November 12, 2013

Webinar Recording: Top Takeaways from the 2013 State of Medical Device Development Survey

Events
Thanks for everyone that participated in the “Top Takeaways from the 2013 State of Medical Device Development Survey” webinar.  The webinar recording is now available if you weren't able to attend or if you would like to watch it again. Transcript from the webinar Q & A follows. http://youtu.be/hHgVsrHjz0w Q: Do companies typically have a dedicated resource to manage this automated system? (NICHOLSON) No, a full-time dedicated resource is not needed to manage a TestTrack installation. With Seapine solutions, there is typically a small group of people who are enabled to make configuration changes for continuous improvement or creating new projects. Our professional services teams usually helps with the deployment and initial configuration, which greatly reduces the effort needed on the front-end. Q: Why have process champions not been able to drive improvements in medical device development? (NICHOLSON) I believe this goes back to the slide we had up earlier about what’s preventing medical device companies from improving processes and tools, which were budget, internal bureaucracy, and gaining a consensus decision. Obviously, the fear of change is always an obstacle. I also believe that validation costs and efforts can disrupt a business, which is why we invited Greg of EngiSystems to be part of this webinar. (PIERCE) In my experience I have observed all the causes indicated in the survey, especially in the areas of Budgeting, Bureaucracy, and Decision. When it is coming down to the process champions driving the improvements, it is sometimes very difficult to achieve the consensus due to internal opinions, agendas, and views. During my firm’s process optimization projects, one observed key aspect is the evaluation and determination of the magnitude and priority. This is where I observed that some organizations struggle to achieve consensus for the prioritization and it is very difficult (internally) to assess the return on investment. In these instances it is beneficial to ask the help of the third party and assess and identify the priority, based on a return on investment analysis. Using benchmarking tools an experienced firm can determine where the focus should be and support the process champion to drive the “right” improvement. Q: Is your thesis that the deployment and use of integrated product development tools is the biggest leverage for improvement in product development? (NICHOLSON) Not specifically, but I believe that good processes should be matured and supported through an integrated framework. Disparate systems that aren’t designed to work together increase your validation efforts, provide little reusability, require more training, and often require more resources to manage—which can increase your risk of effective transfers and do not support the proper visibility needed in today’s world of medical device product development. However, once good processes are discovered and mapped out, an integrated artifact-centric approach would help provide and support a more streamlined way of working for all involved. Using non-integrated tools or manual methods with updating Word and Excel documents is difficult, if not impossible, to defend against in an audit. It might work with a team of three or five people in the same office, but this is not usually the case for complex or higher risk medical device products. (PIERCE) No, I believe it is important to have processes that are streamlined, standardized, and integrated to work together to improve product development process and product quality. Once you have a solid process that is standardized and is transparent for the users of the process to execute and ensures product quality, then the appropriate toolset can help with improving efficiencies in executing the process.