by Paul Pyzowski
Contributing Editor, MEMS Investor Journal
As an executive and entrepreneur who transitioned from the semiconductor industry to life sciences, I am often asked about "medical MEMS" by other executives, engineers, and investors seeking new markets for an existing MEMS or microfabrication technology. These questions include how to identify a need, how to think about partnering and commercialization, and even whether to get into medical markets at all.
First, in spite of uncertainties due to healthcare reform efforts in the US, I am optimistic about the increasing use of MEMS in health and medicine. The life sciences and health markets in mature Western economies are both enormous, comprising 17% of the US economy, as well as incredibly diverse including cancer drugs, hospital equipment, and home healthcare technology.
Emerging economies will continue to increase their spending on healthcare as their economies grow. And in all markets, both government and private healthcare payors will increasingly reward innovation that reduces cost and increases efficiency, and MEMS solutions do both.
Second, a slow but steady implementation of more sophisticated healthcare-IT systems and, in particular, the adoption of mobile computing systems in hospitals and doctors' offices will bolster the fortunes of MEMS component suppliers serving the mobile computing market.
Third, MEMS and microfluidics will play a significant role in healthcare technology advances in the next decade. We are already seeing the impact in genetics and cancer research, where MEMS are a fundamental part of new DNA sequencing systems. Also, new medical devices based on MEMS are being tested for drug delivery (MicroCHIPS), cardiac monitoring (CardioMEMS), and implantable neurostimulation (Aleva Neurotherapeutics).
So, how does a company with a MEMS technology determine where and how it could be used in life sciences? I use a framework of what I call the four Ds -- discovery tools, diagnostics, devices, and drug delivery.
Discovery tools, or life science instrumentation, are the workhouse systems used by biologists and chemists in their quest to understand the workings of life, and by researchers in biotech and pharma to discover new drugs. These tools include molecular biology methods like PCR, sequencing, and gene chips; protein analysis; and cell-based assays. Microfluidics has revolutionized the speed, precision, and throughput of many of these systems. This market is the easiest entry point for MEMS companies, as there are no added regulatory requirements beyond those of a non-medical product.
Affymetrix’s GeneChip technology, originally developed as a tool for biologists to study gene expression, is now used as a diagnostic tool to predict how a specific patient will metabolize certain drugs.
Diagnostics are systems used to detect or predict human disease. Many times a discovery tool can become a diagnostic, as the scientific and medical community become comfortable as a technique originally invented for research proves itself. For example, PCR is routinely used to diagnose infectious agents, and sequencing of cancer tumors is starting to enter the mainstream. Although many time a "research" and a "diagnostic" tool can be one in the same, diagnostics come with a higher burden of proof, quality requirements, and -- importantly -- a need for approval by the FDA and other national regulators.
MEMS devices can also be a part of a therapeutic treatment for disease. A medical device works by some physical, mechanical, or electrical means (think of a cardiac stent or pacemaker), whereas a drug delivery device does so by getting a pharmaceutical agent to the right place. There is certainly some overlap -- a drug-eluting stent is both a device and drug delivery system -- but I tend to think of them as two different areas, if only because the players, regulations, and competition tend to two non-overlapping spheres. Any MEMS device that is involved in a therapeutic treatment, especially if implanted inside the body, will require the highest level of regulatory approval, which may mandate expensive, multiyear clinical trials before being allowed on to the market.
CardioMEMS has developed miniature wireless sensors that can be implanted using minimally invasive techniques and transmit cardiac output, blood pressure and heart rate data that are critical to the management of cardiac patients.
So, assuming one has a MEMS technology and has identified one or more potential medical applications, what comes next? First, assume you are going to need to partner with an existing player to succeed. Medical product development can be a long, expensive, and not necessarily straightforward process, and not all MEMS companies have the funding and timelines to do this on their own.
An early generation of a MicroCHIPS implantable drug delivery device. MicroCHIPS is currently working on implantable devices to monitor glucose levels in diabetics, as well as implantable drug delivery technology.
Second, talk to potential partners and others in the field you are targeting to identify potential pitfalls and other market intelligence. For example, some materials used in MEMS may not be approved for use in the human body, and may actually cause inflammation or something worse. On the other hand, if another company has already developed a non-MEMS alternative to your product, this may be allowed by the FDA as a "predicate device" that will considerably ease the regulatory path.
Lastly, if you have a reasonably well proven platform, don't be afraid to innovate. Although medical and life sciences companies will often shy away from unproven technology, genuine improvements to the cost and quality healthcare will find an audience -- but like many things in the medical markets, it may take a while.
Paul Pyzowski is an entrepreneur and executive whose experience in MEMS includes DNA diagnostics, medical devices for treatment of neurological disease, sensors for homeland security and clean energy, and electronic design automation. He can be reached at email@example.com.
Copyright 2011 MEMS Investor Journal