As medical device complexity grows, the product development process often needs to improve in order to maintain device quality and safety, foster innovation, and reduce costs. Yet teams looking to make improvements often encounter resistance from management. This Ask the Expert focuses on how you can overcome barriers to improving the medical device development process.
Q: “My team is under pressure to streamline the development of two key devices in our product line. I know we can do it if we implement a new software solution, but management keeps telling me there’s no room for it in the budget. How can I convince them that the software is a worthwhile investment?”
To deliver innovative products within reasonable timeframes, you need to invest in tools that give your product teams the time and energy to be innovative. Look at the points in your development process that take the most time to complete. In the medical device industry, those are most likely to be the compliance activities—maintaining traceability, linking requirements to source code and testing to requirements, and so forth.
After identifying these time sinks, find ways to streamline or eliminate them. You might need a whole new process (i.e., Agile or some hybrid of Agile and your current process), or just a new tool. If the compliance effort relies heavily on shared documents, you may need to adopt a more artifact-centric process. If it takes you several hours or days to create and maintain the traceability matrix, you may need a tool to automate that process.
Once you know where your process bogs down and what you need to do or purchase to fix it, then you can determine if the return on investment is worth it. Then, you’ll be in a stronger position to make a solid case for including new technology in the budget and overcoming the resistance to implementing it.
In the 2014 State of Medical Device Development Survey, respondents identified “budget” as one of the most common barriers to improvement. Find out what other barriers they identified.
Q:”Every time I find a tool that would help my team work more efficiently, my boss tells me it’s not worth the hassle to validate it. Is there a way to make the validation process easier?”
Validation overhead is a legitimate issue, where the company needs to spend money on a contractor to help or has to take time out of a real business project to document the system in use. If you think about it, it’s really kind of “busy work,” in the sense that the team is just documenting what they’ve already done.
Some tool vendors are making changes and adding features to address the challenge of validating new tools. I hate to hear about situations where an organization won’t even consider a change because of their fear of validating the new system. So you need to be aware of the real challenge without letting it cause paralysis. Otherwise, outdated systems and practices will remain in place despite the availability of better alternatives.
“Validation overhead” was also identified as a leading barrier to improvement in the 2014 State of Medical Device Development Survey. Find out what other barriers they identified.