Nicole Ferko
General Manager, Value and Evidence
Expertise:
Nicole directs U.S. and global projects to support multi-stakeholder medical device adoption and reimbursement. Nicole has more than 20 years of experience in health economics and research methods within academic, industry, and consulting roles. With her teams, she has successfully completed a wide range of project types including hospital value analysis briefs, market research surveys, economic sales tools, network meta-analyses, Delphi panels, and FDA clinical trial analyses. Nicole has co-authored more than 100 peer-reviewed publications including a book reflecting her area of expertise, entitled: The Science of Commerce: Succeeding in a Changed Medical Device Market. She has a broad therapeutic knowledge-base, having worked across several disease areas for biotechnology, pharmaceutical, and medical device products, including numerous medical device product types.
Nicole’s academic training includes a BSc in Biology and Pharmacology and an MSc in Health Research Methods, both from McMaster University.
Articles by Nicole Ferko
Evidence Hierarchies, PICO Coverage and Real-World Data: Emerging Insights from Early JCAs
As Europe shifts to a PICO-centric model, redefining your Real-World Data (RWD) strategy is no longer optional. It’s essential for market access. The landscape of European Health Technology Assessment (HTA) is evolving. Emerging insights from early Joint Clinical Assessments (JCAs) have made one thing abundantly clear: evidence confidence depends entirely on comparator readiness. If you are relying on traditional evidence generation, […]
Excel in Market Access Success: Key Considerations for Leveraging Your Evidence
Introduction The landscape of launching new medical products presents significant challenges, with a staggering 66% of launches falling short of consensus expectations. Half of these failures are attributed directly to poor market access. Recognizing this, companies are increasingly turning to early engagement with payers during the clinical development phase to glean crucial insights into payer […]
Single-Arm Data: Turning Limitations into Strengths with Numbers
Randomized controlled trials (RCTs) are at the top of the evidence pyramid because they are designed to be unbiased. Unfortunately, for many medical devices, these types of studies are lacking. This is either because they are not required for 510K or post-market approval (PMA), or there are challenges with implementing a randomized study design. Clinical […]