New Medical Technologies at Startups, May 2015

Below is the list of technologies under development at medical technology companies identified in May 2015 and included in the Medtech Startups Database.

  • Nanotechnology-based diagnostic
  • Bone fixation devices, including for post-sternotomy closure
  • Devices and materials for bone lengthening
  • Nanopolymer drug delivery
  • Developing an artificial pancreas; combined blood glucose monitor and insulin pump
  • Terahertz radiation-based measurement of blood glucose
  • Patient-specific orthopedic implants
  • Undisclosed medical technology
  • Novel energy delivery-based medical technology
  • Device for early detection of cardiovascular disease based on endothelial dysfunction
  • Facet joint surgical instruments
  • Neuromodulation technology
  • Electric stimulation in wound healing
  • Mesenchymal stem cell treatment in cardiology, transplantation, and autoimmunity
  • Integrated blood glucose monitor, insulin dosing
  • Surgical instrumentation

For a historical listing of technologies at medtech startups, see link.

 

Medical technology platforms with high growth potential

Specific technologies and broad technology platforms have tremendous potential for market growth based on combinations of recent technology advancement, changes in clinical practice, current forces in the market and other criterial. 

  • Biotech solutions to traditional medical device technologies.  The thrust of medical technology is, and has been for a long time, to make it as effective as possible while being the least possible invasive.  Taken to the extreme, instead of implanting a device, such as a suture or a staple, the almost perfect solution would to be to close wounds with no device at all.  Hence, surgical sealants, fibrin glues and other medical/surgical adhesives, hemostats and related biologicals (and even non-biologicals like cyanoacrylates), having proven themselves clinically and offering very low adoption hurdles, represent a huge opportunity in the medtech market.
     
  • 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 their expansion to new 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 in applications too numerous to mention..
     
  • 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.

(While the above list  is separately a White Paper that I have written, and periodically re-write to reflect new stuff being developed, I find it interesting and worthwhile to revisit frequently and discuss in this blog.)


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

 

 

 

Nature and medical technology trends

If one is in the position of needing to look to the future of medical technology (and who in this industry is not?)—to identify opportunities or predict challenges in the market—then it is hard to not factor into it 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 in early 2008 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), 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 already have 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), 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 enhances 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 enables 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 health care (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 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.


Links:
Accuray (Sunnyvale, CA; http://accuray.com
Hansen Medical (Mountain View, CA; http://www.hansenmedical.com
Intuitive Surgical (Sunnyvale, CA; http://intuitivesurgical.com
Stereotaxis (St. Louis, MO; http://stereotaxis.com)

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.

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.

“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.

MedMarket Outlook: High Growth Medical Technologies

(From the September 2007 issue of MedMarkets)

Drawing upon the clinical and technology sectors we have addressed in MedMarkets and the Market and Technology Reports of MedMarket Diligence, we have previously identified a number of areas where we see substantial growth in medical technology markets. In our white paper, High Growth Medical Technologies, we note those areas we consider high growth due to their “likely success in clearing technology hurdles, the size of their respective current/potential caseloads or target markets and their reasonably short (<5 year) timeline to achieve considerable realization in measurable (or even sizeable) commercial terms.” We highlight them here and note additional areas worthwhile to watch.

Nanotech and MEMS. Applications of [tag]nanotech[/tag] in medical/healthcare are incredibly diverse, from device coatings to complex drug delivery, sensors and other diagnostics. Applications are seemingly limited only by imagination: drug delivery, gold nanoshells for heat-killing cancer cells, diagnostics, nanobatteries for artificial retinas, nanosensors for pathogens, etc. [tag]MEMS[/tag] (microelectromechanical systems) applications include implantable pumps, hearing aids, defibrillators, lab-on-a-chip and other biomedical research.

Drug Device Hybrids. Drug-coated stents are only the most obvious. Demarcations between drugs, devices, biotech and biopharm have become almost arbitrary as the products are now more often defined by their functions than their composition, pitting widely different technologies against each other or combining them into products that are far more than the sum of their parts. These include bioresorbables, drug coatings for biocompatibility, [tag]drug delivery[/tag], tissue ingrowth and myriad other possibilities.

Atherosclerotic plaque reversing drugs. Take an established, invasive device market, or markets ([tag]angioplasty[/tag], [tag]stent[/tag]ing, coronary artery bypass technologies. etc.) and penetrate it with a drug — the word “growth” would be inadequate in describing the potential.

Rational therapeutics. Both drugs and device markets, of virtually all types, are at best symptomatic, arguably with high efficacy, but symptomatic nonetheless. Any clinical intervention, however, that directly addresses the root cause of disease or at least moves further upstream in the pathogenic pathway (e.g., insulin for diabetes is a far better clinical solution than dialysis for end stage renal disease), will have substantially more potential. Pharmaceutical development in general, and biotechnology in even more specific terms, recognizes the value in this. However, many a venture capital dollar has been spent overestimating this value while underestimating the technical challenge.

RFID — Radiofrequency Identification. The integration of information technologies with medical devices is inevitable, given the value of information that can be exploited by identification of devices using [tag]RFID[/tag], from ensuring surgical instrument count in the OR, identifying implants in patients, tracking product inventories, etc.

