Are You Leading or Falling Behind? How Innovative Medical Device Manufacturers are Modifying Their Design Control Process

Most medical device manufacturers continue to rely on manual and Word/Excel-based approaches for design control and risk management—and that’s hindering their ability to achieve critical strategic initiatives, including improving efficiency and accelerating time to market.

That’s according to a recent survey of 100 medical device executives and engineers conducted by Sage Growth Partners. The independent survey, conducted in Q4 2023 and commissioned by Cognition Corporation, found that two-thirds of manufacturers (68%) still rely primarily on manual processes, or on a mix of manual processes and generic design control solutions, for product design control and risk processes.

The full survey findings will be released in May, but this preview into some of the findings provides some noteworthy takeaways.

Sign up here to receive first access to the full market report .

Overall, the survey found that when it comes to design control:

• 38% of medical device manufacturers use a mixture of manual processes and a design control solution
• 30% use manual processes (such as Excel, Word, or paper) only
• 24% use a design control solution that completely eliminates manual processes
• 8% use a homegrown solution

A comparison of responses across these groups found that manufacturers that have completely eliminated manual processes and rely solely on a design control solution experience significant advantages over those that continue to use a manual approach.

Four Noteworthy Findings: A Closer Look at the Advantages Provided By an Effective Design Control Solution

The soon-to-be-released market report includes detailed insights related to each of the above findings, but in the meantime, here are four key data points to consider:

1. Risk management processes: Only 38% of survey respondents that use a manual approach report high satisfaction with their approach to risk management. In comparison, 67% of respondents that use a design control solution report being highly satisfied with their approach.
   
   To learn more about the benefits of a design control solution, read: How to Speed Time to Market.
   
   
2. Audit readiness: More than half (52%) of survey respondents that use a manual approach report that audit readiness is a top challenge for their organization. That percentage is much lower among respondents that use a design control solution. Among these respondents, only 15% say that audit readiness is a top challenge.
   
   To learn more about how to enhance audit readiness at your organization, read: 10 Ways to Achieve Medical Device Compliance.
   
   
3. Traceability capabilities: Less than half (41%) of survey respondents that use a manual approach for design control report high satisfaction with their current traceability practices. Among respondents that use a design control solution, that percentage increases to 65%.
   
   To learn more about the benefits of enhancing your traceability processes, read: How Medical Device Companies Can Leverage Real-Time Traceability.
   
   
4. Integration across key domains: Less than one-third (31%) of survey respondents that use a manual approach say their current processes integrate very well across domains (i.e., requirements with risk, risk with test, etc.). In comparison, that percentage jumps to 85% among survey respondents that use a design control solution.
   
   To learn more about why integration is so critical to design control, read: Rising Risk: Why Many Medical Device Companies are in Danger of Risk Analysis Missteps.

What’s Driving the Advantages? Benefits Provided by a Design Control Solution

The analysis of the survey findings clearly shows that a comprehensive design control solution can help medical device manufacturers streamline and enhance their processes across multiple domains.

Organizations that are ready to make the transition from manual processes—or that are questioning whether their current design control solution is as effective as it should be—should first and foremost seek out a partner with a solution engineered specifically for medical device manufacturers.

These solutions will be much more efficient at meeting your needs, for example, by incorporating guided templates to ensure compliance with ISO 14971, ISO 13485, and 21CFR820.30, and by enabling you to export submission-ready reports—in the required formats—with the click of a button.

Solutions designed specifically for medical device manufacturers will also be much more intuitive to use and will seamlessly integrate into your current workflows, making adoption much easier for your team. For leading medical device manufacturers, these thoughtfully designed solutions can be make-or-break when safely improving speed-to-market, and therefore whether your organization is setting the pace for innovation—or falling behind. Ensure that any solution your organization considers includes both out-of-the box and highly configurable workflows to meet your unique needs.

We will be releasing more survey findings—including how respondents ranked their organizations’ top challenges and priorities—when the full market report is released in May. Sign up here to be one of the first to receive the report.