Meet the team
Three partners. Every side of the table covered
Regulator. Manufacturer. Advisor. We've operated across all three - from Notified Body certification decisions to Big 4 deal rooms to the hospital floor. That depth means we spot risk early and clear the path to market faster.
Deep capability across regulatory, clinical, commercial, and M&A environments in health and medical technology.
Founding Partners
Varun Sukumaran
Founding Partner - Regulatory & Digital Health
15+ years’ experience
Former Notified Body decision-maker and regulatory compliance consultant with deep experience across global regulatory strategy, clinical evidence, AI and market access. Varun supports health and medical technology companies in navigating complex approval pathways, strengthening compliance and progressing products from development through to commercialisation.
His background includes reviewing a wide range of devices and digital health technologies within a Notified Body environment, giving him a clear understanding of regulatory expectations and decision-making processes. He brings practical insight into technical documentation, clinical evaluation and risk management, helping teams identify gaps early and move forward with confidence.
Varun works closely with innovators, investors and leadership teams to align regulatory strategy with clinical and commercial objectives. His experience spans traditional medical devices, software and AI-enabled technologies, with a focus on delivering clear, actionable guidance that supports both approval and market success.
Key Highlights
Former BSI Notified Body decision-maker
Global regulatory strategy and compliance
Clinical evaluation and technical documentation
Digital health and AI expertise
Regulatory input to support market access
Ex-Notified Body Reviewer | Clinical Expert | Big Four Advisory | QMS Expert | Digital Health Regulatory Specialist
Phil Brame
Founding Partner - Device, IVD & Advanced Therapies
20+ years’ experience
Device and clinical specialist with extensive experience across medical devices, IVD and advanced therapies. Phil supports companies in developing clinical and regulatory strategies that align with both approval requirements and real-world use.
His background spans product development, clinical evaluation and post-market activities, with experience working closely with healthcare professionals and industry teams. This provides a practical understanding of how devices are used in clinical settings and how evidence needs to be generated to support both regulatory approval and adoption.
Phil works with organisations across the product lifecycle, from early-stage development through to market access and lifecycle management. His focus is on ensuring that clinical and regulatory strategies are aligned, robust and fit for purpose.
Key highlights
Medical devices, IVD and advanced therapies
Clinical evaluation and PMCF
Product development and lifecycle support
Hospital and HCP engagement
Real-world evidence and clinical strategy
MD/IVD Technical and Regulatory Expert | QMS Expert | Regulatory Strategist | Big Four Advisory
Andrew Dubowski
Founding Partner - Commercial & Deal Advisory
20+ years’ experience
Commercial strategy specialist with a background in Big 4 consulting, supporting investors, acquirers and leadership teams across health and medical technology. Andrew focuses on regulatory due diligence, commercial strategy and market access, helping organisations understand risk, identify value drivers and make informed investment and growth decisions.
His experience includes leading regulatory and commercial assessments in transaction environments, where understanding approval pathways, clinical evidence and compliance risk is critical to deal outcomes. He brings a clear view of how regulatory and clinical factors translate into valuation, timelines and commercial potential.
Andrew works closely with investors and management teams to provide joined-up insight across regulatory, clinical and commercial pathways. His focus is on delivering clear, practical advice that supports successful transactions, product positioning and long-term growth.
Key Highlights
KPMG deal advisory background
Regulatory due diligence and transaction support
Commercial strategy and market access
Investment and valuation insight
Cross-functional risk assessment
Commercial Expert | RTM Strategist | Big Four Advisory | PMO expert
Edo Knijff
A Senior Industry leader in clinical and regulatory strategy for medical devices across EU/US markets (up to Class III [active] implantable devices and SaMD). Supporting CE marking, MDR transition, and clinical evidence generation. Expert in clinical strategy, CER dev, Clinical evidence planning and PMCF programs & clinical investigations.
He has supported clinical strategy and documentation preparation for multiple Class III orthopaedic device portfolios and Software as a Medical Device throughout MDR transition. He has overseen the development and maintenance of CER, PMCF plan & -report, SSCP, PSUR, and clinical documentation packages for global regulatory submissions, and coordinated international cross‑functional teams across clinical, regulatory, quality, engineering, and marketing. He has designed and executed clinical studies and supported investigator‑initiated studies with surgeons and KOL networks. He has been involved in the Clinical Documentation evaluation during several M&A projects.
Partner, Clinical Affairs
20+ Years experience
Key Highlights
EU MDR Clinical Strategy
CER Development
PMCF Programs
Clinical Investigations
Scientific Publications
Clinical Evidence Planning
Medical Writing
Regulatory Strategy
Cross‑Functional Leadership
Clinical Affairs Expert | Regulatory Strategist | Industry Leader | Clinical Evidence expert
What this means for you
Our experience spans regulator, manufacturer and advisory perspectives. This allows us to identify risks, dependencies and opportunities that are often missed when working in silos.
We provide joined-up support across regulatory, clinical and commercial pathways, helping you make better decisions and move forward with confidence.
Speak to the team
Clear, practical guidance across regulatory, clinical and commercial decisions.