Starting a Medical Device Company..

[Kontent]

How would one start it up?

Say, you have an IDEA and you want to take that product to market..

You would like to market GLOBALLY.

From a perspective of COMPLIANCE with the FDA and other requirements, to even methods of distribution.

I have searched these forums and google, and haven't found anything solid enough. I have an idea, but the technology isn't fully developed yet. Lets get the discussion going!

Oh, and I figured I'd start the company as "Stealth Start-up" initially...

 

Dislike ads? Remove them and support the forum: Subscribe to Fastlane Insiders.

[Felix II]

Hello Kontent,


I'm actually develop products for two medical device companies.


One company sells things like devices used to measure grip strength or neck rotation (physical measurement devices.)

The other company sells things like brain implantable electrode arrays.


As you can imagine, there is a huge difference between a device that you squeeze to measure strength and a device that pierces the brain and screws into the skull.


On what end of the spectrum does your device fit?

Honestly, unless you have experience in product development in the medical realm (or you product fits the first example), you are most definitely going to have to hire an experienced consultant. These consultants know how to ensure you are compliant and navigate the maze of regulations and submission procedures. Be aware, these guys are not cheap and may be somewhat hard to come by.

There are so many things to think about, like design histories, document control, material traceability, and then submissions and compliance.

It's not something that can easily be figured out without an expert.

 

[James Fake]

The hard part with medical devices is making the actual product. I use to staff a company that made medical supplies. The weight of each device had to be within crazy measurements and the size of each piece had to be almost perfect. If there was just a slight mis-hap, you just threw that piece away.

And this was something that didn't go in the body, all it was just a knee puller or something like that. Engineering is the biggest hurdle, and then getting the product approved for use.

 

[Smooth]

As far as working with the FDA, try to get in touch with their small business ombudsman. The SBA also has numerous resources about dealing with the FDA. Either way, working with the FDA and EPA is an absolute nightmare. They are grossly understaffed and cannot handle the current workload that they are given.

As far as actually starting the company, like Felix said, it is going to depend on the complexity. I would say the general rule of thumb is the more complex, the more education and experience you or your management team must have-- MDs, Ph.Ds, etc.

Maybe a medical device contract manufacturer could help you out as they might have on-staff consultants and other resources.

 

Dislike ads? Remove them and support the forum: Subscribe to Fastlane Insiders.

[Kung Fu Steve]

The first step for you is to contact a patent attorney and see if you can protect your design.

If not, you should probably move on or find another part of that market to target if that is your passion.

If so, incorporate, patent it, get a draft made, find someone to make a prototype, then find your customers. Either contact major manufacturing companies to see if they would like to license your product from you, or contact the middle men if they would like to purchase these products from you for use in their practice.

Simple, not easy.

 

[Smooth]

Simple, not easy.

Lucrative ideas rarely are...

 

[rod_lleyton]

I think with these "invention" type products, the absolute best route is to go down the licensing path.

If not, you'd have many factors against you -

1. Multi-billion-dollar companies breathing down your neck (their R&D teams will probably develop something better once they see yours);

2. Regulations - certainly with health there'll be very stringent requirements. Health-related products often require unbelievable number of tests and approvals, etc.;

3. Cost to manufacture would be rather high, especially with the QA that's required;

With licensing, you'd eliminate all these and simply receive a small royalty/licensing fee. With this option though, you have to watch out for patenting costs - these can blow out astronomically if you're not careful. Patent attorneys often give you false hope and do an "initial search" and tell you no-one else has it and it's patentable. Often, though, you'd find they meant only a small part of your invention was patentable and others can easily replicate your idea nonetheless.

 

Dislike ads? Remove them and support the forum: Subscribe to Fastlane Insiders.

[Kontent]

Thanks for everyone's responses, sorry I haven't gotten back to you all sooner. The idea is actually 10 to 15 years out, due to the constraints of current technology. Yes, a feasible prototype could be built soon, but I am waiting for everything to fall into place with a little effort on my part.

Felix II: I know I will have to hire quite a few people to make it a possibility, yes it is a class III medical device and I will have to comply to all the DMF, DHF, and the DMR (i think I got them all right, Device Master File, Device History File, and Device Master Record?). Also, I will have to comply with things like 21 CFR Part 11 (the FDA requirement for electronic sign off) so I won't have to deal with the mess of files most companies have to deal with. I know CAPA (corrective action, preventative action) will be a concern as well, and I will do more research into that.

JamesF: I know exactly what you are talking about, the tolerance of each component can have only a certain amount of variance or else the component is scrapped. I believe design will be in house, contract manufacturing and suppliers will be overseas, and final assembly, testing and packaging will be in house. I think that this is the best way to go and not have to deal with vertically integrated manufacturing, although supplier communication might be a problem.

Smooth: The FDA as well as ISO, UL, CE and other compliance issues will have to be taken into consideration. My best friend and future business partner is currently getting his doctorate and I am thinking of going after my MBA in a few years. We will hopefully make contacts that can make this idea an actual product. As it has been said we will need a team of lawyers, doctors, consultants, and business savvy people in medical product development, etc. just to name a few.

Kung Fu Steve: Thanks for your advice, once the actual device requirements are formed we will start looking to invest in a patent and an attorney. Do you feel that it should be before or after we pursue funding?

rod_lleyton: I do agree licensing is a good path, but this project is a passion of mine. I feel that I will not 'work' if I follow this path and take this idea to fruition.

Thank you all for your advice and help, I will take it all into consideration. As I said earlier, this idea is 10-15 years out.. including the technology. There are quite a few things that must be taken into consideration. I have a basic idea of the hurdles that must be overcome, and I will be a student of this for quite a while too.

I will keep you all updated on the progress of my pet project as I continue to learn everything I can. Thanks again!

 

[Kung Fu Steve]

The idea is actually 10 to 15 years out, due to the constraints of current technology. Yes, a feasible prototype could be built soon, but I am waiting for everything to fall into place with a little effort on my part.
As I said earlier, this idea is 10-15 years out.. including the technology.

If that is true and you are still committed, why not create the technology? An example is Revlon who figured out the technology to create razors was beyond what was possible at the time. The precision tooling needed to get the job done did not exist so he made it, and then made the razors.

 

[CommonCents]

10-15 yrs out? How are you going to get investors for that? One avenue might be an incubator program at a college that has good connections in the medical industry. They would have resources and a longer term perspective.

 

Dislike ads? Remove them and support the forum: Subscribe to Fastlane Insiders.