Medical Device Design & Development

INDUSTRY PERSPECTIVES

  • CAPA effectiveness-GettyImages-2283083181
    You Can't CAPA What You Can't Classify

    An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

Who Exactly Owns Quality?

We’ve all heard the rhetorical question, “Who owns quality?” And we all reply with the answer they expect to hear: “We all do!” This mindset needs to be fully integrated into the minds and systems of a company.

The Career Path Through QA Produces Better Medtech Engineering Leaders

Engineers with direct exposure to failure outcomes are more likely to build risk mitigation in from the start, not bolt it on later. When they're tapped for leadership positions, this makes them better leaders.

Navigating The New Era Of Design Controls For SaMDs: A Strategic Guide

This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the evolving landscape of AI/ML.

A Much-Improved Approach For Understanding And Managing Safety Risks

Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

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WHITE PAPERS & CASE STUDIES

The Life Sciences Guide To AI In Quality & Compliance

Implement AI in quality workflows without regulatory risk. Learn how strong governance and clear validation keep you audit-ready for compliance.

Extraction And Chemical Characterization Pitfalls In Complex Medical Devices

Standard extraction protocols routinely fail tissue-derived products, hydrogels, absorbables, and silicone implants. Learn the material-specific study design strategies that prevent regulatory rejection and repeat work.

Accuracy, Safety And Ease Of Use

Safety, ease of use, and accuracy guide modern medical device design, advancing through improved materials, engineering innovation, standards adoption, and user‑centered development.

Color Consistency In UHMWPE Medical Textiles

Color consistency improves surgical visibility, differentiation, and workflow efficiency, requiring medical textiles that deliver strength, compliance, and reliable quality in every color.

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DESIGN COMPONENTS & SERVICES

Class A Solid State Amplifier: 150W1000
Class A Solid State Amplifier: 150W1000

AR’s 150W1000 is a class A solid state amplifier that provides 1500 watts of output power from 80 to 1000 MHz. It has superior gain flatness, an exceptional noise figure, and better efficiency and harmonics than competitive products.

High Flow Diaphragm Air/Gas Pumps: T2-01 Series

These high-performance and high-efficiency diaphragm pumps offer up to 66 LPM free flow. They're ideal for integration into portable aspirators, transport ventilators, and other medical devices used in respiratory or clinical diagnostics applications.

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.

Thin Profile DC Micromotors
DC Motors - Thin Profile DC Micromotors from MicroMo Electronics feature ultra flat dimensions, with no cogging or preferred rotor position
Scintillator Plates for X-Ray Imaging Systems

Hamamatsu’s scintillator plates can be coupled to a CCD or CMOS sensor in order to achieve real-time radiography. This makes them ideal for a variety of x-ray testing systems for medical diagnosis applications.

DC Motors
MicroMo Electronics' DC motors differ from conventional, iron rotor DC motors in that they are equipped with an ironless, self-supporting, skew-wound copper coil. Because of this construction, the rotor is very light yielding a low moment of inertia. The rotor also rotates smoothly without cogging
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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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