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

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.

Laerdal Error-Proofs Medical Kit Assembly With AI-Powered Vision Verifications

Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports continuous improvement through real-time monitoring and visual documentation.

More White Papers & Case Studies

DESIGN COMPONENTS & SERVICES

2 W Xenon Flash Lamp Modules (L12336 Series)

These new xenon flash lamp modules integrate a 2 W xenon flash lamp, power supply, and trigger socket into a compact cube package, the smallest in its class. Other features include high stability, long lifetime, and broad emission range from UV to NIR. The L12336 series lamp modules are suitable for integration into portable instruments used in spectroscopy, blood analysis, and environmental monitoring.

image1
APC Series: Couplings
The 1/4" flow APC Series couplings feature a plastic thumb latch, fewer moving parts, and a smooth contoured design to deliver ease-of-use and excellent flow in a compact size. The APC Series has been expanded to include couplings with valves and thumb latch shrouds. A more rugged design on some models adds durability to increase the APC's application range.
Custom Kits And Trays
Custom Kits And Trays

With decades of experience and a substantial capacity for producing kits, the B. Braun OEM Division is capable of packaging standard components with customers’ proprietary products to meet requirements of each medical procedure and application.

Medical Device Polisher: Scepter Polishing System
The Scepter Medical Device Polisher features automated PC control; integrated air-polish routine; 12 connector support; singlemode and multimode fiber In-line video inspection; telcordia compliant. This fiber optic polishing system is optimized for mid to high volume connector polishing.
Plastic Optical Fiber Devices
The company designs and manufactures plastic optical fiber devices for the transfer of light, data, and images.
Scintillator Plates for X-Ray Imaging Systems

Hamamatsu’s scintillator plates can be coupled to a CCD or CMOS sensor in order to achieve real-time radiography. This makes them ideal for a variety of x-ray testing systems for medical diagnosis applications.

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