A research scientist explains the decisions that go into designing a dual-chamber drug-delivery device.

Amy Heintz

Dual-chamber systems are of growing interest for enabling drug delivery in multiple settings. In the self-administration drug delivery market, they can reduce the number of handling steps and the potential for error by the patient or caregiver during drug reconstitution. In a wound healing or surgical setting, dual-chamber systems can decrease the time to table for reconstitution or other mixing steps. They also provide a means to simultaneously deliver two independent liquid molecules.  

There are several dual-chamber design options that can be classified by how the two compartments are mixed. Traditional dual-chamber systems incorporate a bypass...

May 22nd, 2017
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Advancements in IoT technologies for tracking, communicating, and managing the supply chain are helping to achieve better in-transit medication management. 

Ash Patel

Transporting medicine from pharmaceutical factories to pharmacies is a $78.8 billion industry globally, according to Pharmaceutical Commerce's annual Biopharma Cold Chain Sourcebook.  Traditionally, only the cold chain portion of the total biopharma supply chain—an estimated $12.6 billion market—was monitored for temperature and humidity. 

In recent years, the industry has seen the introduction of biologic-based...

May 21st, 2017
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Medical device designers should consider including packaging in their human factors studies.  

 

Stephen Wilcox

Human factors studies are now commonplace during medical device development, thanks to FDA’s guidance “Applying Human Factors and Usability Engineering to Medical Devices.” But what about during packaging development?

Human factors principles are nearly always applied to medical devices, “and often the packaging,” reported Stephen Wilcox, principal and founder of Design Science. Wilcox spoke at HealthPack in March to a...

May 16th, 2017
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More medical device makers are incorporating connectivity into their products, but that doesn’t mean hospitals are using that capability. How can device manufacturers increase their device’s connectivity in the hospital setting?

Marie Thibault

By now, medical devices with Internet of Things (IoT) connectivity are almost a cliché. Still, that doesn’t mean the devices’ connected capabilities are being widely used.

During a panel at the BIOMEDevice Boston conference in early May, a panel of experts discussed “Considerations for Your Next Healthcare IoT Device.” ...

May 15th, 2017
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There are several misconceptions about the Agile project management methodology that need to be cleared up.

Dr. Justin Kelleher

George Orwell once said, “Myths which are believed in tend to become true.” Of course, a story can become a myth, or indeed the myth often becomes a good story. This particular story has its genesis in the mountains of Utah, in February 2001, when a gathering of some of the greatest modern minds emerged with a set of 12 revolutionary software development principles under a proclamation called the Agile Manifesto. These evangelists declared that requirements should evolve through collaborative efforts using self-organized, cross-functional teams. They maintained that constant change, adaptive planning, faster delivery,...

May 15th, 2017
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Rehabilitation for patients with neurological disorders may be best achieved with support from both robotic and human therapists. Here's what that therapy looks like.

Michal Prywata

According to the Worldwide Health Organization (WHO), 15 million people globally suffer a stroke each year, with the United States accounting for almost 800,000 of those instances. A third of stroke sufferers—approximately five million people—are left permanently disabled and in need of some sort of physical therapy or patient care to help them attempt to regain even a fraction of their original physical mobility.

The loss of motor skills is common in stroke survivors...

May 11th, 2017
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Convolutional neural networks and other machine learning algorithms are gradually transforming our reality. Dentistry is no exception. 

Oksana Bandura

According to the 2016 Aspen Institute Roundtable on Artificial Intelligence, “AI’s use in medicine will increase tenfold within the next five years.” This means there will be more intelligent data mining and advising systems in healthcare that will become more powerful and precise. With further advances in parallel computing and augmentation of training data sets, we can expect that machine learning algorithms lying under the hood of medical data sets and CAD systems will...

May 10th, 2017
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Here's how developing an agile marketing piece allowed for a flexible, integrated marketing campaign for an international medical device product launch.

Angela Hill

Leveraging agile marketing in the medical device industry can mean the difference between failure or success when launching a new product internationally. Oftentimes, U.S.-based marketing departments seek to dictate marketing constraints to sales teams and resellers in other countries without factoring in the need for agility.

Recently, we had the opportunity to help a San Diego-based medical device company as they prepared for an international product launch. Their challenges were a direct result of failed communication and mismanagement of expectations. Sales teams in each country...

May 9th, 2017
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With lower costs, better form factors, and new features, wearable biometric sensor technology is now enabling ambulatory mobile healthcare, with a focus on prevention, screening, and disease management.

Steven LeBoeuf, PhD

Even in the midst of turbulent market dynamics, wearable devices have continued to see a tremendous amount of growth around the world. While key market players have seen their respective market shares increase or decrease, the macro-level growth remains strong—IDC reports over 100M units sold in 2016, up 25% over 2015.

Taking a slightly longer term view, the technology in these devices has also seen a tremendous amount of innovation in the last 20 years. It wasn’t that long ago that ECG chest straps were cutting edge technology before there was such a thing as “wearables.” Since then we’ve seen GPS, accelerometers, gyroscopes, optical...

May 8th, 2017
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Here's how a recent D.C. Circuit Court ruling will impact faxing, which remains essential to the medical device industry because doctor’s offices, hospitals, and pharmacies still rely on it as a primary mode of communication.

Christine Reilly and Diana Eisner

“Believe it or not, the fax machine is not yet extinct.”

So began the split-panel decision of the U.S. Court of Appeals for the District of Columbia Circuit invalidating the Federal Communication Commission’s Solicited Fax Rule in Bais Yaakov of Spring Valley et al. v. FCC, 14-1234 (D.C. Cir. Mar. 31, 2017). The majority’s pithy opening line reflects a truism for many businesses...

May 7th, 2017
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