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

Miniature Single and Multi-Axis Linear Positioners: MX45S Series

This series of linear positioners/stages can be used to provide reliable linear positioning during the development and/or design of medical devices. They’re very small (45mm wide x 25mm high) and have 5mm, 15mm, and 25mm selectable travels.

Miniature Diaphragm Pumps: BTC IIS and TTC IIS Series

Both the BTC IIS and TTC IIS Series by Parker Hannifin comprise brush and brushless DC motor driven pumps ideal for medical applications such as anesthesia monitors, CO2 monitors, wound therapy, urinalysis, and trace detection.

Drug Eluting/Combination Products

ProMed Pharma is a division of ProMed that specializes in manufacturing polymer-based drug-releasing implantable medical device, and combination device components. ProMed’s 25 years of experience working with silicone-based implantables, combination products, and solid implants has allowed them to leverage their molding expertise for established and start-up medical device and pharmaceutical companies.

FILAC™ 3000 Electronic Thermometers
FILAC™ 3000 Electronic Thermometers

Cardinal Health’s FILAC™ 3000 Electronic Thermometer product family uses the most accurate predictive thermometer technology on the market. These thermometers are designed to make fast body temperature readings through the use of the mouth (oral), anus (rectal), and armpit (axillary). Developers can also integrate FILAC™ technology into multi-parameter units, and are therefore provided with the necessary mechanical models, drawings, communication protocols, interface documentation, and component samples for meeting the demands of the market.

Imaging Equipment
A line of imaging equipment for screen printing consists of lighting systems
Color Filter Glass

HOYA’s color filter glass products are ideal for applications involving medical devices, CCDs, imaging, telecommunications, calibration, electronic instrumentation, night vision, CRT/LCD/FED displays, and machine vision.

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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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