Redesigning an existing medical product

[Mike.B]

I found a need to redesign an existing medical product and I know there is a market, but I'm not sure how large.

The existing product has limitations that can cause people their lives if not under close supervision. The modification would be fairly simple. Some people have already patented some modified products and workarounds, but most are to complex or are basically a band-aid.

My first steps will be to find my market size and get more feedback from medical staff on the actual need for the redesign.

The following steps will be to draw up a rough draft, then get a 3D CAD model designed.

Next I'll be applying for a provisional patent before submitting the product for FDA approval.

I'm sure as I get deeper into this process I'll find more steps that need to be taken, but for now this is all I have.

Because money is really tight right now I'll be doing some of the design work myself. Good luck to me!

 

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[Mike.B]

Downloaded FreeCAD and drafted the first part of my design, it went faster than I thought it would. After looking at the existing product again I'll have to make some more minor changes.

Looking at patent information for some of the existing variations, and most of them are from the 80's and they haven't been updated recently. So, if these patents are only good for 14 or 20 years, I think these are fair game.

Spent part of the day talking with medical staff at a local skilled care facility, gathering more information about the actual need for this product. I still need to do a lot more research in this area before spending any more time on design.

That's all for now.

 

[Mike.B]

Okay, today I finally found an application for a US patent that contains an embodiment that "sort of" uses my idea. The description and drawing are general, but describes it enough detail to shoot my idea in the a$$ (I think). This patent was submitted in 2010, published in 2012, but has not been granted yet, so there might be some hope left. Two of the three embodiment's are a bit vague, and the third is building upon patented technology from another company.

I'm not sure if I should come up with a new design or just put this on the back burner for now.

 

[Mike.B]

Devised a new design yesterday that can be retrofit, instead of modifying the existing product. Searching through patents again this morning.

Back on track for now.

 

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[Mike.B]

I've discussed the potential need with more medical personnel that are directly involved, and I'm getting a variety of answers as to the frequency, and urgency, of the problem. At this stage I'm not sure the problem is as wide spread as was initially communicated.

I'm finding it hard to put all of this into perspective and decide whether there is an actual need. I might have to approach the discovery process differently, but I don't know how yet.

 

[youngtrep]

Before you get too far ahead of yourself, don't underestimate the difficulty and expense of getting a medical device or redesign of a current medical device approved by the FDA. I am almost positive you would need a team of lawyers, clinical data and a hell of a lot of money to successfully get approved.

 

[Mike.B]

Before you get too far ahead of yourself, don't underestimate the difficulty and expense of getting a medical device or redesign of a current medical device approved by the FDA. I am almost positive you would need a team of lawyers, clinical data and a hell of a lot of money to successfully get approved.

Definitely aware of the FDA process, which is the main reason why I want to make damn sure there is an actual need. I figured this would be a large barrier to entry.

The good part is that the device itself isn't that complex and neither is the modification, so I don't think the clinical data would need to be extensive (hopefully).

 

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[Nate H]

Definitely aware of the FDA process, which is the main reason why I want to make damn sure there is an actual need. I figured this would be a large barrier to entry.

The good part is that the device itself isn't that complex and neither is the modification, so I don't think the clinical data would need to be extensive (hopefully).

Mike, yes, the 510(k) medical device submission process for the FDA is a large barrier to entry, which is why medical devices have good profit margins. 10, 15 years ago, I worked at a manufacturer of Class I medical devices, which are much cheaper/easier to get through the 510(k) process than Class II or III.

There are consultants out there who specialize in medical device product development, regarding handling the regulatory stuff. You might find one who will give estimates on timeframe, requirements for clinical data (if any), and costs for the whole FDA process. This info may even be free as an initial consultation.

 

[Mike.B]

Mike, yes, the 510(k) medical device submission process for the FDA is a large barrier to entry, which is why medical devices have good profit margins. 10, 15 years ago, I worked at a manufacturer of Class I medical devices, which are much cheaper/easier to get through the 510(k) process than Class II or III.

There are consultants out there who specialize in medical device product development, regarding handling the regulatory stuff. You might find one who will give estimates on timeframe, requirements for clinical data (if any), and costs for the whole FDA process. This info may even be free as an initial consultation.

Thank you for this! Much appreciated.

 

[Mike.B]

Quick update: The need for this has been validated and I'll be going forward with the design process. After doing more research on the design and use of the product, and seeing the product in use, I've realized that the redesign is going to be a bit more involved.

I would like to design something that would retrofit the existing product(s) because I think this would be easier to patent. I don't know if I can make design changes to the existing product(s) and get a patent approved. Will be researching more "prior art" over the next week.

 

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[Kaptain]

Mike, to expand upon Nate H's warning, there is a lot of work involved in getting a product to market in the medical device industry. I'm a process engineer for a large global manufacturer of class I, class II, and class III devices. I'm currently going through pre market approval with my company for a device being reclassified to class III from class II. I don't know what your past experience has been, but do not underestimate how much work is involved in both design and process validation for your product. It sounds like it may be a class III device if it means life or death for a patient, maybe class II depending on how it is used. Regardless, validation for class II and class III is pretty much the same, except that with class III, the FDA must approve all changes to the design or process before implementation if changes are to be made after initial release.

If you plan to outsource production, you will still be held responsible for validation and verification. It's very important to find a quality supplier. I've seen companies box themselves into a corner with crap suppliers who couldn't or wouldn't allocate the time and money to properly validate designs and processes.

I don't mean to turn you off, just seeing if you are fully aware of what's entailed here. You're right though, large barriers to entry, which is a good thing for those who are persistent and have the time/money.

 

[csalvato]

510(k) is the easy route. Let's hope this applies to 510(k) rules.

Mike, if you are serious about this, I have contacts who focus on FDA approvals for their living. Several people. I worked at a biomedical startup for brain interfacing. They may be able to help you find the resources and people you need to make FDA happen.

IIRC, the FDA approval for 510(k) was estimated to cost them around $50k, not counting the regulatory overhead. If they had to go for a full approval (not 510(k)...can't remember what it is), then it would have been closer to $250k IIRC.

 

[Harestock09]

Hey. I'm a director for a company that specialises in medical device development. Feel free to get in touch and I'd be happy to chat.

 

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[Mike.B]

Well I thought since I had some time, I would update this thread. I have not been able to come up with a design that I feel I could get a patent on (because of prior art), and I have seen many work-around's for the existing problem since I first started this project.

I think I'm going to put this on the back burner for now. This project will require a lot of work and I want to make sure it's going to be worth it before I continue.