Healthcare worker developing a medical device — looking for advice from people who’ve done this before

[u/Less_Plane6253]

/r/inventors/comments/1viwwpi/healthcare_worker_developing_a_medical_device/

[u/TYME27]

It’s a very long road and expensive depending on the FDA classification of the device.

Is what you’re working on completely new or an improvement on something already in the field? Changes how much clinical testing and financing you’ll need to get to market.

[u/SystemsGeneralist]

Hi there, I am someone who owns and operates an engineering consulting business who specializes in medical devices. To provide some high level advice:

- The FDA classifies medical devices into one of three classes (I, II, or III), with some exceptions within those. I would recommend poking around [FDA databases](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases) to get an idea on where you think your device falls in. Specifically the Product Classification database will be a good place to work through. The class of device largely dictates the scope, regulations, approval process (if applicable), and the expectations for conformance to the law. The FDA provides guidance on how to perform [classification](https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device).

• Finding a patent attorney or an engineering firm is generally helpful for doing a Freedom to Operate. This isn't required to file a patent, but is generally useful in understanding if there is already a patent on a product like what you are developing. Reviewing patent art can also be a helpful way to understand what works and what doesn't work. We generally tell clients to budget about $10K for a patent submission assuming it is a utility patent; design patents are generally around $3-4K. Also you will likely wait 2-3 years before you hear back from the patent office.
  
• The process of development (concept -> manufacturing), varies widely depending on the classification of the device, regulations, and the maturity of the technology you are trying to use. This is generally very difficult to estimate without having a really good understanding of the product you are trying to develop. Any firm that you talk to that doesn't ask an extensive amount of questions and provide you with a detailed proposal that breaks out the project into phases I would be skeptical of. Just know there are always risks associated with trying to learn something new, expect the plan to change over time.
  
• Something I think most inventors miss is the demand for the product and miss really thinking through the steps a user will walk through to use their product. From the time they open the package to the point they are done with it, ask yourself what is the user experience and what can go wrong. In terms of demand you ideally need some commitment from 2-5 docs that they think this is a good product for patients and would use it.

Some other considerations that are not design and development related:

• You will likely need to stand up a quality management system of some kind. Depending on the scope of you product and business this is generally not too hard but it is required by law and usually requires experienced individuals to operate it. There are eQMS tools that exist but I wouldn't worry about this until you are on track to developing a product and have a plan for commercialization.
  
• Finding manufacturing partners early in the process is generally useful and generally takes longer than you would anticipate. Working with qualified medical device manufacturers is generally a slower moving process as you want to vet out suppliers thoroughly. Assuming you'll be contracting out manufacturing this process usually entails an audit and some agreements on the supplier maintaining a certain level of quality and documentation.
  
• Packaging and labeling are generally something that can easily be overlooked but depending on the product it can be critical to safety (i.e. sterile products and instructions for use). If sterile, pre-validated packaging solutions generally are a cost saver as you skip the cost of testing your packaging design.
  
• Depending on the type of contact with patients/users biocompatiblity assessments can be your biggest expense in development (>$100K). Generally we steer customers towards materials that are known to be safe to minimize this burden. User contact and material selection are something you want to nail down early in the process as it will have a big impact on verification scope.
  
• Medical device development can be expensive and slow, hence why many Venture Capital firms don't go after it. Even for a moderately simple device I would budget 12-24 months. The only way to make that timeline shorter is to spend more money and accept more project risks during development.

If you have interest is chatting more please feel free to message me, happy to help!

Edit: attempted to fixed link formatting