Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

A Better Interpretation Of POH In ISO 24971

Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

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WHITE PAPERS & CASE STUDIES

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.

Laerdal Error-Proofs Medical Kit Assembly With AI-Powered Vision Verifications

Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports continuous improvement through real-time monitoring and visual documentation.

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DESIGN COMPONENTS & SERVICES

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ComfortCoat® Hydrophilic Lubricious Coatings

DSM Biomedical offers ComfortCoat® hydrophilic lubricious coatings to help improve device performance in a wide range of applications and procedures, including cardiovascular and urology. Hydrophilic coatings are designed to enhance the handling of medical devices such as catheters by clinicians during insertion by maintaining lubricity throughout the procedure.

EUROLED Products

LED - EUROLED SMD LED displays and backlights for switches, sensors and LCD displays in medical system and sensor applications, aerospace and transportation displays, and data displays.

Protective Solutions For The Orthopedic Market
Protective Solutions For The Orthopedic Market

For more than 65 years, Caplugs has been a leader in plastic product protection and offers a variety of catalog and custom solutions designed specifically for the orthopedic market. As a qualified supplier to more than 1,300 medical customers including implant manufacturers, Caplugs protects vital components during shipping, storage, and processing.

Air/Gas Micro Diaphragm Pumps: CTS Series

Parker Hannifin’s CTS series of 2.5 LPM free flow air and gas micro diaphragm pumps are ideal for applications involving surgical instrumentation, patient monitoring, compression therapy, negative pressure wound therapy, and medical consumer devices.

AOTF Hyperspectral Imagers

Brimrose hyperspectral imagers utilize a NIR camera with an acousto-optic tunable filter as a monochromator to produce hyperspectral imaging of any target area, or to measure visible or NIR hyperspectral imaging information remotely on a variety of materials.

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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