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Why Today’s Medical Device Teams Need a Product-Centric Approach

Posted in Medical Device, QMS
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FDA Regulated QualityIntroduction

Getting quality and product teams on the same page remains a key challenge for medical device manufacturers. The development of innovative medical devices demands consistent communication across teams to comply with FDA regulations, and each stakeholder group across new product development and introduction (NPDI) plays a crucial role in bringing a safe and compliant medical device to market.

For FDA regulated companies, establishing and following quality systems is a must to ensure products consistently meet regulatory requirements. Making sure all members of the product team have visibility and can collaborate throughout the NPDI process is key to successful product launches and reducing risk. There is much at stake for medical device manufacturers as they bring innovative and life-enhancing products to market quickly and effectively. Failure to follow sound quality processes can increase audit risks, negatively affect patient health, and even result in business closure.   

Challenges of working in silos

Often as companies grow from young startups to more mature companies, quality management and product development processes struggle to keep up with the evolution of their product and overall business. Such organizations will typically find themselves with a slew of point solutions like Microsoft Word, Google documents, email, spreadsheets, network servers, file services, CAD design systems, or other homegrown solutions. Some companies advance to document-centric management systems, but nonetheless find themselves with a disorganized combination of silos to manage product and quality records.

Working in a siloed product management solution presents many challenges, including:

Inability to collaborate effectively between teams early in the NPDI process

When working to bring a product to market, communication across teams is vital. However, each team in the product development process often relies on their own separate tools and processes that aren’t linked together. This creates confusion and hinders communication across teams during the fragile NPDI process.

Difficulty identifying and tracking the latest designs can result in quality issues throughout the product development process

When product and quality records span several platforms and systems, identifying and tracking the latest revision in context to the latest design is difficult. These disconnected silos also prevent executive management teams from getting a complete picture regarding NPDI process performance and risks.

Increased delays getting products designed, tested, and produced

Sifting through a company-lifetime’s worth of information silos inevitably leads to wasted time and resources. Time spent consolidating silos consequently delays the product’s introduction to market, and results in increased product costs caused by scrap, rework, and resolution late in the NPDI process.

Additional cost, audit risk, and manufacturing errors due to manually transferring records from disparate solutions

Manually transferring records across different systems exposes companies to increased audit risks and manufacturing errors. Furthermore, siloed point solutions are not optimized for the seamless transfer of data. For example, transferring one or more designs from electrical, mechanical, and/or software tools to a single solution for downstream teams outside of engineering to collaborate on is difficult if the system can’t handle complex records and bills of materials (BOMs) effectively.  

Updated FDA Mandated Record KeepingBenefits of a single and shared view of the product

A unified QMS solution supports the entire product development and launch process when it can manage and link quality and product records in the same system. By connecting the two, a product-centric QMS streamlines communication between disconnected teams and system silos to help improve collaboration, identify issues earlier in the development cycle, and improve quality. (View a 90-second overview of product-centric QMS)

Every member of every team will reap benefits from a unified system. Key benefits for four of the core groups involved in getting new medical devices to market include:

Benefits for Quality Leaders

    • Simplifies compliance with the latest FDA and ISO quality regulations

    • Enables traceability between every aspect of the product design

    • Accelerates closed-loop CAPA processes by launching corrective actions and resulting change orders in the same system

    • Creates an audit-ready, single source for all documentation, product records, and quality records, which enhances control and quality processes to ensure easier compliance

Benefits for Operations Leaders

    • Provides insights from impacted engineering and quality teams as the product moves through prototyping and into the production phase

    • Ensures early identification of product design issues and/or quality problems to prevent manufacturing errors and reduce costly scrap and rework

    • Speeds time to market

Benefits for Engineering Leaders

    • Provides a single system for mechanical, electrical, and software design teams to aggregate the entire product assembly and ensure interoperability across the design

    • Improves collaboration between engineering, quality, operations, and supply chain partners to streamline early product development

    • Offers immediate and specific feedback resulting from connected CAPA processes to speed resolution of design issues

Benefits for the overall business

    • Fosters seamless collaboration between all stakeholder groups

    • Accelerates time to market

    • Delivers a higher quality, safe, and compliant product

    • Improves customer loyalty by delivering better products that work as designed

    • Increases profitability by reducing operational costs, eliminating design errors, improving product reliability, and lessening the necessity for costly repairs after the product launch

Conclusion

Benefits and OutcomesConnecting quality to product processes during NPDI and throughout the entire product lifecycle results in strategic, competitive advantages in the medical device manufacturer’s highly regulated industry.

Removing issues resulting from siloed quality and product systems increases visibility and traceability–giving product teams the confidence to address and pass audits anytime. Only product-centric QMS solutions offer a single unified system to manage the complete product and quality records together.

To learn more about how applying product-centric QMS to keep your quality and product teams stay on the same page, download our “7 Principles of Product-centric Quality Management” eBook.

About the Author

Scott Reedy
Scott Reedy

Scott Reedy is the Senior Director of Marketing for Arena Solutions. He has held strategic roles with enterprise software companies in consulting, sales, and marketing over the past 20 years. ...

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