How Early Should Clinical Trials Factor into Product Development?
Part one
Product development is a complex and multi-faceted process, especially within MedTech, Life Sciences and Lab & BioTech sectors, where clinical trials are essential for ensuring the safety and efficacy of the final product. However, what many organisations fail to realise is that the process of clinical trial planning should not be left until the final stages of product development. In fact, incorporating clinical trial planning early in your development is not only beneficial but necessary.
In part one of this two-part blog written with Micron Research – a Clinical Research Organisation delivering high-quality, on-time and cost-effective clinical research – we’ll dive into the importance of planning a robust product development roadmap, which incorporates user and product requirements, user workflows, risk management, and how these elements are interlinked with the clinical trial phase. We’ll then hand over to Micron Research who will look at clinical trial delivery and optimisation in part two, after which you should have a good understanding of the ‘concept to clinic’ process and the importance of early integration.
1. Defining Product and User Requirements
One of the first steps in product development is defining clear, comprehensive product requirements. These include technical specifications, intended use, user needs, and regulatory considerations. A key aspect of this is understanding what clinical trials will be required to validate the product. For example, if you’re developing a new medical device, you will need to understand the regulatory pathways, such as FDA approval or CE marking, and the clinical evidence required to meet those regulatory standards.
Designing your product with clinical trials in mind means thinking ahead about how it will be tested and used in a trial setting. It might require specific features, such as data logging for patient safety or ease of use for trial participants. If these considerations aren’t factored in from the beginning, you could end up with a product that’s difficult or impossible to test under the required trial conditions, leading to costly redesigns and subsequent delays.
2. User Workflows and Their Impact on Clinical Trials
User workflows play a significant role in shaping the success of both the product, its associated clinical trials and its subsequent clinical use. Whether you’re developing a medical device, surgical instrument or diagnostic test, it’s essential to map out how users will interact with the product in a clinical setting. This is not only the patient but also the clinician, nurses, technicians and anybody who interacts with the device.
For example, a drug delivery device might need to be utilised in a specific setting, and the workflow around this (such as dosage preparation, administration, monitoring, and data recording) needs to be carefully planned and tested. Similarly, a medical device might require specific handling, maintenance or cleaning during clinical use, which should form part of the user and product requirement specifications which are addressed in the product design phase. Early attention to user workflows ensures that your product is both practical and compliant with the rigorous demands of clinical trials. It also helps identify potential user errors or inefficiencies that could affect the trial outcomes and consequent product success.
We have previously written a blog about the importance of user workflow development, which is well worth a read.
3. Risk Management and Clinical Trial Integration
Risk management is something we, at eg, talk about on repeat, as effective risk management and mitigation is essential throughout the product development lifecycle. In the context of clinical trials, this includes identifying potential risks related to product design, user interactions, safety concerns, and regulatory requirements. Addressing these risks early will not only ensure a smoother trial process, preventing costly redesigns, but will maximise the overall likelihood of developing a more robust, safe and effective product that meets specifications and regulatory requirements.
Clinical trials are inherently risky, and not just in terms of participant safety—though that’s obviously the top priority. Clinical trial risks also include the potential for data integrity issues, recruitment challenges, and compliance concerns. Incorporating clinical trial requirements into your product development risk management plan allows you to anticipate these challenges and develop mitigation strategies from the very start. This might involve designing your product in a way that makes it easy to track patient data, ensuring that the product is safe for long-term use, or ensuring that it meets all necessary regulatory requirements for trials.
4. Iteration
Product development is never a straight line, and reaching the point where your product is ready for clinical trials is rarely achieved on the first attempt. This is why cycling through prototyping phases and iterative testing—throughout all phases of development—is vital for identifying issues early and resolving them before they become costly or insurmountable. This iterative approach ensures that design flaws, usability challenges, or clinical trial bottlenecks are caught and addressed before reaching the formal trial phase. Whether it’s through bench testing, simulated use studies, or pilot studies, iteration builds resilience and adaptability into your product and trial pathway.
Iterative feedback loops also help teams stay aligned with evolving user expectations, regulatory shifts, and real-world conditions that could affect trial performance. The goal is to fail early, fix fast, and move forward in a more informed manner, creating the best possible product.
5. Working with External Expertise
Alongside iteration, bringing in external expertise at key stages can dramatically accelerate your journey to market. Whether it’s a full end-to-end product development partner (such as eg technology), clinical trial specialist (such a Micron Research), a regulatory consultant, or a specialist in bespoke engineering disciplines (also eg!), the right external partner brings focused and leading edge expertise, proven frameworks, processes and systems, and an outside perspective that can de-risk your programme. They can challenge assumptions, uncover blind spots, and help you navigate complex regulatory and clinical landscapes with greater speed and confidence.
Working with expert partners is not a sign of weakness, it’s a strategic move that can actively accelerate your development timeline, whilst ensuring the final product meets the highest standards of safety, usability, and clinical value.
Conclusion
Incorporating future activities into the early stages of product development is not just about ticking off regulatory boxes. It’s about ensuring that your product is designed and developed with success in mind. By defining clear product requirements, considering user workflows, implementing a solid risk management strategy and taking an iterative approach, you set the foundation for the following phases, such as clinical trials, that will validate your product and bring it one step closer to market readiness.
In part two of this blog, written by Sonia Sutherland from Micron Research, we will explore the importance of understanding clinical trial requirements, optimising clinical trial design, regulatory consideration and compliance and incorporating post-market surveillance and closed-loop feedback into your product development pathway. You will get a thorough understanding of the necessity of integrating the clinical trial process early, and how expert consultancy can help streamline this complex aspect of development. Make sure you follow eg technology and Micron research on LinkedIn, and read part two here!
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