Med Device Online: Advancing human health by connecting people, organizations, and ideas in the design and development of medical devices.

FEATURED EDITORIAL

Why You Need A World-Class Quality Culture — And How To Build One

The quality culture of the organization has a clear and direct impact on the ultimate quality of the product, where either the quality is built into the product or is tested against the product for acceptance. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.

Design Of Experiments 101: Understanding DOE’s Foundational Elements
DOE is a very powerful tool that can be used to characterize a process. This article discusses several types of experiments, as well as the basic statistical tools and techniques, that can be used when performing a DOE.
The IMDRF Cybersecurity Guidance: A Comprehensive Analysis
Principles and Practices for Medical Device Cybersecurity clarifies cybersecurity expectations for medtechs selling to a global market and is likely to serve as a blueprint for most regions’ local regulations, including the next round of FDA guidance documents.
What Does IMDRF’s New Cybersecurity Guidance Mean For You?
Principles and Practices for Medical Device Cybersecurity is intended to help facilitate international regulatory convergence on medical device cybersecurity by explaining fundamental concepts, best practices, and recommendations for all stakeholders.

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INDUSTRY INSIGHTS

Improving Health Outcomes With Personalized Apps
Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.

Micro-MIM Succeeds At Making Precise Micro Metal Parts

As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.

Plan For Success With Sustaining Engineering In Medical Device Development And Manufacturing

Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. KMC's executive director of engineering, Scott Leon, weighs in on the subject.

How To Uncover The Hidden Value Of Culture In Supplier Selection

The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.

Taking Micromolding To the Next Level

Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production.

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SOLUTIONS

Rapid Tooling And Medical Device Prototyping

Whether you need a few pieces or a few thousand, Donatelle's highly specialized team can produce parts with near-production tolerances in as little as a few days. As part of their integrated services, they work closely with your design team to select the best polymers and metals to bring accuracy and consistency to your molded components. You can also rely on their expertise with hundreds of exotic materials, including high-temperature, implantable-grade and silicone.

Fischer Plastic Series

The Fischer Plastic Series is a family of high performance, fully insulated plastic connector bodies that are all compatible with Fischer’s metallic connectors. Key features include high reliable signal path, high signal and contact density, clear coding for easy operation, and resistance to large temperature variations.

FluoroPEELZ™ Peelable Heat Shrink

Zeus offers the FluoroPEELZ™ peelable heat shrink designed with quick and easy peel away capabilities to improve product efficiency and safety, and to accelerate catheter production.

Daikyo Crystal Zenith^® Luer Lock Syringe Systems

Quick Time To Market, Significantly Lower Risk

Daikyo Crystal Zenith^® Luer Lock syringes are designed to fit a variety of standard drug delivery devices, and compared to glass they offer unprecedented strength, durability, and protection.

PolyJet 3D Printing Services

Proto Labs is proud to introduce PolyJet technology to their 3D printing capabilities. PolyJet technology is used to provide designers and engineers with the ability to manufacture elastomeric and overmolded prototypes without investing in tooling. This technology can create 3D-printed parts comprising both elastomeric and rigid materials, as well as multiple colors.

Medical Light Sources And Components

SCHOTT Lighting and Imaging delivers medical light sources to help redefine the boundaries of medical innovation, and provide deeper insights in helping medical experts see more of what is relevant to their diagnoses and therapies.

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FEATURED SUPPLIERS

Canon USA, Inc. Optoelectronic Components

Canon U.S.A., Inc., is a leading provider of business-to-business, industrial and consumer digital and optical imaging solutions to the United States, Latin America and the Caribbean (excluding Mexico) markets with an increasing intent for more customized, localized products.

Cardinal Health, Inc.

Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, health systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide.

The company provides clinically-proven medical products and pharmaceuticals and cost-effective solutions that enhance supply chain efficiency from hospital to home. Cardinal Health connects patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management.

MED DEVICE ONLINE CONTENT COLLECTIONS

In the age of connectivity and precision medicine, cybersecurity has taken on critical importance in medical technology development. Software intrusions can risk patients’ health and well-being, as well as their personal data. Device designers must balance these concerns against healthcare provider and patient demand for more connectivity, more access to information, and more ease of use. In this free collection of articles, Med Device Online has collected insights from some of the cybersecurity experts among our editorial contributors.

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