Panel Discussion: 3 Industry Leaders Explore How Medical Device Manufacturers Can Speed Time to Market

How can medical device manufacturers successfully balance the significant pressures of today’s market?

On the one hand, they need to bring new devices to market quickly. On the other hand, devices are becoming much more complex, while at the same time, industry standards and regulations are continuing to evolve.

During our recent webinar, three panelists—Nathan Brown, R&D Fellow at Boston Scientific; Mike Casper, System Engineer Manager at Smith & Nephew; and Eric Maas, a former Medtronic executive and founder of Six Sigma Experts—shared their perspectives on how medical device manufacturers can achieve speed to market, safely.

They reflected on independent market research about the state of medical device manufacturing, as well as their firsthand experience working with engineering teams at small, medium, and large medical device manufacturers. 

All panelists agreed that overcoming organizational inertia and implementing better tools and processes, including those that facilitate connected requirements and risk management, are key to accelerating time to market—and they shared real-world examples in which this has been true in their own careers and their own organizations.

The Value of an Effective Design Control Solution

Panelist Nathan Brown, pointed to the value of an effective design control solution, like Cognition offers, specifically when it comes to enhancing efficiency and collaboration. 

“Using a tool like this globally allows development cross-divisionally—everybody is basically on the same page,” he said. “You're all following not only the same global quality system, but you have a tool that enables that quality system. It contains all of the templates and deliverables that you're producing that become part of your DHF file. When you take a global position like that … people can move from one division to another. An engineer can move to another division and pick right up where they left off in the last division because nothing has changed. It's all the same. It gives that flexibility and it just establishes a very consistent process.”

Automation-Enabled Platforms Provide Significant Value

Panelist Mike Casper agreed, noting that automation-enabling platforms provide significant value to organizations—in multiple ways. 

“We're always trying to find more automated ways of doing testing, and this just seems like such a ripe area to explore automation and take advantage of it,” he said. “I think it all comes down to the efficiency, to automate the creation of documents, exporting those documents very quickly … If not a lot of businesses are taking advantage of a tool to be more efficient in their requirements management, it's probably something that can really increase their efficiency.” 

Effective Design Control Solution Enhances Collaboration 

Panelist Eric Maass also pointed to the value of an effective design control solution in enhancing collaboration and efficiency, but he emphasized that organizations that experience maximum impact will find a solution that connects requirements, risk, and quality management.

One reason? A well-integrated solution ensures that when a change is made in one area, that change is captured and automatically updated at every instance. “With more of an automated system, like Cognition offers, changes are updated everywhere and you can see all the places that are affected by a change or an update.” 

He added that a solution that is integrated, connecting requirements and risk management, not only enhances efficiency, but also enhances accuracy and reduces the risk of error. “If you can have an automated system that can prevent defects in your documentation, have everything connected, and ensure updates are captured in every instance, that can reduce the opportunities for errors in your documentation, in your information flow process, and in the associated DHF files and your design history files … You need to have that in a database so it references the same thing and everything gets updated together and everything gets integrated together.”

Watch the webinar for more insights and takeaways from the panel discussion, including: 

• How to establish consistent processes and connect requirements and risk management  to enhance quality and efficiency 
• How the right tools can increase collaboration between engineering, quality, and testing teams 
• How to streamline information flow, reduce documentation errors, improve requirements management, and ultimately reduce launch delays 
• How to generate buy-in from colleagues who are more comfortable with longstanding manual processes than less familiar, automated ones