You know an FDA audit can happen at any time, but would you really be prepared if it happened today?

Isabelle Noblanc

FDA in December posted the most recent list of inspection observations issued during the agency’s 2016 fiscal year, which ran from October 1, 2015, to September 30, 2016. FDA issues Form 483 inspectional observations or warning letters following an inspection to let the company know that its quality practices are not in compliance with regulatory standards.

The agency is increasing both the number and intensity of its inspections using a risk-...

May 26th, 2017

An expert makes an argument for the wider application of medical technologies and greater investment by hospital administrators to prevent the spread of antibiotic-resistant pathogens.

Jeffrey R. Ellis, PhD, MBA

There is now increasing concern that humankind soon will be coping with pathogenic microorganisms in a “post-antibiotic age.” Antibiotics are increasingly expensive to develop and often take lengthy amounts of time to be thoroughly vetted for side effects. Yet recent reminders—such as the outbreak of antibiotic-resistant Candida auris infections in New Jersey and New York with over 60% mortality—indicate the urgent need to develop alternative technologies for fighting diseases. Provisions need to be made against the likelihood of outbreak of a...

May 24th, 2017

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

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

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

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

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

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

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

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