Bringing novel medical devices to market has advanced healthcare significantly, but achieving this often requires a clinical trial. Launching a medical device without careful planning can lead to costly medical device mistakes. Clinical trials are a daunting undertaking prone to pitfalls. Factors like trial costs, poor design, or a misunderstanding of a regulatory pathway can cause failure for medical device startups. Startups must be aware of these challenges to avoid them as they advance into clinical trials. Working with a knowledgeable fractional contract research organization (CRO), like ActiVie, can be the difference between success and failure.
Common Clinical Trial Pitfalls and How They Can Delay Time to Market
Running a clinical trial is a resource-intensive feat often beyond a startup’s internal capabilities. Many pitfalls—such as design errors and unforeseen complications—can slow down the process, making it critical to be proactive. Knowing common pitfalls can help startups optimize resources and achieve faster market access.
- Firstly, it is important to consider the design of the trial. Trial design should support the regulatory strategy and optimize resources. If not, the trial can result in inconclusive results or poor quality, unusable data leading to a host of regulatory issues and a waste of resources the startup may not have had in the first place.
- Regulatory approval is required to run a clinical trial for a regulated device. However, clinical trial regulations are complex and often require expert knowledge to apply appropriately. Without the proper resources, startups may encounter regulatory non-compliance, failing to adhere to the strict regulatory guidelines, potentially resulting in a failed trial.
- A crucial and often overlooked component is patient recruitment and retention. Testing a medical device for its indication requires the appropriate human population who are willing to participate. However, it is easy to underestimate how challenging recruiting can be and how complicated strategies for retention and compliance can be.
- Lastly, clinical trials are often expensive. Small, early-stage startups often lack internal expertise and may underestimate the high costs of running a trial. This may lead to a faster burn rate than expected and require subsequent raises earlier than anticipated. Proper financial planning and transparent communication between startup leadership and funders are critical.
These are just a few common examples that we’ve seen. Each can lead to a delay in market entry for the device, forcing the medical device company to either redo work or extend timelines that were previously aggressive but necessary for funding milestones. They say the best defense is a good offense; one of the best decisions you can make to set yourself up for success is by working with a fractional CRO.
ActiVie’s Approach to Trial Success
ActiVie is a fractional CRO that uses a unique hybrid CRO model, providing essential CRO support to help startups navigate these pitfalls. The ActiVie team of experts is well-versed in clinical trials and offers services of full-scale clinical trial support. Their combined decades of experience enable them to design trials strategically, addressing challenges upfront rather than facing them as they come. ActiVie places emphasis first on patients, then on data quality and management. Understanding the importance of high-quality data to get the medical device on the market as fast as possible.
Conclusion
Overall, running a clinical trial is necessary but daunting and expensive. Numerous factors can derail a clinical trial and jeopardize a startup’s success. Every medical device entrepreneur wants to improve the lives of people. To set themselves up for success from the beginning, they can work with a fractional CRO like ActiVie to optimize resources while getting their technology to market quickly.