Avoiding Common Pitfalls in Clinical Trials for Medical Device Startups

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…

Why Patient Recruitment Can Make or Break Your Clinical Trial

There are many factors that lead to clinical trial success. Patient recruitment is often overlooked but repeatedly shown to be essential to the success of a clinical trial. Lacking a solid recruitment strategy can lead to delays, incomplete data, and even potential failure. It is imperative for medical device…

The Benefits of Fractional CROs for Early-Stage MedTech Startups

Early-stage MedTech startups take on an enormous challenge if bringing their product to market requires clinical trials. Trials for regulatory approval often require significant resources and money. While traditional contract research organizations (CROs) are a common solution, for a young MedTech startup, a traditional CRO may be out of…

Regulatory Pathway Strategies for International Market Entry

For medical device startups, expanding internationally is a challenge that requires a team working hard every day to succeed. However, international regulations can be more complex to navigate. Each market has different requirements and an understanding of these requirements can bring success to market entry. Fractional contract research organizations,…

Accelerating Time-to-Market Without Compromising Quality

The world of medical technology is fast-paced and time-to-market can make or break a MedTech startup’s success. Speeding up product development while maintaining quality is crucial, especially when conducting clinical trials. ActiVie, a fractional contract research organization specializing in health technology, provides startups with the expertise needed to balance…

Why 75% of Medical Device Startups Fail – And How to Avoid It

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…

The Role of Fractional CROs in Reducing Clinical Trial Costs

For medical device startups tackling complex regulatory requirements, the path to FDA approval can be both costly and resource-intensive. While not all devices demand rigorous clinical trials, high-risk innovations often require clinical data to meet approval standards, adding pressure to already tight budgets. Partnering with a fractional contract research…

Building a Successful Regulatory Strategy from Day One

When developing a medical device, time is a critical factor. The industry of medical devices is fast-paced and complex. Many medical device startups underestimate the complexities of regulatory requirements. Crafting a strong regulatory strategy may significantly reduce the challenges that accompany clinical trial timelines and regulatory approval. ActiVie, and…