Would you please comment on the medical device industry as we move into 2013?

Erol Harvey

As molecular diagnostics (MDx) moves to point-of-care to rapidly deliver species-specific identification of viral or bacterial infections, there are challenges with respect to product development and gaining regulatory approval (preferably CLIA waiver) for complicated products. Microfluidic platforms translate MDx to point-of-care, adding value by employing hands-free sample preparation and protocol automation (including target amplification and various detection strategies) with a platform that provides cost-effective high-volume manufacturing. A staged product development approach enables early risk mitigation on key product elements, materials selection, and design for manufacture, followed by the integration of assay components into fully functional prototypes and appropriate instrument-cartridge function assignment. After design lock down, low-cost manufacturing techniques are implemented alongside rigorous documentation to streamline regulatory submissions.

Addressing these development challenges and applying rigorous product development strategies, companies can enter this market, which, according to a recent Frost & Sullivan report, is estimated to grow to $6.2 billion by 2014. While 75% of the market is controlled by only nine companies (Roche, Qiagen, Gen-Probe, Abbott, Siemens, BD, Cepheid, bioMerieux, and Beckman Coulter), this sector is ripe with opportunities for new products in infectious disease diagnostics (represents 60% of MDx market), with near-patient applications one of the fastest-expanding application areas.

John Belzer
President, TCI Precision Metals

The medical manufacturing industry has seen improvement since the downturn of 2008-2009, but there are now fewer shops to handle the load. A weakened dollar has also provided a boost to help make U.S. manufacturing more competitive and there is evidence that previously “offshored” manufacturing is now being “reshored.” Combine this with high customer expectations and a shortage of skilled labor, and the result is growing backlogs and shops pushing capacity levels. As a result, job shops and manufacturers are facing potential operational pitfalls, including throughput challenges, machining efficiency, controlling cost, and more. Utilizing precision machine-ready blanks is one way manufacturers and job shops are improving production capacity and throughput by as much as 20%. Machine-ready blanks eliminate the need for in-house sawing, grinding, flattening, squaring operations, and outside processing. Each blank arrives deburred, clean, and to customer specifications.

Jacques Hoffmann
President, InterTech Development Company

At InterTech Development, we use advanced technology to improve medical device testing, but even in the age of “online intelligence,” there are basic pitfalls to avoid. Complex calibration methods could mask mechanical issues and slow down production, or even worse, lead to unreliable or inaccurate results. The best approach to leak testing combines best-in-class technology with a thorough understanding of testing.

One of the most common calibration mistakes made by medical device manufacturers is to assume an accurately calibrated leak detector validates the entire test system. This is not a safe assumption. What if there is seal creep? Has the effect of surface finish been anticipated? Always strive to design fixtures that prevent these and other problems or there can be significant gaps between presumed gauge repeatability and reproducibility of the test instrument and the actual test process.

Not even Google can save us from poor assumptions. Just because a company has expertise in design and manufacturing of medical devices does not ensure best results for leak and functional testing. Let a specialist help you avoid common mistakes; it is good advice whether the concern is a personal medical procedure or a quality control system for your business.

Dave Foreman
Vice President, Design Profit Inc. (Munro & Associates software unit)

What we can expect to see more of in 2013 in regards to design, engineering, and prototyping is better information earlier or more “Knowledge Based Engineering.” Not just specific product requirements, but total ownership costs from cradle to grave. When you look at many of the devices that are being developed, you cannot help but be amazed at the brilliant lifesaving technologies that are being introduced and what’s in the works. But, many of the devices are designed purely around form, fit, and function; producibity, which drives cost, is a secondary activity. We need to consider every step in the product lifecycle, and we need to consider it as early as concept. When we consider what we are doing at the concept stage, we are making balance trade studies to determine the appropriate next steps. We need to avoid detailed engineering, as it is time consuming, costly, and locks us into a singular concept. Knowledge is needed to make the right decisions. It’s not about knowing everything; it’s about having the right amount of information at the right time to make the right decision at each step in the development process, from beginning to end.

Paul Imaoka
Vice President, Medical Murray

Contract manufacturing continues to shift from just “manufacturing” to include a full road map of your finished products, including design, test, manufacturability, and distribution.

Selection of a contract manufacturer must take into account companies that have specific knowledge and expertise of not only the component that they provide, but increasingly, the application of the component and finished device. This requires a partner that has the design and development capabilities with extensive experience in product development, material selections, and biocompatibility. Scarcity of raw materials and the experience of alternate materials unique to the medical industry become important should your chosen raw materials go on shortage.

Changing regulations, and the new medical device excise tax, makes selection of a contract manufacturer even more important today. A contract manufacturer that provides forward-thinking in these areas could provide large savings in the long run. Integrated shipping and logistics of finished devices makes you lean and provides even greater cost savings.

Making the right part at the right time, and the right price, is now only the beginning. Added value of your contract manufacturer will be how they become true partners in your product lifecycle and business operations. Real partners understand not only the component they produce, but also its linkage to the design, regulatory, marketing, sales, manufacturing, and distribution areas of your business.