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

Engineering: Design For Manufacturing (DFM)

PTI offers over thirty years of industrial Design For Manufacturing (DFM) experience in determining product requirements and establishing initial design visions. Their expert design and advanced product development teams assist customers in bringing innovative concepts to efficiently manufactured plastic products.

Semiconductor Technology for Implantable Medical Devices

All mission critical functions are accessible within the MST group to provide miniaturized packages. Capabilities include design, substrate manufacturing, component selection and validation as well as all major semiconductor packaging processes.

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.

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.
Miniature Pneumatic Solenoid Valve: Series 11/25/26

Parker Hannifin’s miniature pneumatic solenoid valves provide an ideal solution for OEMs manufacturing devices for oxygen conservation, compression therapy, gas chromatography, and other medical and analytical gas control applications.

ARforBioMedicalLifeSciences
AR Optical Coatings For Biomedical & Life Sciences

Precision Glass & Optics (PG&O) offers anti-reflective (AR) optical coatings for biomedical and life sciences applications. Ideal for coating on quartz, BK-7, glass, and a variety of other optical materials, AR coatings improve performance in optical systems, increasing transmission and enhancing contrast.

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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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