Medical Device Design & Product Development

Medical devices you can rely on

This is where Synectic excels. For more than 30 years, medical device design and development has been the core focus of Synectic’s business model. As industry leaders, we have proven time and time again that we are the experts in getting a reliable medical device to market. With our highly knowledgeable team of engineers who have decades worth of experience designing and developing medical devices, we are able to overcome even the most daunting design challenges. Our medical product development process focuses on usability, cost efficiency, and manufacturability all while maintaining the strict ISO 13485 quality standards you have come to expect from Synectic.

From capital equipment to handheld medical devices, Synectic has designed it all. We know how daunting getting your medical device to market can be and we are here to help. Our experts are available to walk you through navigating the patent landscape, gaining FDA, UL, and ADA approval, clinician feedback/VOC studies, in-vitro and in-vivo design testing, and the myriad of quality documentation necessary for manufacturing. Best of all, our relationship with our parent company 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 and see how we can tackle your challenge. If you do not see a particular medical device design service you are looking for, contact us and we would be happy to discuss your project needs further.

Device Specifications/Requirements

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

Intellectual Property Review

Synectic’s design engineers will review the patent landscape and provide an assessment of the claims and medical 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 an alternative development path.

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 medical product, Synectic can benchmark current medical devices and interview end users to identify potential improvements.

Concept Generation

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

Concept Design

Hand sketches of the device 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 medical device and how the parts are interconnected.

Prototype Development

Parts are fabricated using our extensive array of prototyping 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 medical product development goal.

Testing

To document that the medical 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 development 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 medical design process.

Medical Device Design

Medical devices you can rely on

We Don’t Just Design Medical Devices

We Save Lives

Medical Device Design Capabilities

When you need a reliable medical device

Our extensive medical device design capabilities have you covered.

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