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

canon image
Motion Control Products: DC Motors

Canon offers a variety of brushless, coreless, and ironcore DC motors that are custom manufactured to achieve the exact speed, power, and currents required for OEM applications. These motors are supplied with attached gears, pinions, pulleys, lead wires, and conductors in order to reduce OEM labor and material costs.

Torus Concave Grating Spectrometer - Low Stray Light, High Throughput

Ocean Optics’ Torus miniature spectrometer delivers scientific grade performance from 360-825nm. Torus has a unique toroidal concave grating design for improved thermal wavelength stability and low stray light. Low stray light, high throughput and excellent thermal stability make the Torus ideal for a wide range of demanding research and OEM applications

Miniature Stepper Motors
MicroMo's 2-phase miniature stepper motors are constructed with two different technologies. The AM series motors are constructed with a patented technology allowing for maximum power in a small package
R10699 Photomultiplier Tube

Hamamatsu’s R10699 is a new 28 mm (1-1/8 inch) side-on photomultiplier tube (PMT) with high sensitivity from UV to NIR (185 nm to 900 nm). It also features a high gain value and high quantum efficiency (QE), giving this new PMT very high sensitivity and good signal-to-noise ratio.

LIBS Broadband Spectrometer System: LIBS2500plus

Ocean Optic’s Laser-induced Breakdown Spectrometer Measurement Systems are detection systems that permit real-time qualitative measurements of elements in solids, solutions and gases. These broadband, high-resolution systems provide spectral analysis across a wide 200-980 nm range (depending on the system) at a resolution of ~0.1 nm (FWHM). The LIBS2500plus is a much-improved system from our previous LIBS offerings. Advantages of the new system include a smaller footprint,  Increased system sensitivity due to the elimination of internal fiber and more functionality for use with external triggering options, such as delay generators.

Optics - Perfect To Within λ/30!
Thanks to the development of innovative new surface finishing technologies, ELCAN Optical Technologies can now offer reflective optical surfaces with <30 nm PV accuracies & micro-roughness <0.5nm rms, perfect to within λ/30.
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