HCB News: FDA approval for medical devices is a long, complex process requiring quite a lot of guidance and investment, and there are differences in classification which can make the bar higher, can you comment on that?
ER: A medical device may require premarket review by the FDA before it can be made available in the US market. Timing and process depend on several factors including the classification of the product. A device’s intended use and indications for use determine its classification. Device classification is risk-based. Class I medical devices, pose the lowest risks and generally do not require premarket review. Class II devices are higher risk and are often subject to premarket notification (or 510(k)) requirements. Class III medical devices are those which pose the greatest risk and typically require a premarket approval application including non-clinical and clinical studies supporting the safety and efficacy of the product. This process can take up to 6 months or more.

HCB News: What can foreign firms expect during negotiations in the US? Are we hardscrabble as some perceive?

ER: We see cultural clashes in this regard and it’s our job to smooth that out and make it work. A typical first offer in the US tends to be more one sided, a perfectly acceptable approach in a culture where tough negotiations are expected. In many European countries, by contrast, terms offered at the outset are typically guided by the desire to make a fair and acceptable proposal, so more middle of the road. An advisor is then needed to ‘translate’ the cultural differences to get all parties to a deal.

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