Your Partner in Connected Health

Digital innovation is transforming disease management and empowering patient engagements to monitor and improve their own health. With a track record of developing a broad range of medical devices, we understand your need to scale execution for connected health platforms which often have a non-significant risk profile. Our portfolio includes evaluating user experiences from both healthcare professional and potential patient perspectives, providing important insights into product design and implementation.

As nimble and flexible extensions of your team, we focus on how to best design, plan and execute studies that deliver credible human factors evidence. Robust design validation, usability, healthy volunteer and patient experience data enable you to navigate your technology through regulatory requirements and move toward a successful launch.

Ways that BBA can assist with digital innovation/connected health products

  • Determination of which products will be regulated, enforcement discretion exercised, or not regulated by FDA or other regulatory authorities, to help guide your marketing decisions.
  • Perform product design validation and testing to assess health care professional or user acceptance.
  • Refine device design or instructions to best align with user requirements.
  • Conduct studies to assess clinical concordance on decision making.
    In other words, did the product affect the decision that would have
    been reached without the product?

Ultimately, BBA’s goal is to partner with you to:

  • Deliver high quality health care solutions to enable safe and effective care
  • Demonstrate benefit of your product to deliver actionable data to
    healthcare systems to reduce costs while maintaining or improving the
    quality of care
  • Empower patients to maintain or improve their overall health

How will you experience BBA?

  • Seamless engagement as integral members of your team
  • Triage of key risks and opportunities to align across functions
  • Granular options for concurrent execution of program design including regulatory, clinical, and reimbursement elements
  • Agile, adaptive program management; accustomed to refinements in device attributes as part of wear and use studies
  • Unwavering focus on patient safety, data quality and credible evidence to catalyze approval and market access
  • Effective, transparent review and decision-making

BBA’s Connected Health Team offers expertise in:

● Product Design Readiness
● Regulatory strategy and execution
● Study design, planning and conduct

Let Us Help You Navigate the Course

We are delighted to have worked with a company like BBA that offered us the full spectrum of clinical and data management services, with an integrated approach to study design, data management, statistical analysis and report generation. BBA’s team of industry leading experts was committed to servicing our needs and delivered high-quality results.
— Barbara S. Lindsay, Vice President at Benvenue Medical, Inc.

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