The medical technology and clinical research industry is fast-growing, innovative, yet notoriously challenging. About 75% of medical device startups fail before reaching the market. This can be because of common challenges associated with bringing new medical technologies to market. It is critical to understand these challenges and take proactive steps to overcome them.
Risk of Failure
The medical device industry is a high-risk, high-reward industry that contributes greatly to the high failure rate many MedTech startups experience. Many of these startups fail to make it past regulatory approval hurdles. With enormous financial stakes and a growing need for specialized expertise, the challenges are formidable. Here are some common causes of failure for startups.
- Funding Challenges: Many startups underestimate the full financial costs of bringing a medical device to market. Without enough money to fund the steps required to put a medical device on the market, startups increase their chances of failure.
- Costly and Complicated Clinical Trials: Clinical trials are often required for market entry.. Poorly designed trials can lead to invalid or low-quality results, which may delay market entry and ultimately lead to failure.
- Lack of In-House Expertise: Many startups lack the resources to employ in-house expertise in all required areas like Clinical and Regulatory Affairs. These experts provide the guidance necessary to overcome the complex challenges of clinical trials and medical device development. Without access to skilled professionals, startups are often left “winging it,” which increases their likelihood of failure.
- Regulatory Hurdles: Startups face complicated regulatory hurdles, such as obtaining FDA approval—a process that demands current industry knowledge and expertise. Lengthy approval processes further delay market entry, increasing the risk of failure if not planned for adequately.
Partnering with ActiVie to Overcome These Challenges
Working with a fractional CRO like ActiVie offers a solution to these challenges. ActiVie is a team of clinical research experts that offer cost-effective, flexible, and innovative solutions to the most intricate challenges startups face in bringing devices to market. ActiVie uses a hybrid CRO model that remains scalable to adapt to each project’s needs.
With ActiVie, startups gain access to regulatory expertise that can mitigate market delays. Their services range from full clinical trial support to a la carte data management, documentation, data analysis, and reporting. Startups retain control of their projects while ActiVie handles the complex clinical trial processes in a budget-friendly manner.
Conclusion
For MedTech startups, the journey to market is complex and high-stakes. Understanding common pitfalls and knowing where challenges lie can greatly increase their chances of success. One of the ultimate solutions is working with a hybrid fractional CRO like ActiVie, which offers a strategy that optimizes resources, minimizes risk, and supports a smoother path to market.
Ready to bring your medical device to market? Contact ActiVie to learn more about how their hybrid CRO model can help you overcome challenges and position your device for success.