Testing
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Testing
So We’re All on the Same Page: You Need a Test Plan
I’m a huge fan of lists. Covering every base with an organized way to track everything from my companies’ financial progress to whether the Doritos made it into the car for the drive home from school keeps me functioning. I note things on…Dawn A. Lissy, Empirical 09.01.17
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Digital Health | Electronics | Software & IT | Testing
Coexistence Testing for Wireless Medical Devices: A Guide to Ensuring Reliable Systems
With mobile medtech in healthcare facilities and the home, OEMs must ensure interference is not a cause for concern.Online Exclusives Ashton Hainge, Consultant, Intertek 08.02.17
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Contract Manufacturing | R&D & Design | Software & IT | Testing
5 Tips to Avoid a Clinical Trial Failure
A failed data strategy in medical device trials can be costly for a number of reasons.Online Exclusives Paul Fardy, VP of Data Services, CROS NT 08.01.17
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3D/Additive Manufacturing | Contract Manufacturing | Machining & Laser Processing | Materials | Molding | R&D & Design | Testing
Testing Designs: Prototypes Help Get Medtech to Market Faster
Both traditional and advanced prototyping technologies are seeing increased use to get products to market faster.Mark Crawford, Contributing Writer 07.26.17
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3D/Additive Manufacturing | R&D & Design | Testing
Pro Tips for Prototypes: The Smart Way to Manage Device Iterations
There’s something about hitting the prototype stage of the development cycle that makes everything finally seem real. This is the point at which there is finally an object to hold in your hands—a physical representation of the vision, inv…Dawn A. Lissy, Empirical 07.26.17
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Testing
Discussing the UL/Emergo Merger: A Q&A
Representatives from both firms speak about the transaction, the expected benefits, and what’s ahead.Online Exclusives Sean Fenske, Editor 06.20.17
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Digital Health | Software & IT | Testing
Recent Cyber Attack Enough to Make Medtech WannaCry
It was the U.S. Food and Drug Administration’s (FDA) worst nightmare come true. On May 12, the WannaCry ransomware cryptoworm slithered its way into computers worldwide, infecting as many as 200,000 Microsoft Windows systems in 150 countries…Michael Barbella, Managing Editor 06.06.17
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Digital Health | R&D & Design | Software & IT | Testing
Hire a Hacker
The Internet of Things (IoT) has brought an array of connected technologies that offer a bevy of benefits. From the seemingly superficial, such as a refrigerator that automatically tracks its contents and updates your grocery list appropriately, to t…Sean Fenske, Editor 06.06.17
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Materials | Packaging & Sterilization | Testing
Barrier to Entry
A device’s packaging needs to maintain the sterile barrier, but also needs to be compatible with the sterilization method.Mark Crawford, Contributing Writer 06.06.17
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Testing
Is Your Biocompatibility Program on the Edge?
Regulatory changes in both Europe and the U.S. have created uncertainty among device makers.Online Exclusives Thor Rollins, B.S., RN (NRCM), Senior Scientist, Nelson Laboratories 05.18.17
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3D/Additive Manufacturing | Contract Manufacturing | Machining & Laser Processing | Molding | R&D & Design | Testing | Tubing & Extrusion
Bigger, Stronger, Faster
Strategic relationships with CMOs enable OEMs to exceed their own limitations.Sean Fenske, Editor 05.01.17
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R&D & Design | Testing
The Human Factor
Humans come in all shapes and sizes, ages, and abilities. Sometimes they aren’t logical. Engineers come with logical, rational minds, but sometimes don’t consider emotional behavior. Factoring humans into device design is not always a pre…Steve Maylish and Dave Hines, Fusion Biotec 05.01.17
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R&D & Design | Testing
International Law
Successfully navigating the maze of foreign medtech regulations requires diligence and proactive planning.Lisa L. Michels, General Counsel and regulatory affairs expert, Regulatory Compliance Associates Inc. 05.01.17
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Testing
Peruvian Prospects: The Medical Device Industry of a Country Founded on Precious Metals
It was a lot to take in running on about five hours of sleep following an international flight complete with a lost luggage cliché. Representatives from multiple agencies—governmental, regulatory, medical device companies, hospital purch…Dawn A. Lissy, President & Founder, Empirical 04.03.17
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Testing
Extractable/Leachable Chemistry Testing Strategies for Medical Devices
It has become more prevalent and acceptable to use the results of chemistry testing to assess the overall biocompatibility of medical devices. For many devices with prolonged or permanent patient contact, chemistry followed by toxicological assessmen…Matthew R Jorgensen, Ph.D., and Thor Rollins, BS, Nelson Laboratories; Allison Komiyama, Ph.D., RAC, AcKnowledge RS 04.03.17
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Testing
Getting to the Root of the Problem
By understanding root cause analysis, device manufacturers will be equipped with a prescriptive approach to problem-solving.Jayme Richter and Bridseida Melendez, B. Braun Medical Inc. 04.03.17
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3D/Additive Manufacturing | Cardiovascular | Contract Manufacturing | Diagnostics | Electronics | Machining & Laser Processing | Materials | Molding | Neurological | Patient Monitoring | R&D & Design | Surgical | Testing | Tubing & Extrusion
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Surgical | Testing
ASTM Guide Supports Cleaning Protocols for Reusable Medical Devices
The standard also provides procedures for selecting the appropriate test soil for different kinds of devices.ASTM International 03.21.17
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Testing
Great Expectations
Regulators are raising the testing bar by demanding the rationale behind verification efforts.Michael Barbella, Managing Editor 03.07.17
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Testing
Testing…Testing…Is This Thing On? Should You Outsource Device Testing or Keep it In-House?
When people ask me what I do, I often reply, “I break things for a living.” Yes, I say it with tongue firmly in cheek. That’s a gross oversimplification of a business I’ve been in for almost 20 years: mechanical testing for…Dawn A. Lissy, President & Founder, Empirical 03.07.17
