By providing valuable data that cannot be obtained from preclinical testing, first-in-human (FIH) and early feasibility studies (EFS) can expedite your product development and optimize your opportunities for bringing devices to market.

With specialized product development and clinical trial expertise that smaller companies often lack, we put your decision-making on the path to success. We have a track record of partnering effectively with clients to deliver product readiness via regulatory and clinical support throughout this challenging process.

We support your FIH and EFS programs by

  • Engaging early in product development (at the concept phase)
  • Supporting your design decisions with input on use scenarios
  • Refining device design or instructions to best align with user requirements
  • Designing studies to assess product performance, safety, and patient outcomes
  • Offering strategic guidance on study design
  • Supporting identification of skilled physicians and high-quality sites
  • Navigating regional regulatory requirements for clinical studies
  • Analyzing and presenting key data used to determine the next phases of product development

With Avania, you can expect

  • A team with deep experience conducting FIH trials globally
  • Recognized thought leaders in best practices for FIH and EFS investigational device exemption (IDE) trials
  • Seamless engagement as our team acts as an integral part of your team
  • Triage of key risks and opportunities to align across functions
  • Granular options for concurrent execution of program design, including product design, risk management, regulatory, and clinical development
  • Proactive, transparent review and decision-making
  • An unwavering focus on early patient experience, product iteration, and regulatory positioning

Your product is important, and it takes a team with first-in-human and early feasibility expertise to move it forward. It Takes Avania.

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