The Five Biggest Medical Technology Forces

There are five fundamental forces driving change in virtually every medical technology market. (There are many other forces, of course, that impact these markets, such as regulation, reimbursement, etc., but here I speak of forces driven by technology and the innovators employing them.) They represent challenges and opportunities — depending merely upon how companies perceive and respond to them.

Devices are no longer devices (only).

An inert medical or plastic device is likely to present little competitive threat. The device that succeeds stretches the boundaries of what a device is. Devices can be:

  • Biocompatible
  • Bioresorbable
  • Bioactive
  • Shape-shifting (e.g., nitinol)
  • Hybridized with drugs, cells, other biologics
  • Integrated with RFIDs and sensors
  • Combinations of the above

Competition comes from all directions. And so does opportunity.

Competition in medical technology has long since been defined by the device, having been replaced by the definition of the specific problem solved. And that problem is the disease state and the costs of managing and/or eliminating it. (An angioplasty catheter’s competition is not just angioplasty catheters, but also drug-eluting and/or bioresorbable coronary stents, drug-coated balloons, atherectomy, minimally invasive coronary artery bypass graft, atherosclerotic plaque-reducing drugs, etc.) Successful innovators consider all possible alternatives to solving the disease state need and define themselves by the solution, not the product. The only limitation a manufacturer has is its willingness to pursue all avenues to solving the problem.

Zero invasiveness.

Any technology that is not focused on the ideal of zero collateral damage, zero complications, and zero adverse side-effects will be threatened by those that do. The advances in materials technologies, medical/surgical techniques and understanding of pathology, among other advances, are sufficient to challenge manufacturers to pursue the goal of zero invasiveness. Just as open surgery has evolved to incisionless surgery, medical technologies increasingly take on the potential to be more like drugs, or better — treating the disease on a one-time basis with no complications whatsoever.

Decentralized, point-of-care technology.

Capital equipment is expensive, big and lethargic. A handheld imaging — ultrasound, even MRI — performed at the patient’s bedside or doctor’s office, offers enormous potential to reduce cost and increase clinical utility. But decentralization is not limited to diagnosis, since treatment is the ultimate goal and its incentives are the same. Of course, the trend moving diagnostics and therapeutics from the centralized to the point-of-care is not a new idea, but the reality is that a whole range of therapeutic devices (e.g., numerous ablation modalities) have been developed that no longer require OR suites, general anesthesia and their associated costs, and imaging systems have been shrinking to the point that words like “handheld” and “MRI” can be used in the same sentence (see Butterfly Network).

Research and development tools eliminate excuses.

R&D is inevitably challenged to evaluate ideas thoroughly, considering difficult-to-anticipate obstacles and rapidly evaluating ideas to reveal the best prospects and bring them to manufacturing, then to market. But multiple technologies have been developed and put into use that can accelerate the iterative cycles of development and yield prime product candidates to bring to market — biotech, pharma, biopharm, device, drug/device and others.  Computer modeling of hemodynamic blood flow, computer simulation of drug candidates (hybridized with devices or not), 3D printing (prototypes, custom implants) and many other advances are rapidly accelerating development of products that more perfectly fit the need.


Diabetes prevalence, risk continue to increase, driving up global costs

The International Diabetes Federation released its latest findings on the global picture for diabetes, which is foreboding: 366 million diabetics worldwide (a 22% increase over 2009), an annual death count of 4.6 million, and a health care bill of 465 billion.

The diabetes market, which includes both pharmaceuticals and medical devices, is large, and is growing steadily for four main reasons. First, the prevalence of diabetes is increasing, particularly that of type 2 in developed countries and those with increasing prosperity. Type 1 diabetes is also increasing, though less dramatically. Second, type 2 diabetes is responsive to drug therapy, and there is a continuing search for newer, better pharmacological agents. Third, insulin, required for all cases of type 1 and some of type 2 diabetes, poses administration problems, offering opportunities for new delivery systems. Fourth, patients with diabetes must monitor their condition by frequently checking the level of glucose in their blood, and there are ongoing attempts to make this process easier and more user-friendly by developing more advanced (and expensive) devices.

