Clinicians assume diagnostic tests are accurate, reliable and clinically valid. IVD products require evidence that the test accurately takes a measurement and the risk of false or inaccurate results are acceptable for the intended use population. The tenets of risk assessment may be different for CLIA-waived, direct to consumer (DTC), and home use tests, companion diagnostics and precision medicine, as well as complex technology and software products. This risk analysis informs a clinical study that generates data to support commercialization of these novel IVD products.
Agenda topics include:
- Risk classification of an IVD based on the Intended Use (What) and the Target Population (Who)
- Which, when and why medical device regulations apply to an IVD product
- How Intended Use, Indications for Use, risk classification and regulations inform a clinical study for an IVD product development pathway
- Case Study analysis of an IVD manufacturer and how the assessment for a clinical study and its business strategy was derived from its risk assessment.
The webinar will include a Q&A session at the end of the presentation.
Wendy Schroeder, Global Manager, IVD Clinical, Biostatistics and Data Management Services, NAMSA
Wendy Schroeder has over 20 years of clinical trial experience in multiple therapeutic areas. She has managed clinical trial operations including site recruitment, resource planning and staff training and development. Wendy has a strong background in IVD research and has been a clinical source of truth for IVD/LDT business and regulatory strategy planning with Sponsor companies. She has biospecimen logistics experience in both research and CLIA certified laboratories and a strong reimbursement/billing background from her roles working in various hospitals and clinics prior to moving to the IVD industry. She has recent peer-reviewed journal publications on clinical trial billing, LDTs and NGS/personalized medicine. Wendy is a registered nurse by profession and received her BSN from Arizona State University. She is certified as a research coordinator and project manager by ACRP.
Divyaa Ravishankar, Global Product Marketing Manager, IVD Regulatory and Clinical Services, NAMSA
Divyaa Ravishankar has over 13 years’ experience in product management, market research and management consulting. In addition to authoring numerous reports in the area of in-vitro diagnostics, she has advised clients on market trends, implications, and strategies on diverse topics as next-generation technologies, end user and product/feature/pricing analysis, merger and acquisition target analysis, international market expansion strategies, detailed demand modeling, and competitive analysis.
Ms. Ravishankar earned her master’s degree in Biological Sciences from Birla Institute of Technology.