Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms

Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

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

Xenon Flash Lamps for Medical Devices

Hamamatsu’s Xenon flash lamps feature a long lifetime, low heat output, a high intensity output, and high stability. They’re ideal for use in blood analyzers and in instruments for in vitro diagnostics.

Drug Eluting/Combination Products

ProMed Pharma is a division of ProMed that specializes in manufacturing polymer-based drug-releasing implantable medical device, and combination device components. ProMed’s 25 years of experience working with silicone-based implantables, combination products, and solid implants has allowed them to leverage their molding expertise for established and start-up medical device and pharmaceutical companies.

Solenoid Valves: LFN Series
Solenoid Valves: LFN Series

The LFN Series Solenoid Valves are 2-way, normally closed, diaphragm valves. These valves feature an isolation diaphragm on an inert housing, making the valves suitable for controlling critical and aggressive fluids.

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.

Deuterium Lamps for Blood Analyzers

Hamamatsu’s line of deuterium lamps feature excellent stability, a long lifetime, and high output brightness, making them an ideal light source in blood analyzers.

Miniature Inert Systems of Tubing and Components (MINSTAC)
Miniature Inert Systems of Tubing and Components (MINSTAC)

The Lee MINSTAC System is made up of a variety of small, inert tubing and connection components that are designed to precisely control flow, rate, pressure, filtration and other performance factors of aggressive fluids.

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