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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?
BONEZONE: Can you identify a component of the postmarket 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 determining 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 collected continuously. That accumulating data may reveal new aspects of device performance or a safety profile. So, as the data is being collected and you have a set plan, you have to actually look outside of that—at the real world and the accumulating data on your own product as well as what’s happening in the specific space you’re in, to make sure that you’re adjusting to answer the questions that are evolving over that time period.
If you have a set protocol in postmarket and you’re collecting the data and it raises some sort of question about either the performance or the safety, then you have to readjust.
Also, outside of your own study, if in the general area people are collecting data and there arises a performance or safety question, then that is ultimately going to affect you. Acknowledging, planning for and adjusting for that is important.
The easiest approach is, at the very beginning, determining a data plan about what you will need. You can start defining your postmarket strategy really early if you evaluate your existing data and also the data that’s available from real world evidence.
You can look at trends and gaps, then start planning how you are going to collect the additional data necessary to show that you are along the same trend—or fill in the gaps so that your technology can be fully assessed.
And I’m answering the question almost the same as far as the easiest thing to do: establish your plan based on the information that’s available, and then understand where your product differs, and therefore see what gaps you will have to additionally fill. The problem is that once you’ve established that, it can’t just be left alone—you have to constantly evaluate to see what trends are emerging.
I think that the era of not knowing what is required in order to collect the correct data and evidence is becoming a thing of the past. It’s important to listen and watch what’s happening, because there is a much more open environment of industry + regulators + payors working together to move forward together; that’s an important part of the postmarket scenario.
There’s tremendous forward movement, so I’m excited about the time we’re in.
