MEDICAL DEVICE DESIGN
How Smallfry can help with Medical Design
Medical device design is a complex facet of design that needs specialised care and attention to resolve the challenges of delivering your new product to market swiftly. Smallfry have exceptional experience in this sector having worked on countless designs.
Underpinned by the foundations of innovation; desirability, feasibility and viability, we have an effective process of development to balance speed, quality, and costs.
For many years, Smallfry has worked at the leading edge of science and technology to develop innovative medical devices. Our expertise lies in applying human factors, usability, engineering, and innovation.
We recognize the significance of a robust quality management system and the advantages of establishing and maintaining comprehensive Design History Files (DHF). We can offer help with the creation of a DHF to meet US + UKCA/CE mark requirements for submission or happily work together with your existing team and advisors.
Confidence in Achieving Compliance
Working in accordance with ISO13485 standards, we have extensive experience in developing devices across all classes of the MDR – Class I (low risk), Class IIa (medium risk), Class IIb (medium/high risk), and Class III (high risk). Our approach involves conducting thorough research to uncover key user needs and desires, considering factors such as people, product, place, and risk. Surfacing the risks to vigilantly managing them naturally helps speed the approvals process. These along with the other insights serve as the foundation for creating an optimized 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 and learn early. It’s ultimately quicker
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 startup ‘Stars’ like MicroBioSensor and Quanta DT, as well as established organizations such as Medtronic, Baxter, and prestigious universities like Imperial College London (Hamlyn Centre), University of Birmingham, and Oxford University. Smallfry are members of Medilink Midlands and part of the West Midlands Health Tech Cluster.
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, please give us a call us on +44 2476 545678 or Make an Online Enquiry.
See below some of our success stories within the medical sector.
Click below to find out how we can help you with your latest medical project.