Medical Device Design & Development

INDUSTRY PERSPECTIVES

5 Things Medical Device Engineers Should Know About User Research
5 Things Medical Device Engineers Should Know About User Research

When designing a medical device, nothing beats direct observation of, and feedback from, the people who will be using it. Ideally, this research is performed as a close partnership between the human factors (HF) researchers and the engineers who will be working on the device.

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WHITE PAPERS & CASE STUDIES

The Impact Of Connected Health Services And Smart Device Solutions On The Pharmaceutical Market

This article explores the rise of connected health services and smart device solutions in the pharmaceutical market and how these tools are leading the trend toward patient centricity by enabling direct interaction with end users using real-life data.

Molding Process Validation for Medical Devices: Five Things to Know

Understanding what is involved in injection-molding process validation and why it is important will help you choose a molding partner who can provide you with the confidence that your plastic parts will work well every time.

Designing Connected Health Systems To Improve Outcomes And Deliver ROI

The biopharmaceutical industry is not immune to the new opportunities that mobile and ‘Cloud’ technologies are opening up for new service and business models. Applications that will thrive on this new technology will improve patient outcomes and deliver strong return on investment for service providers.

Radar Technology Is Changing The Standard Of Care For Breast Tumor Localization

While the concept of RADAR (RAdio Detection And Ranging) is firmly entrenched in the common vernacular, the what and how of radar technology is not as broadly understood. 

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DESIGN COMPONENTS & SERVICES

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.

Medical Device Polisher: Scepter Polishing System 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.
Micromolding Micromolding

Micromolding, small injection molding, micro injection molding, and nano-micro molding are just some of the many terms used to describe the exacting process of molding micro-sized parts. Donatelle’s end-to-end attention to detail and perfection in micromolding makes all the difference for leading medical device companies.

RF Amplifier Module for Medical Embedded OEM Applications RF Amplifier Module for Medical Embedded OEM Applications

The need to embed high power RF sources that can be accurately controlled across wide bandwidths is all around us in imaging systems - from ultrasonic to HF RF MRI machines, and for ultra-precision measurement and control of liquids in medical devices. The KMA2040 RF amplifier module is ideal for embedded OEM applications such as these.

Solenoid Valves: LSP Series Solenoid Valves: LSP Series

The LSP Series consists of 2-way, manifold mounted valves with a normally closed design. The valves are equipped with features that including a working pressure of 15 psig, zero dead (unswept) volume, 30ms response time, and a full bore flow path.

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.

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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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