Focusing on organization and talent can help medical device companies establish key account management programs that will benefit both themselves and their customers.

Brian Chapman and Pete Masloski 

The medtech marketplace has experienced drastic changes in recent years. Economic forces have accelerated on hospitals, forcing them to become more cost conscious. Hospital purchasing has become more professional and structured, with purchasers working with clinicians to select appropriate products and make trade-offs clinical stakeholders had not previously been expected to make.

In an environment with mounting commercial pressures, many medtech organizations are reassessing their sales strategies, developing and increasing their investments in key account management. This is not a program...

June 23rd, 2015

Rep-less models are promising but hospitals need to be better prepared and manufacturers must create more comprehensive solutions to bring true value. 

Rick Ferreira

When some manufacturers launched their rep-less solution last year, it seemed a timely and relevant solution for providers.

In many ways, the launch was in direct response to demands from providers that devices be made available at lower costs to better align with the economic realities and reimbursement conditions of value-based care.

Rick Ferreira, president and CEO. Intralign
June 22nd, 2015

Expert tips on human factors engineering for medical devices from a human factors specialist.

Gareth Walker

Owen Mumford’s state of the art test lab analyses its prototypes to ensure new innovations perform as expected.

The term “human factors engineering” is widely recognized across the medical industry. Simply put, it is about designing for people. When designing medical devices, it is easy to focus on optimizing the physical components of a system, but human factors engineering ensures that the end-user—whether this be the patient using the device in every day life, or a healthcare professional in a clinical environment—is considered in the early design stages.

By understanding the intended users, a product can offer the appropriate...

June 19th, 2015

Knowing the ins, outs, ups, and downs of the standards that apply to your product is paramount.

Alena Mitchell

I have worked as a safety engineer in the medical device industry for two years. With prior experience as a design engineer, I felt I was in a good position to navigate the world of medical safety product compliance. As it turns out, learning the ropes of compliance has been one of the most challenging experiences of my career.

One of the toughest concepts to grasp was how the meaning of terms differs between the design and safety product fields. Take, for example, the term “essential performance.” In design, essential performance refers to what is required to make the equipment work” (e.g., Does it need a fully charged battery? Does it need a certain rated power...

June 19th, 2015

Microinvasive Surgery

Minimally invasive surgeries are becoming more and more common, and they have pronounced benefits—from reduced infection rates to faster recovery times—over open surgeries. Today, surgeons are gravitating toward smaller and smaller incisions, and, in some cases, no incision at all by using the body’s natural orifices for surgical access. What were historically higher risk surgeries with extended hospital stays are now accomplished as outpatient procedures during office visits.

Technology miniaturization, specifically the optimization of microelectronics and nanotechnology, will continue to fuel this trajectory. While needle-based arthroscopies that leverage carbon...

June 19th, 2015

Smart Tool Error Prevention

Smart devices are very much a reality in our day-to-day context, but to what extent can such technology extend into medical device development? Building artificial intelligence into diagnostic, therapeutic, and surgical tools could minimize the potential for human error, in turn improving patient outcomes.

By leveraging sensors, actuators, cameras, lenses, medical devices, and even single-use disposables—all of which are quickly becoming commodity technologies—in new ways, we could provide real-time guidance to prevent mistakes and misuse. Imagine a scalpel that prevents a surgeon from accidentally cutting through the wrong type of tissue by utilizing a warning...

June 19th, 2015

Macro Health Optimization

Today, Big Data poses more questions than answers. Now that we’ve successfully created an information infrastructure, how do we leverage the information stockpile that contains billions of data points generated each second?

Big Data’s potential in healthcare is massive, influencing everything from personalized medicine to population health. With the help of cognitive computing, such as IBM’s Watson and predictive analytics, real-time pattern recognition and data tracking could both inform decisions and anticipate or predict outcomes.

Imagine if a physician in a remote village could quickly cross-reference patient symptoms and attributes using a database...

June 19th, 2015

Behavior-Based Treatment

Recently, there has been an influx in preventative health and wellness initiatives aimed at reducing the healthcare burden. These initiatives often focus on lifestyle choices such as diet, exercise, and stress management. Coupling these efforts with the Quantified Self movement, which leverages technology to monitor and measure aspects of our daily lives, is yielding new possibilities for behavior-based treatment.

Systems can now learn an individual’s health habits and patterns over time, enabling real-time guidance, personalized treatment, and early detection and diagnosis. Such systems might suggest a protein-rich recipe based on an individual’s measured energy...

June 19th, 2015

Spurred by recent technological advances, these areas of healthcare are likely to experience rapid change in the coming years.

Steve McPhilliamy


We in healthcare are always predicting the next big thing. We often latch on to research that promises it could “someday lead to” a cure for cancer, diabetes, or any number of other ailments. But too often, those discoveries never even make it out of the lab.

Here are four areas of healthcare we’ve been hearing hyperbolic promises about for some time. The difference is, these areas may have finally reached a critical mass. Technology and technique have advanced to the point where we expect these areas to...

June 19th, 2015

Researchers criticize the current administration for lack of transparency because of the dearth of oversight of FDA guidance documents. At the same time, industry seems to be enjoying increased transparency with FDA.

Jim Dickinson

Roundly faulted for failing to deliver on his 2009 campaign promise to establish the most transparent government in history, President Barack Obama’s administration drew academic criticism in June for insufficient transparency in monitoring FDA guidance documents, a notorious arena of past abuses.

The criticism came in a report from two regulatory policy researchers at George Mason University’s Mercatus Center—regulatory studies vice president...

June 19th, 2015