To access this meeting on Teams, please use Meeting ID: 324 096 054 458 Passcode: xHVSCh

This SPARK Studio session will provide a high-level overview of the U.S. FDA regulatory framework for medical devices, focusing on key requirements for manufacturers. Topics will cover FDA classification system (Class I, II and III), product code selection and premarket pathways (i.e. 510(k), PMA, De Novo). Attendees will gain insights into the submission process, predicate device selection, and ongoing compliance obligations under FDA guidelines. 

Alexandra (Alex) Schardt, Manager, Regulatory Affairs for MCRA will be hosting this talk. Alex has over 7 years  of experience in the biotechnology industry and medical device regulatory affairs. Alex is RAC-certified in medical device regulatory affairs. 

As Manager, Regulatory Affairs, she specialises in both US FDA and international regulatory strategy, writing regulatory submissions, development and maintenance of technical and regulatory documentation, conducting systemic literature reviews, and performing gap analyses. She leads and supports regulatory projects from regulatory strategy assessments through final submission writing and communications with the FDA and Notified Bodies. Alex has supported projects including Clinical Evaluation Reports (CERs), Technical Documentations, 510(k)s, Pre-Submissions, De Novo 510(k)s, Investigational Device Exemptions (IDE), and Premarket Approval (PMAs). She has supported regulatory projects in the orthopaedic, spine, neurology, and cardiovascular spaces. 

Before joining MCRA in 2021, Alexandra worked in viral vector product development at a privately hed biotech company. Alexdra received her Bachelor of Science for Gettysburg College in Biochemistry and Molecular Biology. Alexandra also received a Master of Science in Biotechnology from Johns Hopkins University, concentrated in Regulatory Affairs. 

This SPARK The Midlands event is being delivered as part of Aston University's active involvement in the delivery of the West Midlands Health Tech Innovation Accelerator (WMHTIA). The WMHTIA is funded by the Department for Science, Innovation and Technology, in partnership with Innovate UK and the West Midlands Combined Authority.

To register, click here.

From 4-6 November 2024 leading biotech and biopharma companies and development teams will gather in Stockholm, Sweden to realise BIO-Europe 2024.

BIO-Europe is Europe's largest life sciences partnering conference, designed to foster collaboration, investment, and innovation in the biotechnology, pharmaceutical, and healthcare sectors. It typically gathers thousands of industry leaders, investors, innovators, and business development executives from around the world. The event is known for its one-to-one meetings, networking opportunities, and panel discussions, offering participants the chance to explore new partnerships, funding opportunities, and emerging trends in the life sciences.

BIO-Europe features:

• One-on-One Partnering: Facilitated through a partnering platform, allowing participants to schedule meetings with potential collaborators, investors, and other stakeholders.

• Presentations and Panels: Covering key topics like drug development, emerging biotech innovations, healthcare technologies, regulatory challenges, and market trends.

• Company Showcases: Startups and established companies present their innovations, research, and solutions to attract investment and collaboration.

• Workshops and Networking: Opportunities to connect with industry leaders and experts, share knowledge, and explore synergies.

SPARK The Midlands is joining forces with the Science Entrepreneur Club and their BioEntrepreneur group to host an evening for the SPARK teams to engage with C suite professionals in the health and biotech sector.

For more information on this event, please get in touch with us via the Contact page or email us directly on spark-uk@aston.ac.uk

Drug Safety Forum 2024: A Patient First Approach to Translational Safety. From Nonclinical to Clinical.

Presented by Apconix and held in the Wellcome Collection.

For more information on this event, please click here.

To register for this event, please click here

For this SPARK Studio, Mark Grumbridge, the MHRA Head of Clinical Investigations, will be talking us the through what to expect when applying for authorisation to conduct a clinical investigation of a medical device in the UK. 

Mark is an NMC registered nurse, first qualifying for this position in 1991. Since March 2022 he has been the Head of Clinical Investigations at MHRA having previously held the role of Senior Clinical Advisor and has worked at the MHRA since January 2012. 

He is also a committee member for ISO 14155 (Clinical Investigation of Medical Devices) representing MHRA and the UK. 

His role at the MHRA involves managing all aspects of clinical investigations including: 

• Provision of advice and support for applicants 

• Sourcing expertise 

• Reviewing applications for clinical investigations 

• Managing a team of regulatory handlers 

• Implementing regulation 

Mark has an NHS career spanning over 35 years and has worked in many clinical areas including Haematology, Acute Medicine, Senior Management and Project Management. 

