(The GERD patient population is a largely untapped surgical market; see chart entitled, “Total Potential Market for Endoscopic GERD Therapies”)
Physicians from UT Southwestern Medical Center and engineers from UT Arlington have collaborated to develop a new technology for detecting the occurrence of heartburn and gastroesophageal reflux disease (GERD). Presented in May at the Digestive Disease Week conference in Washington, DC, the new system involves the use of a small chip designed to replace current standard testing procedures, which can cause patient discomfort and impact normal eating habits.
The new wireless system uses radio frequency identification technology (RFID), which is being utilized in many industries for tracking inventory. To create the new device, RFID technology was paired with impedance monitoring.
To monitor the esophageal environment, a small, flexible RFID chip is pinned to the esophagus. The chip utilizes a special plastic material intended to prevent patients from feeling it in their throats. Measuring roughly two square centimeters, the device monitors electrical impulses of liquids moving through the esophagus, and whether they are acidic or nonacidic. The chip collects the data and sends it to a wireless receiver worn around the neck. As patients go about their normal daily lives, the chip will monitor the presence of acid, gas, or water, after which physicians review the data to determine if the patientâ€™s heartburn symptoms coincide with eating a meal or other activities.
Researchers have tested the device in the lab to ensure it accurately identifies the acidity of substances and can send results through human tissue. The next step will involve testing in animal models. It has taken roughly two years to develop the wireless RFID system and enable it to detect and send data. The receiver will include a button that the patient can push when they begin eating. Eventually, the engineers hope to design a device similar to a PDA to store the collected data. This would then be downloaded for analysis at the doctorâ€™s office.
New monitoring methods for GERD are sorely needed to replace current methods, which require placing a flexible catheter tube through the nose and down into the esophagus. The procedure is very uncomfortable and, because the presence of the catheter usually necessitates a change in the way a patient would normally eat and drink, it can produce biased test results. Since no catheter is required with the RFID system, doctors are hopeful that it will make it easier for patients to eat and drink as they would normally and maintain their usual activity levels.
Several other technologies have been developed in recent years that provide a noninvasive alternative for gastrointestinal diseases. These include the PillCam, a small pill-sized wireless camera that snaps photos during its journey through the digestive tract, and the Bravo capsule, another wireless system that detects esophageal acids. Both of these are both also used by UT Southwestern gastroenterologists.
GERD can occur in adults, children and infants; as many as 10% of Americans experience heartburn on a daily basis, and it is estimated that GERD affects 25%â€“35% of the population. Current diagnostic methods include barium swallow, endoscopic manometry, and pH testing. Treatments include lifestyle modification, antacids, proton pump inhibitors, positional therapy and surgery. Complications of GERD are common, including esophagitis and Barrettâ€™s esophagus, a potentially precancerous stage of disease.
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, predictingÂ 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.
– 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 â€œcuresâ€ 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).
– 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.
– 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 â€œless invasiveâ€ juggernaut. It is driving growth in procedures and technologies in nearly every clinical sector.
– 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 â€œreduction in profit marginsâ€) 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.
– 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 â€œwatchful waiting.â€ 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.
– 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.
MedMarket 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)Â 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:
As I was considering topics for the April issue of MedMarkets, I came across a story in Reuters that aspirin was associated with reduced incidence and mortality from cancer.Â That aspirin should have such a therapeutic benefit was not surprising, especially considering the data that has been appearing from different sources that inflammation (aspirin is an NSAID) plays a central role in the etiology of many diseases.Â But this is sobering.Â While medical technologies can run the gamut from the relatively simple (e.g., bare metal stents) to the pretty darn complex (e.g. bioresobable extracellular matrices), the prospect of our sophisticated thinking leading us toward technology solutions that could be virtually preempted by a drug like aspirin makes just such a possibility one that, however humbling it may be do so, must be taken into consideration by medtech innovators.
A report in the June 7 issue of the Journal of the National Cancer Institute (see article in Medical News Today):
Screening for cancer can find tumors that might not otherwise have been diagnosed in a person’s lifetime, a situation called overdiagnosis. Overdiagnosis wastes health care resources. Tests and treatment resulting from overdiagnosis can lead to substantial toxicity and even premature death in patients.
I find this interesting, unsurprising and largely irrelevant. First, I have to note that I was struck with the use of the term “overdiagnosis”, which I would expect to be a term used to describe an exhausted physician. I’m certain the authors intended to mean something akin to “false positives”.
It is unsurprising in that I expect clinical practice to occasionally result in instances where there appears to be a problem that, under further evaluation, turns out not to be a problem. The alternative is to miss the problems, resulting in pain and/or death.
It is largely irrelevant because, in lieu of technology or clinical practice that is perfectly accurate and precise by never missing pathology and never mistaking normal tissue from abnormal, we must err on the side of false positives — excuse me, overdiagnosis. Do we want to minimize the wasted use of our precious healthcare dollars? Are these non-trivial differences between accurate and inaccurate diagnoses? Who can argue against these questions?
A marketing manager was questioned by a new boss about a promotion to get registrants to a conference, and the boss questioned why the brochures were sent out to so many people. The manager responded, “Tell me who will attend the conference, and I’ll only send brochures to them.”