When to implement a QMS guidance for MedTech startups

This video provides an in-depth exploration of Quality Management System (QMS) implementation, specifically tailored for MedTech startups. Axel Strombergsson, Vice President at Veeva Systems for their QuickVault product, and a seasoned veteran with over two decades in MedTech R&D and startup mentorship, guides viewers through the essential 'why, what, when, and how' of establishing a QMS. The presentation underscores the critical role of a QMS in achieving and maintaining regulatory compliance, ensuring product quality, and safeguarding patient safety, all vital for successful commercialization in the highly regulated medical device industry.

Strombergsson begins by establishing the fundamental 'why' behind a QMS, illustrating the stark difference in regulatory requirements between a consumer product and a medical device like a surgical scalpel. He highlights key regulations such as the FDA's 21 CFR Part 820 (Quality System Regulation) and the European Union Medical Device Regulation (EU MDR), explaining how these frameworks mandate a structured approach to business operations. The video then maps out the entire product journey from idea to commercialization, categorizing it into pre-commercial (design, development, testing, regulatory submission) and post-commercial (manufacturing, launch, post-market surveillance) stages, emphasizing that regulations apply comprehensively across all phases. The 'what' of a QMS is broken down into three core pillars: the QMS documentation itself (policies, SOPs, work instructions), Electronic Quality Management System (EQMS) software, and the crucial element of knowledge and training. He stresses that while templated QMS packages exist, they must be meticulously customized to align with a company's unique business processes and technology to ensure genuine compliance.

The discussion transitions to the crucial 'when' to implement a QMS, pinpointing the "point of design selection" or "design freeze" as the critical juncture. This marks the formal shift from the research (R) phase to the development (D) phase of R&D, where design controls (FDA 21 CFR Part 820.30 and ISO 1345) become mandatory. Strombergsson advises MedTech startups to implement their QMS approximately 3 to 6 months before reaching this point, to ensure all subsequent data collection and development activities for regulatory submissions are conducted under proper control, thereby avoiding costly re-dos. For the 'how,' he proposes a pragmatic "two-stage rocket" approach: initially implementing only the pre-commercial QMS elements necessary for regulatory submission, and then building out the post-commercial elements (e.g., customer complaints, post-market surveillance) closer to market launch, ideally at least 6 months prior to expected regulatory clearance.

The latter part of the presentation offers strategic guidance on EQMS selection, providing a unique perspective through the lens of potential acquisitions. Strombergsson cautions that a disorganized or non-compliant QMS can be a significant deterrent during acquisition due diligence, potentially derailing a deal. He encourages startups to choose a stable, reliable, and innovative EQMS provider that demonstrates a deep understanding of the evolving MedTech regulatory landscape. He then introduces Veeva Systems, a prominent player in life sciences, noting its extensive customer base including 19 out of the top 20 largest MedTech companies, and details the capabilities of their QuickVault EQMS product. The video concludes by highlighting the "QuickStart" package, a collaborative offering with Rook Quality Systems, designed to provide startups with essential QMS documentation, QuickVault access, and expert consulting support, addressing a comprehensive need for early-stage companies.

Key Takeaways:

