Eastman’s Gopal Saraiya, global segment leader of medical devices at Eastman Chemical Company, took time to address a number of questions related to the use of materials in medical device development. He was included in the staff written article, “Materials Impact Medical Device Design Trends.” Following are all of the responses he provided.
Human factors engineering, as applied to the design of medical devices, has never been as important as it is today, especially since the release of the U.S. FDA’s draft guidance document Applying Human Factors and Usability Engineering to Optimize Medical Device Design. With the rise of mobile health apps, human factors engineering principles will become even more vital to the success of this industry and to the safety of the patients.
The medical device ecosystem is changing dramatically from stand-alone “device + patient + physician” in the clinical environment to include access and mobility outside the four walls of the hospital. Every medical device manufacturer should consider developing a strategy around how mobile connected health will affect their business models and how they will play in the evolution of the market.
The growth in sales of medical technologies is set to outperform prescription medicines over the coming five years. Data from Evaluate Medtech indicates that over the period 2011 to 2018, the overall global compound annual growth rate for the sector will be 4.4%, in contrast to just 2.5% for drug products.
One of the most interesting things about my position is seeing the changes in one of the most dynamic industries around—the medical device industry (and, in a broader sense, the healthcare industry). In my 13+ years of reporting on this industry, I’ve seen many changes and technological advances. It truly is remarkable to think about how far certain sectors of the industry have come in what is really a very short period of time.
Home healthcare and the use of medical devices outside of the professional healthcare environment are on the rise. Modern medicine allows us to live longer and provides those with chronic diseases the ability to receive medical care at home. Examples of home-use devices are oxygen concentrators, hospital beds, sleep apnea monitors, body-worn nerve and muscle stimulators, and dialysis machines, just to name a few.
The technology at the heart of the next generation of medical devices is critical to our ability to offer comprehensive care in the coming decades. While our current systems of care have served us well thus far, they are crumbling under the pressures of modern expectations of care, economics, scale, and the sheer breadth of medical science.
In recent years, many electronics manufacturers have been adopting the use of video inspection systems utilizing digital cameras to perform many of the visual inspection functions formerly performed with optical microscopes. Digital camera technology has improved to the point where the image quality now rivals that of optical instruments for many applications.
Industry-wide, companies of all sizes are discovering one of the most effective tools in business growth—collaboration. Gartner Research Group findings cite that collaborative capabilities have allowed top patient care organizations to make great strides in enabling high-quality care at optimal economic cost.
Medical device manufacturers should welcome the proposed ruling for Unique Device Identification (UDI); however, being compliant by the effective date (based on classification) for some organizations may be a concern. UDI aims to identify errors involving medical devices and provide more rapid resolution of device problems.
Eric Olson is the chief executive officer and president of Amedica, the only company that produces medical grade Silicon Nitride. He took a moment to participate in the following Q&A about the unique material and its impact in medical devices, specifically in the orthopedic implant area.
Ordinarily, changing from a validated gamma sterilization process to E-beam sterilization requires running a dose mapping study and doing a dose verification study similar to a routine quarterly dose audit. The standard radiation validation requirements of ISO 11137 require that data be “available to show that, using the same sterilization dose, microbial inactivation is not affected by differences...
Next July, certain medical electronics will fall under the scope of RoHS—the European Union’s Restriction on Hazardous Substances. In terms of the electronics industry, that is now a tight deadline for manufacturers. Medical devices that have so far been exempt from RoHS fall into scope under the RoHS Recast (RoHS 2) beginning in July 2014.
While the advent of electronic health data offers impressive potential when it comes to treatment and diagnosis, it brings with it a host of security issues. The issue is cumbersome and often slow-moving regulatory bodies are scrambling to keep up with the quickly changing landscape of the medical world and they’re leaving a path of semi-regulation in their wake.
Nowhere is the concept of developing a system with ‘point-products’ more hazardous than in medical devices. It is here that the performance of every aspect of the system is critical to the long-term behavior of the end product. Interoperability between components takes on a whole new meaning in the context of critical care. Like Shelley’s monster, multiple devices from multiple suppliers will perform differently under identical conditions.