Training in human factors and usability engineering for medical devices

Sensocure, a Norwegian medical technology company established in 2011, has set itself the goal of commercialising IscAlertTM, a novel miniaturised implantable sensor designed for continuously monitor pCO2 (arterial blood carbon dioxide) and enable the earliest possible detection of ischemia. Their vision is to become a market-leading provider of systems and sensors for major life-threatening disease groups, including cancer, cardiovascular diseases and infectious diseases.

In pursuit of FDA (Food and Drug Administration) approval, Sensocure aimed to submit a 510(k) application, a premarket submission made to FDA to demonstrate that the device to be marketed is safe and effective, and has reached a critical stage where human factors validation needed to be outlined and executed. Human factors validation testing stands out as one of the most costly tests mandated by regulatory authorities. Approximately 90% of the usability tests submitted is rejected the first time around, often due to a lack of understanding of the human factors process. 

Despite collaboration with regulatory service providers, Sensocure faced numerous unresolved questions. Recognising the importance of building internal competence and gaining confidence in their path forward, they turned to the Norway Health Tech cluster, member of Nemonoor, for assistance.

Sensocure's highly skilled team, comprising the Head of Development, Project Manager, Product Specialists, and Regulatory Affairs Specialist, participated in the training service provided. Discussions centred around Human Factors Validation testing, encompassing a thorough revision of the Instruction for Use and the Use-Related Risk Analysis, as well as exploration of submission pathways and other technical documentations. 

Towards the conclusion of the service, Sensocure shared their insights and experiences  at a workshop titled "Visualizing Devices of the Future: Human Factors Requirements & Market Insights" hosted at Oslo Science Park.

The human factors engineering (HFE) and usability engineering (UE) to Medical Devices Training, provided by Nemonoor, is a 4-step service to equip companies with the essential knowledge and competence required to prepare for Human Factors Validation (HFV) studies/HFE report. Once the SMEs understand the requirements for creating a comprehensive HFE/UE report, they will gain the confidence to lead their team through the HFE preparation process and collaborate more effectively with consultants. 

• Step 1 – Mapping: To evaluate the company's readiness, target market(s), the device, and the organization's knowledge and expertise in human factors and usability.

• Step 2 – Understanding Requirements and Guidance Documents: To strengthen company’s understanding of the vital components required for conducting the HFV testing and creating an effective HFE/UE report.

• Step 3 – HFV study: To assist the company in understanding the essential tasks and creating effective documentation for the HFV study.

• Step 4 – Managing HFE preparation process: After completing this step, the SME should have acquired sufficient knowledge to oversee the preparation of technical documentation for the HFV study and HFE report and collaborate more effectively with consultants.

SMEs are vital to the economy and play a pivotal role in enabling our societies to adapt to transformations such as technological advancements, demographic shifts and environmental changes. To maintain competitiveness, SMEs must secure access to skilled talent by attracting and retaining qualified workers and by providing opportunities for upskilling or reskilling. Skilled teams are crucial for firms' competitiveness in a knowledge-based economy, presenting a distinct challenge for SMEs compared to larger corporations. Moreover, knowledge should not be confined to regulatory specialists alone. Additionally, executives stress that regulatory knowledge should extend beyond specialists, with leaders taking responsibility for compliance.

The team now possesses a comprehensive understanding of the usability requirements to introduce their solutions to key global markets. This enhances the creation of technical documentation, encompassing testing (formative and summative evaluations), specific submission pathway requirements, and communication with regulators. Collectively, these improvements reduce costs and optimise the time required to enter new markets.

By gaining insight into the regulatory requirements for the US market, the company can now identify specific changes related to product development, particularly concerning technical documentation and the importance of assessing end-user interactions with their solutions in a safe and effective manner.

This signifies a service backed by a high-competence consortium and network with the credibility to support such deliveries.