Week 5: Final Short Course and Breast Implant Tour

This past week we began our final short course with Costa Rican professionals from various companies. I was looking forward to this course as it contained a broad overview of all divisions of medical devices: Research & Development, Legal, Manufacturing, Regulatory, Risk Management, Quality, Clinical, Reimbursement, and Marketing & Sales.

***Shout out to my mom who has a history in sales- entering this week I was extra interested in learning the Marketing and Sales behind medical devices!***

I found this image very useful as a reference to the broad scope of medical device implementation.

Every day in this short course we spent time learning these divisions of medical devices from lectures presented by Dr. Richardson and Luis Diego Gené, a Costa Rican and previous Rice GMI graduate. There was a unique twist embedded in our learning process that truly made this week extra fun. Each group (3 work professionals and 1 Rice student) picked one medical device on the market and applied our new skills deconstructing how this device traveled from ideas and concepts all the way to the market.

I enjoy these hands-on projects for multiple reasons. Project-based learning revamps a typical lecture format (sit down and listen, furiously write/type, try to remember info) and inserts real-life applications (a medical device on the market) through creative processes. At the end of the week each group would be expected to give an English presentation on their device to a panel of industry professionals. When I came to class on Monday, I knew each team would pick one medical device based on group interest and experience- so I came prepared with a rough list of medical devices with varying complexity.

~a very short and very rough list of medical devices which interest me~


Cochlear Implant

Thing that makes you less hungry, stomach clamp thing?

I wrote this list during breakfast on Monday morning, so I didn’t have time to learn what “stomach clamp thing” really was. I was looking forward to my other team member’s input, as I definitely only had interest and no expertise on these medical devices. On my team there was Salem, Pablo, and Maria who had 26, 7, and 1 years work experience respectively. Salem and Pablo had worked together in the past, so they suggested our team should work on their old project on NextGen LAP-bands. I had no idea what this device was, but valued the opportunity learning from 2 experienced minds on this device. After I agreed to work on this device, I flipped open my laptop and typed in LAP-bands. And look what popped up!

It was the stomach clamp thing!! Needless to say I was floored at this coincidence. It was a great start to such a productive week.

On Friday my team presented our “reverse engineering” project to a panel of industry professionals. I was very happy with our results, and it was fun listening to other teams and their presentations as well. After the presentations and a reception, the GMI team had the opportunity to tour a breast implant manufacturing line. The tour was highly detailed and very interesting, and I felt like I was experiencing the TV show “How It’s Made” in real life. Because of strict sanitary codes, we had to dress up in white gowns called Bunny Suits. Men with beards had to wear special face covers, and women couldn’t wear heels and had to have their entire foot covered. Since the group had just finished presentations just one hour prior, several women were wearing heels or flats. Luckily, the company had several pairs of giant socks and disposable shoes handy so we could properly cover our feet. I can’t give much info about the tour since I signed a non disclosure agreement, but here is some general information about my experience:

  • It’s rather difficult to get into a bunny suit without contaminating anything
  • This company makes 1,800 different sizes of implants
  • It usually takes 7-9 days for an implant to be made start to finish
  • You’re not allowed to touch anything
  • The rooms are strategically pressurized to keep dirt particles from flowing in and contaminating the implants
  • Our tour guide was a processing engineer, and it took him 8 months to learn the entire process of breast implant manufacture in chemical and mechanical detail to give a tour. Great job Marlin!
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