MedTech Experts Weigh In on Quality Management

In the wake of the pandemic, many industries, including medical device manufacturers, are left sorting through pieces of what’s become a giant domino effect. Not only has the pandemic exposed weak links in supply chains but also the waste and management of paper-driven processes along with using legacy systems to manufacture complex products.

Trying to figure out how to manage a business in this new paradigm-shifting environment is challenging, especially as internal teams and supply chains are more dispersed than ever. Orchestrating the efforts of multiple teams worldwide can be a daunting task.

Companies must act quickly to guarantee that product work continues promptly, effectively, and seamlessly when business operations are disrupted. Add to that today’s environment of disruptions, changing regulations, and rising customer demands, and you have some pretty big challenges to contend with.

Quality Management approach to ensure successful commercialization and compliance

An approach to quality management that’s focused on the product record can help teams work more efficiently and ensure successful commercialization and compliance. To help better understand the challenges medical device companies face, and what they can do to mitigate the impact, Arena invited Michael Keer, Founder and CEO of the Product Realization Group, and Angenette Nordqvist, Quality Director of SomaLogic Operating Co., Inc. to share their insights.

Both experts have extensive experience bringing regulated products to market and know what’s needed to ensure successful and efficient product development processes. Here are some key points and observations to keep in mind as you approach compliance goals, supply chain issues, and building a quality framework.

What do you see as the biggest challenge in bringing medical device products to market?

Keer noted, “I see challenges falling into three major areas in today’s market: First are resources. Getting skilled resources has been a real challenge that COVID made worse as people got sick or left their jobs. While some hiring areas have eased the past few months as the economy slows, I believe that recruiting and keeping skilled resources will continue to be challenging for MedTech companies.

“Second, component shortages. The availability of key components continues to be a major challenge for electronic high-tech companies. I recently talked with one medical device company that was supposed to start shipping in February. Now they’re not going to be able to ship until November due to component shortages.” Keer added, “And third is remote management of global supply chains.”

Keer said, “Effective management of product data and clear communication continue to be challenging. Since COVID, getting in and out of China is still a major issue. It continues to impact companies trying to bring new products to market that have China-centric supply chains. And there continue to be delays in ocean shipping of parts as well as distribution resource constraints in the U.S.”

How do medical devices and other product companies deal with today’s environment and ensure they deliver high-quality and compliant products on time?

Nordqvist stated, “I would say identifying key suppliers as partners or contract manufacturers are key to building supply chain resilience. These partners should be, ideally, a part of the development process. For me, a responsible device manufacturer, this means building a system that can respond to inevitable supply chain challenges, be it global unrest or natural disaster, or something else.

“From the start of a new product introduction, supply chain risk must be considered so that dual or multiple sources for high-risk materials, components, or items from high-risk suppliers, are identified and built into the design at the start.”

Nordqvist noted, “This means having a strong product lifecycle ecosystem, such as enterprise quality management system (eQMS), product lifecycle management (PLM), and enterprise resource planning (ERP) to better control, collaborate, and communicate with both design and manufacturing partners. And it’s not just the systems that are important, but also the content within the systems, manufacturable components, and materials, solid design, and easily transferable manufacturing documentation.”

Solutions and programs that address all facets of your business

Having the right combination of solutions and programs is imperative in achieving today’s regulatory standards, especially as it pertains to managing the entire product lifecycle across design, quality, supply chain, and manufacturing. The right combination enables medical device manufacturers to scale and respond to ensure a resilient supply chain is in place.

Can you explain how a product-centric approach to quality is different and why it matters?

“ISO standards require a quality management system (QMS) to be process-focused with a risk-based approach,” Nordqvist said, “That’s across the board and is a must for medical device companies. This enables a total quality management approach. It builds that cycle of continuous improvement into the QMS. The QMS framework is very important, from new product introduction, design controls, and risk management programs to controlled design transfer into manufacturing.”

She added, “Once in production, good management of nonconformances connecting to corrective and preventive actions (CAPAs), complaints, connecting the incident back to the bill of material (BOM) or supplier or manufacturing process and/or design requirements and/or risk — being able to connect all the dots and having the structure in the QMS, I think is key.”

“It’s not enough to have the framework in place,” remarked Nordqvist. “It’s the content. We must also connect the dots from a product perspective, from understanding what is critical in the controlled design. What’s critical to quality (CTQ) specifications, and functions in the design? And in reviewing the risk management file, what are the risks in the design, potential harm to patients, providers, and operators of MRIs as an example?” Nordqvist pointed out, “Knowing and identifying and documenting these CTQ specifications, product requirements, and risks is important.

“And to take this further, how do these CTQ specifications and design risks translate in the supply chain world? We need to build that thread into supplier risks, and material risks, and identify what must be required of suppliers. What must they control? And what should we look at for incoming inspection? What critical process parameters in our manufacturing affect the CTQ functionality in the product design? Is it temperature control? Is it contamination risk?”

Nordqvist said, “Ideally, manufacturers have an eQMS and PLM where they can connect the design requirements to specific materials/components and key functions to the certificate of analysis (CoA), incoming inspections, and final inspection. All that evidence in one place and interconnected, connected to the BOM, to the key components, as well as to robust supplier qualifications and controls, is a nice way to manage the product-centric requirements.”

Tips to improve new product development processes in an FDA-regulated environment

Any organization wanting to enter the medical device space must respect the requirements and build the system and structure to enable controls for safe and effective medical devices that ensure patient safety. Compliance is necessary but patient safety is the goal. Taking a proactive quality approach throughout the lifecycle is imperative.

What are your tips for improving new product development processes for regulated companies?

Keer said, “I recommend following eight best practices for new product realization”:

1. Create a cross-functional team, define clear requirements, and have a detailed project schedule.

2. Pick the right development model: Is it an original design manufacturer (ODM), contract manufacturer (CM), or joint development manufacturer (JDM)? You need to understand strategically—what’s the right model?

3. Follow an agile hardware development methodology and create a minimum viable product (MVP).

4. Identify and mitigate risks early such as market, technology, and regulatory.

5. Understand regulatory and environmental compliance.

6. Deploy scalable business systems like customer relationship management (CRM), ERP, and PLM. Keep integration with the supply chain in mind.

7. Develop a robust and resilient supply chain. If it’s a U.S. factory, make sure you can get on-site.

8. Get to know your CMs, spend time and nurture the relationship. Make sure you have a good relationship with your parts supplier.

Planning for future disruptions

Medical device manufacturers are aware that the inevitable can happen—more disruptions to the supply chains. That’s why prevention measures must be put in place. If you think through potential risks beforehand, you’ll have a backup plan ready to keep your product development processes moving despite any issues that should occur.

Having the right ecosystem in place provides better information, and process control, and enables collaboration and visibility. It also helps mitigate risks that are essential to meet today’s QMS regulations. Is a product-centric approach to the quality right for your company?

Watch the full webinar for more insights from these industry experts.