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

Insert Molding For Medical Devices

Insert molding techniques can streamline the production of your next medical device and eliminate the need for additional secondary operations. This type of molding can result in consistency, stability, the potential for reduced size and weight, and design flexibility.

Tethered Plastic Caps For Tube Protection: MCN-TCP Series
Tethered Plastic Caps For Tube Protection: MCN-TCP Series

The MCN-TCP Series of tethered plastic caps are made from a low-density polyethylene to protect medical tubes and ports from contamination.  The caps are designed to be easily removed and reapplied when necessary for applications such as fluid drains.

Linear Servo-Motor Driven Positioner: MX80L Miniature Stage Series

This low-profile/miniature stage measures in at 25mm high x 80mm wide, making it the smallest linear servo-meter driven positioner currently available. It’s been designed to meet rapid-fire positioning of light loads within a small work envelope.

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PurSil® Thermoplastic Silicone Polyether Polyurethane (TSPU)

DSM Biomedical offers PurSil® Thermoplastic Silicone Polyether Polyurethane (TSPU), a novel copolymer that is strong yet flexible with proven biocompatibility and biostability. Because of its outstanding flexibility, oxidative stability, and thromboresistance, PurSil® TSPU is used in a wide range of medical devices, including ophthalmic, anastomotic, and continuous glucose monitoring.

Air/Gas Micro Diaphragm Pumps: T2-03 Series

These micro diaphragm pumps are ideal for medical instrumentation that requires flow up to 2.5 lpm. Their valve design provides the highest flow rates available with the lowest power draw in this package size, and their ideal for applications that require 10,000+ hours of operation.

Ceramic Core Aluminum Nitride (ALN)

Aluminum nitride (ALN) is a hard, dense, non-porous, high purity substrate. It offers excellent thermal conductivity and uniformity, superior moisture and chemical resistance, excellent size and shape capability, a precise and repeatable pattern, and distributed wattage.

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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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