This SPARK The Midlands is being delivered as part of Aston University's active involvement in the delivery of the West Midlands Health Tech Innovation Accelerator (WMHTIA). The WMHTIA is funded by the Department for Science, Innovation and Technology, in partnership with Innovate UK and the West Midlands Combined Authority. 

To register for this event, please follow this link

Join SPARK The Midlands for an insightful discussion on 'Life Science Pitch Strategies and VC Due Diligence.' Dr Glenn Crocker MBE will explore the critical elements of early stage pitches and the rigorous due diligence process. Attendees will gain valuable insights into how to effectively present preclinical research to potential investors, highlighting key factors that VCs consider when evaluating early-stage medtech, biotech and pharmaceutical ventures. 

Topics will include:

• What an early-stage investor is looking for;

• Crafting compelling pitches that capture investor interest; 

• Understanding the due diligence process from a venture capital perspective; 

• Strategies for showcasing the scientific, commercial and financial viability of preclinical projects; 

• Real-world case studies and lessons learned from successful funding rounds. 

This discussion is essential for entrepeneurs, researchers and startup teams looking to secure venture capital funding for their preclinical innovations. 

This talk will be led by Dr Glenn Crocker, who is Executive Director of Pioneer Group, a company that creates human and planetary health ecosystems through venture building and real estate. 

At Pioneer, Glenn is responsible for the venture building and venture investment business. Over 30 years in the industry, he has co-founded and invested in many life science companies, especially in the discovery and development services sector. 

As founding CEO of BioCity Group, he built a successful business that was acquired by Trinity Investment Management in 2021, providing an excellent exit for shareholders and leading to the formation of Pioneer Group.

He has a D Phil in Immunology from Oxford University and qualified as a chartered accountant with EY, where he ran the UK Biotech practice. In 2014 he awarded an MBE for services to the biotechnology industry. 

This SPARK The Midlands event is being delivered as part of Aston University's active involvement in the delivery of the West Midlands Health Tech Innovation Accelerator (WMHTIA). The WMHTIA is funded by the Department of Science, Innovation and Technology, in partnership with Innovate UK and the West Midlands Combined Authority. 

To register for this event, please click here.

Do you want to propel your start-up or innovative project to new heights? A collaboration or partnership with a large medtech or pharma company might be a valuable opportunity to explore. Depending on your needs, it could provide access to funding, resources, expertise, and networks which are otherwise might otherwise remain out of reach. In turn this could help to speed up development and enhance the overall probability of regulatory approval and market success for a new healthcare intervention, thus de-risking the overall development.

To a start-up company , the process of building a collaboration with a large healthcare company might seem daunting and the criteria used for assessing potential deals unclear. During this Johnson & Johnson Innovation – JLABS program we will demystify what due diligence entails, what the pitfalls are and how you might set yourself up for success.

This is an in-person, invite only meeting.

A welcome to the successful applicants who will be joining SPARK The Midlands cohort 2.

To attend this event, please register here

For a start-up or an early phase developer, there are many hurdles to overcome to get from a biomarker that appears clinically interesting, to an in vitro diagnostic (IVD) test that can be placed on the market or offered to patients as a regulated product.

This presentation will take attendees through the regulatory journey, from early-stage discovery (feasibility) to the final stages of device certification in the EU and UK. This starts with the initial considerations of intended use, and what this means. An overview of the EU IVD Regulation (IVDR, (EU) 2017/746) will form the basis for outlining the regulatory considerations that are critical to getting a device to market. This includes the phases of design and development, under a quality management system. Through analytical (verification) performance testing to clinical performance studies (validation). Following these stages, the focus will turn to the certification process, specifically what this entails for the EU and the UK.

In summary, there are key regulatory considerations and milestones that IVD test developers should be aware of and plan for, in order to achieve certification to place the test on the market and make it available to patients. This overview will be followed by a Q&A session, all with Dr Erica Conway. 

