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Color Retention in Materials Can Ease Patients’ Minds

July 29, 2013 12:47 pm | by Gopal R. Saraiya, Global Segment Leader, Medical Devices, Eastman Chemical Company | Eastman Chemical Company | Blogs | Comments

The highly aggressive sterilization methods used on medical devices to help combat healthcare-associated infections (HAIs) are harsh and can cause color shift. Medical devices that become discolored from sterilization can comprise patient safety and public peace of mind.

Addressing UDI Compliance with Direct Printing

July 23, 2013 5:10 pm | by Rachel Hammer, Product Manager, Roland DGA Corp. | Roland DGA Corporation | Blogs | Comments

As a manufacturer, the UDI rule allows us to take more than 30 years of experience in the development of marking and imaging technologies to satisfy a critical need in a new market. In terms of assisting our customers in their efforts to become compliant, we now offer the MPX-90M impact printer.

The FDA’s UDI Rule Is Coming…Ready?

July 23, 2013 5:05 pm | by Scott Pugh, Vice President, Solution and Service Innovation, Verify Brand | Verify Brand, LLC | Blogs | Comments

The FDA UDI rule will standardize the way the medical device industry identifies its products, which is a foundational step toward utilizing companies who offer higher value, more complex solutions. Engaging these solutions is critical to helping manufacturers secure supply chains, deter counterfeiting, and ensure patients have access to safe medical devices.

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Lasers Address UDI Needs

July 23, 2013 4:57 pm | by Thomas Burdel, National Sales Manager TruMark, TRUMPF | Trumpf Inc. | Blogs | Comments

In reference to the UDI rule, the FDA estimates more than 1,200 companies are in need of equipment or have already implemented direct part marking into production. Of the 1,200 companies, roughly 700 are medical implant manufacturers, while the remaining 500 produce multi-use devices, such as surgical instruments.

‘Standards’ for Home Healthcare

July 23, 2013 4:44 pm | by Todd Konieczny, Assistant Chief Engineer, Americas Region; Technical Manager, Medical Division, Intertek | Blogs | Comments

The following standard must be met for all medical products intended to be used in the home: IEC 60601-1-11, which is “Medical Electrical Equipment—Part 1-11: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.”

Complete Understanding of Device is Key to Testing Success

July 18, 2013 3:00 pm | by Maciej Jakucki, Associate Director of Engineering Operations and Team Leader, Medical Device Testing, Accutek | Accutek Testing Laboratory | Blogs | Comments

From a test engineer’s perspective, understanding final requirements, application, and quantifiable goals for testing before a protocol or test plan is executed is crucial to the success and efficacy of a device used directly by the patient.  

Questions to Ask Prior to Designing for Patients

July 18, 2013 2:30 pm | by Al Ng, Director, Engineering—Linear Bearings & Guides, Thomson Industries | Thomson Industries | Blogs | Comments

One recurring challenge in designing products for use directly by the patient is the difficulty in predicting long term aspects and the impact of a given medical device on a diverse group of users due to their varied characteristics and sensitivities, as most new medical technologies have limited information related to their long term results and side effects.

Sensing Success: Designing in the Right Sensor

July 16, 2013 3:21 pm | by A.J. Smith, Director of Product Marketing, Honeywell Sensing and Control | Honeywell Sensing And Control | Blogs | Comments

The biggest challenge for many medical device designers is selecting sensors that can help them optimize designs for size, cost, and complexity. A modular sensor design provides a single device that can be optimized for a variety of markets or customers, enabling a designer to select the right sensor with the appropriate functionality.

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Achieving Design Success via Communication in the Value Chain

July 16, 2013 3:03 pm | by Jonathan Martha, Medical Segment Manager, Portescap | Portescap | Blogs | Comments

In today’s global market, lack of effective communication through the value chain is the greatest obstacle to successful home device design. To gain an advantage in the market, OEMs are continuously outsourcing component design and procurement. By doing so, OEMs increase the number of different entities involved in the value chain.

Considering the User in Device Design

July 11, 2013 4:34 pm | by Nelson Quintana, Director of Marketing, Renesas Electronics America Inc. | Renesas Electronics Corporation | Blogs | Comments

As medical systems move from hospitals to homes and onto human bodies, designers need to realize their users are not professionals anymore. These new at-home users do not understand conditions that could impact measurements and the validity of measurements.

Fighting for the Consumer’s Acceptance

July 10, 2013 9:13 am | by Jason Hayes, Product Development Manager, MiniFAB | Minifab | Blogs | Comments

Consumer-driven user requirements for home-use devices increasingly require more than just usability, safety, and efficacy; strong insight into why the consumer needs the device is also required. From backyard sheds to universities and research groups to small and large companies alike, bright minds have no shortage of invention of medical products designed for home use.

Development Tools Are Critical for Portable Device Success

July 3, 2013 2:58 pm | by Marten L. Smith, Staff Engineer, Medical Products Group, Microchip Technology | Microchip Technology Inc. | Blogs | Comments

Designers should look for a company that not only provides the right silicon, but also development tools, software, and support that are tailored for two main phases of a typical smartphone/tablet-based medical design. The first phase consists of the smartphone interface, and the second phase is the design of the medical device itself.

Home Healthcare Presents Design Challenges

July 2, 2013 11:54 am | by Ryan Striker, P.E., Electrical Engineer, Logic PD | Logic PD, Inc. | Blogs | Comments

To unlock the potential of more frequent therapy, medical devices must move out of the doctor’s office and travel with patients to their homes and offices. But, this great opportunity is not without its challenges. The same patient who stands to reap great benefit from a home medical device may instead endanger themselves by applying the device incorrectly.

