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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Page 9 of 84

9 BONEZONE • December 2016 INDUSTRY UPDATE The history of our research, the competencies gained in 60 years of family expertise, a well-equipped laboratory with excellent technology and a professional team make HPF your best choice in Europe. We design, develop and manufacture innovative implants, surgical devices and orthopaedic products. Our manufacturing capabilities include forging, CNC machining, heat treating. We combine traditional techniques with the revolutionary technology of Additive Manufacturing. Our R&D department adds value to your projects where ideas come to life. WE TARGET SOLUTIONS, TO VALUE YOUR PROJECTS - high precision European manufacturing 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 collect- ing 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. Acknowl- edging, 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 dif- fers, 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. What questions do you have on Postmarket Surveillance? Email them to and we'll get experts like Ms. Anastasi to answer. Ms. Anastasi's OMTEC slides can be viewed and downloaded at

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