As Vicki Anastasi notes, folks may not feel complete confidence in postmarket surveillance strategizing because of the changing regulatory climate.
“[Postmarket surveillance] is becoming more and more of the heavier burden for manufacturers,” she says. “The shift, which used to be premarket, is moving primarily toward postmarket and the cost differentials are almost negated. It’s almost the same. It can be the same burden postmarket as it is premarket.”
Ms. Anastasi is Vice President and Global Head, Medical Device and Diagnostics Research for ICON, a global clinical research organization. At OMTEC 2016, she presented on making postmarket surveillance more cost-effective.
We wondered—throughout her work with orthopaedic device manufacturer clients, what single challenge has surfaced consistently? And how can it be managed?
Vicki Anastasi: Trial design. When protocol changes happen, if studies have to change to any serious degree, then there’s a lot of time and potentially a lot of money invested in data collection that is not usable at the end. It’s important to have a strategy for trial design early.
Adaptive trial design allows the study with preplanned interim analysis to adjust, so that the trial design may not have to be perfect at inception—but at the end, the data that is collected is usable and valuable to move the program ahead.
BONEZONE: If you could provide just one piece of advice to your orthopaedic clients, what would it be?
Anastasi: Start planning very early, and plan with the end in mind.
You have to incorporate what your reimbursement and market access needs are going to be. Look at the possibility of registries and how they may be part of your requirements. Going to a payor early in the cycle and building a payor strategy is critical.
The space is rapidly changing; [payors] are looking for real world evidence, such as registries. Helping manufacturers understand how their product fits into value-based healthcare and understand what real world evidence is available is critical to putting the best strategy in place.
We like to ask our clients questions: How does your device function in an orthopaedic setting? Is it always used appropriately? How do you perceive that payors are going to respond to the introduction of your device into the market? Is it a “same as”? Does it have an enhanced quality, a better payor profile?Basically, in this era of value-based healthcare, what value does the device bring to the treatment paradigm?
Those questions at the very beginning of the program are thought-provoking, and help our clients think ahead to the product’s value proposition, which helps to define the data needed to prove the clinical utility.
Next: What's most often problematic in postmarket surveillance prep? What's the easiest part?