So this makes me wonder:

1. Should we design and prototype fast and think about the compliance later? Or bring in regulatory considerations right from the start?
2. How do small teams or early-developers manage this balance?
3. Can thinking about the compliance from the start make the process smoother in the long run?

I’d love to hear your thoughts on how to approach this balance between innovation and regulations in device development.

Something that has always been on my mind is how the drive for students to be "well-rounded" has resulted in increased participation in internships, co-op programs, and other professional experiences during their college years, sometimes at the cost of a student's mental well-being. 

I have seen some people do full-time internships while being in school full-time to graduate “on time” while also getting the industry experience needed. These friends have been exhausted through the whole semester when they help that co-op/internship with no time to relax. Some colleges have been starting to offer class credits for co-op programs, like NJIT or they have students have class semesters and co-op semesters built into their program. However, the programs may not be a fix-all, mess with their financial aid, etc. 

My questions on this topic: Is it reasonable to expect students to manage both a full academic course load and significant professional work experience? Is there something you think colleges or industry can do to help foster early career development while also focusing on student well-being?

My thoughts: As the job market continues to get more competitive, students feel the need to get all this professional experience. It is reasonable for companies to look for more experienced students for entry level positions but it is unrealistic to expect students to do both work and school. Industry can help by offering more part-time options, giving students offer letters for sull-time from internships, etc. Colleges can try to build out better co-op programs and ask for student input when doing so. Colleges can also cut back some of those theoretical classes to the necessary basics and replace them with practical classes or their co-op program. There are many approaches to support students who are striving to become “well-experienced” and “well-educated” entry level employees.

Between 2004 and 2023, I have held 12 jobs (some simultaneously), and never once in all of those 12 jobs was I ever asked what my MS, MBA, PhD or GPAs were.  Not once.  By 2005, I had totally forgotten what any of those GPA's were.  I still cannot remember.  

This is because in graduate school, GPA's and grades do not matter. What matters is whether or not you can think and figure things out, and whether or not you are conscientious. Can you achieve what you say you will achieve? Can you be where you say you will be? Can you get done what you promise to get done?  Can you take criticism and be held accountable?  These are the things that matter.

There's an old joke that goes something like this:  What do they call the person who graduates last in their medical school class?  Answer:  Doctor

I will make another provocative statement here:  Your ability to get good grades says little or nothing about your ability to perform in the real world. In fact, some of the people with the worst grades make the best workers because they are thinking about things and trying to think outside the box. Granted, there are plenty of people with straight A's who do awesome in industry too.  It's just not a correlation. I have had students sitting on opposite sides of the room write the same exact answers to a test question, because they memorized the text book. They got A's on the exam. There's not enough money in the world that would make me hire either of them to work for me. They got the A, but they didn't think at all. They parroted. That's a good skill if you want to work in a profession where you have to memorize a lot of things, but medical device development is not one of those places, nor is pharma, nor is biotech.

It's nice to get good grades, but don't get lost in the grades. Think about the lessons you are learning and how that will enable you to step up your game in a job someday. Think about how the lesson upgrades your critical thinking and what you may have learned about yourself in the process.

There's another old saying:  Experience is what you get when you don't get what you want, but it's the most valuable thing you have to offer.

You want the grade? You didn't get the grade?  That's ok. You got the experience and that's more valuable. This teaching philosophy perhaps differs from the average academic, but it is a crucial philosophy to understand if one wants to work in industry.

How do your views on grades vs experience differ? On a scale of 1 to 10 how important do you think grades are, if what I'm describing here is a solid "1"?

Taking a medical device to the marketplace is a complex and lengthy procedure. It also requires a diverse number of specialized skills. There are many important rules that one should be aware of at all the stages of the process. There are a healthy selection of comprehensive programs that provide a general introduction as to what devices are and how they are developed and practical workshops and case studies covering each process applicable to device development, marketing, and postmarked procedures.