Medical Device Design & Development

INDUSTRY PERSPECTIVES

Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis

Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations

A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

Building World-Class Global Quality Teams That Break Down Silos

Over 25 years leading global quality and regulatory organizations, I've learned that the most difficult challenges aren't regulatory or technical; they're organizational and cultural. 

Mastering Cultural Intelligence In Global Quality And Regulatory Leadership

The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. Leaders who master cultural intelligence build quality systems that leverage diversity as competitive advantage.

More Industry Perspectives

WHITE PAPERS & CASE STUDIES

Choosing The Right PCD Configuration For Reliable Sterility Assurance

Accurate PCD configuration ensures sterility assurance. Learn how to align validation strategies with ISO standards, optimize cycle efficiency, and select the right BI format for EO sterilization success.

Life Sciences Corporation Implements eLogbooks Across 15 Sites

New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

Implementing A Next-Gen MES At A Fraction Of The Cost

Discover how a top medical device manufacturer accelerated product launch by digitizing assembly processes, streamlining training, and ensuring compliance.

Custom Orthodontic Aligner Manufacturer Ensures Compliance With Tulip

A pioneering orthodontic startup is transforming custom aligner production using 3D printing and software to cut time and costs in half while scaling rapidly to ensure quality and compliance.

More White Papers & Case Studies

DESIGN COMPONENTS & SERVICES

Flexible Heaters for Medical Devices

Heatron designs, and manufactures highly engineered flexible heaters and heating solutions for the medical device industry. These flexible heaters and heating elements are found in some of the world's most innovative and award-winning medical devices.  Heatron offers a range of flexible heaters designed to meet any challenge your engineering team is facing with product design.  If there is not a flexible heater solution, Heatron’s engineering team will work directly with you to develop a customized solution that fits your need.  The lines of flexible heaters for medical devices are:

Flow Control Valves (For Plastic)
Flow Control Valves (For Plastic)

The IMH Flow Control Valves perform functionally as an orifice in parallel with a check valve. Available in 5.5mm and 8.0 mm diameters, each valve features a press-in installation for plastics. Valves can be installed in either direction, providing forward and reverse flow capabilities.

Brushless DC Servomotor: 1218...B Series

With MICROMO’s brushless DC electric motor, the ironless, self-supporting, skew-wound copper coil is a component of the stator.

Medical Grade Silicone For Medical Device Components
Medical Grade Silicone For Medical Device Components

Flexan uses medical grade silicone for implantable and disposable medical devices that require high performance and safety characteristics whenever in contact with a human body. With no side effects and the ability to be sterilized, this material meets or exceeds all USP Class VI test requirements. It will also retain its shape under pressure and temperature extremes.

Plastic Optical Fiber Devices
The company designs and manufactures plastic optical fiber devices for the transfer of light, data, and images.
CNC Turning Capabilities
CNC Turning Capabilities

The Proto Labs CNC turning process is capable of producing custom prototypes and end-use production parts in as fast as one day and is best used for creating parts with cylindrical features, as well as parts with axial and radial holes, flats, grooves, and shots.

More Components & Services

MEDICAL DEVICE DESIGN & DEVELOPMENT

Medical device design and development is the cyclical process of creating a device for a specific task or set of tasks, and then continuously reevaluating its effectiveness and improving upon it until the device reaches obsolescence. Design and development begins with ideation and the creation of a concept that, if found to be both fiscally and clinically viable, is then designed, engineered, and prototyped. This preclinical period includes bench testing — accomplished through simulated use of the product — and animal testing, along with any necessary redesign work.

Throughout the process, the proposed medical device, and the process by which it will be manufactured, is examined for flaws that may negatively impact the device’s safety, market viability, regulatory acceptance, customer satisfaction, usability, or profitability. Any shortcomings are corrected, and the improvements applied to the final design. Due to the wireless connectivity capabilities of many modern medical devices, cybersecurity and interoperability also must be incorporated into the design. Clinical testing is conducted, using human subjects, to further expose flaws and confirm product strengths. Once both the product design and the manufacturing process have been validated and approved by the U.S. Food and Drug Administration (FDA), production and commercialization of a device may begin.

LATEST HEADLINES

More News