In part one of this two-part article, we explored the foundational factors of market acceptance in healthcare, including the difference between iterative and novel innovation, value proposition, and the complexity of healthcare use cases. Now, we turn our focus to the challenges that often undermine the progress of health tech products as they move toward broader clinical use. Let’s dive in and see how we can overcome these barriers. This article will cover the common obstacles, such as usability issues, gaining stakeholder buy-in, and navigating reimbursement complexities, offering insights on how to overcome these barriers to achieve success in the healthcare market.
Focusing on user experience design
User experience (UX) design has a huge impact on the adoption and market acceptance of health technology, whether medical devices or digital health solutions. For medical devices, the FDA places a strong emphasis on usability to ensure products are both safe and user-friendly in clinical environments. Devices that are easy to use reduce training time, minimize errors, and enhance patient safety. The same concept applies to digital health technologies, such as mobile apps and telehealth platforms.
UX design is a key component in regulatory approval. The FDA’s approval process includes a review of usability studies to ensure that products are both functional and user-friendly. Companies that prioritize UX from the start can streamline their applications, facilitating faster clearance and access to the market. This is especially important in the rapidly changing digital health field, where user-centered design not only meets regulatory standards but also provides companies with a competitive edge in driving product acceptance and a wider use.
Aligning design outputs with clinical outcomes
The role of clinical teams in developing new medical solutions and devices goes beyond safety. It includes actionable insights based on real-world clinical use and discovery of the most effective applications of the technology. A critical challenge, however, is that clinical studies often focus on average outcomes, potentially overlooking the finer nuances in device performance across different patient types. Without a comprehensive analysis of the mechanisms that drive device effectiveness, product teams find it difficult to refine technology or translate clinical insights into useful product guidelines. This lack of tech insight not only impairs the process of device optimization but also limits the capacity of clinical and product teams to identify specific patient profiles for whom the device will be most beneficial or contraindicated.
In order to address these issues, clinical teams should include experts, such as anatomists or basic scientists, who can analyze data extremes rather than averages. Examining the “positive and negative deviants” enables teams to identify optimal use case scenarios, and situations where alternative treatments may be more appropriate. This focus on specific patient experiences also speaks to a broader goal: prioritizing treatments that can make a significant impact on patients with severe or life-disrupting conditions.
Building effective collaboration between clinical and product teams
The success of product adoption in healthtech relies heavily on the culture of collaboration between product and clinical teams.This collaboration must go beyond a simple exchange of feedback. It requires a shared understanding of the goals and challenges each team faces.
To facilitate this, both sides must engage in an ongoing dialogue, where feedback is carefully structured and actionable. As the product team works on new tools or workflows, they should continuously check back with clinical teams to ensure that the product is delivering the expected outcomes. At the same time, clinicians need to be proactive in communicating their needs and challenges in a format that the product team can use effectively to make improvements.
Although clinical studies often prioritize health outcomes, usability and workflow integration are equally important for clinical adoption. As the feedback process in health tech has many layers, product teams may use insights from sales representatives, apply comprehensive data collection methods (such as simulation labs, clinical consultations etc.), run surveys, or conduct formal human factors studies. Although questionnaires may provide a high-level procedure overview, the application of immersive observation techniques is the best method for uncovering deeper insights about specific healthcare workflows, as it allows not only observe clinicians in their natural environment but also validate product value proposition and spot potential application issues.
Gaining stakeholder buy-in
The next crucial step after establishing a clear product vision and user-centered design is to ensure that the product is championed by the right people. For health startup founders, particularly those with clinical backgrounds, sales is one of the most challenging jobs of bringing a product to market. The hardest part is often getting in front of the right decision-makers. But even with a well-crafted value proposition and proven clinical results, convincing an institution to invest in a new product can be an uphill battle. Selling to hospitals or large healthcare organizations is a complex process that involves multiple levels of decision-making. As one founder put it, “Everything is death by committee,” meaning that a single decision can require approval from numerous stakeholders, each with their own concerns and priorities. Success in this area requires not just a clear value proposition — such as saving time or reducing costs — but also resilience and the ability to navigate the complex hierarchy of healthcare institutions.
Overcoming reimbursement barriers
In the healthtech market the reimbursement landscape is complex, and requires a strong strategy. Achieving differentiation in this field can be based on clinical effectiveness or economic advantages, so analyzing the level and quality of evidence from covered competitor products can provide insight into the standards you will need to meet. Hospitals which often operate on fixed payment systems may be hesitant to adopt new products without a strong health benefits case. Another thing to consider, if your product is on the higher-cost end, a solid clinical advantage becomes crucial to justify its use.
The selection of the right predicate product for FDA clearance is also crucial. It is critical to pick a product with price and characteristics comparable to yours. This way you set a realistic payment precedent that aligns with your cost structure and product performance. Finally, when applying for a Q-prefixed HCPCS code from CMS, ensure your product is accurately described; misclassification can limit reimbursement opportunities and diminish perceived value.
Conclusion
To summarize, proven technology does not guarantee a successful product. Companies must prepare to effectively market their products, engage with the right stakeholders, and ensure that their solutions fit seamlessly into the clinical workflows and protocols. Successful adoption of a healthtech product requires a blend of clinical research, iterative feedback, strategic pricing, and strong partnerships.
Credit: Getty Images, pixelliebe
Yegor Tsynkevich is an award-winning product design expert, co-founding partner of 415Agency. He specializes in user-centric solutions for digital healthcare and medical technology companies. With a proven track record, Yegor has contributed as UX consultant to over 30 companies, enhancing product design for medical devices, electronic medical records (EMR) solutions, and clinical software.
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