• QMS is Foundational for MedTech: A robust Quality Management System is not optional but a mandatory framework for MedTech startups, driven by regulations like FDA 21 CFR Part 820 and EU MDR, to ensure medical devices are consistently safe and effective.
• Regulations Span the Entire Product Lifecycle: From initial concept and R&D to manufacturing, commercial launch, and post-market surveillance, regulatory requirements apply at every stage, making a comprehensive QMS an ongoing necessity.
• Three Pillars of Compliance: Effective compliance relies on well-defined QMS documentation (SOPs, policies), an efficient Electronic Quality Management System (EQMS) software, and continuous training and knowledge acquisition for the team.
• Customize QMS Documentation: While pre-built QMS documentation packages offer a strong starting point (e.g., Veeva's 53 documents), it's crucial to tailor approximately 10-20% of these procedures to accurately reflect your company's specific operations and product technology, as generic procedures can lead to non-compliance.
• EQMS Software Streamlines Operations: Modern cloud-based EQMS solutions automate critical regulatory processes (e.g., design controls, risk management), provide secure, auditable repositories for all product data, and facilitate FDA 21 CFR Part 11 compliant electronic signatures, significantly enhancing efficiency and security.
• Strategic Timing for QMS Implementation: The QMS must be formally in place at or before the "point of design selection" or "design freeze," which signifies the transition from the research phase to formal device development, as this is when strict design controls become applicable.
• Implement QMS 3-6 Months Before Formal Development: To avoid costly rework and ensure data integrity for regulatory submissions, it's recommended to establish the QMS 3-6 months prior to initiating formal device development and data gathering activities (e.g., animal studies, clinical trials).
• Phased QMS Implementation for Startups: A "two-stage rocket" approach is beneficial for smaller teams: first, implement pre-commercial QMS elements for design and development leading to regulatory submission; second, build out post-commercial elements (e.g., customer complaints, post-market surveillance) at least 6 months before expected market clearance.
• EQMS Selection Impacts Future Acquisitions: When choosing an EQMS, prioritize the provider's stability, reliability, and innovation, as a well-managed QMS is a critical asset during acquisition due diligence, while a poorly managed one can be a deal-breaker.
• Long-Term EQMS Strategy: Consider how the EQMS will scale with your company's growth beyond initial regulatory clearance, supporting ongoing commercial operations, post-market responsibilities, and future product iterations.
• Invest in Expertise and Mentorship: First-time founders should actively engage with accelerators, mentors, and industry communities to gain QMS knowledge. Hiring experienced personnel, even at a premium, can significantly elevate the entire team's understanding and execution of regulatory compliance.
• Budget for QMS Support: Allocate specific funds in your fundraising proforma for EQMS subscriptions and ongoing part-time consulting support from quality assurance and regulatory affairs experts to ensure continuous compliance and effective QMS management.
• Veeva QuickVault for MedTech: Veeva QuickVault is presented as a comprehensive EQMS solution offering document control, change management, quality events, training management, design controls, risk management, and supplier management, widely adopted by large MedTech companies.
• Veeva QuickStart Package: This bundled offering, in partnership with Rook Quality Systems, provides MedTech startups with essential QMS documentation, access to QuickVault (for up to three users), and five hours of expert consulting support per month for regulatory strategy or submission assistance, priced at $1,250/month with a 12-month minimum commitment.

Tools/Resources Mentioned:

• Veeva Systems: A large, publicly traded company providing cloud-based software solutions for the life sciences industry.
• Veeva QuickVault: An Electronic Quality Management System (EQMS) product by Veeva Systems, designed to manage quality processes for MedTech companies.
• Rook Quality Systems: A company specializing in quality assurance and regulatory affairs services for the MedTech industry, partnering with Veeva for the QuickStart package.
• Veeva QuickStart Package: A bundled offering for startups that includes QMS documentation, QuickVault access, and expert consulting support from Rook Quality Systems.
• InnovatorMD: The channel hosting the masterclass, dedicated to showcasing physician innovators and fostering healthcare innovation.
• LinkedIn: Recommended for networking and connecting with mentors.
• Veeva Website (Resources section): Contains a blog post on strategic EQMS selection and a video podcast for the MedTech startup ecosystem.

Key Concepts:

• Quality Management System (QMS): A structured system of processes, procedures, and responsibilities to ensure product quality, safety, and regulatory compliance, particularly critical in the medical device industry.
• Electronic Quality Management System (EQMS): Software that automates and manages QMS processes, offering features like document control, electronic signatures, and quality event management, crucial for efficiency and compliance.
• FDA 21 CFR Part 820 (Quality System Regulation): U.S. Food and Drug Administration regulations outlining the requirements for quality systems for medical device manufacturers.
• EU Medical Device Regulation (EU MDR): The European Union's regulatory framework for medical devices, ensuring their safety and performance.
• ISO 1345: An international standard specifying requirements for a comprehensive quality management system for the design and manufacture of medical devices.
• Design Controls (21 CFR Part 820.30): Specific FDA regulations governing the design and development process of medical devices to ensure they meet user needs and intended uses.
• 21 CFR Part 11: FDA regulations concerning electronic records and electronic signatures, ensuring their reliability, integrity, and equivalence to paper records.
• Design Selection / Design Freeze: A critical milestone in product development where the device design is finalized, and formal development activities under regulatory control commence.
• Pre-commercial Stage: The phase of a medical device's lifecycle encompassing research, design, development, testing, and preparation for regulatory submission.
• Post-commercial Stage: The phase following regulatory approval, involving manufacturing, market launch, distribution, post-market surveillance, and managing customer feedback and complaints.