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The Obstacles to Design Success for Home Care Products

July 1, 2013 4:38 pm | by Garren Walters, Applications Team Leader, Precision Fluidics Division, Parker Hannifin | Parker Hannifin Corporation | Blogs | Comments

As Parker sees it, the three biggest obstacles to [design] success for patient care products, such as oxygen concentrators and ventilators, are portability, battery life, and reliability. To make home care products more portable, Parker has reduced the size of some valves up to 75%.

Developing Devices Anyone Can Use

June 28, 2013 11:32 am | by Jason D. Keiser, Project Manager, Precision Medical Products | Precision Medical Products, Inc. | Blogs | Comments

The greatest challenge [in designing for the consumer] is recognizing the limited knowledge and abilities of a home user. There needs to be an understanding that the home patient is not a medical professional and is not exposed or practiced with the multitude of technologies the designer may have previous experience with.

Weight Is Key in Design of Consumer MedTech

June 25, 2013 4:00 pm | by Jessica Irons, Marketing/Business Development Specialist, Sonoco Protective Solutions | Blogs | Comments

When designing a medical device that is meant to be used directly by patients in their home, the designer has to keep in mind that the environment of a patient’s home is likely going to be dramatically different compared to a medical facility.

Electromagnetic Interference in Device Design

June 19, 2013 1:57 pm | by Donald L. Sweeney, President, D.L.S. Electronic Systems Inc . | D.L.S. Electronic Systems, Inc. | Blogs | Comments

The greatest obstacle to success in the design of a device is that, often times, the design engineer overlooks the need to keep electromagnetic interference in mind when he designs his device. When a product is not in compliance, it can be interfered with by radio waves emitting from other electronic devices in the home, causing the product to malfunction.

Perspectives on Robots in the OR - Michael Berthelot

April 29, 2013 11:57 am | by Michael Berthelot, CEO and President, Pro-Dex Inc. | Pro-Dex | Blogs | Comments

Will the OR of the future see robots completely replace human surgeons? While there are some ways in which robots can replace human involvement during surgery, it’s unlikely that robots will completely replace human surgeons. This is because human intuition, reasoning, and experience will continue to be invaluable.

Perspectives on Robots in the OR - A.J. Smith

April 26, 2013 2:41 pm | by A.J. Smith, Director of Product Marketing, Honeywell Sensing and Control | Honeywell Sensing And Control | Blogs | Comments

Will the OR of the future see robots completely replace human surgeons? Robotic technologies combined with improved sensors and sophisticated intelligence will make inroads into many aspects of medical care, including surgical centers and operating rooms.  

Perspectives on Industry Insight, Part II

January 17, 2013 12:00 am | by MDT Staff | Minifab, Tci Precision Metals, Intertech Development Company, Munro & Associates, Inc., Medical Murray, Inc. | Articles | Comments

  Would you please comment on the medical device industry as we move into 2013? Contract manufacturing continues to shift from just “manufacturing” to include a full road map of your finished products, including design, test, manufacturability, and distribution.  

Perspectives on Industry Insight, Part I

January 16, 2013 12:00 am | by MDT Staff | Syspro, Honeywell Sensing And Control, Portescap, D.L.S. Electronic Systems, Inc. | Articles | Comments

Would you please comment on the medical device industry as we move into 2013? The need for medical device manufacturers to have product recall plans in place was reaffirmed by the release of the latest figures on medical device unit recalls. According to the quarterly ExpertRECALL Index released August 22, 2012, over 123 million medical device units were recalled in the second quarter of 2012...

Perspectives on Supplier Differentiator, Part II

October 19, 2012 2:10 pm | by Deborah Kacera, Daniel Rudolf, Dan Walsh, Christine Forcier, and Bill Leverich | Pilgrim Software, Inc., RBC Medical Innovations | Articles | Comments

The next evolution is the focus on the supply chain and ensuring the detailed processes are in place and that products/processes provided by downstream suppliers are validated and real. With globalization as the post facto now, it will require more stringent supplier controls from the initial selection of suppliers through the monitoring phases. How will suppliers select and monitor their supplier base?

Perspectives on Supplier Differentiator, Part I

October 19, 2012 11:49 am | by Joe Rotino, Alan Walsh, Aidan Petrie, Carol Tucker, and Michelle Lott | Pro-Dex, Logic PD, Inc., Ximedica, Vention Medical, Inc., Xeridiem | Articles | Comments

As external industry influences like excise taxes, longer approval process time, and reimbursement pressures bear down on device manufacturers, development partners must look to areas of opportunity and how to best support medical firms in these pursuits. While opportunities such as the growing and aging population and emerging markets are getting a lot of play, it’s also important to realize that progress (i.e., technological advances) poses perhaps the most significant area of opportunity in transforming healthcare.

Perspectives on Evolution of Miniaturization

October 17, 2012 3:39 pm | by Steve Kuckworth, Jessica Willing-Pichs, Ian Hardy, Chad Marak, John Beigel, Trygve Olsen, and Chris Ault | Clariant Corporation, Ximedica, Crane Aerospace & Electronics, Littelfuse, Inc., Meder Electronic Inc. | Articles | Comments

As medical devices migrate from the hospital to the patient’s home or workplace, two concepts will become increasingly important: manageability and security. Remote medical devices must often provide continuous care, regardless of their location. Consequently, IT teams will need to manage and control the devices remotely...

Perspectives On A Question of Safety

July 25, 2012 11:54 am | Accutek Testing Laboratory | Articles | Comments

How has news questioning the safety of medical devices misled the public about testing protocols?

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