Meet our team
Alper Hulusi MA (co-founder)
Alper has 25 years’ experience as a qualitative researcher, discovering unmet needs all over the world. Following his Master’s degree in Sociology of Education, his career began as a Social Policy Researcher working at the National Centre for Social Research, TNS-BMRB. He then worked as a freelance specialist qualitative researcher, and then as Research Director at a global medical market research agency. He is now also a Director of Harvey Medical.
Alper’s experience and expertise span many diverse areas. Alper’s skilful moderation, project design and insights have enabled some of the top medical device manufacturers to better understand how to design, develop and market their devices.
This expertise spans across the whole product development lifecycle, from early stage ideation through to post-market insight.
Nicholas Hitchins (Technical Director)
Nicholas has a detailed knowledge medical device development and has over 10 years experience in medical device development, specialising is medical device process and assessing device risk. He is a Mechanical Engineer by background with an MSc in Biomedical Engineering.
His experience comes from working as an engineering consultant specialising in medical devices with a focusing on surgical, drug delivery and In-vitro diagnostics (IVD). This included extensive time spent managing elements of later stage development programs including, DVT and multi-cavity injection moulding programs. He was previously head of technical at a medical device start-up driving forward both internal and external development, managing internal engineers and driving company strategy where he drove multiple class II devices intended for global low resource settings including Africa. He is also the Cambridge Biomedical Chair for The Institute of Mechanical Engineers (IMechE) and sits on boards in the IMechE and Imperial College, London.
Louisa Harvey MSc (co-founder)
Louisa has worked in the medical device and pharmaceutical industry for 15 years. She excels in project management, and never fails to meet a target.
During and following her MSc in Industrial Pharmaceutical Science, she has worked with start-up companies through to global pharmaceutical companies in both technical and commercial roles and has an in depth understanding of the medical device regulatory processes globally. Her passion lies in the field of usability, ensuring that devices are safe, easy and effective for use in their proposed setting.
Louisa co-founded the Medical Human Factors Network UK in 2019. Louisa enjoys being an entrepreneur and has successfully started three companies namely Harvey Medical Consulting, which was founded in 2012, Healthcare Fieldwork, which was bought out in 2019, and ROOTS Medtech.
Sam Shelley (Quality & Regulatory Director)
Sam’s career started as a mechanical engineer specialising in Quality Assurance, she began working in the medical devices field, quickly adding Regulatory Affairs to her Quality Management Systems responsibility. She has held various positions in Quality Systems management, Compliance and Regulatory Affairs with a wide range of medical device manufacturers and sub-contract manufacturers over 25 years, before setting up her Quality and Regulatory Consultancy in January of 2015.
Sam has specifically targeted her business at Medical Device start-ups, for whom early access to Quality and Regulatory resources is key to developing their product and Quality Management System in accordance with regulatory requirements, reducing the potential delay in launching due to late discovery of the requirements to be met.
She has worked with devices as diverse as metered dose inhalers through to orthopaedic implants.
Our voluntary scientific advisory board
Alex Stokoe MEng
Alex is an engineering consultant and project manager at TTP plc where he has over 4 years of experience developing novel medical devices and in-vitro diagnostics. He has used his specialism of system level device design to integrate an ultra-low cost, rapid PCR engine into a patent pending flu screening device that LEX Diagnostics plans to take to market. During his degree at the University of Bath, where he studied Integrated Mechanical and Electrical Engineering, he worked with the charities Engineers Without Borders and Partner West Africa (PWA). In 2016 he spent a summer living at PWA in Ghana to assess unmet healthcare needs in a low-income community and created designs for a rudimentary medical centre alongside a phased funding plan.
Alex has recently returned to the UK from Perú where he worked as the social enterprise development officer for Light Up the World (LUTW) coordinating the last mile distribution of off-grid PAYG solar energy kits in Latin America. He hopes to be able to bring his expertise in social enterprise models, field work in low-income countries in combination with his medical device work at TTP to assist ROOTS in achieving their mission to bring impactful devices to those left unserved by the premium cost medical devices market.
Dr Marie Chivers
Marie is a GPhC registered pharmacist with a PhD in Biopharmaceutics from University College Cork, Ireland. Marie has worked in product development in the pharmaceutical industry for the last 10 years across multiple therapy areas and indications, including dermatology (eczema, psoriasis), infectious diseases (HIV, malaria), rheumatoid arthritis, and oncology. Past projects have included the development and promotion of novel drug products and formulations intended for use in resource limited settings, such as the tafenoquine paediatric oral formulation (MMV/GSK collaboration), long acting HIV treatments, and microneedles for vaccine delivery. Marie now works at PRMA Consulting developing pricing, reimbursement, and market access strategies for new pharmaceutical and biopharmaceutical drug products globally.
Dr Chris Vincent
Chris is heading the PDD Healthcare Sector with a focus on human factors engineering and ergonomics. He has experience across healthcare, defence and aerospace. Chris has managed many formative and summative usability evaluations on a diverse range of medical devices from consumables through to complex dialysis equipment in the UK, US and China. He has experience of regulatory aspects and risk management. Chris was awarded a PhD in 2005 and previously worked at the University College London Interaction Centre (UCLIC), as a postdoctoral research associate. During that time he worked on the Engineering and Physical Sciences Research Council (EPSRC) funded project to investigate ways to make medical products safer. This involves understanding the relationship between human factors, human error and interactive device design.
Alison Kwok MEng
Alison is the Founding Director of Medev Solutions Ltd, a medical device development consultancy company. An accomplished Programme Manager, Alison has successfully launched five medical device products, operating with stakeholders at the Director and Board levels. She has 20 years’ experience in the medical device and pharmaceutical industries, having worked for world leading organisations such as GlaxoSmithKline and medical device specialists Owen Mumford as well as a successful entrepreneurial start-up Oval Medical.
Her experience covers early stage development to mass manufacturing in the respiratory and sterile injectable products, as well as wearable electro-mechanical devices.
Alison is a Chartered Engineer who holds a first-class Masters in Mechanical Engineering from Loughborough University. She chooses to work in the medical industry in order to utilise her skills to save and improve the quality of life for millions of people around the world.
Alim Thawer MPhys
Alim is a Principal Engineering Physicist at Cambridge Consultants. He has 6 years' experience developing multi-faceted, integrated systems as an engineer and technical leader, with a background in Physics from his MPhys master’s degree completed at Oxford University. He has developed several differentiated products within the medtech and consumer sectors. Within healthcare, he has significant experience in developing and derisking novel technologies and has integrated them into surgical, drug delivery, diagnostics and acute care systems. This has been achieved through fluidic, optical and mechanical design, alongside robust approaches to technical risk management. In doing so he has several patents to his name and continues to develop healthcare solutions from early stage concepting through to mass manufacture. Alim has experience developing drug delivery devices, surgical tools and point-of-care rapid diagnostics.
Alim has focused on understanding routes to developing products targeted at low resource areas and processes used to undergo developments with technical, commercial and clinical confidence. He is motivated to reduce the level of global health inequality we see today through novel, implementable technology developments.
Thank you to our company partners
