FEATURED EDITORIAL

Does Quality Even Matter? 10 Things Quality Departments Should Stop Doing Now
Does Quality Even Matter? 10 Things Quality Departments Should Stop Doing Now

Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success. What would cause business partners to look at quality in such a way?

  • Digital Health Companies Chasing US, EU Markets Need To Move With The Regulatory Pendulum
    Digital Health Companies Chasing US, EU Markets Need To Move With The Regulatory Pendulum

    By addressing four areas of common requirement, medical device companies will be in a stronger position to secure authorization and maintain products on both the US and EU markets.

  • Dos And Don’ts Of Assessing Usage Risk
    Dos And Don’ts Of Assessing Usage Risk

    Effectively conducting a uFMEA not only facilitates correct identification of existing usage risk, it aids in the generation of crucial design updates for risk reduction or elimination.

  • Understanding FDA’s Quality In 510(k) “Quik” Review Program Pilot
    Understanding FDA’s Quality In 510(k) “Quik” Review Program Pilot

    On Sept. 6, 2018, FDA announced the launch of a new pilot 510(k) program. This initiative, the Quality in 510(k) “Quik” Review Program Pilot, proposes an alternate pathway to regulatory submission and approval for medical devices. Quik is in its early stages and is therefore limited in scope, but it nonetheless offers another approach to premarket notification. This article examines what makes Quik different from traditional 510(k) submissions, plus its benefits and challenges for medical device manufacturers.

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INDUSTRY INSIGHTS

  • Improving Health Outcomes With Personalized Apps
    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

Low Volume Molding 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 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.

Medical Micromolding Medical Micromolding

The margin for error when it comes to critical components for medical device manufacturing is zero. That's why Accumold ensures robust production processes, extremely tight requirements, and part-to-part consistency. 

Standard Solutions and Containers Standard Solutions and Containers

B. Braun provides an array of parenteral pharmaceutical solutions, including those for use in standard IV, irrigation, nutrition, and anti-infective therapy applications. The EXCEL® and PAB® containers and the DUPLEX Drug Delivery Systems feature biologically inert, PVC-Free and DEHP-Free, non-toxic plastic construction for a safe and accurate method of administering IV medication.

HD Performance Handheld Infrared Camera: FLIR T1030sc HD Performance Handheld Infrared Camera: FLIR T1030sc

FLIR offers the new T1030sc Long-Wave Infrared Camera designed to capture images with 1024 x 768 pixels at 30 frames per second (fps). The camera provides high thermal sensitivity, fast raw data streaming, and a high speed interface (HSI) connection for streaming lossless HD radiometric imagery at 120 Hz or up to 480 Hz with windowing.

Caplugs Custom Medical Molding 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.

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FEATURED SUPPLIERS

Caplugs Caplugs

Caplugs, a global leader in protective solutions since 1948, offers extensive custom molding capabilities and a catalog of products available for same day shipment for the medical industry. With more than 1,300 medical customers, a series of ISO certifications, a Class 8 certified Clean Room and a stringent quality control process, Caplugs understands the unique challenges and needs of the medical field. Whether you need a custom molded solution or an in-stock component, our dedicated team of medical experts is available to guide you through the process.

SCHOTT Electronic Packaging SCHOTT Electronic Packaging

SCHOTT Electronic Packaging, a business unit within SCHOTT, is a leading developer and manufacturer of hermetic housings and other components for the reliable, long-term protection of sensitive electronics. Our core technologies are glass-to-metal and ceramic-to metal sealing, thermal sensing components as well as a variety of cutting-edge specialty glass competences. In the medical field, SCHOTT EP manufactures hermetic, customizable, and fully autoclavable LEDs, connectors, and component housings for medical devices. SCHOTT components meet the challenging sterilization requirements of medical devices and have been tested to withstand over 3,500 autoclaving cycles in humid heat at a temperature of 275 degrees Fahrenheit.

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 EVENTS

Reimbursemnt and Contracting January 23 - 24, 2019
Philadelphia, PA
6th Annual Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
Drug Delivery Partnerships (DDP) January 28 - 30, 2019
Palm Beach Gardens, FL
Patients Registries & Real World Evidence Summit January 30 - 31, 2019
Miami, FL
PAP 2019 March 5 - 6, 2019
Baltimore, MD
IVT's Statistics in Validation March 6 - 7, 2019
Philadelphia, PA
Medical Device Validation Week March 12 - 14, 2019
Minneapolis, MN
Life Sciences Accounting and Reporting Congress March 20 - 22, 2019
Philadelphia, PA
15th Annual Pharma Forum 2019 March 24 - 27, 2019
New York, NY
20th Annual Computer and IT Systems Validation April 23 - 25, 2019
San Diego, CA
6th Annual FMV Congress May 1 - 2, 2019
Philadelphia, PA
5th Annual Endpoint Adjucation May 1 - 2, 2019
Philadelphia, PA
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