MedTech Intelligence sat down with James Thompson of Siemens to ask him about growth in the medical device industry. Thompson spoke about how digital infrastructure will lead medical device manufacturers to more advancements and innovation in the industry. Let’s look at the key quality manufacturing pillars that medical device and diagnostic (MD&D) manufacturers can use to shift from detecting to avoiding quality issues.
Challenges in the industry
There is no shortage of regulatory requirements and disruptive market conditions in the medical device industry. MD&D manufacturers have to continuously pivot to keep up with new challenges.
All MD&D manufacturers face the same challenges – increased complexity in products, growing regulatory requirements, and global supply chain uncertainty due to COVID-19. Regulatory requirements aim to ensure the safety and efficacy of medical devices. These include the FDA’s Case for Quality program and the European Union’s Medical Device Regulations (EU MDR). However, these regulations are a constraint on innovation and speed to market.
FDA’s quality manufacturing pillars
While quality inspections become more difficult, it is important to identify manufacturers who follow quality best practices. These manufacturers can help others raise their standards. The FDA has defined six quality manufacturing pillars to leverage:
- Traceability: Manufacturers can demonstrate traceability through their production process, suppliers and distribution of products.
- Control: Manufacturers can demonstrate a focus on establishing and improving control over their production, supply chain and product quality.
- Visibility: Manufacturers can demonstrate visibility in their data and metrics so relevant metrics are visible through all levels of management and staff.
- Analytics: Manufacturers can demonstrate effective use of metrics and advanced analytics capabilities.
- Safety: Manufacturers can demonstrate a high patient safety focus and responsiveness to issues and speed in identification.
- Prevention: Manufacturers can demonstrate a strong focus on proactive prevention and continuous improvement.
To compete in this industry today, medical manufacturers need the proper digital infrastructure foundation. This digital infrastructure for medical devices will support quality best practices and bring innovative devices to market. Implementing such a foundation can help accelerate innovation, reduce cost and achieve high-quality products while ensuring compliance. Siemens understands industry market needs and has created solutions that give companies the tools for operational excellence through smart manufacturing.
Learn more about how Siemens can help you bring medical devices to market quicker with operational excellence here.
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