Medical Device Design & Development

INDUSTRY PERSPECTIVES

Conducting A Medical Device Stability Study: A Practical Guide

Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.

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. 

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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.

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DESIGN COMPONENTS & SERVICES

Electrospun Polymer Solutions For Controlled Biological Interaction: Bioweb™ Technology

Zeus offers Bioweb™ electrospinning technology that produces polymer fiber solutions with thickness ranging from nanoscale to microscale sizes. These fibers can be used to electrospin fabrics with complex shapes, and produce a broad range of fiber and fabric properties. Possible solutions include encapsulation technology, spin membranes/sheets, and 3-D structures for coating substrates of varying shapes and sizes.

D Series Connectors

Engineers who design medical devices or equipment are constantly tasked with finding highly reliable solutions for the systems they’re creating. High reliability interconnect solutions are no exception, particularly where electrophysiology catheters, patient monitors, MRIs, intravascular ultrasounds, defibrillators, infusion pumps and laboratory equipment are concerned.

Cleanroom Injection Molding for Disposable Medical Devices

Phase 2 Medical’s Rochester, NH location was recently outfitted with 2,500 sq. ft. ISO Class 8 (100,000) cleanroom facility with an injection molding press. This was done in an effort to integrate quality plastic components in their customers’ disposable medical devices.

Light Capacity Rodless Miniature Linear Positioners: LCR Series

This series of linear positioners is ideal for medical device OEMs looking to automate light payloads. They’re ideal for applications involving sample preparation, liquid handling, microtiter automation, and elevators and storage/retrieval axis.  

Miniature Proportional Valves: VSO® LowPro Series

Parker Hannifin’s VSO® LowPro Valves are designed to offer enhanced flow control for inert gases in applications where typical flow rates reach up to 50 SLPM with a maximum of 1.5 Watts at room temperature. These miniature valves are 16 mm wide by 14 mm tall, with an orifice of up to up to 0.080” (2.03 mm) and a weight of 12 g. They can be inserted into the smallest portable devices to improve performance, size, and weight, and can perform the function of valves three times their size without sacrificing the power.

Semiconductor Technology for Implantable Medical Devices

All mission critical functions are accessible within the MST group to provide miniaturized packages. Capabilities include design, substrate manufacturing, component selection and validation as well as all major semiconductor packaging processes.

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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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