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Medical Technologies - Regulatory and Market Access

Toni Day

Director of Quality and Regulatory Affairs, OrganOx Toni Day

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 Regulatory Strategy.

Prior to this, Toni served 7 years at Oxford Immunotec Ltd, starting as a Senior Scientist working alongside the CEO and then through promotion to Director of Product Development, with line management responsibilities for 12 scientists and senior scientists.  Toni has over 15 years experience in Product Development and Regulatory Submissions for both European and US approval. She can offer support and advice on the regulatory process required for CE Marking and medical device development.

Toni can advise on:

  • Regulatory strategies for medical technologies
  • Regulatory submissions

Richard Hall

QMS Consultancy Richard Hall.PNG

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, India
  • Product Classification, MD, IVD, SaMD
  • Quality Management Systems, QMS & ISO 13485

Ben Wensley-stock

Managing Director, MPS-UK and Wensley Stock Ltd BWS_edited.PNG

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.

Steven Haken 

Director at Odelle TechnologySteven Haken.PNG

A Director of Odelle Technology based in the UK and France, Steven specialises in Market Access, reimbursement, and Government Affairs for MedTech’s.

Steven previously co-invented and commercialised 28 Medical technologies across the EU and USA. PhD in Mathematics and further education in Physiology and information technology. Clinical experience in ICU, CCU, Operating theatres, Neurology and Emergency Medicine.

We work with firms such as Smith & Nephew, Hologic, CMR Surgical, Baxter, Fresenius, and others. We work with leaders in HEOR, HTA and Value & Access teams to develop the market access strategy.

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

Deborah Rizzi

Director at Odelle TechnologyDeborah Rizzi.PNG

Deborah started her medical career as a Registered Nurse in Australia. Throughout her ten years in this position, she worked in numerous areas in both medical and surgical fields.

In 2006, she transitioned into Industry, working with both smaller businesses and Blue-Chip companies. This experience allowed her to gain a unique insight into the industry by exposing her to all sides of the medical device spectrum.

Deborah has extensive experience in bringing new products to market, and in helping clients secure the successful distribution of their technology. She also has a natural talent for building and strengthening long-term working relationships, allowing her to create a vast network of professional connections.

With her clinical and commercial expertise, Deborah has a depth of understanding unique to medical professionals, which combines with the business acumen from the device industry.

 

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

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