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Best Practices for and Common Pitfalls in Creating Device Listing Files

July 24, 2013 2:32 pm | by Howard Shatz, SPL and ACA 6004 Project Manager, Data Conversion Laboratory | Comments

Since June 2009, all drug listing submissions have been done electronically using Structured Product Labeling (SPL) files. Now, devices can be listed using SPL as well. While the FDA does not require that devices be listed using SPL, the ability to do is there, with benefits including providing product exposure on sites such as the National of Library of Medicine’s (NLM) DailyMed.


Renew Focus on Quality in Medical Device Manufacturing

July 23, 2013 4:34 pm | by James Pink, Partner, NSF Medical Devices, Part of NSF International’s Health Sciences Division | Comments

While regulators are understandably focused on compliance, industry needs to focus on quality. The terms are often used interchangeably, but there’s a big difference between quality and compliance. Think of quality as the processes, procedures, and culture that permeate an organization—enabling it to consistently develop and produce high-quality medical device products that will meet or exceed regulatory requirements.


IEC 60601-2-34 Issue 3: Changes to Recovery Test

July 22, 2013 2:11 pm | by Jeff Lind, CEO & Jose Cabanillas, Hardware Engineer, Compliance West USA | Compliance West USA | Comments

The IEC has made a change to the Recovery Test, 60601-2-34. Issue 3 offers modifications that make it more beneficial for engineers as a custom test system is no longer required for this specific test. This article reviews the full breadth of the test and how it can impact medical device manufacturers.


Quality Control Compass for Leak Testing in Flexible Manufacturing

July 18, 2013 2:14 pm | by Jacques Hoffmann, President, InterTech Development Company | Comments

As flexible manufacturing becomes a more attractive option to medical device manufacturers, ensuring that the processes involved with it all work in sync is critical. With leak testing in this system, there are a number of factors that need to be considered. This article reviews the areas that engineers need to keep in mind when adapting to this option.

Medical Device Testing’s Requirement for Axial-Torsion Loading Regimes

July 18, 2013 12:47 pm | by Vincent Milano, Biomedical Account Director, ADMET | Admet, Inc. | Comments

Medical device engineers rely on an array of testing instruments and equipment to verify the safety and efficacy of their products. An axial-torsion testing system is just one of them; however, it has a variety of indications across various device sectors. This article looks at two products for which this testing instrument is invaluable.

Using Notebook Studies to Help Ensure a Successful Reusable Device Cleaning Validation

July 16, 2013 2:34 pm | by Patrick Kenny, Director of Analytical Services, Microtest Laboratories | Microtest Laboratories, Inc. | Comments

Device manufacturers need to ensure their product will be sufficiently cleaned by healthcare professionals. This article will focus on the areas of the FDA’s guidance document that are causing difficulties in cleaning validations, and will demonstrate how pre-validation laboratory work can help save time and money.


Ensuring the Right Fit: Medical Device Testing and the Human Factor

July 16, 2013 2:12 pm | by Chris Evans, Director of Innovation—Pharmaceutical Delivery Systems, West Pharmaceutical Services | Comments

Device testing is required for a wide array of variables in the development of a medical device. When it comes to devices used directly by the patient, however, it is critical to test the patient/device “relationship.” This article looks at examining and testing the human factor when it comes to the handling of a medical device and how the design can be improved to enhance that relationship.


The Power of LEDs Inside Medical Devices

July 15, 2013 3:12 pm | by Chuck DeMilo, Global Director of Product Marketing, Lighting Business Group, Luminus Devices | Comments

The medical device industry is constantly changing. New technologies and products enter the market, replacing outdated or inefficient equipment. There are numerous benefits in using LEDs for medical illumination applications including longer life, less heat, dynamic control, lower energy consumption, and in many cases, lower cost.


Designing for the Critical Care Environment

July 12, 2013 2:49 pm | by Barry Crane, Chief Technical Officer, GlySure Limited | Comments

Critically ill patients present a number of challenges to effective monitoring. Various disease states complicate blood chemistry, compromise perfusion, and cause fluctuating blood pressure levels, heart rates, body temperatures, available oxygen, and pH. Furthermore, the pharmaceuticals used to treat these conditions can skew body chemistry and vital signs, adding to the complexity.


Former Part-time Employee Heads Global Empire

July 12, 2013 10:43 am | by David Mantey, Executive Editor, PD&D | Comments

Glenn Smith celebrates his 40th anniversary with global distributor Mouser Electronics as the company’s president and chief executive officer. Smith recently took a moment to discuss disruptive technologies, the electronics industry’s inevitable slowing, and how some companies still inconceivably refuse to embrace the internet.

The New ASTM F1929-12: Which Method Is Right for You?

July 11, 2013 2:55 pm | by Jason Simon, DDL Packaging Lab Manager; Tami Presler, DDL Packaging Lab Supervisor; and John Cook, DDL West Lab Manager | Comments

Until recently, there was one method using dye to test for seal leaks in porous medical packaging. Now there are three methods manufacturers can select from for their product’s packaging. Which one should be used and why? This article attempts to tackle that question.

Considerations for Successful M2M Platform Deployments

July 10, 2013 2:42 pm | by Brian Anderson, VP of Marketing, Solutions & Services, Sierra Wireless | Comments

Cellular machine-to-machine communications are opening the door to a world of innovative new healthcare applications. With the ability to collect real-time data from people and devices anywhere, and at any time, healthcare organizations and technology vendors are creating useful applications that improve people’s health and well being.


Molders Address Biggest Device Issues

July 9, 2013 5:14 pm | by Sean Fenske, Editor-in-Chief, MDT | PolyOne Corp., JunoPacific, Inc., Advanced Molding Technology | Comments

There are many “hot button” issues that are of concern to medical device companies, such as infection control, the UDI rule, or the trend toward home healthcare. Since plastics are such a huge part of the design of medical devices, the molders who work with the OEMs are doing everything they can to address these same issues to help alleviate the challenges faced by designers.


How MedTech Manufacturers Save by Outsourcing Their Warehousing

July 8, 2013 2:48 pm | by Dennis Deming, Agency Owner, ICAT Logistics, Portland | Comments

Warehousing products can be a costly proposition for medical technology and device manufacturers. It requires leasing and management of a facility, as well as the overhead that goes along with that proposition. Using a warehousing provider can offer a more cost-effective and hassle-free way to fulfill orders.

Bringing Healthcare Home: Telemonitoring Gains Enthusiastic Demand

July 3, 2013 2:35 pm | by Melissa Barnes, Associate Editor, MDT | Comments

The exciting growth the medical telemonitoring sector has seen recently is impressive. According to Frost & Sullivan, the industry is expected to exceed double the revenues of previous years. The reason for this growth is twofold: necessity and innovation.



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