Medical Device Design & Development

INDUSTRY PERSPECTIVES

Bad Cardiac Rhythm Causes The Blues
Bad Cardiac Rhythm Causes The Blues

At least 2.7 million Americans are living with AFib, according the American Heart Association (AHA), and that number likely is close to 45 million people worldwide. What advances are being made in the management of this condition?

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WHITE PAPERS & CASE STUDIES

  • The Smart Guide To Designing For Manufacturability

    To eliminate unneeded costs and reduce production time frames for custom injected molded plastic parts, it is important for designers to understand how to optimize the part design from its conception and throughout its production. 

A Medical Product To Effectively Treat Battlefield Wounds

The Office of Naval Research (ONR) sought a practical solution to a difficult problem that has been around since the advent of warfare: effectively treating wounds in a dirty, stressful environment.  

A Better Approach To Developing Medical Device Instructions For Use (IFU)

The common approach to designing and developing an Instructions For Use (IFU) has been largely unchanged for years: once a product is designed and made ready for manufacturing, an IFU is then written and tested. When errors are found, changes are made, and the cycle repeats until there is an acceptable IFU version that most users will be able to comprehend. Clearly, this approach is often time consuming and costly.

Keys To Bioabsorbable Process Development: Consistency And Control

A medical device company developed a bioabsorbable fixation design and concept that was commended by many surgeons in the industry. Unfortunately, after several years of working with a reputable molder, there was limited consistency and success in producing the part that was in their original drawings. MTD assisted the company by guiding them through material characterization and the development of a unique tooling construction concept to reduce secondary operations. MTD’s micromolded parts achieved minimal and consistent IV loss and were much more consistent shot to shot.

3 Consideration When Designing Injection-Molded Parts With Rapid Overmolding

Rapid overmolding sidesteps assembly hassles, simplifies product design, and can improve the characteristics of many injection-molded parts.

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DESIGN COMPONENTS & SERVICES

High Load Ceramic Bearings High Load Ceramic Bearings
Until now, the only way for design engineers to increase shaft loads on precision gearheads was to specify expensive ball bearings to replace cheap sintered bearings.
PAX-10M 10-Watt Precision-Aligned, Modular, Xenon Light Source Product Note PAX-10M 10-Watt Precision-Aligned, Modular, Xenon Light Source Product Note
Excelitas Technologies’ latest precision-aligned and pre-calibrated xenon module, PAX-10M, offers a full 10 Watts of power in a compact, modular design with a remote flash head allowing for easier integration in space-limited applications. The PAX-10M is the ideal pulsed Xenon light source with “Plug-and-Play” functionality for clinical diagnostics, invitro diagnostics, life sciences, drug discovery, proteomics, and analytical instrumentation applications.
PMC12 Series: Couplings PMC12 Series: Couplings
The 1/8" flow polypropylene PMC12 offers many of the same configuration options as the PMC. The polypropylene material adds greater chemical resistance for more demanding applications. PMC12 couplings are also gamma sterilizable.
Medical Silicone Processes Medical Silicone Processes

FMI is committed to providing the highest quality of silicone components for medical devices. Using the highest process controls alongside the most rigorous quality tools, FMI is able to ensure patient safety and 100 percent inspection of every single component before it ships.

Safe and Cleanable Connecting Solutions for Medical Applications Safe and Cleanable Connecting Solutions for Medical Applications

The Fischer Core Series of stainless steel connectors are comprised of 316L, PEEK, and EPDM materials for outstanding chemical, temperature, and radiation resistance. This line has been specifically designed for use as a long-term and reliable connector solution in severe environments.

Miniature Optical Encoders For Medical Positioning Devices Miniature Optical Encoders For Medical Positioning Devices

The SR series of miniature optical encoders has been designed to fit into motion control devices with limited space, such as robotic arms for surgery, nanopositioning stages, microscopes, and other medical devices.

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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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