GxP Lifeline
EU to U.S. Market, Part 2: Strategic Audits for Expansion Into U.S. Medical Device Market
Medtech companies invested $24 billion in research and development in 2022, emphasizing the need for a strategic approach when expanding to the U.S. medical device market.1 This significant investment not only highlights financial stakes, but also the potential hurdles in accessing new markets. Navigating these challenges is crucial when aiming to deliver life-saving technology. Part 1 of our series focused on the key regulatory differences between the EU and U.S. markets. Part 2 focuses on three ways manufacturers can leverage audits for streamlined entry, avoiding costly mistakes, and taking advantage of this underused tool to ensure U.S. Food and Drug Administration (FDA) compliance.
1. Audits for Gap Assessment
Manufacturers can utilize internal audits to spotlight gaps between their current processes and FDA requirements. Instead of the traditional internal audit approach, a targeted gap assessment evaluates requirements line by line, pinpointing areas lacking FDA compliance. Employing digital quality management systems streamlines this process, allowing auditors to search for keywords and quickly assess compliance.
Some digital quality management systems also integrate internal audit management software, linking corrective actions to specific gaps. This integration enables managers to visually track the nonconformance status, ensuring adherence to crucial timelines and milestones. The gap assessment audit provides a holistic view on how your business processes contribute to quality within your organization. This enables decision-makers to effectively leverage digital quality management systems for identifying opportunities and strategically allocating resources.
Additionally, the gap assessment audit can identify opportunities to leverage existing processes and documentation. This can highlight areas where current processes align with submission requirements and ensure FDA compliance. For instance, documentation and quality management practices adhering to EU standards can often serve as a solid foundation that only requires minor adjustments to plug seamlessly into the corresponding U.S. regulatory documents.
2. Audits for Supply Chain Risk
Another strategic application of audits involves understanding the risks inherent in a supply chain, especially in a new U.S. market expansion. This audit evaluates the supply chain’s FDA compliance, ensuring a smoother transition into the U.S. market. Supplier audits target specific processes related to the quality of your product with a laser-focused approach to dig deep into critical components or device attributes.
If digital quality management software is used, the supplier management workflow may integrate with the internal audit management software to track suppliers, quality agreements, and supplier audits.
It is often more cost effective for a medtech company to outsource supply chain audits to certified third party auditors, particularly for startups. A risk-based approach ensures FDA compliance of critical suppliers, while the supplier’s internal auditors can manage less critical suppliers. Studies have shown that auditors who are more familiar with the supply chain provide a higher quality audit and lower audit fees.2 Supplier audits identify weaknesses in the supply chain as it relates to your product.
3. Audits for Verification
Medtech companies often already possess detailed knowledge of their process gaps and have corrective action/preventive action (CAPA) plans in place. However, to ensure unbiased FDA compliance, a verification audit may ensure effective CAPA closure.
Independent, external auditors can review all documentation associated with CAPAs, whether on paper or within internal audit management software. As an independent, unbiased outsider, these auditors can objectively determine the effectiveness of CAPAs and confirm the CAPAs were verified or validated prior to implementation. They can also ensure the CAPAs do not adversely affect the finished device.3
A verification audit can dig deeper into issues, identifying systemic problems. Complete FDA compliance should include an assessment of whether area staff were made aware of the CAPA, including area management at the point of use. The addition of the independent auditor provides a fresh perspective to review the corrective and preventive actions, which can highlight potential oversights.
Conclusion
While often considered a ‘dirty word' in the medtech industry, audits can be valuable tools when strategically utilized. In the context of U.S. market expansion, audits play a crucial role in achieving FDA compliance, shining a light on gaps between known requirements and current practices, evaluating the supply chain, and verifying corrective and preventive actions. Audits are great tools for identifying quality and business process efficiencies, saving time and money, as well as correcting critical issues. By employing audits strategically, medtech manufacturers can streamline their entry into the U.S. medical device market.
References
- Pulse of the Industry medical technology report 2023, www.ey.com.
- Johnstone KM, Li C, Luo S. Client-Auditor Supply Chain Relationships, Audit Quality, and Audit Pricing. AUDITING: A Journal of Practice & Theory. 2014;33(4):119-166. doi.
- Corrective and Preventive Actions (CAPA), U.S. Food and Drug Administration, Published 2023. Accessed February 27, 2024.
Becky Blankenship is a technical writer at Cannon Quality Group. She has a background in quality management at pharmaceutical and medical device manufacturing. She has a bachelor’s degree in chemistry from the University of Southern Mississippi. Prior to joining CQG, she worked for more than a decade as an auditor and technical writer.
