Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

A Better Interpretation Of POH In ISO 24971

Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

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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.

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DESIGN COMPONENTS & SERVICES

Optical Design On Steroids
This is the second in a four-part series on "design for manufacturing and assembly" or DFMA for short — an innovative way to bring prototypes, or even cocktail-napkin concepts, into profitable production.
Caplugs Custom Medical Molding
Caplugs Custom Medical Molding

Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.

Medical Module
ELCAN Optical Technologies can boast of being on the leading edge of technology while enjoying an accomplished history that reaches back to the very beginnings of modern optics.
Solenoid Valves: IEP Series
Solenoid Valves: IEP Series

The IEP Series is made up of 2-way, extended performance, axial-flow solenoid operated valves. Each of these valves are supplied with a 1/16” inlet and outlet stainless steel tubing, allowing the valves to be connected through the use of standard high-pressure chromatography fittings, or welded directly in place.

Plastic Injection Molding
Plastic Injection Molding

Our plastic injection molding process produces custom prototypes and end-use production parts in 15 days or less. We use aluminum molds that offer cost-efficient tooling and accelerated manufacturing cycles, and stock more than 100 different thermoplastic resins.

Rapid Medical Device Prototyping

ProMed sets themselves apart from other silicone molding contract manufacturers by eschewing popular 3D printing techniques that create prototypes made from similar materials to what the end result will actually be. Instead, they leverage their Rapid Prototype Development Department to offer their medical device manufacturing customers molded parts using the specified, final material in less than one business week.

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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.

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