Ted Kucklick

“A nuts and bolts talk”

Medical devices are a hot area, along with sustainable design.

C.P. Snow: The Two Cultures

#1 You have to start with a need. Especially true in medical device. Have to keep the clinical impact at the center of what you are doing. Clinical utility is at the heart of any good medical device.

#2 Understand regulatory. FDA, CDRH (devices), CBER, CDER (pharma). Two departments barely talk and have deep divisions with little common terminology. Try to get an easier regulatory path such as a 510(k). “Safe and effective:” the FDA standard. First do no harm.

#3 Understand economics. Primary driver of reimbursement is Center for Medicare/Medicaid Service.

#4 Biocompatibility. Any material used in a medical device has to pass a test before human use. Contact and duration. Must be aware from prototype through production. Material must be tested as used–processed and sterilized. Must be tested in final form. Sterilization affects various materials. There are pre-certified materials. This testing is expensive and time-consuming (8 weeks). There are different tests for different types of use depending on contact and duration. pacificbiolabs.com

#5 Know manufacturing methods. Good Manufacturing Practices (GMP). QSR: Quality Systems Regulations. Lot traceabilty, sterilization methods, sterile packaging validation, specialized equipment, clean room manufacturing. Go to a medical device contractor manufacturer to do these things without the overhead.

#6 Learn by observation. Medical procedures evolve over time. Lots that seems to not make sense until you see it firsthand. Don’t rely on books or second-hand info. Get into the OR and see the procedure firsthand. Know OR protocol. Where to stand, when to talk, when to shut up. Good place to learn is through a medical device sales rep. If you ask a doctor if there is a problem, the answer is always No. You have to see it firsthand.

#7 Know the device and procedure background. Procedures are idiomatic, evolutionary, regional, non-intuitive. Lots of differences between doctors based on training, device history, etc. Watch out for repurposing devices! PUBMED is a great resource for digging up information about medical procedures through articles.

#8 Use medical illustration. A medical illustrator can help you visualize the anatomy you want to approach. Find them at the Association of Medical Illustrators. ami.org

[A long discourse on medical illustration history occurred here.]

#9 IP is Key. You need to have the exclusivity to get the value out of a medical device because of the enormous expense. Get anyone working on the project to sign an NDA and patent assignment. Includes illustrators, engineers…anyone.

#10 Learn from the pros. Ideas alone, not executed, have no value! Prototype and test early and often. Don’t change procedure. Franchise value. Not technology-driven! The clinical need must drive the product, not the technology.