A20b. Building a Resilient Startup in the Diagnostic Device Market: Lessons Learned from Failures in Self-Test Devices
Tracks
GxP Principles
| Tuesday, June 3, 2025 |
| 4:30 PM - 5:30 PM |
| C2.4 |
Chair & Speakers
Chelsea Tooze
Global Director Of Quality & Regulatory
2San Pty
Building a resilient startup in the Diagnostic Device Market: Lessons learned from failures in Self-test Devices
Abstract
The self-test diagnostic device market has witnessed rapid growth, driven by increasing demand for accessible, at-home healthcare solutions. However, the journey for startups in this sector is fraught with challenges, particularly when it comes to developing devices that are both innovative and compliant with stringent regulatory standards. This informational presentation will explore key lessons learned from startups in the diagnostic device market, focusing on how they have overcome early failures to build resilient, successful businesses.
Starting a business in the diagnostic device industry requires navigating complex regulatory environments, maintaining high standards of product safety and accuracy, and addressing significant public health needs. Despite the promise of groundbreaking innovations, many startups face setbacks such as delays in product approvals, technical issues with device performance, and challenges in gaining market trust. These failures, while daunting, offer invaluable lessons for entrepreneurs seeking to succeed in the competitive self-test device market.
This session will highlight several key aspects of building a resilient startup, including the importance of learning from early failures—whether that be incorrect test results, regulatory challenges, or product recalls. By embracing failure as a learning opportunity, startups can refine their designs, improve quality control, and develop stronger relationships with healthcare professionals, regulatory bodies, and consumers.
The presentation will also address how startups can cultivate a culture of resilience, emphasizing the need for strong leadership, adaptability, and a willingness to pivot when initial ideas do not meet market needs. Real-world case studies will be shared, showcasing how startups turned initial failures into critical insights that shaped more successful and sustainable products.
Ultimately, this talk will provide delegates with practical strategies for navigating the complex regulatory landscape of diagnostic device development. By examining how failures in the early stages can lead to stronger regulatory practices and more reliable products, this session will help regulatory professionals understand the critical role they play in fostering resilience in startups and ensuring the market readiness of self-test devices.
Starting a business in the diagnostic device industry requires navigating complex regulatory environments, maintaining high standards of product safety and accuracy, and addressing significant public health needs. Despite the promise of groundbreaking innovations, many startups face setbacks such as delays in product approvals, technical issues with device performance, and challenges in gaining market trust. These failures, while daunting, offer invaluable lessons for entrepreneurs seeking to succeed in the competitive self-test device market.
This session will highlight several key aspects of building a resilient startup, including the importance of learning from early failures—whether that be incorrect test results, regulatory challenges, or product recalls. By embracing failure as a learning opportunity, startups can refine their designs, improve quality control, and develop stronger relationships with healthcare professionals, regulatory bodies, and consumers.
The presentation will also address how startups can cultivate a culture of resilience, emphasizing the need for strong leadership, adaptability, and a willingness to pivot when initial ideas do not meet market needs. Real-world case studies will be shared, showcasing how startups turned initial failures into critical insights that shaped more successful and sustainable products.
Ultimately, this talk will provide delegates with practical strategies for navigating the complex regulatory landscape of diagnostic device development. By examining how failures in the early stages can lead to stronger regulatory practices and more reliable products, this session will help regulatory professionals understand the critical role they play in fostering resilience in startups and ensuring the market readiness of self-test devices.
Biography
Chelsea Tooze is an accomplished Quality and Regulatory executive specializing in In Vitro Diagnostics (IVD) and Medical Devices, bringing a robust background in biomedical science and a deep commitment to healthcare innovation. She is passionate about fostering a culture of resilience within startups, emphasizing the importance of learning from early failures to build robust, market-ready products. Currently, she serves as the Director of Global Regulatory and Quality at 2San, where she drives regulatory strategy and quality management across global markets. Chelsea actively engages with prominent regulatory authorities including MHRA, TGA, and FDA, overseeing complex compliance frameworks and providing strategic leadership to international teams in the United Kingdom, United States, and Australia.
A trusted advisor for start-ups navigating the complexities of medical device development, Chelsea has also successfully guided diverse teams through significant certification processes such as ISO 9001:2015, ISO 13485:2016, MDSAP and the implementation of advanced electronic Quality Management Systems. She has demonstrated exceptional skill in managing risk and change management initiatives at corporate and system levels, enhancing organizational effectiveness and market readiness.
During the height of the global pandemic, Chelsea held the pivotal role of Deputy Director of Regulatory, Quality, and Compliance at the UK Health Security Agency. In this capacity, she led comprehensive regulatory and compliance strategies, ensuring the operational readiness and quality assurance of crucial diagnostic testing technologies for SARS-CoV-2. Her expertise significantly contributed to public health response efforts, positioning her as a thought leader in crisis management and regulatory excellence.
In addition to her corporate role, Chelsea is the Managing Director of Tooze Consulting Limited, where she provides strategic consulting services to emerging companies in the healthcare and medical device industries. Her consultancy focuses on guiding startups through the regulatory landscape, helping them transform early challenges into opportunities for growth and resilience.
Chelsea holds a Bachelor of Science in Biomedical Science with honors and has completed advanced training as an internal auditor for ISO 13485:2016, Medical Device Single Audit Program (MDSAP), and Good Distribution Practice (GDP). As an active member of the Regulatory Affairs Professionals Society (RAPS), British In Vitro Diagnostic Association (BIVDA), ARCS, and former BSI Committee Member for CH/212 (IVD’s), she contributes extensively to regulatory best practices and professional development. Chelsea's strategic insights, combined with her commitment to maintaining high ethical standards and quality assurance, make her an influential speaker ideally suited to address contemporary regulatory challenges and innovations at ARCS.
