Can you develop a new product, THEN make it comply to the requirements related to medical devices?

Let’s say that you’re an entrepreneur or business that has designed a new product that has a healthcare application and you want it to be compliant with some common medical requirements (this would seem to make sense due to the type of product that it is).

Should you go through the development process first ensuring that it complies with medical device requirements from the beginning?

How best to develop this product?

In this case, I’d highly recommend developing the product first and launching without being preoccupied with regulations relative to medical devices. This will help you to focus on validating that the product works as expected, can be sold, etc.  Then later once it’s on the market and making sales you can decide if you want to re-develop it in a way that is compliant with medical device regulations and sell it with medical claims.

Why?

Medical device requirements are, as you may expect, detailed and they add an extremely large amount of complexity to a project (in comparison with most regular consumer devices). By definition, medical devices are subject to more requirements than many other products due to the high bar set for their effectiveness and (particularly) safety.

Many an entrepreneur has wilted under the sheer weight of research into regulatory texts, implementing the QMS, and more. This theoretical work could be more alone than than the electrical engineering required to build a fully functioning PCB.

Medical Device requirements need to be ‘baked in’

It’s simply unfeasible to develop a new product and then say “now let’s make this comply with medical device regulations”. The compliance needs to be baked in during development. Auditors will look at evidence that work was really done in a certain order, according to a pre-set plan, and so on and so forth.

To give you some idea of what’s needed…

ISO 13485:2016 gives you a structure for all the design & development work (including risk analysis according to ISO 14971), and implementing that structure itself adds a lot of extra work before you’ve even done the development. Then, the EU’s Medical Device Regulation 2017/745 adds another huge layer of work. US FDA 21 CFR may not add a lot, fortunately, but all in all it’s an enormous amount of extra work.

To launch a medical device it is required, but if this your first time launching a product like this, is it even necessary to go down this very tough route straight away?

Testing costs aren’t insignificant, either

In addition to developing the product in the correctly structured way, testing the product will probably not be cheap. Let’s say you develop an electronic wearable device. You will need to test it to IEC 60601, which is a family of standards. When you add up all the standards from that family that apply to your product and its intended functions, you may be up to 10,000 USD or more in testing costs (this will vary depending on each product). The more functions you claim, the more tests will be needed, and there are other medical device-specific points to test, such as biocompatibility (or at the very least absence of dangerous substances) in materials that might be in contact with a user’s skin, that will come up following the necessary risk analysis.

Other common tests you may need to understand

Regarding compliance with UL, FCC, and RoHS, we’ve created this introductory guide: 11 Common Electronic Product Certification And Compliance Requirements

So, how to go from non-medical device to medical device more smoothly?

From a business perspective the following sequence might work for entrepreneurs and businesses who are doing this for the first time:

1. You develop and sell your product as a comfort/fitness/[anything non-medical, without claims that make it medical] product.
2. Make sales, get some good press, and build the business up.
3. Now that the product has some success, get a medical institution excited about it with a view to them helping you with a clinical evaluation and perhaps even paying you a fee in advance.
4. Now, do all of the preparation work mentioned and the work of re-developing and manufacturing that product as a medical device.