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Top 3 Hardest Steps for Inventors During Medical Device Development

Updated: Sep 25, 2023

The process of developing your device idea may seem daunting. There’s a lot of steps and rules to follow to ensure a successful launching of your product. We’ve provided a list of the three hardest steps for inventors during development and ways Vita Group can guide you through the difficult parts.

1. Research & Development:

The first step in the process of commercializing your product is researching the basics surrounding your device idea to get a better understanding of what direction to go with development. This research includes assessing the market and competitors to see where we can make improvements on your product. User research and testing is also done to ensure the device is relevant, functional, and user-friendly for whoever will use the device. There should also be research done on what the estimated cost of developing the product will be. All of this information should be included in a business plan to eventually show investors.

Development is the second half of commercializing your product. Development entails creating prototypes that eventually leads to a fully functional device. First, the engineers will sketch designs for the concept. Those sketches are then refined and tested to ensure safety, functionality, and efficiently. Eventually, after a lot of trial and error, you’ll end up with a high-fidelity, functional prototype that can be used when designing for manufacturing. Fortunately, Vita Group covers all these services to ensure your project is ready for the market.

2. 510k Submission/Manufacturing:

This is the part where many inventors get stuck. 510k submission and manufacturing can be confusing and overwhelming. There are many layers to gaining FDA approval to make sure the device in question is safe and effective to be legally marketed. The process takes time and perseverance to get it right. Unfortunately, there is no “510k form” that you can simply fill out and send to the FDA. For submission, you must include the following:

  • Device classification

  • Predicate device(s)

  • Proposed labeling

  • Description of the device and specifications, including engineering drawings, photos, etc.

  • Performance data such as clinical testing

  • Sterilization information (if applicable)

Yes, we know it’s a lot. This is why Vita Group provides you with a regulatory pathway plan. We guide you through the approval process and take care of the hard part so you don’t have to.

3. Sales/Distribution:

Now that you have a functional prototype, FDA approval, and manufacturing for your device, you need to find a way to distribute it. Again, it is usually the inventor’s responsibility to fulfill and hire a sales team. This entire process is extremely difficult and time consuming. Instead of searching elsewhere for selling and marketing, Vita Group takes currently developed products and transfers that information to our plug-and-play sales team, Vita Solutions. Vita Group trains our sales team on the project's usage and specifics so they are experts and can achieve efficient distribution.

It may seem like the road of development is never ending. There are so many steps to complete, and it takes a lot of trial and error. At Vita Group, we are prepared to help you through these steps to provide a pain-free experience. Are you ready to learn more about developing your innovative medical device ideas?


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