Empowering emerging medical device manufacturers

Leveraging the digital infrastructure to align with best practices and accelerate growth

Detecting and avoiding quality issues

Medical device and diagnostics (MDD) manufacturing is a challenging industry for all players. Not only are technology and products becoming more complex, but regulatory and supply chain factors increasingly compound the requirements bearing down on businesses. The U.S Food and Drug Administration (FDA) is rewarding manufacturers that implement critical-to-quality practices in design and production, shifting its focus to quality first versus compliance.

Today, competing in this industry necessitates the proper digital manufacturing foundation to address these growing requirements. Larger, more entrenched MDD manufacturers have the capital and experienced human resources to implement a digital foundation that improves both quality and cost, creating the most efficient environment for bringing innovation to market.

Siemens Digital Industries Software has been a leader in developing that proper digital infrastructure, having worked alongside the FDA throughout its Case for Quality program. The program identifies best practices for moving from detecting to avoiding quality issues. The FDA’s work has identified the six pillars of quality manufacturing shown in figure 1. Siemens has championed the systems that support these quality best practices and is a longstanding leader in manufacturing operations management (MOM) systems tailored for the MDD industry. The MOM systems used by MDD leaders enforce all of the manufacturing behaviors identified above.

SMB MDD manufacturers

Trends in the MDD industry

Whether an MDD manufacturer is a global leader or an emerging player, they operate within the same complex environment. They compete to get innovation to market as quickly as possible, with the race against time often an existential challenge for the emerging competitors. MDD manufacturers produce two things – the product and the device history record. Ideally, both must be perfect – perfect product quality, perfect compliance. Yet the trends that face all manufacturers in this segment work against achieving that perfect state.

Increased complexity in products

As innovation and consumer demand pushes us toward mass customization, product complexity is increasing. For MDD products, technologies like the internet of things (IoT), wearables and connected devices are all increasing the complexity in the manufacturing process. As personalized medicine increases, so, too, does the potential impact on the production cycle, leading to concepts of lot size/batch size of one.

The are several implications for this growing product complexity. First, the connection between manufacturing production and product and process design must be strong. Not only do the capabilities of the shop floor need to adjust with the product requirements, but the design teams must understand the constraints of the production environment. As lot sizes decrease, changes to production lines must be done more rapidly. And all of this must be done while maintaining the highest product quality and the details of regulatory compliance.

Global supply chain uncertainty

With the COVID-19 pandemic disrupting global supply chains on a monumental scale, manufacturers have had to reconsider how they plan for and source raw materials and components. For MDD, sourcing requirements have always been significant, with regulatory and quality requirements weighing heavily on supplier selection and ongoing quality monitoring. With 3D printing options becoming more available, component material alternatives have become more significant.

The impact on the manufacturing process includes more complexity in tracking and tracing, as well as supply quality processes. In addition, the options for replacing traditionally sourced components with 3D printed components must be vetted with manufacturing constraints and product quality issues. The opportunity for 3D printing to impact personalized medical devices is also in play.

Growing regulatory requirements

The regulatory environment for the MDD continues to be a significant constraint on innovation and speed to market. In the U.S., the FDA initiatives are shifting its focus to product quality rather than traditional compliance. The European Union (EU) Commission’s proposal for Medical Devices Regulations establishes a modernized and more robust legislative framework to ensure better production of public health and patent safety – presenting new challenges for operations in that geography.

Despite regulatory intentions, product recalls are still rising. With social media and consumer engagement, the repercussions of recalls will be increasingly damaging to medical device company brands. Quality inspections will become more difficult to manage, while manufacturers will need to collect data through the entire product lifecycle. Further, the emergence of value-based care will continue to put pressure on costs and production efficiency. | Americas: 1 800 498 5351| Europe: 00 800 70002222 | Asia-Pacific: 001 800 03061910 | For additional numbers, click here.