Upcoming dates to note.

Our SPARK Studio hybrid sessions focus on four major topics: drug discovery and development, medical device development, diagnostics development and business funding.

At SPARK we believe that collaboration is key to success. Each SPARK cohort come together once a month to discuss their progress on the programme; to share their insights and learned experiences with one another.

We would also like to use SPARK as an opportunity to bring industry experts to the region to share their knowledge and opinion with those interested. We hope that this gives current and future translational scientists better understanding, and thereby the confidence, to bring their innovation to clinic.

SPARK Studio talks are recorded with permission and these are linked below. If you would like to be sent any of the presentations shown during these, please email us through the Contact page.

SPARK Studio recordings

  1. Importance of a Quality Management System (QMS)

Led by Henry Sibun, a consultant in the medical devices industry and an IRCA registered lead auditor for medical device quality management systems. 

3. Product Classification in the EU - The borderline area between medical devices and medicinal products

Theresa Jeary, Global Head of Medicinal and Biologics Team of BSI, a Notified Body, gives this talk.

5. Risk management in medical device development

Dr Peter Bowness from MCRA talks through the requirements from EU MDR 2017/745 and ISO 14971:2019 for medical devices.

7. Life Science Pitch Strategies & VC Due Diligence

Dr Glenn Crocker MBE, Executive Director of Pioneer Group shares what he looks for in a business pitch and what to expect of the VC due diligence process.

9. The FDA Pathway: How Medical Devices Get To Market

Following on from our MHRA talk, Alex Schardt, Manager, Regulatory Affairs for MCRA gives us a high level overview of the FDA review process for medical devices.

2. From gene to clinical candidate: a (very brief) overview of target-based drug discovery

Presented by Dr Ben Davis, Director of Business Development and Research Fellow at Vernalis Research, a biotech company.

4.Drugs, Devices and Diagnostics: broad brush, real-world experience

A ‘fireside chat’ with Will Burton, who previously managed the Manufacturer Registration Scheme Business Unit of the UK Medical Devices Agency (now MHRA). Now the founding Director of Russell Square Quality Representatives (RSQR) Ltd.

6. Biomarker to CE/UKCA-marked IVD test – the regulatory journey

Dr Erica Conway from MCRA takes us through the regulatory journey of IVDs, from feasibility to the final stages of certification.

8. All Things Clinical Investigations and the MHRA

Mark Grumbridge, the MHRA Head of Clinical Investigations, goes through the Clinical Investigations application pathway for medical devices.