DYSIS Smart Colposcopes

Based on previous positive work by another team, DYSIS Medical engaged with i4pd as their new medical device design consultancy to enhance the DYSIS® Ultra Colposcope, but this project developed significantly to include a totally new product – the DYSIS 'View Colposcope'. The company's range of smart colposcopes, with care coordination features and innovative computer-aided cervical mapping, generates the data to help advance the expertise of healthcare professionals to detect cervical lesions and direct the patient journey.

Medical Designs with Distinction.

Background

DYSIS Medical is an innovative medical device company that combines computer-aided cervical mapping technology with advanced colposcope design to help healthcare professionals detect cervical lesions in their patients. The colposcope manufacturer first approached i4pd to collaborate in the redesign of its flagship smart colposcope, DYSIS Ultra, and this relationship led to the further development of its compact colposcope, DYSIS View.




Challenges

Some challenges within the brief included:•  All materials used could not allow rust to develop and needed to have smooth surfaces that were easy to clean• The final assembly of the Ultra's arms to the unit should only require a set of Allen keys with no special tools or training required• No aspect of the Ultra's arms should have required on-going maintenance throughout the product’s life• Constant force hinges had to be employed in all joints of the Ultra, with forces that were consistent regardless of the point of rotation• A key target to reduce cost of the View was to replace the articulated arm system with a lower cost solution• The View's ergonomic positioning was important, as face-to-face contact between clinician and patient provides reassurance

Approach

The DYSIS family of smart colposcopes that i4pd worked on included DYSIS Ultra, the premium model from the manufacturer's product line. Our design team was selected to redesign the aluminium arms of the colposcope. Using our wealth of mechanical engineering experience, the team found an innovative way to incorporate gas springs into each arm to allow the product to have superior stability and move smoothly at all times, but especially during examinations. Following the successful delivery of the redesigned arms for DYSIS Ultra, our medical device design consultancy was then selected to expand the DYSIS product line. This took shape in the form of the compact and portable DYSIS View colposcope, which was designed to navigate around an examination table with ease.

Product Research

Key members of the design team were invited by DYSIS to visit a Luton-based hospital in the United Kingdom, where they were able to investigate the environment in which the DYSIS View colposcope would be used. This helped our team further envision the user work flow and enabled our industrial designers to have a comprehensive understanding how the product will interact with both the patients and clinicians. As the DYSIS View aimed to be a more compact version of the Ultra, the team observed and experienced the examination table dimensions that helped shape the final design. Data was also gathered from US colposcopy locations as part of this research.

 

Concept Generation

Our design team created a broad range of options for the DYSIS View. We focused on creating a minimal, sleek form factor with a great deal of effort placed on maintaining a discrete appearance. While it was important to have a clean aesthetic, it also had to be easy to clean from a practical perspective. Ergonomics shaped each design concept as this was a huge deliverable for the client. The colposcope’s colour scheme was selected with whites and cool greys to blend in with the medical environment.

i4pd ergonomic model of medical device

Prototyping

In earlier stages i4pd created 3D-printed models, initially for ergonomic evaluation purposes, and then for internal review and some specific functionality testing. It was paramount that the products would have the right ‘feel’ when being used by healthcare professionals, and that they were easy to manipulate into position whilst remaining stable.

High-precision prototypes were then made by CNC to allow the team to perform fit and further functionality testing. The design team would hold regular feedback sessions with DYSIS throughout the project. 40+ custom components in total were created (some of which were used on multiple occasions) including all screws and washers for the DYSIS View assembly, allowing the team to see how the entire colposcope would fit together. This helped to inform the client on the design-for-manufacturing process. The model was created to a level of detail that it included some of the final product's electrical components and wiring.

Tooling & Manufacturing Support

Manufacturing processes for the DYSIS Ultra and DYSIS View differed in that the latter will be manufactured in higher quantities. Design for manufacture and subcontract assembly support were important phases of work for both projects. As their medical device design consultancy we were on hand to provide that support as both products transitioned to production. In respect to the DYSIS Ultra, the image on the right illustrates what the team assessed. For this smart colposcope, the client intended for its arms to be manufactured and assembled by a subcontractor. The team assessed the design by disassembling and reassembling each arm using the necessary hand tools with the final manufacture time of a complete arm assembly (Optical and Display Arms) completed in just 60 minutes.

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