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

Low Profile Miniature Positioner: MX80S Stage

This 35 mm high x 80 mm wide stage offers reliable positioning in space-restricted medical device applications. The multi-axis platform can be used in normal or cleanroom environments and has selectable travels of 25, 50, 100, and 150 mm.

IRPrestige-21 Spectrophotometer
Shimadzu was the first company to offer dynamic auto-alignment as a standard feature in an FTIR spectrometer in its' price range. With state-of-the-art technology, the Shimadzu dynamic alignment system continuously maintains optimal alignment during data acquisition, ensuring consistently reproducible spectra without the need for tedious mechanical adjustments.
Miniature Medical Device Motors

MICROMO’s range of miniature medical device brushed motors has expanded with the addition of two new graphite commutated motors.

Miniature Diaphragm Liquid Pumps: LTC Series

These liquid pumps offer up to 650 mLPM free flow and are ideal for clinical diagnostics devices for urinalysis, liquid chromatography, and clinical chemistry. Maximum suction, priming, and continuous dry operation is made possible through a monolithic diaphragm pump design.  

Imaging Couplers

These imaging couplers are designed to connect to an endoscope in order to provide high resolution and high definition images. This is particular useful in medical procedures like surgery, gastrointestinal and respiratory tract observation, and more.

Hexapod Multi-Axis Motion Systems
6-Axis Micro Robotic Positioner

Hexapod motion systems are based on six high-resolution actuators acting on one platform through a parallel kinematic arrangement. The advantage is a smaller design, with higher dynamics and precision compared to classical multi-axis motion.  A sophisticated controller allows the user to change the pivot point at will.   The bottom line is an extremely versatile motion,  very similar to a human hand, which is why in medical engineering hexapod positioners are often used for handling systems and for surgery and endoscopy. In therapeutics, they allow the patient to be placed in exactly the right position, e.g. for the treatment of a tumor.

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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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