Medical Product Development

Medical Product Development

​

Every few weeks, someone posts on our communities that they would like to create a medical device or develop something in the health technology realm. It's not surprising, given that we are in the best position to determine what products need to be developed to serve our clinical needs. That said, the process from ideation to the creation of an actually functioning device or product or service is long and unpredictable. In the case of a medical device, it can be many years before a business plan is created, financing is secured, a prototype is made, proof of concept and safety are completed, a patent is acquired, and things go through the FDA approval process and are ready to be brought to market.

 

You could try doing it alone, but in most cases, people tend to work with teams. There are several groups/advisory firms out there that can help you navigate the experience based on experience helping many individuals and companies through it.

​

Below, we briefly cover the steps in the process.

​

Brainstorming/Preparing

Flush out the idea and do some preliminary market research on what you think the chances of success are.

• How big of a problem is it?

• What's your total addressable market?

• Who would purchase from you - individuals or healthcare systems?

​

Map out the process to approval and make sure you're up for it.  Learn a little bit about the regulatory aspects of the process and how your product will need to go through the FDA process. Depending on what your product is, it could be relatively smooth or it could require human trials. All of this will significantly affect how long the process will take.  Realize that things that are low risk to the patient or are variations to existing proven devices are going to be a lot shorter of a pathway to approval than something novel, invasive, or potentially dangerous if they malfunction.

​

Think about the funding that you will need. Can you self-fund this or do you need to find funding sources?

​

If you want to work with a company to develop this, this is a good time to start vetting the different companies and seeing who you'd like to work with.

 

Make sure you protect your intellectual property. If you work for an academic health system, it's important to know what your contractual obligations to them are in terms of ownership, as well as explore what ways they can support you if you intend to use university resources. Having your own contract attorney in this case may be of benefit, because the university will certainly have someone on their side protecting their interests. Explore the idea of getting a provisional patent, and eventually going through the full patent process. This will likely require speaking to a patent attorney.

​

Research and Development

Create a prototype.  This will likely start out with drawings and maybe some 3D printed models, but eventually may require some funding to help create, depending on what you're doing. 

​

Float the prototype to some people and see what they think (ideally, they'd sign NDAs). Depending on how reproducible it is, you're going to have to decide how close-lipped to be about it. There's a fine line between making sure you're getting feedback and knowing what to improve (or even, when to quit), and giving your idea to someone else to run with. Don't be so afraid to tell others that you don't get feedback though. We've all seen pitch decks for products and services that should never have made it to market.

Research the regulatory aspects in more detail and make sure you're in compliance with how you develop and test out your product.  Be objective about potential risks of your product, because you don't want to invest a lot of time into this only to find out it would never make it past FDA approval. Ask lots of others for objective feedback.

​

Gather as much data as you can. You will likely have a team by this point, including someone that has experience with study design as well as with making sure that you are appropriately gathering and documenting all the evidence you'll need to make it through the approval process.

​

The FDA approval process is beyond the scope of this article, but readily Google-able!

​

Go To Market

Hopefully you've been networking along the way! (Learn more about growing your side gig.)  You want to make sure you have your target audience defined and how you're going to:

1. Convince them they need your product

2. Get them to convince the people in charge of purchasing, if that's not them.

​

For example, a lot of physicians may love your idea, but they may need to convince their hospitals to buy it, which is not always easy!

 

Work with relevant firms to enhance your chances of success.

There's a lot of details in between the basic pathway above, and there are many potential outcomes of this process on the whole. Some include:

1. It could turn into an expensive experiment (hopefully not!).

2. One of the major device companies may like what you're doing and offer to support you and acquire your company along the way.  

3. You maintain control throughout the approval and development process and are ready to bring the product to market (at which point you will still have to have a go to market strategy that leads to market adaptation).

​

As you can tell, this is a real endeavor that can turn into much more than a side gig, and may actually result in you working more than you do in your clinical job.  But, on the flip side, it is a really educational and exciting journey that has the potential to impact medicine in a big way!

​

​