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The healthcare industry has witnessed some amazing advances in technology to prolong and enhance the quality of life for many people. Things thought impossible just a few years ago are now becoming a reality. The future looks bright for medical device product development, however, there are a lot of challenges. Here are some of the challenges you may face when bringing new devices to market and why you may need some assistance from a company like MDI.


Sometimes it can be hard to determine if medical device product development is the right choice. For example, there may be a definite need for your device, but it can be difficult to determine if bringing it to market can be profitable. Since no one has a “crystal ball” to see the future, it takes a lot of hard work from experienced industry experts to make even the best concept a reality. If you or your staff lacks this experience, you need to tap into other sources for guidance. MDI is very well positioned to provide that guidance.

FDA Approval

Perhaps the biggest challenge facing medical device product development is complying with regulations. Unless you know exactly what the Food and Drug Administration expects from your design plans, you could be facing an overwhelming task with little chance for success.

MDI has experienced engineers who have helped many companies understand what to expect, so they can meet the challenges head-on and get through the difficult process of getting approved and complying with all the regulations.

Other Medical Device Product Development Challenges

You will have to deal navigate intellectual property laws, and other legal matters. It is important to have staff with a lot of specific knowledge of the medical industry too. To talk to someone about your research and development needs, call MDI today at 800-852-1472. We can help you get your new devices to market!