Ideas for medical devices can come to anyone, anywhere, anytime. You don’t have to be an experienced engineer or highly skilled surgeon to bring a novel device to the medical and healthcare industry. Still, many people stop their ideation process right there just because they think that the medical device industry is too regulated and they will face too many roadblocks. While it is true and there is a lot to consider, it is a very rewarding path that is worth pursuing.
If you too have come up with an idea that can help solve a medical issue or make some treatment or health check easier, just know that Medical Device Companies are out there to help you transform your idea into an actual product and launch it in the market. But, before that, you should follow the below steps.
What to Do Before Medical Device Development Phase
- Market Research
Do market research to find out if there is in fact a market for your product. Ask yourself a few questions.
- Will my device fulfill the unmet need of medical device consumers?
- Who will buy my device and what segment of people will seek my product?
- What are the competitive products/technologies/services available?
- How is my medical device superior to those competing products?
If there are competitors to your products, researching them would greatly help you measure your proposal. Your product market size will also help you determine how much capital you need to raise.
- Project Timeline
Once you decide to pursue your idea, also figure out the timeline of your project that includes estimates of each phase and not just the overall project timeline. It will help assign capital amounts accordingly, manage your resources efficiently, and creating an accurate budgetary estimate.
- Regulatory Path
Have an idea of the regulatory path. While things may change as your product evolves, your path to clearance or approval will have a substantial impact on project timing and cost.
- Product Testing Plan
Testing is typically overlooked in the beginning. It is often much more costly than companies realize. If your product will need to come in contact with patients in any way, you will most likely need to consider biocompatibility testing which can be very expensive in some cases. So, get an idea of what types of testing your product will need to go through and collect funds for this phase as well.
- Target Countries
Determine if you wish to launch your product nationally or internationally. To register a device in different countries, there are costs involved in the form of paying registration fees, obtaining a license, or simply paying someone to handle the registration process.
- Hidden Costs
It is common for new companies to miss their launch deadlines due to budgetary limitations. This happens mainly because of hidden quality management system costs, for instance, repeat testing, compiling Design History Files, and so on.
- Potential Revenue Estimation
You also need to calculate potential revenue because commercialization and reimbursement are key components of any business model. You are not going to get the same market value for your product in one country that you may in another. The same goes for even states within a country.
Be proactive with a medical device project plan and know that it can change and evolve along the way. Once you follow all these steps, you are ready to contact one of the best Medical Device Companies that can help you design and develop a novel medical device and assist you throughout the launch process.