Medical Device Design & Development

INDUSTRY PERSPECTIVES

Selecting The Right eQMS To Maximize Quality Maturity

Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

How To Stop (Most) Medical Device Recalls Before They Happen

Supplier quality failures are a leading cause of medical device recalls. This article distills a practical framework for managing supplier quality, from standard off-the-shelf items to custom contract-manufactured components.

A Case Study: Control Strategies For A Multi-Dose Pen Injector

A case study highlighting the importance of drug and device team alignment on control strategy, defining what to control and which controls can and should be implemented.

Control Strategies For Injectable Drug Delivery Combination Products

Defining combination product CQAs across drug and device enables an end-to-end control strategy that improves product quality from the start of development.

More Industry Perspectives

WHITE PAPERS & CASE STUDIES

  • GettyImages-614956020 textile factory
    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.

Deterministic Nondestructive Seal Integrity Testing

Deterministic, non-destructive seal integrity testing delivers validated, quantitative results. Learn why this method outperforms traditional approaches in ensuring patient safety and product quality.

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.

More White Papers & Case Studies

DESIGN COMPONENTS & SERVICES

oem
OEM Genius 3 Tethered Tympanic Thermometer

Cardinal Health offers the Genius™ 3 OEM tethered OEM tympanic thermometer designed specifically for OEM integration. A developer’s kit contains all of the vital information needed to facilitate integration of the Genius™ 3 Tethered OEM Tympanic Thermometer into a multi-parameter device.

Precision-Aligned Xenon Light Sources: PAX Family
Excelitas Technologies’ PAX Family of Precision-Aligned Xenon Light Sources offers OEM customers "plug-and-play," pre-aligned and calibrated pulsed Xenon Light Engine Modules. These compact, precision-aligned Xenon light engine modules generate light over a continuous spectrum from ultraviolet to infrared and are ideally suited to a wide range of clinical diagnostics, invitro diagnostics, life sciences, drug discovery, proteomics, and analytical instrumentation applications.
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.
Tethered Silicone Caps For Tube Protection: MCN-TCS Series
Tethered Silicone Caps For Tube Protection: MCN-TCS Series

Caplugs offers the MSN-TCS Series of tethered silicone caps for protecting tubes and ports from contamination. The caps are constructed from USP class VI silicone, and are designed for easy removal and reapplication for a variety of medical procedures such as fluid draining.

Solid State Amplifier for EMC Compliance Testing: 50S1G6
Solid State Amplifier for EMC Compliance Testing: 50S1G6

AR’s solid state amplifiers are often used in medical EMC compliance test efforts. The 50S1G6 is a class A solid state amplifier which provides 50 watts of output power from 0.7 to 6 GHz.

2642 & 2657 CRX Motors

The new motors, the 2642 and the 2657, deliver from 23 to 35 mNm of continuous duty torque in compact dimensions. Using leading edge processes, the motors are constructed with high performance materials. 

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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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