MEDICAL DEVICE DESIGN
Our Approach to Medical Device Design
We use award-winning insight and design expertise to help ambitious med-tech companies create world-leading, easy to use medical products.
We operate within robust quality management systems, as demonstrated by our ISO 9001:2015 certification. We also regularly work within clients’ ISO 13485 systems, enabling us to integrate as an extension of their team.
Confidence in Achieving Compliance
Working in accordance with ISO13485 standards, we have experience developing devices across all classes of the MDR – Class I, IIa, IIb, and III. Our approach involves conducting thorough research to uncover key user needs, considering factors such as people, product, place, and risk. Early risk identification leads to smoother regulatory approval. Along with others, these insights serve as the foundation for creating a validated design specification.
“Smallfry took the time to really understand what we were trying to achieve and rapidly became a key part of the team here at Microbiosensor. They were really easy to work with, always professional and well informed and continually delivered on time and to budget.”
“The medical device sector has its own particular challenges and constraints, but Smallfry have enough experience to take all this in their stride, helping us narrow down our design brief, build and evaluate early prototypes, source suitable manufacturing partners and then complete the CAD/CAM work-up and commission our final commercial product. We couldn’t have done any of this without them!”
“Smallfry bring a wealth of design experience to a project, combined with practical problem solving skills and insight into user needs that are essential to success – we couldn’t recommend them highly enough.”
Gordon Barker
CEO at Microbiosensor Ltd
Addressing the key challenges surfaced by the research insights draws on the inspiring creativity and almost obsessive attention to detail of the team. Mindful of the importance of sensitivity to the patients’ needs, our knowledge and experience enables us to carefully balance the tensions between appropriate manufacturing processes and commercial realities.
Planning for Medical Design
Effective planning is nowhere more essential than when developing medical devices and equipment. Our stage gate process supports an impressive track record of successes. Effectively planning from the beginning enables the key risks to be identified early, intellectual property to be captured, recorded, and exploited to maximum effect, while the whole program of work is orchestrated towards a positive outcome for all the stakeholders involved.
Fail Fast & Learn Early
Throughout the design process, we continuously iterate and improve concepts while adhering to the necessary MDR and FDA certifications. We subject the device to rigorous testing and validation using a wide range of prototyping techniques to enhance performance and refine the design. At each stage, we measure usability and human factors, generating evidence for the device’s safety of use, including compliance with IEC 62366 and FDA human factors pre-market evaluations.
Smallfry’s extensive experience spans medical device start-up “stars” including MicroBioSensor and Quanta DT, as well as established organisations such as Medtronic, Baxter, and prestigious universities like Imperial College London (Hamlyn Centre), University of Birmingham, and Oxford University.
Smallfry are also a patron of Medilink Midlands, a member of the West Midlands Health Technologies Cluster, and a delivery partner on the West Midlands Health Tech Innovation Accelerator.
We believe in working closely with our clients to ensure we create devices that are intuitive, efficient, effective, and embraced by all the people whose lives they improve.
For a no obligation discussion about your next innovation, make an online enquiry or call us at +44 2476 545678.
