Medical Device Design & Development

INDUSTRY PERSPECTIVES

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. 

Mastering Cultural Intelligence In Global Quality And Regulatory Leadership

The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. Leaders who master cultural intelligence build quality systems that leverage diversity as competitive advantage.

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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

Penny Motors
Penny motors from MicroMo feature no cogging or preferred rotor position. These motors are ultra-flat with low current consumption...
Light Capacity Rodless Miniature Linear Positioners: LCR Series

This series of linear positioners is ideal for medical device OEMs looking to automate light payloads. They’re ideal for applications involving sample preparation, liquid handling, microtiter automation, and elevators and storage/retrieval axis.  

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.

canon image
Motion Control Products: DC Motors

Canon offers a variety of brushless, coreless, and ironcore DC motors that are custom manufactured to achieve the exact speed, power, and currents required for OEM applications. These motors are supplied with attached gears, pinions, pulleys, lead wires, and conductors in order to reduce OEM labor and material costs.

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.
Solid Imaging Systems
The SLA series of solid imaging systems creates accurate, detailed parts and prototypes
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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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