Frequently Asked Questions
What primary services do you offer ?
Consulting services to clients developing medical devices. I can pitch in on design, the systems supporting the design effort, or the partnerships with contract manufacturers.
What do you specialize in ?
All the tasks to arrive at a design with sound human factors, a strategically understood bill-of-materials/processes, and a well-documented transfer to manufacturing. All of the above is easier to accomplish within a modern QMS; so for some clients the QMS becomes the design project that needs human factors, BOM/BOP, and Transfer activity.
Do you do longer-term interactions ?
Sure. Some projects naturally take longer, especially if the ask is for "project management." I once worked on a design-of-experiments for the shelf-life study of a bioresorbable component that took three years to complete, so even technical work can demand longer commitments in some cases. Usually I am filling a gap, so my scope of work is a day, a week, a month, or a quarter. But on occasion, the project demands more and in those cases I can write a scope to match.
What core technologies are you familiar with ?
Injection Molding. Device Assembly. Metal Stamping. Polymer Extrusion/Coextrusion. Bioresorbables. Blow Molding. Laser Welding. Resistance Welding. Adhesive Bonding. Graft Sewing. Graft Washing. Nitinol Heat Treat. Electropolishing. Sterile Barrier Packaging. Sterilization.
What is your educational and work background ?
I have a degree in Mechanical Engineering from the University of Minnesota. My first job was in a Corporate Lab at 3M doing long-range research on Coextrusion and Multi-layer Films with several polymer scientists and many operating division partners. While at 3M I completed a Master's degree in Manufacturing/Systems Engineering. I moved to SCIMed to work on the first non-compliant balloons for PTA & PTCA and stayed through the acquisition by Boston Scientific. After a 2-year stint at NIKE researching the elimination of SF6 gas in their polymeric cushioning systems, I have focused on medical device start-ups and the transitions to their strategic suitors.
What auditing credentials do you maintain ?
I am certified to audit to ISO13485:2016 through BSI/Exemplar Global. I average 5 audits a year, so this is NOT my primary role, but I can help if your concern is at a critical supply chain partner where I am familiar with the technical aspects of their core technology.
Are you "R&D", "Ops", "Quality" or "Reg" ?
To start with, I am NOT typically tasked individually with Regulatory Strategy work, but I do often contribute related technical sub-tasks like writing product/process descriptions, change management history, or validation results. Out of necessity at a small Class III product start-up, I maintained Technical File documentation, wrote the CER, and initiated annual post-market surveillance plans; but this is not my sweet spot. I am best suited to help on design projects where the transfer-to-manufacturing needs additional resourcing. This could be due to structural failings in the QMS or a failure to communicate between R&D & Operations or even a poor selection of a supply chain partner. Whatever the cause, I can help complete all the Design Control tasks while fulfilling the necessary Regulatory obligations. In longer-range research projects where the materials science or human factors are the fun part, I can also lay the groundwork so the transfer-to-manufacturing, with its IQ/OQ/PQs and GRRs, does not become stalled.
Are you experienced with a START-UP work environment ?
Yes. Over the last 20 years I have been an early hire on several occasions - first Ops hire on Nitinol stent/graft project, first polymer science hire on a bioresorbable project, first full-time engineer on a ground blade surgical tool project. I understand the perseverance and creativity needed in the early Entrepreneural effort of an under-resourced team. I have also glided along in the corporate labs of the Fortune 100, so I have a sense of how new ideas germinate in many corporate cultures.
Do you consult on non-medical device projects ?
Not often, but I have worked in footwear, adhesive tapes, and teaching. I do love great products with unique materials and a human factors twist.
What are your terms ?
Let's talk it over.