Early-stage orthopedic medical device companies face unique challenges: tight budgets, regulatory hurdles, and the pressure to deliver compelling data to secure funding. Medrio’s recent eBook, “Run a Nimble, Cost-Effective Trial In Any Industry Climate,” offers actionable strategies to tackle these issues. Here’s how to apply them to your orthopedic trial.
1. Focus on Must-Have Data
A lean data strategy is critical. Collect only the data regulators need to greenlight your device—skip the extras. Medrio notes that Phase I studies saw a 35% jump in variables from 2017 to 2023, despite fewer subjects, driving up costs and complexity. Align your team—data managers, statisticians, and orthopedic experts—early to define essentials. Standardize using tools like CDISC to keep it simple and compliant.
2. Design for Scalability
Your trial must adapt to shifting winds, like funding cuts or protocol tweaks. Don’t start from scratch each time—reuse templates for case report forms and study builds. This cuts setup time and eases scaling, whether you’re adding sites or adjusting endpoints. Pair this with quick, hands-on training to keep your team nimble, especially with orthopedic trials’ high turnover.
3. Use Smart Technology
Paper-based data collection is a relic that slows you down. Switch to tools like EDC for data management, ePRO for patient feedback, and RTSM for supply logistics. Medrio highlights that mid-study changes—common in Phase II/III trials—cost up to $8 billion annually. Flexible tech with validation environments (like Medrio’s) lets you test changes fast, avoiding costly do-overs.
4. Lean on Experts
You don’t need all expertise in-house. Partner with vendors who know orthopedic trials and can simplify regulatory mazes, study design, and database builds. Medrio’s Nicole Latimer emphasizes pragmatic partners who cut through complexity—a must when resources are thin.
Why It Matters
In orthopedics, where innovation races against funding realities, a cost-effective trial can make or break your path to market. Quality data, scalable processes, affordable tech, and expert guidance keep you agile. Dive into Medrio’s eBook for more—your next trial could be the one that changes the game.