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

Medical Micromolding

MTD Micromolding is solely committed to providing the highest quality micromolding services of advanced medical products. MTD offers their innovative skills in exploring and producing very small, delicate, and intricate components required for advanced medical applications and products such as specialized surgeries, bioabsorbable devices, and implant devices. With a constant demand for newer, smaller, never-before-seen micro medical devices, MTD is also prepared to assist their strategic partners in the development of new solutions.

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.

Intensified 16 Bit sCMOS Camera: pco.dicam C1

pco.dicam C1: intensified sCMOS camera

PCO introduces the new pco.dicam C1 and as the first intensified camera systems to exploit the full performance inherent to scientific CMOS sensor technology. The camera features optical coupling of 25 mm high resolution image intensifiers, an excellent high efficiency tandem lens system, and a 16 bit 4 MPix sCMOS sensor.

Caplugs Custom Medical Molding

Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.

Low Volume Molding

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

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.

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FEATURED SUPPLIERS

MTD Micro Molding

MTD is a focused micro medical device manufacturer that’s built for high performance in one area: the micro molding of advanced medical products. Our experienced team will consult with you to help you refine and develop your design, using the most advanced materials and micro molding technology. We’re here to help our customers it right – from design through production – so companies can produce a high quality device, and get it to market quickly.

Ophir Photonics

Ophir Photonics, a Newport Corporation, began making laser power meters, energy meters, and beam profilers in 1979, and we’ve never looked back. We have headquarters in the United States, Israel, Japan, and Germany, as well as distributors in over 50 countries worldwide.

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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