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Lack of Interoperability Contributes to Medical Errors

March 19, 2015 10:04 am | by AAMI | News | Comments

For years, healthcare technology professionals and patient safety organizations have decried the lack of medical device interoperability in hospitals. Now, another voice, nursing, is echoing the call for better interoperability, saying a lack...

Consider the Patient to Ensure Safety in Device Development

March 19, 2015 8:30 am | by Deborah Kacera, Regulatory and Industry Strategist, Pilgrim Quality Solutions | Pilgrim Quality Solutions | Blogs | Comments

It will be no surprise that the most critical consideration to ensuring patient safety when developing a medical device is to consider the patient: who are they, who will be using the device, how will they interact with the device, and what’s...

Focus On 'Why?' Instead of Just 'How' for Device Design

March 19, 2015 8:30 am | by Ed Trevis, President and CEO, Corvalent | Blogs | Comments

Every facet of the process – from circuit board design and assembly to on-site implementation of fully developed medical equipment – can affect the patient experience. Because of this, design strategies that consider long lifecycle and consistent...

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FDA Advances Medical Product Innovation

March 18, 2015 9:03 am | by Margaret A. Hamburg, M.D., Commissioner, Food and Drug Administration | Blogs | Comments

On March 10, I had the pleasure of appearing with my colleague Dr. Francis Collins before the Senate Committee on Health, Education, Labor and Pensions to testify at a hearing on the subject of “Continuing America’s Leadership in Medical...

How Long Does Clearance on a 510(k) Submission Take?

March 17, 2015 5:13 pm | by Sean Fenske, Editor-in-Chief, @SeanFenske | Blogs | Comments

Debate rages on over the FDA — Has it become less efficient? More efficient? Is it a barrier to innovation? Is it doing exactly what it needs to do? While these questions are not likely to be definitively answered anytime soon, one query that many do have regarding the FDA could be resolved...

FDA Approves Left Atrial Appendage Closure Device

March 17, 2015 9:04 am | by Boston Scientific | News | Comments

Boston Scientific Corporation has received U.S. Food and Drug Administration (FDA) approval for the WATCHMAN Left Atrial Appendage Closure Device. The WATCHMAN Device offers a new stroke risk reduction option for high-risk patients with...

Devices Safeguard Patient Safety Only When They Work

March 16, 2015 10:57 am | by Ellen Turner, Market Development Manager, Specialty Plastics, Medical Devices, Eastman Chemical Company | Blogs | Comments

Medical devices are under a lot of pressure — doing more for caregivers and patients with each innovation, all while having to withstand the wear and tear that comes with constant use. A heightened focus on patient safety, resulting from evolving...

Patient Safety Takes Center Stage at AAMI

March 16, 2015 9:55 am | by AAMI | News | Comments

The goal of using healthcare technology to deliver safe and effective patient care is front and center this week at AAMI with the kick-off of the National Coalition for Infusion Therapy Safety and a separate meeting for experts who are committed...

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FDA Wants More Info on Scopes Linked to "Superbug" Outbreaks

March 16, 2015 9:34 am | by Matthew Perrone, AP Health Writer | News | Comments

Federal health officials are stepping up their oversight of medical scopes linked to potentially fatal "superbug" outbreaks. The Food and Drug Administration released stricter guidelines for manufacturers of reusable medical instruments, including...

FDA Approves CPR Devices that May Increase Chance of Surviving Cardiac Arrest

March 14, 2015 8:30 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration approved the ResQCPR System, a system of two devices for first responders to use while performing cardiopulmonary resuscitation (CPR) on people whose hearts stop beating (cardiac arrest). The devices may...

Don't Make the Same Device Design Mistakes

March 13, 2015 10:09 am | by Michael Appel, M.D., Anesthesiologist, INCOSE | Blogs | Comments

We must not only anticipate any new hazards, but must also carefully consider the common underlying risks that have already been identified in previous devices. Using more than just a hypothetical risk process, we need to evaluate known problems...

Improved Development Processes and Compliance with Cloud-Based PLM

March 12, 2015 11:44 am | by Alaine Portnoy, Director of Marketing, Omnify Software | Articles | Comments

LoneStar Heart, Inc., based in Laguna Hills, Calif., is developing cardiac restorative therapies for patients with heart failure that harness the heart’s ability to repair itself. Based on its integrated cardiomechanical and biomolecular...

