Overcoming MedTech Challenge #5: Varying and Restrictive Regulations

By Riccardo Consonni

According to Axendia, regulatory compliance continues to constrain improvement in MD&D manufacturing efficiency and productivity. “Our primary research shows that medical device companies list regulators/government agencies as the top business disruptor,” says Daniel R. Matlis, president of Axendia. The United States Food and Drug Administration (US FDA) and the new European Union Medical Device Regulations (EU MDR) are driving new requirements. Specifically, the US FDA is shifting regulatory focus to product quality versus traditional compliance, while the EU Commission’s proposal for the regulations on medical devices establish a modernized and more robust legislative framework to ensure better production of public health and patient safety. Both efforts present new challenges for operations in their respective geographies.

Regulatory inspections are disruptive. Companies are finding it difficult to manage and respond to inquiries, and product recalls are still rising. With social media and consumer engagement, the repercussions of recalls will be more damaging to medical device company brands.

Here are a few key insights related to these trends:

  • A restrictive regulatory environment is the biggest growth challenge perceived by medical device manufacturers (58.3 percent), according to Frost & Sullivan
  • According to Axendia, 85 percent of medical device manufacturers define the role of quality as compliance with regulations or internal policies or procedures. Only 10 percent define the role of quality as driving product/process improvements

New manufacturing challenges that affect a MD&D company’s digital technologies are arising in relation to these new regulatory schemes:

Quality inspections will become more difficult to manage. When product traceability is hidden in paper records and downstream data is not integrated into the product master record, it is impossible to properly conduct root-cause analysis and define preventive actions, resulting in regulatory agency actions or recalls.

Manufacturers must collect data throughout the product lifecycle. Manufacturers in the US will be required to expand the data collected across the product lifecycle and respond to the FDA Regulatory Framework for the Total Product Lifecycle (TPLC). Medical device companies will collect data, including concept, prototype, feasibility, stability, clinical, design transfer, manufacturing, in-process testing, product release, quality inspections, nonconformance reports (NCRs), corrective and preventive action (CAPA), field actions, adverse events, post-market surveillance, complaints and obsolescence.

Quality and compliance are often confused. Medical device companies focus on compliance activities because the FDA guidance demands it. Compliance does not equal quality and having great compliance does not ensure high-quality products. Quality and compliance are often confused.

Manufacturers need to understand the FDA’s quality metrics guidance. “Our primary research on the medtech industry’s ability to build a culture of quality and innovation shows only 62 percent of manufacturers are familiar with FDA’s Medical Device Industry Consortium (MDIC) Case for Quality,” says Matlis. The agency recognizes manufacturers who are high performers and will shift their resources to products/areas that need more attention. Manufacturers should learn about and become active in the FDA’s Case for Quality.

The EU MDR contains a series of important improvements to modernize the current system. They include:

  • Stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at the EU level
  • The reinforcement of criteria for designation and processes for oversight of notified bodies
  • The inclusion of certain aesthetic devices that present the same characteristics and risk profile as analogous medical devices within the scope of these regulations
  • The introduction of a new risk classification system for in-vitro diagnostic medical devices in line with international guidance
  • Improved transparency by establishing a comprehensive EU database of medical devices and a traceability system based on unique device identification (UDI)
  • The introduction of an implant card containing information about implanted medical devices for a patient
  • The reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorizing multicenter clinical investigations
  • The strengthening of post-market surveillance requirements for manufacturers
  • Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance

Focusing on product quality and compliance

The MES automatically controls the manufacturing environment according to product and process definitions, while simultaneously collecting as-built data. Although the opportunities for errors, NCRs and field failures are dramatically reduced, compliance becomes a by-product of a digitally controlled process. Managing inspections is greatly simplified, reducing the time and overhead of producing documented evidence with technology solutions that provide rich, timely and accurate data.

Manufacturers must leverage MES to automatically create device history records, accelerating their ability to respond to inspections and more intelligently prevent quality issues.

Access to real-time data and full traceability allow better decision-making and predictive analytics across the product lifecycle. MES provides this source of data for TPLC.

Ultimately, using MES supports the FDA’s case for quality. The FDA is looking for manufacturers to adopt technologies like MES to allow them to focus on efforts that improve product quality, rather than focusing on documenting compliance. Medical device manufacturers that adopt MES will be in a much stronger position to reduce the amount of regulatory scrutiny relative to manufacturers that don’t.

As with FDA regulations, using MES is critical for supporting EU regulatory requirements. Using MES enables you to automatically record as-built data, providing visibility into useful manufacturing data that can add to the entire product lifecycle from R&D to manufacturing to patient (post market) and back using closed-loop feedback.

Read the eBook to learn about more trends facing the Medical Device industry, and how integrated MES is addressing new challenges.

Learn more about MES for Medical Device.

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This article first appeared on the Siemens Digital Industries Software blog at