Medcial Devices



Medical devices product development consultant in London

I support companies in the medical devices sector around London and Cambridge in a variety of product development activities. From planning and roadmapping all through documentation and CE / FDA technical file compilation. Medical devices product development requires special attention to the regulatory requirements which includes Verification, Validation and Risk management. My experience in compiling technical files for drug delivery and medical therapy devices allows me to identify aspects that might need special attention and prioritise development activities to cover all regulatory factors.

Drug delivery and medical devices product development require a thorough and well documented design process that also allows breakthrough innovation and a fast design and engineering process. Having worked in several consultancies and with start-ups in  the medical sector around London and Cambridge, I am used to provide a quick and efficient response to design, engineering, usability and regulatory challenges.

My experience is mainly on CE and FDA regulations. I follow ISO 13485 and 21 CFR processes where I have developed class I, IIa, IIb and III devices with complete technical files including design verification and human factors validation.

I am familiar with the most relevant ISO standards, such as:

-60601 (electrical safety)

-62304 (software)

-10993 (biocompatibility)

-14971 (risk management)

-62366 (usability)

 Within the medical sector, I specialize in drug delivery, wound care and medical therapy, but have worked in diagnostics, surgical and other devices including connected devices and electromechanical systems

 I have experience in designing products for a wider range of sectors and technologies, including Drug delivery, surgical devices and medical therapy.  



Drug Delivery




Maximum attention to detail and understanding of complex regulatory regulations.







Understanding of advanced technologies that require high tolerance processes.



Therapy devices




With patient outcome and experience as a priority to deliver the ideal treatment.


Surgical Devices


Precision, ergonomics and cost that improves complex procedures.



Intimate care



Understanding patient’s concerns and responding with appealing solutions


wearable 1   

 Finding the right balance between a consumer and medical product


Medical Devices Development process

When developing medical products, it is critical to follow a rigid documentation process to deliver a comprehensive technical file and documentation in compliance with different regulatory requirements.

My approach is to follow a “V” model that aligns with ISO 13485 and 21 CFR. This model sets out the documentation and quality requirements from early stages, including a detail look at risk management following 14971 processes and the required verification and validation stagey from the outset.

My experience not only concentrates on the design and engineering, but can also assist companies and clients in the medical sectror on their regulatory documentation, technical file and design verification process. 



Connected devices design and enginering

Connectivity has become a key technology area that can be used to improve patient’s compliance and behaviour.  I have worked on the design of several connected drug delivery devices, developing different platforms and technologies to track how a device has been used and assist patients on the learning process of how to use their device efficiently.

Connected devices require special attention to several areas. On one side the technical aspects such as using the right sensors and optimizing energy use to reduce battery size. Another one, is an efficient use of electronics and software to obtain a sleek performance and communication. Finally an intuitive and elegant interface that will engage patients



Regulatory roadmap and strategy consultancy

A critical aspect of medical devices development is to have a clear understating of the regulatory process, documentation requirements and define a regulatory strategy. I support medical devices and drug delivery companies in planning product development activities where we set clear goals, targets and milestones that align with available budgets and stakeholders’ requirements.

The chart below describes how complex the regulatory documentation workflow is and that having a good planning in this area will help delivering the required documentation at each stage.

To learn more about the regulatory strategy, look here



Design Verification

This is perhaps the most critical aspect of a medical device development programme as it will demonstrate that the product is fit for purpose and safe to use. Testing has to be conducted following a series of standards, with validated protocols using gage R&R or other methodologies and calibrated equipment. Planning in this area is essential and having a good verification strategy and plan will reduce costs and timescales considerably. My experience in this area covers from drug delivery devices to class III caseworks.




Human Factors Consultancy 

Regulations have become more demanding on demonstrating that devices are safe to use and free from use or user errors. This is a relatively new field where there is not a clear process to be followed and each device may require a different usability strategy. I have developed human factors reports that included formative and summative reports.

In my experience, the key on Human factors is the quality of the studies and not the quantity and conducting them at the right development phase, not to with every iteration. Also, allowing formative studies to be flexible and fast, while summative being rigorous and exhaustive. 

More about Human Factors and Usability




Helping you

I support from start up to multinational pharmaceuticals on different aspects of the product development and leading design teams. I can collaborate on contract, consultancy or associate basis. I am based in Cambridge and London UK

Find out more on how I work or contact me

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