The Medical Technology Future as Defined by Startups

Not every start-up succeeds. But every single successful medical technology company was once a start-up. From a primary consideration, start-up companies have been founded based on: (1) what technologies they consider possible, and (2) the need for clinical solutions to problems that exist in health care. For this reason, we look at the range of technologies under development, the common themes that exist among them and what this implies about the future medical product industry.The two drivers of start-ups — current technology possibilities and current/emerging/future clinical need —can often drive each other, with technology possibilities creating demand, and with changing clinical need (e.g. the aging population) demanding technology solutions. Predicting the future can, therefore, often be accomplished by anticipating the technology response to the clinical need or, conversely, predicting the emerging demand resulting from new technologies.

The Range of Clinical and Technology Focus at Startups

Taking a sampling of newly formed medtech start-ups (see Database), one can see the trends and the opportunities emerging. In the MedMarket Diligence Medtech Startups Database, which categorizes companies by areas of clinical and/or technology focus, common threads appear in the technologies of start-ups, indicating the clinical demand and technology possibilities. While the categories below do not reflect all categories of clinical/technology focus in medtech (nor all categories in the Medtech Startups Database), they are illustrative of a broad range of technologies at start-ups.

BLOOD, ORGAN & TISSUE. This represents an enormously active area, principally because of steady advances in cell biology, tissue engineering and the ever-controversial stem cell therapy. These include advances in basic science that, in turn, precipitate commercial development, as well as advances by medical technology entrepreneurs in applying blood, organ and tissue technologies to clinical problems. Two areas of significant activity are in: (1) dermatology, wound management and plastic surgery, and (2) application to treatments of ischemic heart disease.

In the first case, the application of tissue/cell technologies to aesthetics and wound management come as the result of the relative ease of developing tissue that replaces skin, fills dermal defects or accomplishes less challenging functional goals than is the case with tissue-engineered internal organs (pancreas, kidney, liver). In the second case, ischemic heart disease is one which, despite (or simply because of) the enormous market success of CABG and interventional cardiology (angioplasty, stenting), there remains strong demand for effective clinical solutions. The recent late stage thrombosis problem associated with drug-eluting stents simply furthers the drive for new technology solutions.

Common threads:
– Dermatology/aesthetics/plastic surgery, wound management and plastic surgery
– Cardiac applications (e.g., treatment of ischemia)
– Organ replacement technologies (e.g., pancreas, kidney, liver)

CARDIOVASCULAR THERAPEUTICS. Heart disease represents a huge market potential that will remain until “cures” are possible, and while genome therapeutics may one day accomplish this, for now there remains tremendous demand for medical technology device solutions. The drivers behind development are to reduce restenosis (without late stage thrombosis), create solutions that are increasingly less invasive (e.g., percutaneous bypass or valve replacement) and further penetrate the surgery-only option with minimally invasive approaches (e.g., percutaneous treatment of chronic total obstruction).

Common threads:
– Stents, of course
– Chronic total occlusion
– Minimally invasive valve replacement/repair
– Treatment of congestive heart failure

INTERVENTIONAL RADIOLOGY AND VASCULAR SURGERY. Interventional radiology/vascular surgery procedures, being the less demanding (i.e., less acute) caseload served by many of the same technologies used in interventional cardiology and cardiac surgery, still represents a strong area of potential, if only for the ability to retool (or just re-market) many technologies originally developed for interventional cardiology and cardiac surgery applications. For this reason, the use of peripheral stenting for vascular as well as nonvascular (e.g., ductal therapies as in urology) represent strong growth areas for the future. Separately, (and with no analogous cardiac application), there is strong demand for products in the treatment for deep vein thrombosis.

Common threads:
– Deep vein thrombosis
– Chronic total occlusions
– Peripheral stenting

MINIMALLY INVASIVE THERAPY. Virtually all procedures that were accomplished previously by open surgery, and many that are already being performed by a less invasive approach, are targets of development to perform the same procedures even less invasively. With the increased sophistication of percutaneous technology, endoscope technology and the growing potential for non-device technologies to compete head-on with device technologies, there really is no stopping the “less invasive” juggernaut. It is driving growth in procedures and technologies in nearly every clinical sector.

Common threads:
– Valve repair
– Coronary artery bypass
– Ablation technologies
– Orthopedic/musculoskeletal surgery
– Spine surgery

ORTHOPEDIC/MUSCULOSKELETAL. The orthopedic and musculoskeletal treatment arenas have seen challenges in reimbursement (read “reduction in profit margins”) that have driven the pursuit of improvements in devices to sustain premium pricing (biocompatibility, less invasiveness of procedures) and/or lower the costs of innovation (to widen the margin). However, the market has also seen the innovative development of traditional orthopedic technologies (fracture fixation, joint replacement/repair) being applied to small bone and joints. These are not huge markets, but do represent upside for companies in orthopedics facing shrinking opportunity in traditional markets.

