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

Micro-PMT

Hamamatsu’s micro PMT is an ultracompact photodetector about the size of a fingertip, with the same characteristics as a conventional photomultiplier tube (PMT). Its small size, robust structure, high sensitivity, low noise, and fast time response make the micro PMT a suitable detector for high-performance portable devices and instruments. In addition, micro PMTs are easily mass produced and customized.

IDI Coaxial Probes

IDI Coax Probes consist of an extensive line-up of high reliability coaxial probes uniquely designed to address specific requirements such as testing at high frequencies, or needing an RF interconnection. The probes include features such as a controlled impedance signal path with reliable connect/ disconnect operations, a ring, quadrant or rectangular array footprint, customizable power, ground and signal paths, and advanced mechanical docking and interconnection systems.

Avalanche Photodiodes for Industrial and Analytical Applications
Avalanche Photodiodes – Silicon and InGaAs APDs
Excelitas’ rear entry “reach-through” silicon APDs offer the best compromise in terms of cost and performance for applications requiring high speed and low noise photon detection from 400 nm up to 1100 nm. These APDs feature low noise, high quantum efficiency and high gain while maintaining reasonably low operating voltage. The active area varies from 0.5 mm to 3 mm to accommodate a large variety of applications including laser range finding, confocal microscopy, free space communication, fluorescence detection, DNA sequencing, and particle sizing.
Solenoid Valves: 120 Series
Solenoid Valves: 120 Series

The 120 Series Solenoid Valves are composed of 2-way, ultra-miniature, magnetically latched solenoid valves. As the smallest solenoid valves in the world, it sets a new industry standard in reducing space, weight and power consumption.

Imaging Equipment
A line of imaging equipment for screen printing consists of lighting systems
CMOS Image Sensor
The company offers a 0.35 micron CMOS Image Sensors (CIS) process technology.
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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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