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.

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

Electrospun Polymer Solutions For Controlled Biological Interaction: Bioweb™ Technology

Zeus offers Bioweb™ electrospinning technology that produces polymer fiber solutions with thickness ranging from nanoscale to microscale sizes. These fibers can be used to electrospin fabrics with complex shapes, and produce a broad range of fiber and fabric properties. Possible solutions include encapsulation technology, spin membranes/sheets, and 3-D structures for coating substrates of varying shapes and sizes.

D Series Connectors

Engineers who design medical devices or equipment are constantly tasked with finding highly reliable solutions for the systems they’re creating. High reliability interconnect solutions are no exception, particularly where electrophysiology catheters, patient monitors, MRIs, intravascular ultrasounds, defibrillators, infusion pumps and laboratory equipment are concerned.

MicroMo DC Motors
DC Motors - MicroMo specializes in the design and assembly of miniature DC drive systems, components and controls based on the world's highest precision fractional and sub-fractional horsepower miniature DC motors...
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.

Design and Development of Advanced Optical Applications

Precision Optics Corporation, or POC, was formed over 30 years ago with the purpose of designing, developing, and realizing advanced optical applications and for volume production of specialized medical optical systems.

Short-Run Injection Molding for Medical Devices

PTI Engineered Plastics offers short-run injection molding for medical device design and molding, whether the need is for 15 pieces or thousands per year. Short-run molding reduces lead times and gets products to market much faster.

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