Common threads:
– Small bone work
– Small joint replacement/repair
– Biomaterial (grafts, ceramics, polymers, etc.)
– Tissue engineering, cell scaffolds

UROGENITAL. This category encompasses a wide range of clinical applications and technologies, many of which have strong growth potential. Treatments for urinary incontinence span bulking agents, surgical procedures, device solutions, drugs and others, all targeting a caseload that has been ill-served in the past, leaving much latent demand. Benign prostatic hypertrophy is the subject of many different technology solutions, from surgery, to various ablative technologies, to drugs, and even “watchful waiting.” Until one or more technologies prove themselves far superior to alternatives, there will be incentive for new technologies. The urogenital arena is also particularly well-suited, given the sophistication of urologists in performing advanced clinical procedures, for the application of a whole range of ablative technologies (cryotherapy, RF, microwave, thermal therapy, laser, etc.) to treatments for fibroid tumors, endometriosis, BPH and others.

Common threads:
– Incontinence
– BPH
– Fibroid tumors
– Ablation therapies applied to urogenital applications (fibroid tumors, endometriosis, BPH)

New technologies and new solutions of any type to clinical demand are not the exclusive mandate of start-up companies. Indeed, companies like Medtronic, J&J, Boston Scientific and many others are highly proficient in developing new products that capitalize on new technology possibilities while competitively responding to clinical demand.

However, start-up companies hold a certain value in gauging future medtech markets for their tendency to focus on new technologies in which they see clinical opportunity as being so significant that they are not just introducing a new product, but they are founding a new company to do so. With such commitment being demonstrated, it is therefore well worth paying attention to their activities.


Startups Database Screen Shot of Search ResultsMedMarket Diligence’s Medtech Startups Database is a live resource of newly established medical product companies (adding 10-15 new companies per month and updating existing company data) with focus on medical devices, biotech, biomaterials and others competing in frequently overlapping clinical applications. (See details.)  The complete listing of clinical/technologies covered include:

  • Arrhythmia
  • Biomaterials
  • Biotechnology
  • Blood, organ, tissue
  • Cardiovascular Diagnostics
  • Cardiovascular Therapeutics
  • Critical Care
  • Dental/Oral Surgery
  • Diagnostic Imaging
  • Diagnostics
  • Drug Delivery
  • Drug Discovery
  • Interventional Radiology / Vascular Surgery
  • Minimally Invasive Technology
  • Neurology/Neurosurgery
  • Oncology
  • Ophthalmology
  • Orthopedics/Musculoskeletal
  • Patient Monitoring
  • Pharmaceutical
  • Surgery
  • Urogenital
  • Wound

Tags: medtech, startups

 

The Role of Sealants and Glues in Surgery

The terms “sealant” and “glue” tend to be used interchangeably in the surgical context, but in fact there is a difference in adhesive strength between sealants, pioneered by fibrin products (sometimes homemade) and the later, stronger glues of which cyanoacrylate-based products were the leaders.

Fibrin sealants represented a revolution in local hemostatic measures for both bleeding and non bleeding disorders. Tourniquet, pressure and sutures have been used for controlling excessive bleeding during surgical procedures for hundreds of years. Fibrin sealant has the potential to provide life-saving control of excessive bleeding in many critical surgical operations and during a number of elective procedures. It is used for local hemostasis and as an augmenting material during arterial bleeding. It has been applied to every organ except eyeballs. It has been shown to be very useful for local hemostasis, a valuable tool for adhesion, sealing, anastomosis, vascular and nerve grafts, and many other procedures

Fibrin and other sealant products have been approved and used outside the USA for many years and their use has created strong awareness of their surgical and economic benefits in Europe, Latin America and Asia. As a result, many products that have been on sale in these regions for up to twenty years and have been developed for a variety of surgical uses. In the USA, these products are approved mainly as hemostatic adjuncts to suturing; elsewhere they are used much more extensively as sealants and low-strength glues, as well as for their hemostatic properties. Listed below are some applications found in a recent survey of surgical procedures around the world. We believe that this represents an untapped market opportunity within the US market for these products.

More than 25 million surgical procedures are performed in the, USA each year, and proper closure of all wounds is vital to achieve efficient healing. Sutures and staples are the most common methods of closure, but often they are sub-optimal. They do not have inherent sealing capabilities, and therefore cannot stop air and fluid leakage (for example in lung resection) and fluid leakage at the wound site. Furthermore, friable tissues such as the liver, brain or spleen, are fragile and often cannot support sutures or staples. Therefore, other means of wound closure are required for repair of these tissues.

