Balancing Innovation and Risk in Healthtech

When it comes to adoption of new technologies, healthcare professionals are conservative. And for good reason. They constantly make high-stakes decisions in a setting where risk management and consistency are critical. Even when innovations promise to increase efficiency or patient outcomes, the challenges of change, technological complexity and potential workflow disruptions often outweigh the perceived benefits. This article explores ways to balance innovation and risk in order to create and implement healthtech solutions that seamlessly integrate into the high-stakes world of healthcare delivery.

Practical impact over technical details

The adoption process requires balancing the promise of improved clinical outcomes against the operational realities of healthcare delivery. Innovative healthcare technologies may demonstrate clinical benefits in controlled settings, but their true value is determined by how well they fit into the existing healthcare workflows.

Very often products that show clear clinical benefits, such as reducing surgical errors or speeding recovery time, face barriers to adoption when they disrupt routine processes or require significant healthcare workflow adjustments. For instance, a device designed to automatically count surgical sponges at the end of a procedure addresses a critical issue, but it is often underused because it requires surgeons and staff to change long-standing practices. In this case the product owner has to clearly understand the procedure flow and fine-tune the product to seamlessly integrate it into existing protocol, without the need for substantial training or process alteration. When communicating with clinicians, especially surgeons, their first concern will not be the underlying technology, algorithms or applied data models. They will focus on understanding how a tool will affect their workflow and impact their clinical practice. They are looking for practical answers to questions like, “How will this change the way I perform surgery?” or “How will this improve patient outcomes?” For clinicians, the real value of technology lies in its ability to support clinical decision-making without adding complexity. 

Despite the fact that the decision to purchase or adopt a tool might rest with the CMO or procurement teams, clinicians are the ones who will ultimately use the product. They need to become your main product champions, a feedback source to help you shape the product. If the tool’s benefits are not immediately clear to them, there is a risk they may use it only when required and revert to familiar methods when not closely monitored. The key challenge is ensuring that feedback from clinicians is effectively translated into product designs that meet their operational needs, fostering adoption and consistent use.

Regulatory risk management 

Regulatory approval can be a significant barrier to novel healthcare technologies. One strategy to overcome it is to carefully execute regulatory pathway planning. Although the FDA’s review processes are rigorous, they are also critical in establishing trust with clinicians and healthcare systems. For many medical products FDA approval, whether through the PMA (Pre-market Approval), de novo, or breakthrough device designations, is critical for both credibility and market acceptance. Approval signals that the product has met safety and efficacy standards, providing a sense of security for those who will use it in a clinical setting. Let’s take the De Novo classification as an example. Companies can leverage the De Novo classification process in cases when no existing device serves as a predicate for a new technology. This process allows startups to get approval for novel products and at the same time manage the risks of market entry by ensuring that the device is correctly categorized for its intended use. Apart from the approval process companies also need to consider the post-market surveillance requirements to avoid compliance risks.

Reducing risk through user experience

In the context of healthcare innovation, poor UX is a major factor that can increase both the perceived and actual risks of new technology. A tool that requires additional training or introduces new steps into a well-established process is likely to meet resistance.

One of the most effective ways to mitigate this risk is through intuitive product design.

The User-Centered Risk Analysis (URRA), Human Factors Engineering (HFE), and UX design are critical components of healthtech risk management. Integrating these methodologies into the design and development process improves usability and ensures that products are safe to use and efficient in real-world contexts.

A tailored Use-Related Risk Analysis (URRA) is an essential step in medical device design and development. Depending on nuances, complexity and development stage of the product, the application of a granular URRA process plays an important step in detecting and managing potential hazards associated with user-device interactions and assessing their impact on product performance and safety. The application of this analysis allows  product teams to pinpoint subtle risks that may not be evident in a high-level analysis and ensure that every potential user error is addressed and safety measures are integrated into the device early on.

Human Factors Engineering (HFE) complements the URRA. It centers around understanding how user-related factors affect device usage and applies studies about human behavior, abilities, limitations, and other characteristics of medical device users to improve design safety and usability. The key focus of HF is risk management to eliminate incidents related to device misuse, complexity and to ensure a safer, more efficient and intuitive device interactions through user-centered design, summative validation studies, formative evaluations. Product teams may apply HF techniques, such as task analysis, to evaluate how clinicians interact with a device throughout a procedure, break down procedure flow into its component steps, determine critical points where performance may alter, or challenging parts where the interface could be simplified to prevent errors. The application of the HFE helps to align the product with real-world use, and make it safer and more effective for end-users.

UX design is integral to both URRA and Human Factors Engineering. It bridges the gap between technical design and user needs and focuses on mechanisms behind user-device interactions. UX design takes into account user needs, behaviors, perceptions, conditions, and translates them into product design that is usable, intuitive, functional. A key strength of UX design is its emphasis on iterative testing. Through formative usability studies product and design teams can identify potential risks and usability issues early, and make design adjustments before the product is released. This iterative process helps to avoid costly design flaws and guarantees that products are both user-friendly and compliant with regulatory standards. Further post-market feedback allows developers to adapt products to emerging risks and to ensure product safety and effectiveness long after the release.

Conclusion

While new technologies may demonstrate clinical benefits in controlled settings, their true value is determined by how well they fit into existing healthcare workflows. By aligning product development with clinician feedback, operational needs, and regulatory standards, healthtech innovators can close the gap between promise and real-life application and keep risks associated with innovation to a minimum.

Photo: erhui1979, Getty Images

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