Dr Conway has over twenty years of regulatory affairs and quality assurance experience, primarily within In Vitro Diagnostic (IVD) medical device field. Dr Conway joined MCRA, a consultancy company, in Aug-2022 as VP IVD Regulatory Affairs. Prior to MCRA, Dr Conway’s first industrial experience started in the regulation of pharmaceuticals before moving into clinical trials for medicinal products. Dr. Conway moved into the field of IVD medical devices in 2006 for a major diagnostics manufacturer, before becoming an independent consultant, working within the IVD and medical device fields on aspects of regulatory affairs and quality management systems. Latterly, Dr Conway spent 8.5 years as Global Head of IVDs and the Head of IVD Notified Body (NB) at the British Standard Institution (BSI). At BSI, Dr Conway was pivotal in the implementation of the IVD Regulation (IVDR, (EU) 2017/246) and the successful designations of both the UK and the Netherlands organizations to the IVDR.

Dr Conway has a Bachelor of Science (BSc Hons) in Physiology from the University of Sheffield, U.K. and Doctorate of Philosophy (PhD) specializing in neurophysiology from the University of Bristol, UK. Dr Conway did a short post-Doctoral position at the University of Cambridge before entering industry.

This SPARK The Midlands event is being delivered as part of Aston University's active involvement in the delivery of the West Midlands Health Tech Innovation Accelerator (WMHTIA). The WMHTIA is funded by the Department of Science, Innovation and Technology, in partnership with Innovate UK and the West Midlands Combined Authority.

This is an invite only event, but there may be spaces available. If you would like to enquire about this, please head to our contact page and get in touch.

This full day session will be led by Janette Benaddi, a business mentor, international speaker/trainer and expert consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Throughout her career Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles.  In addition, she set up a very successful medical device CRO company in the late nineties which she later successfully sold to another large multinational organization in 2013. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.  Specifically, she has been involved in writing and reviewing hundreds of Clinical investigations/evaluations for the medical device industry, she has also provided training to Notified bodies on medical device studies as well as other medical companies.

The objective of this training is to provide participants with a comprehensive understanding of medical device clinical evaluation, including regulatory requirements, methodologies, and best practices. Through workshops and case studies, participants will gain practical experience in conducting clinical evaluations for medical devices.

To attend this event, please register here.

This workshop, hosted by Dr Peter Bowness, will focus on the requirements of risk management under the EU MDR 2017/745 and ISO 14971:2019, covering the foundational concepts and risk processes to be applied, including the interface of risk management with other mandated requirements in the regulations. Delegates will learn the regulatory and legal requirement for risk management for medical devices and how to interpret the ISO14971 standard as the methodology for compliance to these requirements.

Dr. Bowness was a decision maker and regulatory and technical specialist for the EU Notified Body and UK Approved Body, BSI, where he led the biologics technical team. At BSI, Dr. Bowness was the subject matter expert on risk management for medical devices under ISO 14971, information to be provided to users under ISO 20417 (replacing EN 1041), graphical symbols for medical devices under ISO 15223 and procedure packs under Directive Article 12 and Regulation Article 22 and wrote procedures and guidance on the interface between risk management, clinical evidence, PMS/PMCF and information provided to users. Dr. Bowness worked in industry for 8 years, running stability and drug release testing for recombinant antibody therapeutics in a GMP testing laboratory and in medical device R&D, leading projects to develop animal tissue collagen implants for guided tissue regeneration in a range of clinical applications. 

In addition, Dr. Bowness is chair of the British Standards Institution technical committee CH/210/WG3 and Member ISO/TC/210 (Quality management and corresponding general aspects for medical devices), Member CH/210/04 (Risk analysis for Medical Devices) and Member CH/194 (Biological Evaluation of Medical Devices).

The LifeArc Translational Science Summit will highlight and encourage discussion on how translational science can bridge the gap between basic research and clinical applications, featuring presentations and insights from leading scientists, experts, policy makers and innovators.

Read through the full day’s agenda here.

To register for this event, please visit this page.

This session will cover:

1. Why you should regulate

2. Common MedTech / Pharma companies’ (not just spinouts’) failures

Will Burton will lead this SPARK Studio. He is a seasoned Pharmacist, Medicinal Product Qualified Person, Medical Device Expert, and registered international lead assessor. He is the founding director of Russell Square Quality Representatives (RSQR) Ltd, a company providing a range of Regulatory and Quality consultancy, training and troubleshooting services to the international medical device, pharmaceutical and biotechnology sectors. Prior to founding RSQA in 1995, Will was the Professional Services Manager of the Manufacturer Registration Scheme Business Unit of the UK Medical Devices Agency (now MHRA). He managed the UK team of medical device expert assessors performing worldwide quality systems audits of medical device manufacturers against the requirements of the Department of Health’s Quality Systems Documents and formed the foundation for ISO 13485 (Quality Management System (QMS) for Medical Devices). Will has very extensive auditing and quality systems experience and was closely involved in the selection, training and monitoring of UK Notified Bodies. He was also instrumental in the development of the original EU Medical Device Directive (93/42/EEC, 1993), which still forms the basis of the current EU Medical Device Regulation (EU 2017/745).

