Our last week is underway and I have a lot to look forward to! I am excited to see my family and road trip from New York to Houston with my sister. I’m eager to get started on our design and implementation projects and I am looking forward to getting settled in and trying all the fusion cuisines Houston has to offer! I am sad to say goodbye to Costa Rica for now, but I hope to take Spanish classes and come back in the future.
Most recently at work, I spent time on an urgent Supplier Engineering project defining components of permanently implanted devices that are manufactured in Coyol, Costa Rica. As industry standards have changed, Boston Scientific is updating all materials that have long term contact with the body to be “medical grade”. This is a rating given to qualifying materials by the U.S. Pharmacopeial Convention (USP). Current Boston materials are biocompatible, but don’t necessarily have this rating. I evaluated the risk of these components based on the grade of material currently in use and the length of implantation time of the component. Many of Boston Scientific’s stents are manufactured in Coyol, and certain parts will have to undergo material changes in the coming few years. This is a huge undertaking and will require testing of new materials, finding new manufacturers, or requiring manufacturers to change their ways.
For Boston Scientific’s acquisition of nVision, I put together a spreadsheet of components of the Mako 7 device that are not currently manufactured by a company that is on Boston Scientific’s Approved Vendor List (AVL). For each of these parts, I have compared their prices to those of manufacturers that are on the AVL. Hopefully, Boston Scientific will be able to move forward with pre-approved vendors that are able to make the components needed for the Mako 7. Using approved vendors speeds up the launch process because further audits do not need to be performed and agreements have already been signed. Every day that the Mako 7 is not on the market is a day that women do not have access to this ovarian cancer diagnostic tool, so Boston Scientific’s aggressive timeline is crucial.
Through this internship, I have gotten a more complete sense of the medical device development process, from raw material acquisition through manufacturing. Although R&D and the design process get the reputation for being exciting and creative, there is problem solving to be done in material selection, cost analysis, and designing for manufacturing, and a device could not be put on the market without them. I’m glad that the experience I had at Boston Scientific shed light on some of the less sparkly, but equally important and complex, aspects of medical device and product development. I think that this knowledge will help me as a designer, too.
From a less technical standpoint, through this internship and my time in Costa Rica I have gained friendships with both colleagues and fellow GMI students that are very meaningful to me. I am excited to go back to Houston and have ten familiar, motivated, funny, insightful friends to spend the school year with. I have also gotten to spend some time with my colleagues outside of the office, celebrating birthdays and babies, and meeting their dogs and seeing their homes. I’m sad to say goodbye to so many of my coworkers who have welcomed me to Costa Rica and Boston Scientific so warmly. I will keep Whatsapp just for them!
GMI’s Supplier Engineers (from left: Theresa, me, Hannah)