IVD Clinical Development Strategy
Strategic guidance for companies navigating the clinical and regulatory pathway for in vitro diagnostics — from study design through market authorization.
Start a conversationAbout
We work with IVD developers, biotech firms, and laboratories to build evidence strategies that satisfy regulators and stand up in the market.
ClinDev Diagnostic Strategies was founded to close the gap between scientific innovation and regulatory approval in the IVD space. Our work begins where the data begins — at study conception — and continues through submission, review, and post-market commitments.
We bring deep experience with FDA 510(k) and De Novo pathways, CE-IVD under the IVDR, and companion diagnostic co-development. Our clients range from early-stage diagnostics startups to established in vitro manufacturers seeking to expand cleared indications.
We don't offer generic regulatory templates. We read the clinical literature, understand your assay, and build the evidence plan your submission actually needs.
Services
Strategic diagnostics consulting spanning the full evidence development lifecycle — from proof-of-concept through clinical validation and clinical utility. We translate strategy into rigorous study designs built to support regulatory approval, payer acceptance, and adoption into practice.
Evidence Strategy
End-to-end strategic planning across the evidence lifecycle — from early proof-of-concept through analytical validation, clinical validation, and clinical utility. We build integrated evidence plans that serve regulatory, payer, and clinical adoption goals simultaneously.
Target Product Profile
Structured development of TPPs that define what your diagnostic must demonstrate to succeed. We validate TPPs through engagement with Key Opinion Leaders and Health Authorities, ensuring alignment before you commit to a study design.
Regulatory Strategy
Classification review, predicate analysis, and submission strategy for FDA 510(k), De Novo, or PMA — and CE-IVD under IVDR. Know your path before you invest in clinical data.
Clinical Evidence
Protocol development for analytical and clinical validation studies. We design studies that generate decision-grade evidence — statistically powered, site-ready, and built to satisfy regulators, payers, and clinical practice guidelines.
Literature & Evidence
Systematic literature reviews, clinical utility assessments, and benefit-risk analyses in support of regulatory submissions and payer dossiers.
Submission Support
Authoring and review of submission documents including clinical evaluation reports, performance summaries, and substantial equivalence arguments.
Advisory Boards
Design and facilitation of advisory boards bringing together Key Opinion Leaders, clinical experts, and Health Authority perspectives. We structure agendas to generate actionable insight — on TPP validation, unmet need, study design, and clinical adoption — and translate outputs into decisions your development team can act on.
Contact
Tell us about your diagnostic and where you are in development. We'll respond within one business day.
Whether you're selecting a regulatory pathway, designing a pivotal study, or preparing a submission, we're happy to have an initial conversation at no charge.
We work with teams globally and are set up for remote engagement from day one.
david.morgenstern@clindevstrategies.com