Medical Technologies - Regulatory and Market Access

Dr Toni Day

Senior Director Regulatory Affairs ONA and New Ventures, OrganOx Ltd 

Toni holds a BSc Honours degree in Biochemistry and a DPhil in Neuropharmacology from Oxford University. Previously Toni has worked for a number of start-up companies in the medical device, in vitro diagnostics and pharmaceutical arenas. She joined OrganOx Ltd in April 2011 to build the Quality Management System and the global Regulatory Strategy.

Prior to this, Toni served 7 years at Oxford Immunotec Ltd, as Director of Product Development, with line management responsibilities for 12 scientists and senior scientists.  Toni has over 20 years’ experience in Product Development and Regulatory Submissions in a number of territories including, EU, UK, Canada, Australia and US. She can offer support and advice on the regulatory processes required for market approval and medical device development.

Toni can advise on:

• Regulatory strategies for medical technologies
• Market approval submissions for medical devices and IVD
• How and when to communicate with the regulators
• Medical device design and development pathways

Mr Richard Hall

Director, QMS Consultancy 

Richard is an experienced QA professional, having worked within the medical device industry since 1993. With experience of developing and manufacturing medical devices in a range of companies, from start-up to blue chip international healthcare businesses, Richard has a strong understanding of new product development; he has been named on two patents and lectures at Imperial College London regarding Regulations and CE Marking. He spent 5 years as Quality and Design Manager for Bio-Rad Laboratories before starting QMS Consultancy in 2014. Richard now specialises in supporting medical device start-ups to gain ISO 13485 certification and to gain Regulatory approval for their devices.

Richard can advise on:

• Medical Device Regulations, MDR, IVDR, UKMDR, FDA, WHO, MDSAP,
• Product Classification, MD, IVD, SaMD
• Risk Management, to ISO 14971
• Quality Management Systems, QMS & ISO 13485

Dr Ben Wensley-Stock

Chief Executive Officer, MPS Medical-Product-Service UK Ltd

Ben Wensley-Stock has over 20 years’ experience in HealthTech and MedTech industries working in CxO positions within both established multinational and start-up companies (including some Oxford spin-outs).

Ben now tends to specialise in network connected medical devices that involve software or that employ deep-learning or machine-learning technologies.  Ben has successfully helped over 30 medical device companies of varying sizes across the globe to bring innovative products to market.

In early-stage innovation the challenges of navigating the various regulations and standards can seem overwhelming.  Ben employs a number of strategies to help teams understand the big picture; he advises on what activities to prioritise when turning an early-stage innovative idea into a saleable product and medical device.

Ben can advise on:

• Device classification and regulatory planning;
• Product realisation planning;
• International medical device, security and privacy regulations;
• Research and design/development strategies for innovative technologies;
• Research and ethics planning;
• Quality and Information Security Management Systems, which elements of these to concentrate on early and in which order to adopt them to foster innovation but avoid pitfalls later;
• Medical device and information security risk management;
• Regulatory submissions;
• Healthcare data and integration strategies;
• Tooling and platforms that support innovation and ease compliance.

Dr Steven Haken 

Director at Odelle Technology

A Director of Odelle Technology based in the UK and France, Steven specialises in Market Access, reimbursement, and Government Affairs for Biotech, Pharma and MedTech’s. A systems thinker bringing clinical, operational, payer and patient perspectives to bear in decision-making, ensuring strategies are fit for purpose and can be understood and executed across all stakeholders. Proficient in contextualising problems in healthcare with over 30 years’ experience.

Steven previously commercialised 28 Medical technologies in Biotech and Lifesciences across the EU. Successfully obtained 167 National Guidelines through Health Technology Assessment organisations, with clinical experience in ICU, CCU, Operating theatres, Hospital Management and HEOR.

His team work with firms such as Smith & Nephew, Hologic, CMR Surgical, Baxter, Fresenius, and others. We work with the payer not the surrogate.

Steven can advise on:

• Market Access and Reimbursement in the UK and EU
• Routes to progress across the EU
• Career development for early career researchers
• Value proposition development
• Payer interviews both nationally and regionally.

 Ms Amy Peters

Head of Government Affairs and Policy for AbbVie UK

Amy Peters is the Head of Government Affairs and Policy for AbbVie, a global biopharmaceutical company deeply committed to advancing healthcare solutions that improve patient outcomes worldwide.. She is responsible for the company’s businesses interactions with the Government, Department of Health and Social Care, NHS England National Organisations, as well as other relevant stakeholder within the clinical and patient communities. Her expertise within AbbVie includes the business strategic priorities around regulation policy, digital and data ecosystem policy, NHS access to innovation, and investment strategies.  She has also previously worked on general surgical technology, orthopaedics, cardiovascular and metabolic solutions directed at delivering clinical and economic value to healthcare systems. 

Amy brings with her an outstanding 25-year career which spans across clinical and R&D work, product management, NHS clinical work and disease awareness, and strategy development which ultimately culminated in her position at AbbVie UK.

Known for putting the needs of patients first, Amy is passionate about strengthening AbbVie’s footprint in the UK and shaping sustainable solutions that positively impact the health of millions of people.

Amy can advise on:

• Higher stakeholder management with UK Government officials and civil service,
• Regulatory policy
• Data policy
• The NHS ecosystem including access and uptake of innovation, and environmental and sustainability policy as it pertains to single use medical devices and pharmaceuticals.

Please contact the Translational Research Office to book a meeting with our experts in residence.