Here's how middleware’s capabilities can move medical devices from charting to active patient monitoring and intervention.

John Zaleski, PhD, CAP, CPHIMS

Historically, medical device data has been isolated, trapped in silos, each having unique communication protocols, physical connections, update rates, and terminology, but key advances have put medical devices on the precipice of an evolutionary leap from charting and documentation to active patient monitoring and intervention.

Tracked through multivariate, temporally trended information, clinicians can apply historical and real-time data to facilitate real-time clinical decision-making that is based upon changing and evolving trends.

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January 12th, 2017
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The first installment in a series on women in medtech focuses on Marlou Janssen’s impressive career and outstanding results at Biotronik.

Maria Shepherd

Who better to ask about how to increase the number of women executives in the medical device industry than Marlou Janssen? Janssen is president of Biotronik, Inc., and is one of the most prominent women in medtech.

The accelerated track of Janssen’s career is impressive. She started at Medtronic but moved to Biotronik in 2001. At  Biotronik, she rose rapidly through the ranks to global vice president, Cardiac Rhythm Management. After a short stint at St Jude...

January 10th, 2017
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A new list breaks down ten recent medical innovations and gives executives practical steps to determine whether the technology is right for their hospital.

Marie Thibault

The capabilities of today’s medical technology offerings may seem ever-expanding, but unfortunately hospital budgets have a firm limit. That leaves hospital executives with the dilemma of trying to determine which new medical products are the best investment for their facilities.

A number of factors can play a role in hospital purchasing decisions—budgets, priority areas of therapy, competition from other neighboring facilities, and long-term visions. A new report from the ECRI Institute, “2017 Top 10...

January 9th, 2017
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Specialists use market research and color psychology to help companies successfully use color as a powerful design tool. That research can be applied to create successful medical devices.

Christine Park

Hours and hours of sweat and tears go into designing and developing a medical device. But when it’s time to choose a color, companies have no clue what it should be. So they guess and hope for the best.

That's too bad.

The potential to use colour to increase market acceptance, establish brand identity, optimize usability, and raise patient comfort is lost.

The truth is, many industrial design schools do not include color design as part of the curriculum. Many designers lack the understanding to make a confident colour decision. I was introduced to...

January 9th, 2017
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Learn how to use risk management tools and techniques to streamline medical device and diagnostic product development.

Claudia Campbell-Matland, PMP

The implementation of effective best practices and policies are essential for successful market introduction of new products or services. In the medical device and in vitro diagnostics (IVD) industries, it is vital that new product development programs:

  • produce safe and effective products that meet customer requirements;
  • comply with applicable regulatory and quality management system (QMS) requirements;
  • achieve timely market entry. 

Additionally, ensuring compliance with QMS requirements and guidances for developing and commercializing products helps achieve long-term...

January 5th, 2017
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Device manufacturers may find themselves advocating equivalence to FDA for the 510(k) process while also differentiating their product from the same device in a patent infringement suit. 

Eric P. Raciti, Jessica L.A. Marks, and Drew D. Christie

Medical devices—encompassing everything from contact lenses to hemodialysis machines—are fundamental components of modern medicine. The regulatory bodies that govern these devices include FDA, which is charged with ensuring the safety and efficacy of the devices, and the Patent and Trademark Office (PTO), which seeks to encourage innovation by rewarding inventors with patents.  While truly new devices must go through FDA’s rigorous Premarket Approval (PMA) process, the majority of devices utilize the Agency’s...

January 3rd, 2017
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We asked industry experts to weigh in on what medical technologies will be big in 2017. Here's what to expect in the field of sensors. 

Craig Scherer

From expanded indications for transcatheter aortic valve replacement systems to bioresorbable stents, medical technology took some big leaps forward in 2016. So what might 2017 have in store? We asked industry experts for some predictions. Here, in their own words, are the medical technologies they expect to see making headlines in 2017. 

Sensors

We’ll be hearing a lot more about sensors in 2017. We hear a great deal about body-worn sensors, but sensors are being incorporated everywhere—not only because of the data gathering possibilities, but also the ability to drive better outcomes. Sensors are evolving...

December 26th, 2016
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We asked industry experts to weigh in on what medical technologies will be big in 2017. Here's what to expect in the field of advanced wearables. 

Nick Rollings

From expanded indications for transcatheter aortic valve replacement systems to bioresorbable stents, medical technology took some big leaps forward in 2016. So what might 2017 have in store? We asked industry experts for some predictions. Here, in their own words, are the medical technologies they expect to see making headlines in 2017. 

More Advanced Wearables

Wearable diagnostic devices are likely to be significant in 2017. Rather than just measuring footsteps and heart rate, the latest wearables under development are significantly more “invasive” in that samples such...

December 22nd, 2016
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This is the time of year for crystal ball gazing. Here are three unique forecasts for the medtech industry in the year ahead.

Marie Thibault

Many medical device industry onlookers have made educated guesses about the sector’s outlook in 2017 and there seem to be some consensus opinions forming. Value-based care is here to stay. Medical therapy will become increasingly more personalized and artificial intelligence technology will improve by leaps and bounds.

Still, there are unique takes on what 2017 might bring for the industry. A few of these...

December 21st, 2016
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We asked industry experts to weigh in on what medical technologies will be big in 2017. Here's what to expect in the field of surgical robotics. 

Dougal Adamson

TransEnterix anticipates filing for 510(k) clearance of its Senhance Surgical Robotic System in early 2017.

From expanded indications for transcatheter aortic valve replacement systems to bioresorbable stents, medical technology took some big leaps forward in 2016. So what might 2017 have in store? We asked industry experts for some predictions. Here, in their own words, are the medical technologies they expect to see making headlines in 2017. 

Surgical Robotics

Surgical robotics is an undeniable major trend and so...

December 21st, 2016
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