|O Danny Blog Entries|
Connecting07: Medical Device Design: 10 Things You Need to Know
"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.