From Concept to Design
When a customer needs specialized or non-standard products, the Bioconnect team kicks off the product development cycle of customer contact, research, requirements evaluation, drawings and design, model prototyping, tooling design and prototyping, first article fabrication and, on to actual product production. This was the process followed when the medical division of a large conglomerate approached us to develop this specialized cable and connector required for a newly designed event recorder.
The Design Process
- Part design
- Tool design
- The Manufacturing Process
Customer Contact and Research
In discussion with the customer, we learned that size was the most critical criteria for the cable, but the connector had to accommodate six pins and five shielded leads. The team conducted market research to determine if any commercially available components could be incorporated into the design while meeting all necessary performance specifications.
Requirements Evaluation
Research determined that a new connector system, cable termination and PCB connector must be developed to meet the customer’s needs. Simple as it may seem at times, the design process is quite complicated and requires constant evaluation and modification from the Engineering, Marketing, and Quality departments of both the vendor and the customer. When designing a new device, there are many ways to “skin” the proverbial cat, but usually very few are agreeable to all parties involved.
Drawings and Design
The design process can be broken into three areas: part design, tooling design and design of the manufacturing process. All components of the device are identified, sourced, and/or manufactured by Bioconnect. Part design is the design of the device to be created during the manufacturing process. Tool design encompasses the design of the mold tooling, fixtures, and all other related hardware items required during the manufacturing process. The manufacturing process is the creation of specifications, procedures, processes, materials requirements and related support criteria, such as testing and manufacturing monitoring.
3D Model and Prototyping
Preliminary sketches were evaluated by the design team and a few were rendered in 3D format. This 3D model is an ideal environment to determine required dimensions and verify clearances and mate-ability. The cable connector and PCB connector had to have a minimal insertion force, but have adequate retention to prevent disconnection during the course of normal daily activities by the patient wearing the device. This was a challenge. After the electronic 3D model approval, a physical prototype of each component was created to test function and fit. This process revealed that the original design was too small to accommodate optimum soldering of the device. The design was changed, a new model was rapid prototyped, drawings were revised and the go-ahead was given to develop the necessary tooling.
Tooling Design and Production Prototyping
Drawings were then generated for the design of the two sets of tooling: mold cavities, bars, inserts, bases and related devices that will be used to create the molded parts. These designs were submitted to a tool shop and after further evaluation by the toolmaker, the 3D drawings were used to program CNC equipment to create the tooling. Device Prototyping and Fine Tuning Using the new tools, prototype parts were molded, fabricated, evaluated and inspected for adherence to the original model specifications. As is typical, the new tooling required several small adjustments and modifications before it performed correctly. Prototypes were carefully evaluated by members of the design team and potential users and noted their feedback. Several dozen first run devices were manufactured and sent to the customer in time to preview their new device at a major medical show. Everyone, including the customer, had rave reviews for the finished device.