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Quality Products/Services to our Aging, Technologically Astute Population

September 5, 2014 8:30 am | by Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Software | Blogs | Comments

As the world population’s average age is increasingly rising, the home health industry is continuing to grow and mobile healthcare-related technology is evolving. As a result, more digital health companies and mobile devices will emerge...

Keeping Pace: A Continuous Improvement Process

September 4, 2014 8:30 am | by Bill Betten, VP of Business Solutions, Medical/Life Sciences, Logic PD | Blogs | Comments

I believe it is important that the FDA continuously revisit their decision regarding medical device apps. As of 2013, the FDA had cleared and registered just over 100 medical apps, nowhere near the current pace of app development, which...

Higher Risk and Longer Investment Window

September 3, 2014 8:30 am | by Marc Dubreuil, Vice President of Business Development, Farm Design | Farm | Blogs | Comments

In some ways, venture capitalists and high net worth individuals are already doing this by funding syndicates that number anywhere from six to 20 investors. However, these are seasoned investors who possess a vast knowledge of the competitive...

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Necessary to Understand Market Demand

September 2, 2014 8:30 am | by David Bratvold, Founder, Daily Crowdsource | Blogs | Comments

I believe crowdfunding for medical device development is not only viable, but it's an absolute necessity. However, the biggest benefit of crowdfunding is not the money you receive to develop your device, but rather a concrete understanding...

Voting with Their Dollars

August 28, 2014 8:30 am | by Jonathon Kemnitzer, Principal, KEM STUDIO | Blogs | Comments

At KEM STUDIO, we’ve successfully funded an industrial design project, called “Skate Bench No. 1,” through Kickstarter in 2011. This skateboard-inspired bench was noticed by professional skateboarders Mike V (Vallely) and Tony Hawk who used...

Opportunities for Attraction

August 28, 2014 8:30 am | by Alex Fair, Chief Crowdologist, MedStartr.com | Blogs | Comments

I run the leading crowdfunding site for medical innovations and about a third of our clients have some sort of medical device. So far, we have helped about a dozen medical device companies get found and funded just with rewards and donations...

Solving a Customer's Problem

August 27, 2014 8:30 am | by Walter Hock, Director, Product Management, Portescap | Portescap | Blogs | Comments

In today’s rapidly changing market, clinicians and aspiring entrepreneurs with an idea for a medical device should first be very clear in understanding the problem they are solving for the customer. Often, clinicians and entrepreneurs are...

Risky Device MMAs Should Be Regulated

August 25, 2014 2:31 pm | by Steven G. Richter, Ph.D., President and Chief Scientific Officer, Microtest Laboratories Inc. | Microtest Laboratories, Inc. | Blogs | Comments

I agree that the FDA should regulate mobile medical apps (MMA) because there is a potential that certain apps used to treat and diagnosis disease states can be harmful to patients when not working properly. When the FDA published the current...

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Reassessing Risk in the Design Process

March 11, 2014 3:09 pm | by Brian Gough, Projects Director, IDC | Blogs | Comments

The recent change in ISO 14971:2012 Application of risk management to medical devices, requires a change to the way risk is assessed during the design process. Where user risk was once mitigated by the Instructions for Use (IFU), the IFU...

Know Your Material Debris for Implantables

February 7, 2014 12:42 pm | by Elaine F. Schumacher, Senior Research Scientist, McCrone Associates Inc. | McCrone Associates, Inc. | Blogs | Comments

McCrone Associates is a consulting laboratory with extensive experience in materials analysis, much of it in the area of medical device development. Growing use of joint prostheses, combined with introduction of novel materials and coatings...

New Developments in 2014 Bring Challenges for Designers

January 31, 2014 1:53 pm | by Mike Brousseasu, Manager — Safety Group, and Joe Langton, Business Service Line Leader — Chemical, Intertek | Blogs | Comments

In the coming year, medical device manufacturers will need to focus on getting their products compliant, available, and possibly re-designed to keep up with the ever-changing standards associated with the medical device industry. The Affordable...

Thermal Management Solutions for MedTech

January 27, 2014 12:21 pm | by Matt Connors, Engineering Group Leader, Thermacore, Inc. | Thermacore, Inc. | Blogs | Comments

Regardless of whether the 2.3% medical device tax is here to stay or not in 2014, regulatory and competitive pressures are forcing medical OEMs to consider new technologies to reduce costs. Active thermal management technologies, such as...

Securing Patient Information Is the Top Priority

January 22, 2014 12:46 pm | by Steve Spatig, General Manager, Electronic Access Solutions, Southco | Southco, Inc. | Blogs | Comments

With HIPAA audits scheduled to begin in 2014, many healthcare providers are concentrating their efforts on their approach to how patient information is secured. With audits focusing on breach notification, it is essential that healthcare...

