Arena customer Epic Medical Concepts & Innovations (EMCI) develops disruptive technologies by translating high-level scientific research and medical innovation into market-ready devices.
According to EMCI’s strategic-minded Vice President & COO Peter B. Lucas, Arena’s flagship PLM product, BOMControl, and Arena Quality, helped him meet the design demands of his company’s seven new product introduction (NPI) phases. However, Arena Projects, which links to the product record to allow global collaboration around items, changes, files, and tasks, also played a huge role in optimizing EMCI’s NPI processes. In this interview, Lucas discusses how Arena Projects helped his medical device company succeed.
Arena: How has Arena Projects helped you manage your company’s NPI processes?
Lucas: Our NPI process has seven overarching phases with probably 100 tick boxes that have to be checked off with documentation attached. So, we’re using Arena Projects not only for simple project management — we’ve also created SOP templates for design control in new product development. We’ve created templates that have all of those phases and sub tasks delineated such that we can assign dates. When those are closed out we can attach the specific records to each.
All the notes in our NPI processes are embedded directly onto that Project’s template where we can also attach any required documentation right to the record. So our management review deliverables are no longer paper based. Additionally, anyone with permission can access it, make changes or perform audits.
Arena: How has Arena Projects helped you manage all the punishing documentation that accompanies any NPI process?
Lucas: Instead of having what essentially added up to six, eight, or ten four-inch binders plus lab notebooks — now all of those records are attached directly to the Project module in Arena PLM — electronically. Permanently and in an organized manner.
So, Arena Projects removes having tons of paper floating around; it puts all the documentation in one place so when somebody audits our design control function, they can just pull up whatever project they want to look at and pull up the details to determine if proper signoffs were made.
Basically, we’re getting rid of all the paper associated with the laborious manual checks of our NPI process. We no longer have to dig through piles or paper and ask, “Did I get that CAPA verified and signed off? Did I get everyone to sign off on the ECR?”
Arena: What’s the downside of not properly managing your documentation?
Lucas: Before we had Arena Projects, we had to get the SOP and flip through the binder manually and check each item off. The FDA is a stickler to make sure everything is there. If you don’t have your documentation in place, it could be perceived to be intentional or fraudulent; they can put a padlock on your business and throw you in jail.
Arena: How many of Arena PLM’s modules do you use?
Lucas: We use all of them. I don’t think any medical device company could get away with less than all those modules. As soon as my engineers design a part, every change that is ever made to that part is tracked by and through the system. You can’t ever untrack it. The history is there no matter what. Even if I abandon the part, that history stays there forever. This is incredibly important to tracking and managing your NPI processes and ensuring the requirements of an FDA compliance audit are met.
From breakthroughs in personalized medicine, genomics, and medical devices, healthcare and life science companies are finding ways to advance human health more cost-effectively. Yet increased regulatory requirements challenge innovative medical device companies to get to market quickly. Arena PLM can help medical device companies reduce compliance risk and accelerate NPI processes to win.
Click here to learn more about Arena Projects and stay tuned for an upcoming webinar with Lucas to hear his insights on how medical device companies can streamline their NPI processes for maximum business results.