LANDRICH GROUP
Clinical Trial Management and Regulatory Strategy for Consumer Diagnostics
In part 1 of our series on consumer diagnostics, we reviewed the secular trends driving growth in this sector of IVD product diagnostics and clinical trials in the coming decade. This second part of our series focuses on key considerations for trial management and regulatory affairs.
In a Boston courtroom last month, the former CEO and two high-ranking executives of the IVD firm Magellan Diagnostics pleaded guilty to criminal charges with the possibility of up to three years in prison. The executives were charged with fraud and negligence, failing to disclose that their company’s lead-testing devices produced inaccurately low results in tens of thousands of patients.
A decade ago, Magellan’s LeadCare fingerstick product line accounted for more than half of all blood lead tests conducted in the United States. By hiding the device malfunction, a U.S. attorney contends the company endangered the lives of thousands of patients, including children and pregnant women who are most at risk from lead poisoning.
Magellan offers a cautionary tale of failure to adequately plan and disclose diagnostics trials. During FDA clearance studies in 2012, Magellan discovered it produced falsely low blood lead level results due to a sensor malfunction. The company failed to notify the agency and released the product to the public in 2013. When customers reported inaccurate results a year later, the company failed to submit a Medical Device Report to the FDA. When Magellan finally did report the defect in 2017, the company falsely claimed the malfunction was discovered from post-market customer complaints, hiding the discovery during the initial clinical trial.
A wide array of diagnostics entering the mass market hold the promise to radically improve public health at a global scale. However, the very urgency of the opportunity and the potential to impact billions of lives means that device makers need to be more pro-active than ever before in ensuring the safety and efficacy of their products.
IVD manufacturers must consider their product roadmap with clear and intentional strategies for clinical trial management and regulatory affairs. They must aggressively manage risks associated with mass market products, particularly in domains with novel %technologies and breakthrough enhancements. This approach applies to the diverse field of firms now working in the consumer diagnostics sector, including traditional medical device manufacturers like Abbott as well as consumer electronics firms such as Apple, Google, Nvidia and Meta.
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A product that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.
Manufacturers work with the FDA to manage oversight of the devices in the US. Inn the European Union, the European Medicines Agency (EMA) oversees regulation via the Conformité Européenne (CE) Mark. Other organizations that oversee regulations in other countries include Health Canada and the Pharmaceuticals and Medical-grade Devices Agency (PMDA) in Japan.
Trial Management Options
Because they are typically designed for usage by regular people in an everyday setting, consumer diagnostic products are ideally suited for adaptive, decentralized trial techniques. Such trials often use real-world data (RWD) to reduce costs and increase patient diversity. Software tools incorporating machine learning and AI can optimize tasks such as patient recruitment and retention by identifying participants to maximize trial goals and predict dropout risk for preemptive intervention.
When it comes to endpoint selection, consumer diagnostics firms should focus on patient-centric outcomes. A commonly cited example of this is the various international RWD trials that collectively demonstrated the Abbott FreeStyle Libre’s contribution to improved glucose management among a global population sample. It’s also critical to get validation that endpoints are aligned with regulatory expectations for safety, efficacy, sensitivity and specificity. Resources such as the SEED program by the National Institutes of Health provide clarity for approval in the US market.
Data Management Essentials
Consumer and at home devices pose a range of the key data management choices. For diagnostics enabled via smart phones and wearables, the first step is to be pro-active and transparent in assessing any limitations. The validity of biomarkers can vary greatly based on phone device model, sensor technology, the condition being measured and even individual traits of the device users. Heart Rate Variability is one example of a biomarker enabled by different methods based on smart phone make and model.
Regulatory Engagement
The Magellan case underscores the risks of failing to align with regulatory agencies in a pro-active and transparent manner. It’s also critical to follow design controls and post-market surveillance required by the FDA Quality System Regulation in Code for Regulations 21 Part 820.
In another example of what to avoid, Abbott’s 2019 defibrillator product was recalled due to a manufacturing defect where some aluminum wires in the device were not fully insulated. This created a risk of electrical shorting during the delivery of therapy to a patient. The defect is another example of failing to adhere to basic quality guidelines that could have catastrophic outcomes for high utilization in the general population. Abbott’s failure to adhere to QSR requirements mandated by the FDA resulted in a costly, embarrassing recall that sullied the firm’s reputation for patient safety.
In addition to standard quality monitoring, consumer diagnostics manufacturers must also prioritize special standards for patient safety in uncontrolled environments with no clinical supervision. The standard IEC 60601-1-11 is used to test home health care medical equipment with testing that includes drops, shocks, vibration and electrical hazards in homes with unreliable grounding and voltage fluctuations.
Despite the megatrends that will enable phenomenal benefits in consumer diagnostics, the examples of Magellan and Abbott highlight the peril for IVD product development teams that fail to plan, communicate and monitor during clinical trials and regulatory engagement. Innovators in this space have a spectacular opportunity to improve the world and create lucrative global market opportunities. They also have a solemn responsibility to adhere to best practices in safety and efficacy for regulatory partners and their customer base.
Questions on strategy? Landrich Group is a leader in clinical trial management and regulatory affairs for product development in the consumer diagnostic space. Let's connect and discuss they key factors in delivering innovative new devices to market.
