Anyone that has been involved with designing, developing, and deploying medical devices knows there are lots of questions the product development team – and the larger organization – need to address in order to achieve success. Unfortunately, the magnitude of daily “small” questions can crowd out the fewer “big” questions, thus leading to drift, frustration, and failure.
Over the years, I’ve found there are ten questions that are vital to successful medical device development. They include:
- Is there a market for the medical device?
- Who will purchase the medical device?
- What should we charge for the medical device?
- Who are the users of the medical device?
- Where will the medical device be used?
- What is necessary to successfully use the medical device?
- Can we build the medical device?
- Should we build the medical device?
- Did we build the medical device right?
- Did we build the right medical device?
While this list of questions is by no means exhaustive, they are key high-level questions that, if answered correctly, can contribute to appropriately focusing scarce resources and achieving product realization. Moreover, without concrete answers to these questions, the product development team may be setting themselves up for failure, or at the very least, a very rocky development lifecycle.