Struggling to incorporate clinical trial teams' feedback into your bioengineering prototypes?

Start by designing a detailed data collection plan that specifies the types of data needed and the methodologies for obtaining them, such as surveys, interviews, direct observations, and electronic health records. Utilize advanced technologies like mobile apps and electronic data capture systems to facilitate real-time data collection and minimize errors. Engage the clinical trial team through regular communication, training, and clear protocols to ensure consistent and thorough data recording. Additionally, implement rigorous data validation processes and regularly review the data for completeness and accuracy.

Organize and categorize feedback from clinical trial teams to prioritize changes based on usability, efficacy, and safety. A comprehensive understanding of the feedback helps in making informed decisions, ensuring that the most critical issues are addressed first in your bioengineering prototypes.

We can learn a lot from the tech industry the likes of the Amazons and Apples and Googles of the world. What they do before any big project is pre-mortem analysis where they try to gather "what may go wrong" and prevent them from achieving the final goal. This helps everyone to get on the same goal, define milestones and gather action plan on how to optimize the chances of making the trial more successful. It's critical though to collect insights not just from the clinical trial team but different stakeholders like vendors, investigators, regulators, and patients.

Analyze feedback critically to identify patterns and recurring issues that indicate fundamental design flaws. Differentiating between one-off comments and systemic problems helps prioritize necessary modifications for the prototype's next iteration.

Start with Why, what are you trying to achieve with this trial and then identify the feedback critical to achieving your goals. It's essential to have a Northstar metric that should unite the team before, during and after the trial.

You must incorporate direct feedback from end users and conduct usability studies to understand their challenges with the current design. Ensure that all revisions comply with regulatory requirements and are documented meticulously to maintain compliance. Perform risk assessments to address any new risks and validate technical feasibility through prototyping and testing. Consider the impact on ongoing trials, ensuring data consistency and a smooth transition to the revised design. Collaborate with a multidisciplinary team for diverse perspectives and maintain detailed documentation of all changes.

Focus on critical feedback to redesign your prototype, ensuring functionality while addressing user needs. Prioritize feasible revisions that maintain the prototype's integrity and align with your product's goals.

45% of clinical trials end up with at least 1 substantial amendment. And each amendment can cost the trial hundreds of thousands and weeks and months of additional money and time. It's worth going into every single detail of the design and trying to prevent the need for such amendment. Sometimes the way to achieve that is by collecting feedback but also backing it up with regulatory insights and historical trial information of already approved trials.

Comprehensive testing helps verify that the modifications enhance the prototype’s performance, safety, and usability, meeting both clinical and regulatory standards. Rigorous testing also minimizes the risk of unforeseen complications, ensuring that the product is reliable and effective in real-world applications. Additionally, thorough testing builds confidence among stakeholders, including regulatory bodies, healthcare professionals, and end-users, by demonstrating a commitment to quality and safety. Ultimately, it leads to a more robust and dependable product, increasing the likelihood of successful implementation and adoption in clinical settings.

Thoroughly test design revisions under conditions similar to initial trials to ensure issues are resolved. Monitor new issues that may arise, and be prepared to iterate further if necessary.

You can stress-test your design with KOLs and patient advocates as a start but make sure you consider country-specific differences in the way patients are treated (their local standard of care).

The story of NASA managing to go to the Moon is a great example of how close collaboration is critical. But the essence of this story is to make sure no matter how big or small a team you deal with, you have a clear communication and information flow so that everyone is on the same page.