BONEZONE

DEC 2016

Published by ORTHOWORLD Inc., BONEZONE delivers strategic sourcing & product commercialization solutions to orthopaedic device company decision makers and their partners.

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8 BONEZONE • December 2016 A s Vicki Anastasi notes, folks may not feel complete confidence in postmarket surveillance strat- egizing because of the changing regula- tory climate. "[Postmarket surveillance] is becom- ing more and more of the heavier bur- den 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 strat- egy 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 criti- cal 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. BONEZONE: Can you identify a component of the postmar- ket surveillance process that seems to be the most problematic for clients? And on the other hand, what seems to give them the least trouble? Anastasi: I would say that the most problematic is determin- ing and anticipating how your data collection strategy might change in response to the data that's accumulating in real life, while you're collecting data. As you know, orthopaedic studies will go on for a time period, a couple of years, and you're accumulating data throughout that time period. That's also occurring in the real world; there are other products for which data is being col- lected continuously. That accumulating data may reveal new INDUSTRY UPDATE CLINICAL DATA The Postmarket Surveillance Challenge Planning goes a long way in moving from premarket to postmarket data collection. "FDA's guidance clarified that adaptive design is well understood within the Agency and therefore, if it's applicable to your clinical program, it can help you collect data, have the data submitted to FDA and move forward with your commercialization plans in a more efficient manner," says Vicki Anastasi, Global Head of Medical Device & Diagnostics Research at ICON. "You save patients, money and time to market. For FDA, that is important. If you can enroll 100 patients vs. 300, that benefits everybody. What we're seeing from executive teams of companies is that people are looking at adaptive design as a good business model. Having more data and the ability to have data to then make decisions always tends to be a good business model." - Anastasi on Adaptive Trials in December 2015

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