In the past five weeks in Costa Rica, we have taken three short courses that have delved into the entire product development process- covering the front and back ends. As a recap, the first class was taught by Paul Fearis during the first week we were in Costa Rica and explored the process of finding needs and developing solutions for issues we identify in the medical field- essentially the front end part of medical device design. A few key points that I took from that course was: how to craft needs statements, the importance of de-skilling certain processes, never to jump to solutions immediately after seeing an issue, and the potential to target an upstream issue when looking at the root cause. The second course was taught by Dr. Richardson and Dr. Wettergreen and emphasized the design and prototyping phase of medical devices. This course really opened my eyes to the importance of low-fidelity prototyping and the ability to mimic an idea through craft supplies, before investing a lot of time/money on an idea. And last but not least, the implementation course that we completed this past week taught by Dr. Richardson and Luis Diego (a former GMI graduate) tied it all together by covering the back end part of product development and most of all gave a great introduction to the parts we will be involved in during our internships at Boston Scientific.
One may ask, what is the back end of the product development process? A vital question indeed as it takes up about 80 – 90% of the entire process! Essentially it includes the following: quality management, manufacturing, regulations and reimbursement codes, clinical strategies, and sales and marketing. All of this was covered in just 4 days in the short course that we took at Establishment Labs. The class was made up of working professionals in the medical device industry in Costa Rica from all different companies and departments. On Monday we assembled into teams and chose a product that we would apply the aspects we learned about throughout the week.
Team Utrust! Pablo, me, Nicole, and Marco (left to right).
My team was made up of 2 RDI engineers (one who used to be a manufacturing engineer) and a civil engineer/manufacturing engineer working in the medical device industry. Our product was a based off a Hologic tissue removal device used in the uterus, called Myosure. Based off the intent of the device, my team was called Team Utrust (get it?). The system worked by moving in axial and rotary directions to cut and suction out the tissue. It was inspiring to have different experiences and backgrounds in a group, as each person was able to bring their own expertise to the project. I would hope such efficient collaborations existed in the industry! I really enjoyed the structure of this short course because we typically had lectures and in-class exercises before lunch and group project work time after lunch. This really allowed us to develop our projects in the short week.
This course also brought to light a lot of factors that need to be taken into consideration when analyzing the back end of product development such as:
- The importance of design for manufacturing (DFM) principles (fun fact: engineers in the toy industry have the best strategies) and there should be a synergy between the R&D and manufacturing department.
- Take the trail that leads to money already instead of going through the long process of creating a new reimbursement code.
- Quality management systems are always in a state of flux and make up the nervous system of the product development process.
- Validation and Verification (V&V): Validation is made up of external feedback through clinical outcomes and is done at the end. Verification happens within the internal processes.
Presenting about our device Myosure.
On Friday, we had the opportunity to present our projects in a showcase where Establishment Lab and Hologic employees
Gowned up in the proper PPE before entering the clean room at Establishment Labs.
gathered to see the work we had done this week. After our showcase, we toured Establishment Lab’s clean room where the manufacturing of the breast implants occurred. It was really cool to see how the process worked and got me excited about my internship starting very soon at Boston Scientific. This week I found out that I will be in process development of urethral stents, so I will be taking on a project dealing with building prototypes of these stents!
Birthday cake surprise!
Looking back on this week outside of class- Tuesday was my birthday, so all the GMI’ers joined me for dinner and surprised me with a chocolate cake after dinner! Saturday was eventful as we experienced our first black out in Costa Rica! In fact all of Central America underwent a power outage for 5 hours because of a power overload in Panama. Upon further researching the event (once we actually had Wi-Fi), I learned that “the Central American countries are interconnected by an electricity transmission line of 1,820 kilometers, which extends from Panama to Guatemala”. A lot of
Fresh fruits and vegetables from the Feria del Agricultor.
businesses had back-up generators, while other businesses had to shut down during this time period and traffic was severely affected. On Sunday, we started off our morning by visiting the nearest Feria del Agricultor – which is a weekly farmers market that takes place all over Costa Rica in several towns. I got to stock up for the week with lots of fresh fruits and vegetables!
This next week we will begin our orientation to prepare us for our internship for the next six weeks at Boston Scientific! I am really looking forward to learning about the real-time medical device process in the industry. I am hoping to have a hand-on approach in the project I take on during my time there and learn about all the different aspects of process development, including the inlets and outlets of it.
Thank you for reading! Tune in next week for an insight on what I will be doing at Boston Scientific! Pura vida.