This is the official deadline day for SPARK The Midlands cohort 2 applications.

Please complete the following form to be considered for SPARK.

This is an invite only event.

HALSEC Huddle: Navigating the Health & Life Sciences Landscape. Join fellow innovators in our established community for an informative and interactive event designed to empower your Med Tech & Life Sciences journey.

Venturefest West Midlands continues to bring together regional businesses, universities, science parks and business support organisations.

To access this event, please visit this page.

Led by Theresa Jeary, this session shall provide an overview of the Regulatory Classification of Health Products and examine the borederline area between medical devices and medicinal products detailing key considerations in product development and regulatory strategies. 

Theresa holds a Master's degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and has over 30 years' experience working in both the Pharmaceutical and Medical Device industries. 

In addition to her product development and regulatory expertise, Theresa has over 14 years Notified Body experience, having worked for both LRQA, where she held the role of Head of Notified Body, and BSI, working as a technical specialist in the Medicinal and Biologics team, having responsibility for devices with ancillary medicinal substances, device classification decisions and Article 117 NB opinions. 

Theresa is a regular presenter on MDR Implementation and contributes to various scientific publications, as well as regulatory guidance documents. She has extensive experience interacting with EU Competent Authorities. 

Please visit the event page here.

Put together by VA Founders, the objective of this event is to facilitate meaningful discussions and partnerships between life sciences founders and investors in the healthcare sector, offering insights into the challenges and opportunities in building successful healthcare start-ups.

To access this talk, please follow this link.

Led by Dr Ben Davis of Vernalis Research, this presentation will give a brief overview of the processes involved in identifying and developing small molecule ligands for a therapeutically relevant target, and what is then needed to turn these ligands into clinical candidates, and eventually drugs. The emphasis will be on the early stages of target-based drug discovery; the various ways in which novel chemical matter can be identified and validated as interacting with the target, and some potential pitfalls that can be readily avoided.

Dr Ben Davis is the Director of Business Development and Research Fellow at Vernalis Research, a biotech company based in Cambridge UK which has been at the forefront of applying biophysics and fragment-based approaches to drug discovery since 1998. In particular, this has involved developing biophysical techniques to enable drug discovery against challenging therapeutic targets and systems, and in using NMR and other technologies to help guide medicinal chemistry programs where other structural methods are not readily applicable. Since 2022, he has been responsible for business development at Vernalis, supporting a broad collaborative business model where Vernalis’ extensive expertise can support a wide range of drug discovery partners.

For more information on Vernalis and Ben’s work, click here.

Presentation by Henry Sibun, a consultant in the medical devices industry and an IRCA registered lead auditor for medical device quality management systems. He has audited hundreds of medical device and pharmaceutical companies against ISO 13485 and medical devices regulations, and now supports companies in achieving certification and CE marking against these requirements.

A QMS is often seen as an additional headache with lots of paperwork that is best left until the last minute before applying for regulatory approval.  However, this is not what it should be and starting a basic QMS early in the design process can save significant time, effort and cost in getting new products onto the market.  This presentation will look at the basics of quality and quality management systems, as well as the costs and benefits, and certification to ISO 13485.  It is aimed at anyone who is involved in bringing a new medical device to market, from the first concept to applying for CE marking.

To register for a ticket to attend in person: https://www.eventbrite.co.uk/e/spark-studio-importance-of-a-quality-management-system-qms-tickets-803814399507

To register to join online: https://www.eventbrite.co.uk/e/spark-studio-importance-of-a-quality-management-system-qms-online-tickets-810105486317

To coincide with the first cohort meeting of the entire programme, SPARK The Midlands will also be hosting an official launch event to welcome the programme partners and project teams.

*By invitation only

A fellow partner in the WMHTIA, Plug & Play are officially launching their first cohort of businesses they are working with.

*By invitation only