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

New Product Development for Silicone Medical Devices and Assemblies

ProMed’s Rapid Prototype Department and Technical Center allows them to focus on developing new silicone-based medical devices and assemblies quickly and efficiently. Prototyping gives their customers engineering samples to get a feel for what’s been designed before production, and their technical center makes prototypes that are or can be fully validated.

Direct Metal Laser Sintering Capabilities
Direct Metal Laser Sintering Capabilities

Proto Labs’ Direct metal laser sintering (DMLS) process is an industrial 3D printing process that is ideally used for prototyping in production-grade materials, functional, end-use parts, and for reducing metal components in an assembly. These fully functional metal prototypes and production parts can be created in 7 days or less.

Tethered Plastic Caps For Tube Protection: MCN-TCP Series
Tethered Plastic Caps For Tube Protection: MCN-TCP Series

The MCN-TCP Series of tethered plastic caps are made from a low-density polyethylene to protect medical tubes and ports from contamination.  The caps are designed to be easily removed and reapplied when necessary for applications such as fluid drains.

Hydrogels For Medical Devices
Hydrogels For Medical Devices

Cardinal Health’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.

UV Curing Light Sources

Hamamatsu offers UV-LEDs for curing adhesives in stents, catheters, needles, hearing aids, and other therapeutic medical devices. Their high output power makes them especially ideal for UV curing, and their low power consumption makes them an energy saving and environmentally friendly light source.

Protective Solutions For The Orthopedic Market
Protective Solutions For The Orthopedic Market

For more than 65 years, Caplugs has been a leader in plastic product protection and offers a variety of catalog and custom solutions designed specifically for the orthopedic market. As a qualified supplier to more than 1,300 medical customers including implant manufacturers, Caplugs protects vital components during shipping, storage, and processing.

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