Industrial Product Development
Spotlight
Company: Polychrome Medical
Industry: Medical Diagnostic Equipment
HQ: Eden Prairie, Minnesota, USA
Webpage:
PolyChrome Medical LLC has been involved in sweat chloride testing for 20 years, manufacturing the CF Indicator™, a qualitative screening test for cystic fi brosis. The CF Quantum® Sweat Test System is PolyChrome’s new quantitative diagnostic test
Product/Project Highlights
Quantum Analyzer
Client: Polychrome Medical
- Part of the CF Quantum System to detect cystic fibrosis in infants
- Image processor analyses sweat samples collected on a disposable pad
- Digital signal processing (DSP) algorithm designed by Solid processes the image if the seat reaction of the pad and calculates a rating of the degree the sample represents a true positive result for cystic fibrosis
- Solid developed the product from initial concept thru pilot production
- Solid engaged and directed Electrical and Firmware engineering resources”
Situation:
PolyChrome Medical approached Solid to create a new class II medical device to capture an image and digitally analyse it to calculate the degree from 0 to 99, of the image representing a perfect positive for Cystic Fibrosis. The image to be captured would be of an obsorbant pad treated to change colour in the presence of chloride, a marker for Cystic Fibrosis. This image processing device needed to determine the relative quantity of chloride contained in a sample of sweat. A touch screen interface was desired to control the analysis process and display the concentration numerically in terms of a mmol/liter estimate.
Quantum Analyzer
Client: Polychrome Medical
Process:
Solid participated from the beginning through prototype testing and a small production run following our Phase Gate Process for product design and development. Involvement included all Industrial Design, mechanical engineering, design and project management. Electrical engineering was conducted by a contracted resource managed by Solid. We started by working with PolyChrome Medical to summarise the product requirements, FDA requirements for this type of Class II medical device and then developed multiple conceptual approaches to meet these requirements. Together with our Client, PolyChrome Medical, Solid developed the product architecture, physical form, mechanical functionality and user interfaces. Once the conceptual approach was refined and approved by our Client, Solid completed the detailed design in CAD, conducted detailed design reviews and created engineering drawings. At first a crude benchtop prototype was built to prove out the design and support continuing firmware programming. Solid then sourced suppliers and solicited proposals for both full prototyping and production quantities and for production tooling. Solid then coordinated all prototype component moulding, printed circuit build and final programming. Solid was instrumental in determining the strategy and functionality for firmware and the electronics.
Solution:
The Quantum Analyzer was born! With some final changes to the firmware everything works well and the product looks great. The user interface is easy to follow and users love the improvement over previous methods which took many hours and were uncomfortable for the patients, often infants. Once the sweat sample is gathered onto the treated pad, a chemical reaction changes the colour in a patern on the pad which is dependant on the concentration of chloride in the sweat collected. The digital signal processing (DSP) algorythm developed by Solid, provides the user with an estimated concentration number, the higher the number the more of a positive indication of Cystic Fibrosis.
