Medical Devices Development Services

IDSC offers its medical device clients preclinical and clinical development consulting services in the areas of strategic planning, regulatory compliance, clinical development, and market assessment.  A key component of the development process for a medical device is navigating through the regulatory path, and many of our clients come to IDSC to guide them through that path and help them to with their regulatory strategy.

 

Many of IDSC's services in the medical device area, both eluting and non-eluting, are listed under the headings below.  However, in addition to specific consulting services around regulatory & clinical strategy and market assessment, our clients come to us for the following key steps in their development process:

 

  • Draft a program review
  • Draft a gap analysis
  • Draft a preclinical and/or clinical development plan

Regulatory Compliance

IDSC's medical device clients come to us for regulatory support.  We help them:

 

  • Optimize their regulatory strategy
  • Ensure their program activities and goals are aligned with their regulatory strategy
  • Prepare the appropriate regulatory documentation
  • Create and deliver their regulatory submissions
  • Prepare for meetings with regulatory agencies

Clinical Development

 

IDSC's experienced Clinical Development Directors help our clients to:

 

  • Establish and manage clinical advisory board
  • Identify and utilize KOLs
  • Determine the clinical pathway to registration
  • Design their clinical protocols
  • Ensure nonclinical studies & other activities align with their clinical plan & regulatory requirements
  • Manage their clinical program and trial execution

Strategic Planning

Our directors have years of experience in strategic planning, and in the area of medical devices, we help our  clients by:

 

  • Guiding the development of the company strategy:
    • Establish a business plan integrated across R&D, manufacturing and clinical lines
    • Set and track company goals, timelines, budgets, and milestones
    • Generate an exit strategy
  • Identifying and overseeing external vendors

Market Assessment

Our clients come to us for a number of market assessment, due diligence, and valuation services including:

 

  • Evaluate client asset
  • Determine market size and potential market penetration
  • Gather competitive intelligence
  • Position client to manage negotiations with investors/ partners in order to receive highest value for their asset
  • Performing product valuations are not just in the domain of "big-pharma"
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