Designing and manufacturing a custom medical fixture

I was asked about this and it has been a while since I researched the legal implications on medical devices. This is not used inside of a body, just a fixture used in surgery.

It would be good project and it appears to be low risk.

laminar-flow said:

I was asked about this and it has been a while since I researched the legal implications on medical devices. This is not used inside of a body, just a fixture used in surgery.

It would be good project and it appears to be low risk.

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"just a fixture used in surgery" might be low-risk OUTSIDE of the USA Health Scare environment. Many nations figure medical practitioners who are doing their best are doing their best. "Malpractice" lawsuits for big bucks are essentaily unheard of. Other MD's will judge an MD if (s)he is not up to standards expected.

The US? Any medical practitioner or medical goods or consumables supplier is simply considered part of the food chain.

"Low risk" it may seem to be technically. "low risk" legally is simply wishful thinking.

What can you do for the industrial building maintenance market?

I have an old friend who did rather well off the back of a line of goods for cleaning the stalls of horses. Obsolete as they might seem to be, it was good money, and he was never sued for "malpractice", contributory negligence, or any other of those legalese terms.

Thanks for the comments. My concern is only legal. I would really like to accept this project as I do not like to turn down a good design fabrication job.

I've never called my lawyer and asked him for recommendations on speeds and feeds. I have to wonder why you would ask for legal advise here.

I do not *personally* know about the US industry in fact but have plenty of practice in similar fields in several countries.
And my family has a law practice, fwiw.
And lots of experience and anecdotes from US clients and similar cases.

Designing and manufacturing the fixture has low-zero risk if You and Your business have zero relationship to the product made.

After that, it depends.

How well can You insulate Your capital goods and other business from being attached and put a lien on, in case You are sued by someone, for something ?
A funded competitor could simply sue You for (theft IP, copy of) ideas, patents, or poaching with zero reality in fact but still keep You in court for years, and usually attach your assets if they can post bonds for same.

Not saying it will happen. Saying it is common with big us corps, brands, trademarks.
Have received the 1000 page legal doc on behalf of a client.

I suggest that the costs and legal and unknown unknowns are probably 10-20x the price of the fixture.

You can get business continuity insurance from loyds, alliance, whatever, but what happens when they don´t pay and You need a second plant tomorrow to keep producing ?
While Your doors are sealed by court order/bailiffs etc ?

I did not say not to do it.
I suggest probably upsizing pricing by about 10x and producing it in a way that avoids likelyhood of your plant being closed by bailiffs.
You can always agree to credit the customer by 80% after x months if they assume all liability.

Point taken Larry. But that reminds me of something. I never hesitate to ask doctors about medical stuff when out at a party or wherever. If they say they can't give medical advise except in office, I inform them that when I was an aircraft mechanic, docs never hesitated to ask me about issues with their plane....

It is not wishful thinking.
We have 10+ lawyers on staff.

Low risk is making it very unprofitable and unlikely for anyone to initiate legal proceedings, and very expensive and hard for them to proceed profitably.
98% of legal issues are abandoned - due to costs and profits.

It is not "just" or right, but it is how most of the systems works esp. USA and UK.

Northern EU is much easier/cheaper/honest overall.

thermite said:

"low risk" legally is simply wishful thinking.

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laminar-flow said:

I was asked about this and it has been a while since I researched the legal implications on medical devices. This is not used inside of a body, just a fixture used in surgery.

It would be good project and it appears to be low risk.

Click to expand...

The "just a fixture used in surgery" does sort of put it in the category of being used inside of the body. There would not be the issue of direct FDA approval but is not necessarily a low risk endeavor.

To protect yourself on this you need to make sure that this is built specifically to the customers requirements and design and all of the documentation needs to state it as such. It is best if you never refer to this as a medical device at all. It is just a tool or fixture with unspecified purposes for a particular customer.

I'm assuming that somebody like an Orthopedic surgeon is asking you to make something.

The whole problem with this is that our society is so litigious and the attorneys like to shake trees to see what falls out meaning they will look for anyone in the supply chain for money.

I suspect your biggest chance of screwing up is in the materials used for the fixture. You will need to verify and document everything just to protect yourself.

Basically here is how it works in the USA.
Something goes wrong, people want someone, something so they go to a lawyer.
The lawyer names as many people as he/she can in the suit. Often this list is a hundred firms.
Anyone even remotely involved that they can get a name on.

A friend of mine made saws which are admittedly closer than you are.
With no malfunction of his devices he was getting sued 3-10 times a month.
What are know as nuisance suits. Legal beagles hoping for a handout.
It was a big surprise to him and a source of a lot of stress but he had insurance that would bat this monkey off his back.
He has done very well and expanded to other medical stuff but the early days.... took a toll and he was clearly beaten up.

Without said insurance you would have to hire an attorney to answer such frivolous lawsuits.
Unprotected is kind of what the legal side hopes for. Give us a thousand dollars and we will go away and you will not have to go through all the pain.

Not a problem doing it, just make sure your insurance company will cover it as they can and do remove these sort of things everyday.
......Or you could roll the dice.

Ti's a messy arena. If you are simply producing to print for another company and your name is in fact buried you have better odds.
This is why the medical manufacturing stuff carries the attractive price tags. There is an unseen and not part of your floor cost.
It can be a VERY lucrative place to be but you need to cover your ass.
Bob

One dividing line is if a product will require FDA approval. It adds a whole new level (often for good reason) of oversight and traceability.

If you can work as a contractor for someone assuming any legal risk (and competent to do so) after consulting your own lawyer might be a good opportunity.

Some of the most successful shops now specialize in medical work. The more you do of it, the better you get at dealing with regulations and staying out of trouble.

Surgery? And you say low risk?

Guy dies on the table. He was 99 and on his last gasp before entering the operating room. Wife/kids get a lawyer and he looks for ANY thing to sue over. IT DOES NOT MATTER THAT YOUR DEVICE COULD NOT POSSIBLY HAVE CAUSED THE PROBLEM. All the lawyer needs to convince a jury of is that it MAY HAVE. And even if he can not convince that jury, you may wind up paying your lawyer two or five times your net worth just defending yourself.

Go ahead and talk to a lawyer. Get some professional advise. But also call a good insurance company and just add the cost of the insurance to your price. That insurance is not optional.

Ever wonder why medical devices cost so much. There it is.

Even if it is some simple device how will it be sterilized? Can you do sanitary welds in stainless that meet FDA approval. Must be easy to assemble and reassemble all parts to clean. no sharp internal corners to collect bacteria etc.
Bil lD

laminar-flow said:

I was asked about this and it has been a while since I researched the legal implications on medical devices. This is not used inside of a body, just a fixture used in surgery.

It would be good project and it appears to be low risk.

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I'm not 100% sure what your question is (not trying to be difficult here). One key distinguishing piece of information for your legal requirements to have FDA approval/clearance is whether or not you are intentionally making or selling a device to be used in a medical environment. Example: a pair of pliers that is marketed to be used in a surgical setting needs FDA approval/clearance and must be made in an FDA registered facility but a pair of pliers from the hardware store does not. If a surgeon flashes a pair of pliers from the hardware store and uses them in a medical setting, the pliers company is not liable because it was used in a way that was not intended.

*** disclaimer *** in no way is my post to be construed as legal or medical opinion or advice. Please contact your legal professionals for guidance.