As of today, several hemostatic agents, including fibrin and other sealants, provide hemostasis and sealant capabilities by complementing and accelerating the body’s natural blood clotting processes. The adhesive strength of fibrin and other sealant products is often considered to be insufficient to close wet tissues on their own, and the hemostatic characteristics of these products are sometimes viewed as inadequate for actively bleeding tissues. For these reasons, these products have been considered as adjuncts for many closure applications; in the USA, the FDA has approved products as adjunctive for hemostasis and closure of surgical incisions. As examples, the FDA approved a number of surgical sealants including RapidSeal Patch introduced by Fusion Medical Technologies, the Tisseel product sold by Baxter, and Haemaseel fibrin sealant distributed by Haemacure. The RapidSeal Patch was approved for the indication of sealing air leaks in lung surgery, and Hemaseel and Tisseel were approved for cardiovascular and severe splenic injuries. We believe that there is justification for these products to be considered by surgeons as vital adjuncts for specific surgical indications where tissues are friable, where there is a risk of continued leakage of fluid or gas, and where hemostasis is important to the outcome of the procedure.

The exhibit below illustrates the major surgical applications of fibrin and other sealants.

 

Applications of Fibrin and Other Sealants

  • Local hemostatic measures for both surgical and trauma cases
  • Surgery in patients with bleeding disorders (e.g. hemophilia, severe thrombocytopenia) and non-bleeding cases with suspected fluid oozing
  • Surgery in nonsuturable organs (e.g. brain, liver, lung, pancreas, thymus) or to repair unhealthy tissue (e.g. irradiated bowel or tissue of elderly patients)
  • Cardiovascular, microvascular surgery and vascular grafts (e.g., aneurysm repair, coronary bypass, etc)
  • Nerve grafts
  • Skin grafts, particularly plastic surgery
  • Surgery of small or difficult to reach organs (e.g. tympanoplasty, ENT, eye)
  • Sealing of body cavities, fistulae, pneumothorax, cranium, etc
  • Anastomosis of gastrointestinal, tract and other ductal organs

Source: MedMarket Diligence, LLC

As an example, in trauma, uncontrollable bleeding and complications associated with the requirement for massive blood transfusion account for the majority of deaths in patients requiring surgery for intra-abdominal hemorrhage. Approximately 15 percent of trauma patient admissions involve intra-abdominal hemorrhagic injuries. Unfortunately, high rates of failure and mortality are seen with existing surgical procedures, which are based on the use of quantities of gauze for blood absorption, and application of localized pressure to treat hemorrhagic injuries such as these. This unsophisticated technique has the further disadvantage of the need for further intervention after a few days to remove the gauze. Fibrin and other sealants offer improved success rates for these operations.

In addition to controlling bleeding during trauma surgery, cardiovascular bypass, angioplasty, cranial and spinal sealing, total knee and hip replacement procedures, pneumostasis during lung surgery, and liver and spleen surgical operations are the most immediate untapped opportunities for sealant products in the USA. Research into current practice outside the USA has revealed that fibrin and other sealants have a role in many types of surgical procedures (see report #S145).

(From “Worldwide Surgical Sealants, Glues & Wound Closure, 2007,” report #S145, published February 2007.  Copyright 2007, MedMarket Diligence, LLC.)

 

Tags: medtech, glues, sealants, fibrin

Medical Devices Fill Gap in Slowing Pharma Pipeline

I have to admit that at times I feel like a broken record, repeatedly pointing out the fact that medical technologies — medical devices in particular — are frequently found to be providing clinical solutions to problems that neither drug companies nor biotech companies are able to achieve.  It’s a sort of yankee ingenuity made possible by device manufacturers who create remarkable innovations that just plain solve the problem in lieu of “cures” or “rational therapeutics”.  Just getting the job done.

So, I was pleased to see the CNNMoney.com article corroborating my rants and raves.

Tags: medtech, device, implant

Categories on medtech companies tracked

Not a great picture, I know, but this is partly due to technology limitation (mobile phone pic sent to go@mobile.com). But this is a screenshot of the one of the database data entry forms used in our internal company database, which in turn is used to track medtech companies (and other entities (e.g., VCs, providers, etc.) active in medtech. The categories include technology type (biopharm, device, pharm, biotech), major clinical applications (cardio dx, cardio tx, surgery, orthopedics, cell therapy, tissue engineering, patient monitoring, minimally invasive therapies, etc., etc.). We also segment by manufacturer, distributer, healthcare provider, etc.

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