Medical Device Design & Development

For more than 30 years, medical device design and development has been the core focus of Synectic’s business model. We have proven time and time again that we are the experts when it comes to getting a working medical device to market.

Our medical product design process focuses on user experience, cost efficiency and manufacturability all while maintaining the strict ISO 13485 quality standards you have come to expect from Synectic.

Best of all, our relationship with Mack Molding means your design remains in-house during every step of the process, from initial concept all the way to high-volume manufacturing.

Learn about all our medical device design services below or visit our Design page for examples of our work.

Device Specifications/Requirements

The Product Development Specification (PDS) outlines the user and functional requirements for the device. A PDS is a critical document that has been a standard component of Synectic’s design process for over 30 years to ensure that all requirements are communicated accurately between the customer and the design team.

Intellectual Property Review

Synectic’s engineers will review the patent landscape and provide an assessment of the claims and device being developed. This assessment will determine if the IP is expired, how specific the claims are or if the same functionality can be achieved via a different mechanism.

Competitive Device Analysis

Being second or third to market can have its advantages, because understanding the opportunities for improvements often creates a better solution. To ensure you go to market with the best possible product, Synectic can benchmark current devices and interview end users to identify potential improvements.

Concept Generation

Synectic’s engineers, inventors, designers, and manufacturers collaborate with the client to brainstorm initial design concepts that solve the identified problem and are manufacturable. These concepts are communicated using hand sketches, breadboard models, or CAD.

Concept Design

Hand sketches of the concepts are converted into detailed CAD designs using Solidworks or ProEngineer software. Individual parts are created to a level of detail that allows the parts to be fabricated using rapid prototyping techniques. Assemblies are created that depict the entire device and how the parts are interconnected.

Prototype Development

Parts are fabricated using machining, SLA or FDM services and first article inspections are conducted to ensure that the parts were made accurately. Individual parts are assembled and tested by the design engineer to verify that they meet the intended design goal.

Testing

To document that the design meets the intended functionality, Synectic conducts all tests using an approved protocol based on the Product Development Specification. A test report is written documenting the findings.

Quality Documentation

As part of our ISO 13485 compliant quality management system, Synectic is diligent in documenting product specifications, weekly updates, design review minutes and decisions, and testing results. Maintaining a detailed Design History File is a core value and a differentiator of Synectic’s design process.