2 min reading time

If you want an education about human factors, who better than a university professor who is an AAMI chair to teach it?

I have the recording, slides, and transcript from MaryBeth Privitera’s 10x talk for you today.

Human Factors: MB’s Main Takeaways

• Users are unpredictable, and that’s the point. Doing risk and use-risk analyses, you need to consider all the ways a user could behave.

• Physical and sensory questions. What will the user see and hear? What manual dexterity and strength are required? Can they reach everything in the proper order?

• The “correct answer” may not be the correct answer. Paraphrasing, “Pistol grips for laparoscopic surgery are ergonomically incorrect. But if I change it, physicians may balk because that’s how they were trained to use it!”

• Perception and cognitive questions. What confirmation can we give the user to say they did it correctly?

• Guidance documents. MB shared four guidance documents (two from IEC, one from MRHA, one from FDA) and why each is important.

All the specifics

For the full overview of MaryBeth’s presentation, head over to the 10x Medical Device Conference site for the recording, slides, and transcript.

+++

You May Have Missed…

• Can you put a value on “improved patient outcomes?” How much will a Payer pay to save a life?

• $350 worth of free advice about reimbursement A new CPT code doesn’t guarantee your procedure will be reimbursed. Plus, the answer to ‘how much Payer would pay.’

• How I lost A LOT of money on my medtech investment Everything seemed so perfect.

• What You Need to Know Before Manufacturing a Wearable Device The necessary steps to build a better wearable device and get it cleared through FDA.

• A Much Easier Way to Access and Use FDA Databases If you ever access FDA.gov databases, this may save you time and effort.

+++

Thank you for being part of our Medical Devices Group community!

Please this article if your network will benefit.

Joe Hage
Founding Principal,
Medical Devices Advisory Group

P.S. If you’re looking for work, we added new jobs this week here!