IN THIS ARTICLE, TED TALKS ABOUT DFM, ONE OF THE BIGGEST CHALLENGES FACED BY MEDICAL DEVICE MANUFACTURERS.
Describe your responsibilities at Gray Optics.
My role as an opto-mechanical engineer is to design sub-assemblies for medical devices. For example, we’ll develop an end-to-end vision system or a camera module designed to fit within a given spatial envelope that will later merge with our client’s system mechanics. I also develop fixturing for precision alignment, either 3D alignment or setting lens focus on a sensitive system in our internal fixturing.
Our client base varies. It can be a sole entrepreneur with an idea who outsources all the engineering or larger clients with their own teams of mechanical engineers. Optical design is a niche capability, so having both mechanical and optical expertise is one way we add value.
What’s the medical device market like right now?
We’re seeing an increase in coronavirus testing projects as companies develop more accurate, more sensitive tests. Many of our clients had existing prototypes already developed, and the pandemic served as the driving force to get the device into production quickly. That’s where the challenge comes in – balancing budget and schedule without sacrificing quality.
You mention quality management. Is Gray Optics ISO certified?
We’re working towards ISO 13485, with plans to be certified next year. So, we are currently laying groundwork for that. Our team members, including Dan and I, have worked in ISO environments. Although we are not currently certified we follow those best practices regardless.
Is DFM the biggest challenge you help customers solve?
Yes. It’s one thing to breadboard a device and get good results. It’s another to do it in such a way that enables efficient scaling. In volume manufacturing, consistency is key – you need to find ways to minimize variability. That means you need a solid supply chain, quality machine shops, and skilled opticians to make sure you’re getting good parts. In theory, everything goes together perfectly within the bounds of variability that you expect. I think people overlook that that aspect of it – they get excited about this awesome idea they have and now they want to move right into production, and as you know, the devil is in the details. These challenging problems are exciting to solve.
What should medical device innovators look for when choosing an optical design partner?
Transparency and agility are critical in order to communicate and to pivot. It’s important to make sure everyone is on the same page, not only at the outset, but throughout the project because things change along the way. Manufacturers need to make sure their optical engineering firm knows how to set up a solid requirements document and is willing to have open and transparent discussions with you. Trust and transparency should be part of their partner’s company culture.
We are unique in that we’re not bound to a certain manufacturing method. We work with different contract manufacturers who help us understand their processes so we can design something that will result in a more seamless transition from design to manufacture.
Overall, I find that developing close partnerships with our customers is more engaging and more efficient in a lot of ways. We provide the most value helping them transition from prototype to manufacturing, especially when it comes to selecting and managing a contract manufacturer.
What types of projects do you enjoy most?
Projects involving 3D imaging are at the top of the list. Being able to trick your brain into thinking it’s looking at an actual object and getting that full immersive feeling is pretty wild. These systems tend to be very sensitive to assembly errors so getting tolerances and fixturing right is critical.
I also like working on projects that transition from prototype to manufacturing – whether it’s something we’re going to be developing internally or working with a contract manufacturer. The fun part is when you get to see something you worked on out in the real world. In my past life I’ve worked on devices that have been sold in high volumes. I’ve even seen some of my stuff on television. It’s pretty exciting to see your project out in the real world. At Gray Optics, I have the opportunity to work on medical endoscopes that may someday be used on me or someone I know. Medical devices can change people’s lives. It’s inspiring; it drives me.
Tell me about your hobbies outside of work.
At the top of my list is hanging out my kiddos: Playing outside, playing soccer, taking hikes, ice skating, whatever it is they feel like doing that day. Individually, motorcycles are my passion. They’ve been a part of my life for a long time. I have a classic 1973 Harley project bike, a Harley that’s my daily driver, and I have a few Hondas kicking around. Some have sentimental value, and some are just old and in really good shape with very few miles on them. Some of my favorite routes are up through the White Mountains in New Hampshire. I enjoy the back roads – the long sweeping rides without many people or cars. The scenery is fantastic.