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Regulatory

Postmarket Surveillance and M&A

Data collection is paramount to the success of any orthopaedic device. What happens to the much-coveted postmarket data/initiative during and after a merger or acquisition? We posed this question to Vicki Anastasi, Vice President & Global Head, Medical Devices & Diagnostics Research with ICON plc.

“If the company is already in the postmarket surveillance portion of data collection, other than looking for trends in the data, there is typically little change to the plan because it’s already been initiated.

“If the merger and acquisition is bringing a small innovative company into a larger one, then there are many times opportunities to look within the larger company’s experience and potentially utilize data sets that have been collected in a like program, and then restructure the postmarket study plan while still in the planning stage.

“If it is two large companies that are merging, then what you often see is that, over time, there becomes a more coordinated effort to have the postmarket plans mirror each other, so that the data generated is usable across the broader organization.”

We learned, too, from Ms. Anastasi that managing postmarket surveillance—grasping what’s important, what’s needed to do it well and do it efficiently—requires a certain mindset. She wasn’t referring to M&A specifically, but to the overarching, ever-present postmarket surveillance challenge.

In considering her comments, though, we assert that during M&A activity, it may prove valuable to identify and retain those individuals who can appreciate its complexities. Here is what she had to say:

“It’s important for manufacturers to understand the investment needed. [Postmarket surveillance] is a challenging area because of the changing regulatory climate. It’s becoming an increasingly heavier burden for manufacturers. The shift, which used to occur premarket, is moving primarily toward postmarket and the cost differentials are almost negated.

“One of the most challenging components of postmarket surveillance is determining and anticipating how your data collection strategy might change in response to the data that is accumulating in real time, as you’re collecting your data. If there are other products for which data is [also] being collected, that accumulating data may reveal new aspects of device performance or a safety profile. You have to look outside [of your plan] to make sure that you’re adjusting to answer the questions that are [continuously] evolving.”

As David Finch alluded to in his article, it’s reasonable to assume or rather to expect that individuals critical to the postmarket surveillance initiative will be acquired or lost through workforce restructuring as the result of M&A. During due diligence functions, you’ll seek to identify those employees who possess essential knowledge.

Ms. Anastasi shared a number of questions that she poses to clients when helping them understand their postmarket approach; we submit that you will find them useful to identify those employees whose “tribal knowledge” will  be key to retain, to ensure minimal disruption to your path to market.

  • What is the clinical utility of the device?
  • How do you perceive that payors are going to respond to the introduction of the device into the market?
  • Is there a comparable device on the market? How was that received?
  • In this era of value-based healthcare, what value does the device bring to the treatment paradigm?
     

What postmarket issues are challenging for you? Ms. Anastasi will answer them here. Please send questions for consideration to julie@orthoworld.com.