Fostering client collaboration,
accelerating product compliance

A2HF was founded on a diverse experience portfolio of applying Human Factors to medical device projects, ranging from start-ups to large multinationals.

Core Values

A2HF is built on a genuine interest in human behaviour and the interactions that occur when users engage with medical devices. Though Human Factors is often viewed as a final regulatory box to tick, here it is a core philosophy. Every protocol written, interface tested, and workflow refined is driven by a single, overarching mission: protecting and improving product users lives.

Achieving this mission requires commitment to scientific rigour, accuracy, and uncompromised data integrity. Medical device evaluation is approached through an empirical lens, ensuring that findings are repeatable and objective. This scientific precision directly informs the quality of A2HFs documentation. The clean, thorough, audit-ready reports are tailored to withstand the deepest scrutiny of global regulatory bodies. By blending this meticulous attention to detail with deep expertise in regulatory compliance, A2HF helps clients confidently navigate the path to market, mitigating risk at every milestone.

Breakthrough Human Factors Engineering cannot happen in a silo. True progress demands an environment of innovation, where assumptions are actively challenged to uncover safer, more intuitive design solutions. This is achieved through true collaboration and teamwork, operating not as a detached third-party vendor, but as an agile, deeply integrated extension of your team. Whether partnering with an emerging startup or a global multinational, we align our collective expertise to foster a transparent relationship built on trust, excellence, and shared success.

User Safety

Ensuring devices are designed to minimise risks and reduce use errors, for healthcare professionals, caregivers and patients.

Ergonomic Excellence

Applying rigorous ergonomic principles to optimise device safety and efficacy for the intended users, uses and use environments.

Collaborative Partnership

Working closely with clients to tailor human factors solutions that meet specific project goals and challenges.

Alex Agis
Founder/Director

Alex is a seasoned Human Factors professional with over 14 years of experience in the medical device field. Grounded in a unique prior academic foundation of human behaviour and design (holding two respective BSc and BA degrees) and also holding a Masters in Human Factors from Loughborough University.

He has worked on HF/usability projects globally as part of product entries in the U.S., E.U. and Asian Markets. In industry, he has had cross functional interaction with development teams and within consultancy settings, he has worked with start-ups through to multinational companies providing HF input for devices/systems within the areas of drug delivery, diagnostic and surgical. He is skilled at conducting HF activities at all stages of the development process – from front end user needs research through to formative studies and validation for product submission to regulatory bodies.

Reflecting his commitment to advancing the discipline, Alex has collaborated with highly skilled Human Factors professionals on the publication of industry reports and seminars.

Massimo Micocci, PhD
Associate

Massimo is a Human Factors and Human-Centred Design specialist with 10+ years of experience helping MedTech companies bring safer, more usable devices to market and into clinical practice. He is a product design engineer by training (MSc) and holds a PhD in Human-Centred Design from Brunel University London. He is an Honorary Research Associate at Imperial College London’s NIHR HealthTech Research Centre in In Vitro Diagnostics and has published widely in peer-reviewed journals and at international conferences.

As co-founder of the consultancy partner Lumina Health Tech, he leads usability engineering programmes that meet UK, EU and US regulatory requirements. His work covers in vitro and point-of-care diagnostics, infusion and drug delivery systems, and AI-enabled diagnostic software, in hospital, community and home settings. He specialises in high-fidelity clinical simulation and real-world workflow studies. These studies expose the use errors and adoption barriers that benchtop testing misses, and the findings feed directly into design decisions, regulatory submissions and NHS adoption evidence.

Massimo also contributes human factors strategy to successful national and EU grant applications for MedTech innovators.