Accelerating the Adoption of Advanced Manufacturing Technologies to Improve Quality, Access, and Outcomes 

Advanced manufacturing technologies are introducing promising tools like Artificial Intelligence (AI), machine learning (ML), digital twins, digital threads, virtual/augmented reality, additive manufacturing, and closed-loop quality management to the medical device industry. These innovations have the potential to streamline production, enhance quality, and ultimately improve delivery times for devices that patients rely on. The result? Opportunities for increased efficiency, cost savings, and a meaningful impact on patient care. 

A recent report from MDIC’s Advanced Manufacturing Clearing House (AMCH), developed in partnership with the life sciences advisory firm Axendia, examines the benefits and challenges of integrating these technologies within the medical device sector. Titled “Digital Transformation Across the Product Lifecycle: Realizing the Benefits of Advanced Technologies,” the report brings together industry insights and practical steps that can help companies navigate this evolving landscape.

Inside the Technology: From Digital Twins to QMS 

Drawing on insights from a global survey of decision-makers and practitioners, the report reveals that 85% of industry leaders agree that advanced manufacturing holds significant potential to reshape medical device production. From quality control to digital transformation, the industry is eager to understand how these technologies could streamline processes and elevate standards.  

The technologies surveyed range from widely adopted electronic quality management systems (eQMS) platforms, which support quality management functions, to emerging tools such as digital twin, AI/ML, and closed-loop quality management. While eQMS platforms are increasingly common, newer tools face varied adoption rates, influenced by factors like cost, complexity, and perceived value. For instance, only 13% of respondents have fully implemented digital twin technology, with another 17% in pilot projects and nearly half with no plans for adoption, suggesting a cautious yet growing interest. 

As Seema Sodhi, Data Science and Data Engineering Leader at Medtronic, notes, “AI/ML implementation can initially be costly due to new technology adoption and vendor partnerships. The benefits, such as improved insights and proactive capabilities, emerge over the long term.” This highlights the industry’s need to balance initial investments with long-term gains. Through AMCH, MDIC provides a platform for companies to exchange insights and share early lessons, supporting the sector’s understanding and approach to these emerging technologies.

Voices from the Field: Industry Leaders Weigh In 

Across engineering, quality, and regulatory roles, decision-makers bring unique perspectives on the potential impact of these innovations. Engineers, for example, emphasize how advanced technologies can streamline production and support product development. Quality professionals see opportunities for product consistency, defect reduction, and even support for sales and marketing efforts. Regulatory experts, meanwhile, highlight the value of streamlined documentation, which could make regulatory compliance more attainable. Notably, 87% of quality personnel rated the impact of advanced manufacturing on process efficiency as high, while 76% observed improvements in product quality. 

Despite differing viewpoints, the consensus is clear: the potential of advanced manufacturing is substantial.

Overcoming Hurdles: Navigating Financial and Regulatory Roadblocks 

While the enthusiasm is there, barriers persist that limit broader adoption of advanced manufacturing technologies. One of the most significant challenges is the financial commitment required—particularly for smaller companies. Convincing stakeholders to invest in costly technologies that deliver returns over the long term remains a complex task. 

Regulatory challenges are another major factor, with nearly 48% of respondents identifying these as a barrier. Advanced manufacturing can improve compliance, yet complex regulatory frameworks often slow down adoption. Parker Tyler, Director of Reliability Engineering at Edwards Lifesciences, explains, “Fundamentally, the goal is to design the product in a way that minimizes the need for advanced manufacturing since this approach offers the greatest benefit.” In life sciences, advanced manufacturing is often used to “eliminate or reduce the impact of variations on inputs, ensuring the highest product quality since any mistakes can affect patient lives.” This focus on minimizing variation at the design stage underscores the industry’s commitment to patient safety. 

MDIC’s AMCH supports the industry in these areas by facilitating conversations and the sharing of best practices among regulatory bodies, industry leaders, and innovators. This collaborative environment allows companies to navigate regulatory complexities with approaches that align with compliance requirements and patient safety priorities. As Rob Becker, Vice President of Quality at Edwards Lifesciences, notes, “The decision to automate is influenced by factors such as reducing variation, meeting volume demands, ensuring safety, and improving efficiencies.” Regulatory requirements shape not only which technologies companies adopt but also how they implement them across diverse production environments.

Josh Rabinowitz, CEO of Articulate Labs, shares that “feedback from potential partners in orthopedics and physical therapy indicates that they’re already highly interested in treatment personalization and related data outputs specific to each patient’s compliance and progress.” However, he notes that “the primary concern with the implementation of this tech is reimbursement… collaboration with CMS and private payors will be important.” Collaborations like those facilitated by AMCH may support Digital Twin initiatives by helping companies identify valuable data metrics for clinical trials to demonstrate health economic benefits, while also navigating reimbursement processes.

Scaling advanced manufacturing solutions across different production settings presents yet another challenge. Integrating these technologies into established operations requires both financial and technical resources. 

Charting the Way Forward: Practical Steps for Adoption

The report offers actionable recommendations to support companies in overcoming these barriers. One suggestion is to align internal practices with the FDA’s regulatory expectations, potentially easing the documentation burden by relying on vendor-supplied validation reports. 

Other recommendations include implementing pilot programs to demonstrate tangible benefits, securing C-suite support early, and setting clear goals and milestones to maintain momentum. Companies are also encouraged to invest in training programs that allow cross-functional teams to test and integrate advanced manufacturing solutions effectively.                                                                    

By following these steps, companies may improve their ability to deliver high-quality products to patients more efficiently, potentially contributing to positive patient outcomes.

MDIC’s Commitment to Advancing Quality and Patient Care

Through the Advanced Manufacturing Clearing House, MDIC is committed to fostering collaborative efforts and industry-wide conversations to address the challenges in adopting advanced manufacturing technologies. By engaging with regulatory bodies, such as the FDA, and partnering with medical device companies, MDIC helps align industry practices with evolving regulatory expectations, supporting the integration of innovative technologies that can enhance product development and manufacturing. This ongoing work highlights MDIC’s dedication to advancing quality improvements, access, and patient-centered outcomes across the medical device industry.