Lab-Developed Tests vs In Vitro Diagnostics – Balancing patient safety, access, innovation, and commerce

By Thomas Maeder
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On July 19 and 20, 2010, the Food and Drug Administration held a public meeting on regulatory oversight of laboratory-developed tests (LDTs). This is considered a major step in an ongoing debate on how best to handle two different, but often overlapping, sets of diagnostic tools in a manner that best serves patient safety and public health, while recognizing the realities of clinical practice and medical product development.

Stakeholder interest was intense. The original meeting space reached capacity and registration closed within two days, prompting FDA to shift the conference to a larger venue. Nearly 650 people attended, while 650 more watched via webcast.  FDA’s sense of urgency on the matter was further suggested by the June 10 issuance of “it has come to our attention” letters to six genetic testing companies, followed by another 14 on the opening day of the conference itself.

What are the issues? Why the concern? What does it all mean, and where might the Agency go?

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Building the Clinical Risk Perspective into Medical Device Manufacturing

By Thomas Maeder
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The evaluation and management of risk throughout the product life cycle is the single most important concept in the regulation of medical devices. Yet it is difficult to define precisely what “risk” means or how to assess it in an industry where some 115,000 devices are produced by thousands of manufacturers, employing a dizzying array of technologies destined for use in varying health settings for every imaginable indication. So who determines the risk, and where do problems typically arise?

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Jeff Wickham, P.E. is the Principal at LifeHope Medical, Inc.
Jeff Wickham, P.E. is the Principal at LifeHope Medical, Inc.
Ask the Engineer

Three Discussions on Bonding a nylon component to an SLA part, First production run of an impeller assembly, and Plastic part with bosses for screws

By Jeff Wickham, P.E.
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Q: I tried to bond a nylon component to an SLA part, but the adhesive easily peeled off of the nylon even though I used what I thought was a very good adhesive. Any recommendations on how to get these parts bonded together? A: Plastics have different characteristics based on whether their material structure is semi-crystalline or amorphous. Plastics are composed of long polymer chains. In an amorphous structure these polymer chains are tangled together like a plate of spaghetti noodles. Typical ex…

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