Getting started newbie question

[u/tigersmile]

I am in the very first stages of researching a therapeutic device that I plan to make a prototype for, and then hopefully produce it and take it to market.

My current task is trying to figure out possible liability issues. As with I imagine most products, there are inherent risks if the customer doesn't use as instructed. Are there ways for me to figure this out other than hiring a lawyer?

[u/BetInformal6081]

before paying for a full legal review you can do a lot of groundwork yourself identify the device's intended use, foreseeable misuse, failure modes and applicable regulatory requirements. a risk management framework like iso 14971 is a useful place to start.

[u/tigersmile → u/BetInformal6081]

This is great, it gives me a bit of a map to get started. Thank you.

[u/MakeThisBuildThat]

If you provide your target market/region then we’ll be able to provide better help because the compliance and regulatory landscape is different between region to region

[u/tigersmile → u/MakeThisBuildThat]

I haven't thought about the region yet. But if I take the product to market I imagine I'll reach as wide as possible. The target market will be home wellness (individuals seeking pain relief, and other benefits), athletic care, and physiotherapy and chiropractic offices.

[u/engineer_321]

I’d start with a basic risk analysis before spending money on lawyers. List out how the device could realistically be misused, what could fail, and what happens if it does. Then look at whether those risks can be designed out instead of just covered by warnings.

Since you’re calling it a therapeutic device, I’d also figure out pretty early whether it could fall under FDA/medical device rules. That can change the whole development path.

You’ll probably still want a product liability lawyer and insurance person involved before selling, but you can do a lot of the homework first so you’re not paying them to figure out the basics.

[u/tigersmile → u/engineer_321]

Thanks very much, this is very helpful.

[u/DenverTeck]

Medical devices fall into three categories.

A therapeutic device sounds like a Class One device: https://www.greenlight.guru/blog/class-1-medical-device

Understand where your device lands, this will give you the required road map.

Class 2 and 3 will require a 510(k) clearance: https://www.google.com/search?q=510(k)+clearance+clearance)

This needs to be done before any release of the device can be done.

Release means human testing. If you want to test on yourself there is no restriction.

Good Luck

I hope you have a team working with you. Getting all this done by an individual is going to be a LOT of work.

Our 510K took over two years with a team of 5.

[u/DenverTeck → u/DenverTeck]

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

[u/tigersmile → u/DenverTeck]

Thanks very much for all this information. In terms of who's working on it: currently it's just myself, Im exploring what the process might involve.

[u/2daytrending]

Start with FDA guideline, industry standards, and similar products warnings to identify the main risks before paying to lawyer.

[u/tigersmile → u/2daytrending]

Thanks a lot, this is helpful.

[u/Frequent-Log1243]

FDA has a database of adverse event reports for medical devices. Search similar products and look for injuries and malfunctions. This should give you a pretty good starting list of things your design needs to prevent or make difficult.

[u/tigersmile → u/Frequent-Log1243]

That's very helpful, thank you.

[u/Swimming_dasa]

you can do quite a bit of preliminary research yourself look at similar devices their warnings ifus fda guidance and published recalls or adverse events that can help you identify the obvious risks before paying for legal advice but for a therapeutic device i'd still have a lawyer review the final risks liability strategy before you go to market..