Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms

Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

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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

Fused End Bundles: PowerLightGuide
For long-term performance, PowerLightGuide all silica fiber optic bundles, fused-end bundles, and assemblies set the standard. Tested for well over 40,000 continuous, unfiltered hours, our PowerLightGuide bundles exhibit level, steady transmission at 95% of the original input!
Miniature Optical Encoders for Medical Positioning Devices
Miniature Optical Encoders For Medical Positioning Devices

The SR series of miniature optical encoders has been designed to fit into motion control devices with limited space, such as robotic arms for surgery, nanopositioning stages, microscopes, and other medical devices.

World Class Optical Thin Films

DELTA has been providing world class optical thin films for applications involving optical coherence tomography (OCT), image transferring systems, Point of Care (PoC) instruments, flow cytometry, raman spectroscopy, high performance monochromators, biomedical laser systems, and more.

Optics - Perfect To Within λ/30!
Thanks to the development of innovative new surface finishing technologies, ELCAN Optical Technologies can now offer reflective optical surfaces with <30 nm PV accuracies & micro-roughness <0.5nm rms, perfect to within λ/30.
R22i Optical Transmissive Encoder
MicroMo Electronics, Inc. is pleased to announce the new R22i optical transmissive encoder. The R22i has rugged PET 530 housing material with an IP-40 rating, making it a perfect match for light automation and office automation applications.
Medical Ventilator Integration

Parker's broad portfolio of high performance products – in conjunction with their ability to design and manufacture complex integrated assemblies – makes them a strong, reliable partner for respiratory care and anesthesia delivery device manufacturers. From concept to launch and long-term sustainability, Parker delivers innovative solutions for:

  • Inventive system solutions utilizing a broad range of products and sub-assemblies
  • Advanced technologies that are smaller, lighter, more energy efficient, and highly reliable
  • Acute care ventilators
  • Home care ventilators
  • Transport ventilators
  • CPAP and BiPAP
  • Anesthesia ventilators
  • Airway management
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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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