How would you describe the change in medical device development and healthcare? Is it slow or rapid?
Drew Prindle, in his article “As Tech Trickles In, Medicine is About to Hit Warp Speed” claims the rate of innovation and technical progress in medicine is exponential, despite certain roadblocks keeping the industry from adopting new tech as quickly as it evolves.
Surprisingly, this is not what the majority of American Medical Device Summit’s participants thought, when Dr. Marco Costa asked the same question. Yet, Dr. Costa proved example after example, the rate of progress and innovation in medical device in the last decade alone has been incredibly rapid.
Why did the AMD’s visitors think otherwise? “Quality Management Systems (QMS) are considered mission critical” says Ian McCulley who was at the ADM show in Illinois last week, “and Risk Mitigation is at the forefront of medical device development”. To most, this is one of the factors that may slow down rapid cycle. “A lot of teams are still doing Risk Mitigation in a silo and want the ability to manage risk in house, along the requirements and testing, in a one stop shop type of environment”, adds Kenzie Larson, also present at the Summit. This is a definite cause of lengthy product development. When all the information is scattered, there is no way to have a complete image of any project, or instantly access information that needs review and improvement. “There was a common message of disorder in storing compliance information, increasing the risk to not only the user of the product, but also the company producing the product,” said Jess Stetson, who participated in the AMD Summit with Ian and Kenzie.
How do we solve the issue of Risk Mitigation? Kenzie and Jess say a repository where you can keep all the information for more complete traceability, coverage, and more collaboration and communication around the development process is critical. “A lot of times, people need to make documentation for the sake of documentation, to submit critical information to FDA or open it up to an auditor, and you need to be sure all of that you provide is correct,” says Kenzie. Every time a change occurs in a project, somebody needs to go back to the spreadsheet and manually update the information to make sure everything is done and connected correctly. Now imagine you can actually focus on your work and project in real time, vs. retroactively. And that at any point in time you can just export your project and actual work, without the hassle of updating information or creating extra documentation. Sounds unrealistic? Find out for yourself!