Medical device questions asked

I thought I'd answer some questions that people have attempted to find answers for on this blog, keep in mind that I'm no expert- and looking at everything from a USA point of view, you should double check everything I say.

If you validate a medical device with one sterilization method (ETO), do you have to revalidate if you change methods (to gamma)?

Yes, you will almost certainly have to revalidate almost everything. I can't think of any concrete exceptions now, if I do think of some or hear of some I'll add them at a later date. I think you may be able to justify your way out of redoing some performance studies depending on what you had to show.

Do you have to sterilize all medical devices?

No, the term "medical device" covers a wide range of products including things like defibrillators, ECG machines, and external pumps. Some classifications don't require sterilization, find your classification on the FDA website starting here and go from there. A good rule of thumb is if you're going to contact something not normally exposed to outside air, then you have to sterilize it.

What do I need to get a medical device ready for clinical trials?

Medical devices manufactured to GMP and a 510(k) if you're going down a 510(k) path. If you're following a PMA path in my experience you'll need to convince the FDA that you have a quality system and manufacture to GMP, biocompatibility validation, safety validation which may include a few animal studies, and a some decent test results- along with whatever else the FDA and the hospital review board say you need.

What is the accepted standard deviation for medical devices?

I have no idea if this is related to lab results or what, but there is no standard accepted standard deviation for medical devices, however, if you go less than two, you should be prepared to justify it. This does not mean that two is required, you just have to justify it, please keep this in mind if you are transferring from the drug industry!

How can you tell if a medical device needs FDA approval?

Check the FDA web site, it really is very informative. Find your device classification on the FDA website starting here and go from there.

What is a typical day for a medical device representative?

I talk with these guys from time to time, it generally involves driving around to doctor's offices and hospitals to try to sell and then complaining that the company doesn't have any good products in the pipeline.

How many people to hire for a medical device start up?

I think I've covered this before, but I'll go for it again, 1 QA, 1 manufacturing, 1 engineer and 1 management is a starting point to build from. You really do want all of your departments covered from the start or you'll have a big mess on your hands when you try to finalize things.

Are medical devices good or bad?

They are good!

How much money to start a medical device company?

If you have a cheap, simple, 510(k) device and are somewhat knowledgeable about the field, I bet you could do it for less than $1 million. If you have some drug coated, ground breaking, research intensive device you'll need many times that.

What is the medical device standard expiration date?

There is no standard expiration date, but unless there is a good reason otherwise, you can label for 6 whole months without validating the packaging and saying you'll "hand carry" everything to the site. Hand carrying involves someone flying on the plane with the boxes. This is useful because you don't want to validate your packaging until you have a final product. On the other side of things, it used to be you tried to label for a 5 year shelf life, but I think lately a lot of products and companies are content with less, 2 or 3 years is fine.

What is a sample IQ/OQ/PQ?

I think I'll do a post on this later, until then search the MDI archives.