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

Polyester Etch Foil Heaters

The new HEATFLEX polyester etch foil heaters from HEATRON are designed to utilize advanced circuit imaging combined with chemical etching in order to allow designers to distribute wattage while creating multiple heat patterns in a single heater. These heaters are constructed using an etched foil heating element, and are available with custom watt density and multi-zone controls for added efficiency.

Cermax VQ Xenon Lamps - Metal Body Parabolic

Cermax Short Arc Xenon - metal body parabolic reflector lamps have operating power ranges from 300 to 400 W. and are typically used for fiber optic illumination, analytical instrumentation, endoscopy/laparoscopy, and microscopy.

Contract Manufacturing Services

KMC Systems offers decades of experience in manufacturing high-value, complex platforms for use in the clinical environment, including their Manufacturing Execution Systems (MES) and Quality Management Systems (QMS). KMC can partner with customers at any stage of the product’s life cycle, from development to pilot production or full-scale manufacturing, and assume all responsibility for medical contract manufacturing needs.

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Production Ready 3D Optical Profiler: ZeGage™ Pro

The ZeGage™ Pro and ZeGage™ Pro HR are scanning white light interferometers that provide 3D optical surface profiling for the measurement of precision surfaces that require non-contact metrology. The base ZeGage™ Pro model delivers surface mapping at the nanometer scale, meeting the needs for most industrial surfaces. For smoother samples with a much finer surface finish, the ZeGage™ Pro HR offers more than 20X higher precision with 0.15 nm vertical precision.

High-Performance Batteries for Active Implants

These high-performance batteries are based on lithium-iodine or lithium-manganese dioxide. They feature high volumetric energy densities and low self-discharge. They’ve been specifically designed for use in medical implants.

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Bionate® Thermoplastic Polycarbonate Polyurethane (PCU) Polymers

DSM Biomedical offers a proven family of highly biocompatible, medical-grade polymers for use in long term medical implants. Bionate® Thermoplastic Polycarbonate Polyurethane (PCU) polymer family is one of the most extensively tested families of biomedical polymers and is backed by a comprehensive FDA Material Master File.

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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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