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

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.
MTD - micro design
Micro Part Design

MTD's micro part design uses three in-house micro technology tools  - MicroFill, MicroFlow, and MicroRunner - to optimize your micro part design.

LPV Series Pumps
LPV Series Pumps

The LPV Series is composed of variable volume, positive displacement pumps available in standard and high performance models. The pumps are designed with a small, light-weight size to permit the pumps to be located where the fluid requirements are needed, reducing the required transport volume of the system.

Product Development And Product Design
Product Development And Product Design

Donatelle offers product development and product design services that are integral to product success – spanning functionality, repeatability and cost effectiveness. Their highly qualified team of engineers, designers, machinists and toolmakers consult with customers from the start to help ensure critical medical devices and components are delivered on spec to market as quickly and cost-effectively as possible.

Rapid Medical Device Prototyping

ProMed sets themselves apart from other silicone molding contract manufacturers by eschewing popular 3D printing techniques that create prototypes made from similar materials to what the end result will actually be. Instead, they leverage their Rapid Prototype Development Department to offer their medical device manufacturing customers molded parts using the specified, final material in less than one business week.

Scintillator Plates for X-Ray Imaging Systems

Hamamatsu’s scintillator plates can be coupled to a CCD or CMOS sensor in order to achieve real-time radiography. This makes them ideal for a variety of x-ray testing systems for medical diagnosis applications.

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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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