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

ER:Yag Laser Optics
The company offers standard and custom optics, including lenses, mirrors, and beam splitters for new and replacement applications in medical, surgical, and dental laser systems.
Linear Motor Positioners: mSR Series

The mSR (miniature square rail) series is made up of miniature, dual square rail guided, linear positioners designed to provide submicron level precision in two different form factors. These linear motor positioners utilize selectable levels of linear encoder technology configured to match the application need. Within the same form factor, OEMs have the option of either the precision grade mSR; the most accurate standard positioner able to achieve a repeatability of 5.0nm, or a cost competitive version; uses magnetic encoder technology for less precise applications.

Silicone Molding

ProMed’s state-of-the-art silicone molding for medical devices takes place in one of several class 10,000 cleanrooms with equipment which features integrated automation, multi-drop, cold deck technology, computerized control, and precise injection units operating off of proprietary technologies.

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NS4 ABS Series: Medical-Grade Couplings

Patented NS4 Series couplings feature non-spill valves in a compact size at a great price. These innovative couplings are lightweight, chemically resistant, and easy-to-use.

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Aliphatic Thermoplastic Polyether Polyurethane (ATPU) Polymers

DSM Biomedical offers medical-grade Aliphatic Thermoplastic Polyether Polyurethane (ATPU) polymers designed with exceptional physical and biocompatibility properties, specifically for lower processing temperatures. The combination of high strength and elongation makes them ideal materials for temporary implant applications.

High Speed Solenoid Valves: VHS Series
High Speed Solenoid Valves: VHS Series

These high speed solenoid valves can dispense microliter and nanoliter volumes at up to 1200 Hz and are ideal for high throughput screening in medical devices, as well as drug discovery. They feature a 250 million cycle (minimum) lifetime, response times as fast as 0.25ms, and operating pressures up to 120 psi.

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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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