Developers Neglect Privacy and Security in Health Apps

March 12, 2015 9:47 am | by Plataforma SINC | News | Comments

Telemedicine researchers at the University of Valladolid have proposed a series of recommendations to programmers to improve the security of health applications on mobile devices. According to these specialists, it is a rapidly growing area...

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3 Patient Safety Considerations for Medical Device Development

March 12, 2015 8:30 am | by Maria Shepherd, President, Data Decision Group, Medtech Whitespace and Strategy Research | Blogs | Comments

Usability is the piece of the medical puzzle that supports good engineering design. Simply designed devices with simple instructions reduce the possibility of use error, and the CDRH receives approximately 100,000 Medical Device Reports...

Include Test Application Engineers to Get the Details Right

March 12, 2015 8:30 am | by Jacques Hoffmann, President, InterTech Development Company | Blogs | Comments

Failsafe testing of medical devices is a non-negotiable pre-requisite for release of a device to the market.  Most realize that simplistic truth but there are far too many who do not appreciate the “devils in the details” of test applications...

Rebooting the Healthcare System

March 11, 2015 2:30 pm | by Sam Brusco, Associate Editor, @SamISureAm | Blogs | Comments

Patients with chronic health issues in particular often do not receive the personalized care that they require – hospitals typically take a reactionary approach to these patients, treating them only as soon as a major health issue arises or...

Regulating Hip Replacement Devices to Prevent Unnecessary Surgery

March 11, 2015 9:08 am | by University of Warwick | News | Comments

A new study from the University of Warwick is calling for more UK compulsory regulation of devices used in hip replacements to reduce the need for further traumatic and expensive surgery. In a paper published today in the British Medical...

Automating SOP Management Helps Medical Device Manufacturers Avoid Risk

March 10, 2015 11:23 am | by Mika Javanainen, Senior Director, Product Management, M-Files Corporation | Articles | Comments

Medical device manufacturers must comply with increasingly strict compliance requirements in order to sell products in the United States. The Current Good Manufacturing Practices (cGMP) and Quality System regulations (21 CFR Parts 211 and 820)...

Medical Device Designers' Guide to FDA’s Substantial Equivalence

March 9, 2015 11:15 am | by Quynh Hoang, Lynette Zentgraft, Senior Regulatory Experts; Elaine Tseng, Partner, King & Spalding | Articles | Comments

A Premarket Notification or “510(k)” submission is the most common pathway by which medical devices receive authorization to enter the U.S. market, with over 3,500 510(k)s submitted to the U.S. Food and Drug Administration (FDA) yearly. FDA...

Unregulated Internet Marketing of Cancer-Related Gene Tests

March 6, 2015 9:40 am | by Dana-Farber Cancer Institute | News | Comments

Websites that market personalized cancer care services often overemphasize their purported benefits and downplay their limitations, and many sites offer genetic tests whose value for guiding cancer treatment has not been shown to be clinically...

6 Tips to Understand the Collaborative Innovation Cycle

March 6, 2015 8:46 am | by Kathryn Stecco, M.D., Co-Founder and Chief Medical Officer, Panthera MedTech | Blogs | Comments

The medical device landscape is littered with failed products produced by companies whose management forgot - or ignored or didn't know - the cardinal rule of assessing potential value: Validate the market based on physician input before...

Testing the Claims of Digital Healthcare Devices

March 5, 2015 1:26 pm | by GE Reports | News | Comments

A century ago, Sigmund Freud developed the radical idea that there is a lot more going on inside our heads that we know. Today, many doctors (and patients) still stick by his groundbreaking theory. But it comes with a problem. As neuroscientist...

FDA Launches Drug Shortages Mobile App

March 5, 2015 9:07 am | by U.S. Food and Drug Administration | News | Comments

Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved...

A Look Ahead: 3D Printing for Final Device Manufacture

March 5, 2015 8:30 am | by Clive Nicholls, Product Design & Development Manager, Owen Mumford | Articles | Comments

The applications of 3D printing in the medical industry will continue to grow throughout 2015 and beyond. Recent research by SmarTrech shows that by 2020 the number of 3D printers being shipped annually for medical use will have almost...

5 Tips to Maximize Intellectual Property Portfolio Value

March 4, 2015 12:04 pm | by Frank Becking, Co-Founder, IP Counsel, Chief Technology Officer, Panthera MedTech | Blogs | Comments

A strong Intellectual Property (IP) position can be one of a start-up company's most valuable assets. A weak (or poorly defined) IP position can also be one its greatest liabilities. All this is particularly true for developers in the medical...

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