Implementation: Eviva La Vida

 

The medical device product development process consists of three main steps: identification, innovation, and implementation. We spent our first several weeks in Costa Rica focused on identifying unmet needs throughout various hospitals in the country, including Clinica Biblica, Hospital Mexico, and Hospital Liberia, and innovating solutions for those needs during the innovation short course with Dr. Richardson and Dr. Wettergreen. For the last week, we have been focused on the implementation aspect of medical device design through our implementation short course with Dr. Richardson and Luis Diego (one of the GMI students from last year’s cohort).

The members of this course consisted of the GMI students, as well as industry professionals from a variety of medtech companies and departments. On Monday, we chose our groups and a medical device that we wanted to use for our case study for the remainder of the week. I joined Natalia, Juan, and Andres from Hologic, and we became team Eviva La Vida. Our team name was based off of the medical device that we chose to analyze for this course, the Eviva breast biopsy system from Hologic, and the phrase “viva la vida,” which means “long live life.” Surprisingly, the team name was something that I came up with (I say surprisingly, because I have never been good at coming up with team names), and I think that it fits well with the device that we chose, as biopsies are crucial in the detection of cancer and helping patients live a long and healthy life.

Throughout the week, we learned several components of the medical device implementation process, including:

  • Intellectual property
  • Manufacturing
  • Quality systems
  • Regulatory strategies
  • Clinical strategies
  • Reimbursement
  • Sales and marketing

The course was structured so that we had lectures in the mornings that included various small activities and project-based learning in the afternoons, in which we did workshops to apply the principles we had discussed in the lectures. I really enjoyed this structure, as I tend to learn best by doing, and I appreciated getting to apply the lecture information to the medical device we chose to analyze as a team. Some of the work that we did included a patent and prior art search, a labor, burden, and materials (LBM) analysis, a design for manufacturing (DFM) analysis to reduce cost, a design failure modes and effects analysis (DFMEA) and risk mitigation plan, a regulatory pathway analysis for FDA approval, a clinical trial plan, a marketing plan and sales model, and a reimbursement evaluation.

I know what you’re thinking, how on Earth did we manage to accomplish all of that in four days? The answer is Dr. Richardson is a wizard. I’m totally kidding, although he may be superhuman, as he managed to finish this week strong despite having a horrible cold (major props to him for sticking it out). In all seriousness, one of the greatest aspects of these short courses is the limited amount of time that you have to complete your project. That may seem counterintuitive (I would’ve thought the same prior to this program), but in reality, having such a short amount of time to reach a goal makes your team work more efficiently to get the job done and limits you from overanalyzing everything. I will admit that accepting these short deadlines was a bit of a challenge for my inner perfectionist, but these experiences have forced me to work outside of my comfort zone and have inspired a lot of personal and professional growth, which I am grateful for. Self-improvement is something that I try to strive for every day, and working with these industry professionals over the last week was a perfect example of how to do just that. I find it inspiring that these people took an entire week “off” of work (I say “off” because many of them still had to work before and after our class every day) in order to continue learning about the field that they work in and develop additional skills outside of their job titles.

On Friday, we presented our work to the other groups, as well as representatives from various companies. Everyone did an excellent job, and again I am amazed at the Costa Ricans’ ability to present so well in English. After our presentations, we got to tour Establishment Labs, which is the first medtech company that originated in Costa Rica. We got to walk through the entire manufacturing and assembly process for their breast implants, which was quite a unique and valuable experience. I really enjoyed getting to see the process in action and walking through all of the steps. Prior to Friday, I didn’t realize how extensive the manufacturing process can be and how much of an impact it has on product development.

On a less serious note, one of the highlights of my week was finally finding creamy peanut butter! Creamy peanut butter is not very common here in Costa Rica, so I was really excited when I found some at the grocery store. Also, 6 of us decided to attend a yoga class on Thursday evening, which turned out to be a lot of fun and surprisingly relaxing (shout out to Tasha for the idea!). I was slightly skeptical prior to the class, as my previous attempts at yoga turned out to be very stressful and not relaxing at all. Despite not being able to understand the majority of what the instructor was saying (I’m still working on my Spanish skills—ha!), I had a really great time.

We have settled in our homes for the next 6 weeks in Santa Ana, which are incredibly nice (thanks Dr. Richardson and Sheretta!) and will be relaxing this weekend in preparation for our internships beginning on Monday. Pura Vida!

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