This is the second in a 2-part series written by Tom Kochem, one of Olin's first alumni. Here he talks about all that's involved with bringing a medical device to market.
I have become extremely passionate about the importance of a strong design process in creating great products, from start to finish. Asked to reflect on working in the medical device industry, I have realized that this passion is probably the single most important thing that I have gained (and that I might not have gained if I had not gotten into a medical field).
When engineering students think about "design," I think a lot of them think about sketch models, SolidWorks, 3D printing, and maybe the ergonomics and users of the product. But in reality, these represent a very small piece of the design process. A proper design process really begins with extensive research to understand the context and market the product will be used in. How much can it cost? Who uses the product? Who pays for it? What is the reimbursement, and what regulatory approvals are needed? How effective must the product be for it to be a viable? The answers to these questions inform the top level requirements, from which more detailed specifications can be derived: What power does it run on? How much can it weigh? How large is it? What flow rate does it achieve? What languages must the user interface incorporate?
Getting the right specifications and requirements can be a challenge early on in any design process, but it's absolutely essential to a successful project - especially when many people become involved. After appropriate requirements are in place, there is a period where early sketches and prototypes are used to explore the feasibility of various concepts. There is early assessment of the product's risks, and how they are mitigated. This is the Research of "R&D." Once a valid approach has come into focus, and the hurdles are better understood, the detailed development begins. This is the stage where the prototypes become more refined, and we begin to generate detailed drawings and assembly instructions. We build, test, iterate, and test again, making decisions based on data. We are now taking into consideration manufacturability, serviceability, cost, etc. And a more thorough risk analysis is performed to ensure the product will be safe and effective.
Once a design has been completed and documented, we move into the verification and validation phases. In these phases, we must use objective testing to show that our product meets its specifications (verification), and that the product is effective at achieving the top level requirements (validation). Essentially, did we build what we meant to build, and was that the right thing for us to be building in the first place? After successfully passing verification and validation, the product can finally move into commercialization.
What I've described is a thorough design control process in the context of a quality system. We don't just use a design process like this because it works; it's also required by federal law. When I was graduating Olin, I would have had absolutely no interest in any of what I just wrote about. I would have considered the whole topic dry and cumbersome, or too abstract - I was interested in the concrete, more intrigued by a clever use of a cam, or a simple feature change to save cost by eliminating a core pin from a mold. And that's all important.
But the reality is that a thorough design process is critical in creating great products. Commercially infeasible product lines can be avoided entirely by accurately understanding the market and user up front, before design even gets underway. Poor durability can be avoided by writing appropriate requirements for the device's safety factor, and the temperatures and chemicals it will come in contact with. And, in the case of a medical device, lives are saved through proper risk analysis and mitigation.
As engineers, our job is not to "design" things - our job is to solve problems. And that often means solving the whole problem. I love spending time designing in CAD, but it's a very small fraction of what I do, and it's probably one of the least important skills an engineer can bring to the table in my line of work. If we want to make a difference in the world, we must invest ourselves in excelling throughout the whole design process. There are many fantastic and well-designed products that have failed to make an impact in the world because the overall context wasn't properly understood.
Many of my Olin classmates said that they may not work as engineers after they graduated - but they knew that the problem solving approach they learned at Olin would be valuable in any field. Similarly, I don't know if I'll stay in a medical device company forever. It's a great way to make a positive difference in the world, and a project like Fractyl's brings deep satisfaction. But if a day comes when I go off to explore another industry, the lessons I've learned about a thorough start-to-finish design process will be invaluable.
So to any engineering students reading this: if you're interested in design, remember that there's a lot more to the puzzle than foam models, lofted surfaces, and colorful Post-it notes. We may not have any bicycles hanging from the ceiling, but medical device is a fantastic industry to learn a process for designing great products and solving real problems.
And isn't that why we are engineers?