As originally asked by Peg Graham.

Have identified a provider willing to test a prototype for a patented Class II assistive device; they are raising concerns about who foots the bill for medical coverage of any harm that might arise from use of the device. I am investigating whether or not my device is eligible for Investigational Device Exemption. Is anyone aware of any other solutions that I should look into?

Brian Bone
Principal at b.One Design
I’m wondering why you need to go through a provider to complete your safety/usability evaluations. You could recruit your own small sample of target users and run the testing yourself, without the complications of involving a provider. I am a product design and development consultant, specializing in human factors and medical devices, and do this type of evaluation all the time for my clients. There are costs involved in recruiting and paying incentives to participants, but there are ways to minimize these costs and still get some great feedback on your design.

Jerrold Shapiro
President and CEO, Fem-Medical LLC
Peg, check the websites of Contract Research Organizations, or CROs, that design and run clinical trials. You will find that the manufacturer often has to provide liability insurance to both the patient and the healthcare provider if an adverse event occurs. I agree with Matthew that this should be a Class I device, possibly exempt as well, if it’s not much more than a toilet seat.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Another connection through the group. I never tire of this.

Peg Graham
Improving the Caregiving Experience, Chair of the YANA Health Forum
Just accepted your invitation to link in. Let’s continue the conversation privately. Thanks for your assistance with working through the liability question.

Matthew Schmidt
Additive Manufacturing Manager
Thats interesting that its Class II? 510K then it is. Wow. I admit I dont know your idea, but most beds, wheelchairs, commodes (home healthcare devices) are Class I but if you asked the FDA, it must be correct. Predicate devices? Im going to consult with my Regulatory Manager, Jennifer Palinchik, who is familiar with this to see if we can offer some advice on testing protocol. Feel free to contact us at JALEX Medical anytime with questions.

Peg Graham
Improving the Caregiving Experience, Chair of the YANA Health Forum
Thanks for responding Matthew. It is a patented innovation to the traditional bedside commode – I have a 513(g) letter classifying this as a Class II which means minimal risk. This question is coming from the Divsn of Geriatrics leadership who have never done a product evaluation before. We are discussing a simple safety and usability trial, assessing whether patients discharged to home with the improved device (1) actually use it; (2) and safe, easy to use as intended. Very basic. The Geriatric docs believe that the home health agencies will raise this issue when I approach them.

Matthew Schmidt
Additive Manufacturing Manager
Without knowing what the device is, its difficult to say. There are many prototype processes and mfg methods capable and approved for implant. Again, without knowing what materials, its hard to say. Is this feedback you have from a hospital Internal Review Board (IRB)? We have experience directing Regulatory pathway with all class medical devices, but more information would be needed.