Medical industry? How to get in?

[The One]

Dear Fastlaners,

How does one enter the medical industry? Since, I wish to create a product, I have started sketching the concept and possible methods to construct and all. However:

• investments
• qualified medics
• scientist
• programmers
• research team

and many more staff are required to start this? Since, everything has to be sophisticatedly done. Especially for all legal aspects and all.

What can I do? Who do I talk to?

 

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[Happyheart]

Dear Fastlaners,

How does one enter the medical industry? Since, I wish to create a product, I have started sketching the concept and possible methods to construct and all. However:

• investments
• qualified medics
• scientist
• programmers
• research team

and many more staff are required to start this? Since, everything has to be sophisticatedly done. Especially for all legal aspects and all.

What can I do? Who do I talk to?

Medical product law and regulatory affairs are no joke.

You either have a few million dollars at hand to hire the expertise, or you are an expert yourself, in which case you would not be asking this question…

 

[basuragone]

I'd start by asking whether the "medical product" you're sketching is truly needed (and what solid data/evidence have you already gathered to assert this need). Re: your question on how to gain access to:
"

• qualified medics
• scientist
• programmers
• research team"

I'm unsure of how one could effectively sketch/create a product without first having access to/consulting with professionals in these fields. How did you come up with the MVP from the start? For reference, I'm in the medical research field.

 

[Caminsky]

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[The One]

which case you would not be asking this question…

That’s the whole point of finding an investor

 

[The One]

I'd start by asking whether the "medical product" you're sketching is truly needed (and what solid data/evidence have you already gathered to assert this need). Re: your question on how to gain access to:
"

• qualified medics
• scientist
• programmers
• research team"

I'm unsure of how one could effectively sketch/create a product without first having access to/consulting with professionals in these fields. How did you come up with the MVP from the start? For reference, I'm in the medical research field.

So, as entrepreneurs we

I'd start by asking whether the "medical product" you're sketching is truly needed (and what solid data/evidence have you already gathered to assert this need). Re: your question on how to gain access to:
"

• qualified medics
• scientist
• programmers
• research team"

I'm unsure of how one could effectively sketch/create a product without first having access to/consulting with professionals in these fields. How did you come up with the MVP from the start? For reference, I'm in the medical research field.

In regards to your question. My product is actually going to help diabetic people.

As entrepreneurs are to think of a problem and try fix it, that is what I am trying to do.

The problem is nocturnal or non-nocturnal hypoglycaemia which isn’t great, poor sleep ( leading to many problems itself), and anxiety and stress.

So, I thought let’s create a device and a software to combat this.

I’ve done research on the current products in the market, but, I am going to implement both software and a product to prevent hypos at night at all. Hence, the solution.

 

[Mikkel]

This seems like a huge task.

Both software and a product. Both very well might be required to be labeled as a Medical Device. Check out this YouTube video, the video was directed towards an Indian population so there is plenty that might not be relevant like when they talk about CE, but the guy speaks in regards to FDA, medical devices, and start ups who are using software. This might be a first step for you.
YouTube Link

This path seems to have a very high barrier to entry. I'm not one to tell people to avoid a road just because it is diffult, but it is difficult. I tried this process twice. First time, failed simply due to the scale of complexity and the massive amout of resources needed. The second time, I was able to menuver around the medical device classification based on a technicality on how we would market. Just to apply and get the medical device classification, you're probably looking at atleast a 6-figure payment to the FDA. That isn't even including the research and development.

Personally, once I understood how much of a pain in the a$$ the FDA and the medical device classification is to get, I told myself I would try and avoid that fight as best I can.

I wish you the best. When in doubt, call the FDA. You should probably also determine the class of your device. They have a phone number where you can speak to someone at the FDA that can provide you with an unofficial classification of the device. The lower the classification, the less difficult this process will be.

 

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