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Looking Ahead at Imaging Technology

January 20, 2014 1:52 pm | by Adrian Wilson, Head of Technologies, Element Six | Blogs | Comments

Today’s magnetic resonance imaging (MRI) technologies, aiding the measurement of illness diagnose and treatment, even when stretched to their limits, have not allowed for resolution beyond a few micrometers and traditionally require expensive...

MedTech Strategic Convergence Set for 2014

January 17, 2014 12:28 pm | by Deb Kacera, Regulatory & Industry Strategist, Pilgrim Software Inc. | Pilgrim Quality Solutions | Blogs | Comments

In 2014, we will see the next evolution of the most effective utilization of resources across the medical device industry, based on “smart” information that will touch almost every healthcare stakeholder, where key data will have a tighter...

Direct Part Marking for UDI Needs

January 16, 2014 3:01 pm | by Gerry Gunderson, CPP, VP of Engineering, Quality Tech Services | Blogs | Comments

The Final Rule for FDA’s Unique Device Identification (UDI) mandate is now released and will be in focus in 2014. Class III device manufacturers will need to comply by September 2014, unless granted an exception (and excluding grandfathered...

Developing Medical Devices at a ‘Sprint’ Pace

January 15, 2014 2:04 pm | by Eric Sugalski, Founder and CEO, Boston Device Development | Boston Device Development | Blogs | Comments

In 2014, the medical device industry will see increasing interest in “agile development,” a process of iteration that has become a mainstay in software development. Rather than following the standard waterfall process, teams will rely on...

Newly Insured Bring New Opportunities and Challenges

December 19, 2013 4:12 pm | by Michael Frank, Healthcare Industry Expert, PA Consulting Group | Blogs | Comments

The medical device sector has emerged from the winter of the great recession into a much more price sensitive market. Pressure is mounting to reduce cost of devices where there are cheaper alternatives. While the 2.3% medical device excise...

Wireless, Disposable Sensors for Patient Monitoring on the Way

December 18, 2013 4:11 pm | by Jonathan Sbert, Product Line Manager for Healthtech, Texas Instruments | Blogs | Comments

Technology that enables wireless and disposable human diagnostic sensors for ECG, pulse oximetry, heart monitoring, temperature, and other measurements will be prevalent in 2014. Imagine the day when a patient lies in a hospital bed completely...

Reducing Costs by Extending Product Life

December 17, 2013 2:25 pm | by Tim Taylor, Director of Sales, Medical, XP Power | XP Power | Blogs | Comments

As a manufacturer of medical grade power supplies, we see many changes in the coming year. The U.S. healthcare industry is going through a transformation that will have a different landscape. The medical device manufacturers that are leading...

A MedTech Accelerator Model

December 16, 2013 3:13 pm | by Laura Faulconer, Business Development Manager, STC | Blogs | Comments

With the dramatic growth of the IT sector over the last decade, novel commercialization models like the start-up accelerator have emerged. A typical IT accelerator provides a small investment (usually $10,000 to $50,000) alongside rigorous...

Test Equipment Critical for Successful Kidney Dialysis Devices

October 16, 2013 4:47 pm | by Gene Grilli, Director of Global Sales, Uson | Uson, L.P. | Blogs | Comments

Most people know that a major function of the kidneys is to remove waste products and excess fluid from the body. These waste products and excess fluid are removed through the urine. When the kidneys become damaged or diseased, it becomes...

Antimicrobial Materials Can Aid with Patient Safety

October 16, 2013 4:39 pm | by Lawrence Gabriel, Business Development Manager, Molding Compounds/Performance Polymers, Evonik Corporation | Evonik Cyro, LLC | Blogs | Comments

As a leading supplier of acrylic-based thermoplastic products, Evonik Cyro is continually working with its end-users on the identification of current and future product needs. Citing the demand for products that have antimicrobial capabilities...

Enhancing Safety with Human Factors Design

October 16, 2013 4:34 pm | by Zach Marks, Director of Strategic Marketing, Pharmaceutical Delivery Systems, West Pharmaceutical Services | Blogs | Comments

Human factors design and testing, combined with improved instructions for use, can greatly enhance patient compliance and health outcomes. Many well-intentioned devices are underutilized because the patient cannot understand the proper way...

Driving Patient Safety Throughout the Development Process

October 16, 2013 4:02 pm | by Jonathan Martha, Medical Segment Manager, Portescap | Portescap | Blogs | Comments

At Portescap, we supply motors and gearing that go into critical care home medical devices. To ensure patient safety, we use prevention, containment, and OEM feedback. During product design, we use a stage-gate system that incorporates multiple...

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