of orthopaedic biomaterials can involve analysis of the market (actual and potential) and of the industry which supplies these materials and the devices of which they are made.  Segmentation of the orthopedic biomaterials market can be made as follows:

  • Bone
  • Polymers
  • Ceramics
  • Other Orthopedic Biomaterials
    • Growth Factors
    • Surgical Sealants and Glues
    • Tissue Engineering

 

Below is the geographic segmentation of the worldwide market for orthopedic biomaterials (drawn from Report #M625):

 
The current valuation of the orthopaedic biomaterials segment is around $5 billion, representing over 17% of the orthopaedic total. It is also estimated that this market segment will grow at over 13% per year, which is more than double the rate for the overall orthopaedics market. At this rate the biomaterials segment will achieve a value of $9.4 billion by 2011 and will represent 28% of all orthopaedic product sales.

 


Drawn from “Emerging Trends, Technologies and Opportunities in the Markets for Orthopedic Biomaterials, Worldwide,” report #M625. This report may be purchased online or via Google Checkout, below. 
 

























New technologies at recent medtech startups

Another sampling of new technologies in various stages of development at recently founded medical technology startups:

  • Surgical drain and other technologies
  • Novel wound healing and drug delivery based on unique hydrogel
  • Nitric oxide coatings for blood-contacting medical devices
  • Bioresorbable implants for a range of surgical applications
  • Device to block transmission of pathogens via intravenous catheters
  • Self-expanding stent for femoral and popliteal applications
  • Cancer therapeutics
  • Device for treatment of chronic obstructive pulmonary disease (COPD)
  • Wound closure device to improve aesthetics without sacrificing strength

These technologies and details on the companies developing them are provided in the Medtech Startups Database.  Unlike other sources of “emerging medical technologies” or meetings focused on investment and in “innovation” (you know the ones), which often have companies upwards of ten or more years old (and apparently spent all that time attending more investment meetings than actually “innovating”), the companies in the Medtech Startups Database are true startups, some only weeks (or days) old, some up to a year or two old and some up to a few years old who may have stayed in “stealth mode”, were it not for our efforts!


Below please find a list of recent MedMarket Diligence reports.

Coming in August 2008

Ablation Technologies Worldwide Market, 2008-2017

Published Reports

Spine Surgery Worldwide, 2008-2017: Products, Technologies, Markets and Opportunities

Wound Management, 2007-2016: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World

Obesity Drugs, Devices: Worldwide Market for the Clinical Management of Obesity, 2007-2015

Sealants, Glues & Wound Closure: Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007

Ophthalmology: Products, Technologies, Markets and Opportunities in Ophthalmology Surgical, Device and Drug Markets Worldwide, 2007