A fifth driving factor in the diabetes marketplace is the search for a fundamentally better way to manage the disease. Some options are mainly surgical—transplants of pancreatic cells, for example. Another focus for research is to combine glucose monitoring with insulin administration in a self-controlled wearable device. And farther in the future are prospects for using stem cells to grow new beta cells, and for using genetic knockout techniques to block the metabolic processes that cause diabetes.

A Many-Sided Market

The diabetes market includes both pharmaceutical and medical device elements. The pharmaceutical aspect is again divided between insulin and oral antidiabetic drugs. The medical device aspect is made up of instruments for diagnosis and monitoring with their attendant consumables, and a range of devices for administering insulin. Some of these devices contain prepackaged insulin, so that they may be regarded as both medical devices and pharmaceuticals.

See IDF story at Medical News Today: 366 Million Diabetics Worldwide, Alarming Death Rates As Epidemic Continues To Worsen.

The global market for products in the management of diabetes is detailed in the MedMarket Diligence Report #D510, “Diabetes Management: Products, Technologies, Markets and Opportunities Worldwide 2009-2018.”

Continuous Blood Glucose Monitoring in Diabetes

Please note that the original data on glucose monitoring referenced in the post below was compiled in mid-2010 — considerable change has taken place in the market since then.

One of the fundamental challenges in managing diabetes, especially insulin-dependent diabetes mellitus (or “juvenile onset” diabetes) is the lag between a sharp trend in blood glucose levels (up or down) and the diabetic’s awareness.  The sooner a diabetic can become aware of becoming hypo- or hyperglycemic, the sooner he/she can act to preempt this adverse affects, some of which (especially for hypoglycemia) can be dangerous.

Couple this with another fundamental challenge in diabetes — the need for painful, frequent blood glucose testing involving finger pricks for blood sampling — and it becomes clear why continuous blood glucose monitoring (cBGM), especially non-invasive, holds potential.  While the challenge of providing cBGM is currently more economic than technical, as a practical matter the solution has not yet emerged that is supported by industry.

Below (and in response to an inquiry from a Quora member) is a 2010 listing (perhaps in need of a recent update) of manufacturers developing continuous blood glucose monitors.

Developers of Continuous Blood Glucose Monitors

CompanyProduct(s)Key FeaturesRegulatory Status
AbbottFreeStyle NavigatorAdvanced hypo- and hyperglycenia alarms. Has integrated FreeStyle meter for calibrationApproved
AiMedics Pty Ltd.HypoMonNoninvasive, electro-physiological, chest skinÐbasedIn development
ArKal Medical(Unnamed)Improved convenience and easeIn development
Biorasis Inc. (aka Bio-Orasis)GlucowizzardImplantable sensorIn development
Cascade Matrix, Inc.Based on the AutoSampler automated vascular blood sampling systemNoninvasive mid-infrared/microfluidDevelopmental
DexCom, Inc.SEVEN, SEVEN PLUSCan be worn up to 7 daysApproved
Echo Therapeutics (formerly Sontra Medical)Symphony tCGSNoninvasive (needle-free), wireless, transdermal, sonophoresisIn pilot trials
GluMetrics, Inc.GluCathSingle-use catheter and sensor system for real-time intravenous monitoring of patientÕs glucose; for hospital useIn development
MedtroniciPro 2 ProfessionalDisposable glucose sensor. Small automatic data recorder. Small, lightweight, watertight. Allows 288 readings in 24 hour period, uploadable via internet for remote accessCE Mark, launched outside the June 2010, approval pending in 22 other countries
MedtronicParadigm REAL-TimeParadigm CGM combined with Minimed pumpApproved
MedtronicGuardian REAL-TimeCGM onlyApproved
MenariniGlucoDay SFor type 1 and type 2 diabeticsApproved in Europe
RocheSCGM1Glucose measurement at 5 min intervals for up to 4 days. Microdialysis-based measurementInvestigational
Ultradian DiagnosticsBiologueWireless, predict and alarm user 20 minutes of a high or low glucose level, calibration-free interface to an insulin pumpIn development

Source:  Report #D510, “Diabetes Management: Products, Technologies, Markets and Opportunities Worldwide 2009-2018”, Report #D510.