Infection control. The global population and its increasing capacity to migrate brings pathogens from, and to, all corners of the globe. The overuse of antibiotics has stimulated a startling number of drug resistant bacteria. Nosocomial infections represent a huge cost in healthcare systems. These reasons are enough to point to the huge potential for products in infection control.

Obesity Drugs. Effective drugs to treat [tag]obesity[/tag], and preempt all the downstream healthcare complications of obesity, represent potential recognized by a growing number of pharmaceutical companies, even in spite of the recent failure of Accomplia (rimonabant) by Pfizer. High volume caseload with high healthcare costs are strong drivers in support of continued obesity drug development.

To these high growth areas previously identified, we add a number of additional ones, due to the emerging potential seen as high volume potential is matched with achievements in technology development:

Apoptosis. “Programmed cell death” is a normal part of an organism’s life cycle, encompassing necessary functions of cellular differentiation, but also orepresents an area of tremendous study for its potential in areas as diverse as cancer therapeutics and other disease treatments due to the normal or even dysfunctional role it plays in those diseases.

Gene-driven drug development. The mapping of the human genome was a major stumbling block for the development of gene-based medicine, but it is not the only hurdle. The complex interactions of the human genome as it operates in molecular biology, resulting in either healthy or pathogenic tissue systems, are a gargantuan puzzle more complex than the genome mapping goal itself. However, we predict that the progress made in understanding the genetic basis of disease will yield dramatic successes in the development of drugs created based on this knowledge or, in the least, screened against genetic profiles that will dictate the likely success of pharmaceutical candidates.

Neuromodulation. In the September issue of MedMarkets, we highlight some of the developments in [tag]neuromodulation[/tag] and [tag]neurostimulation[/tag]. While applications are diverse, the apparent commercial successes in this field have been limited, but certainly significant to have been noticed (or created) by companies like Medtronic. The human nervous system has an architecture and function that make it innately less amenable to yielding its secrets than are other organ systems, yet advances in implantable devices have converged with the huge unmet need of chronic pain management to create enormous opportunity in the market.

As we have noted previously, the potential markets for © 2018, MedMarket Diligence, LLC -- advanced medical technologies appear to be limited only by imagination. Manufacturers have demonstrated time and again their ability to create product types, product combinations, applications and all their various customized variations in order to capitalize on the convergence of technical achievement and umet market demand.

The (Medtech) World is Getting Smaller

It has already been said that medical technology is getting complicated. Now it’s time to point out that the world is getting strikingly small(er).

Even the youngest startup has to consider market opportunity on a global scale. So a little medtech startup with not much more than a patent (and sometimes not even that) and with a staff you can count with one hand, is highly likely to be considering their moves based on global markets. The opportunities are all too apparent and tangible.

A caseload of 100,000 U.S. patients annually as prospects for a new device can be reasonably attractive if the device offers a measurable clinical advantage over alternative approaches  — approaches that may include a device, a drug, a hybrid of both or just a lifestyle change — and if that advantage is tangible and can be sold as such. But if the real potential market is any healthcare system sophisticated enough to use the device, willing and prepared to pay for the device and one reachable by distribution systems, then that U.S. caseload can actually represent a minor share of the total. The “rule of thumb” is that for most medical device markets, the U.S. represents roughly 50% of the world market, and while clearly the U.S. healthcare system is ready, willing and able to pay for medical technology that sometimes shows only marginal clinical advantage, that remaining 50% is comprised of an awful lot of Westernized, democractic, and capitalistic geographies, with sophisticated distribution systems, well established reimbursement schemes and, not least of which, painfully favorable currency exchange rates against the dollar. Combine this with increasingly sophisticated manufacturing and design companies capable of producing prototypes, CRO’s capable of generating clinical data, and tax structures, work forces and economies globally just begging for outsourcing opportunity and it seems a rather foolish notion to limit market consideration to the U.S., does it not?

Then there is that other earth-shrinking force, information technology. Time was when my business’s worldwide focus meant a rather heavy FedEx bill to deliver reports to Europe, Japan, China, Australia, Korea and the Middle East, but thankfully, the idea of the “paperless” world is getting more and more real, since now the vast majority of business reports are ordered and delivered electronically within 30 minutes from start to finish. It’s only the deliberative dialogue that takes longer as clients decide on the relevance of report content and that process takes place largely electronically, of course.

Worldwide markets MedMarket Diligence have covered recently:

Obesity (final edits in process)
Ophthalmology
Surgical Sealants
Orthopedic Biomaterials
Micro/Nanotechnology
Diabetes
Wound Management

Tags: medtech

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

 

MEMS and Nanotech in Medicine

In initiating our report on “Micro- and Nanomedicine“, which details the full spectrum of products, technologies and markets in the application of MEMS and nanotech to medical use, I elected not to approach this as an update of the report we did in 2003, for several reasons. First, I was able to draw on very qualified resources for the current report, and was particularly interested in the analysis capitalizing on this by having an “unbiased” view of the market. Second, the market continues to be driven heavily by R&D, which by its nature results in a rapid flux in the players, the nature of their nanotech/MEMS initiatives and the actual status of development.Since our prior analysis, a very great deal has changed in the fields defined by those corporate, academic and government entities pursuing medical development of nanotech and MEMS. We currently profile about a 100 companies, but there are easily 4-fold more that one might consider for profiles given the number of companies and their current or potential involement in micromedicine or nanomedicine.

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