An expert shares tips for tackling the trickiest hurdles of the consumer health segment and where he thinks the field is headed.

Marie Thibault

There has been plenty of talk about patients becoming consumers of healthcare and their expectations for medical products shifting. Consumer-med, that blurred area between consumer products and medical devices, is a challenging field. Yet, it’s one of the most exciting areas of convergence, according to Kevin Young, SVP, Product Experience at Continuum.

“I’m personally and professionally fascinated by this overlap, this growing category of products that are between...

April 28th, 2017

Personal medical devices should be designed to be as intuitive to use as consumer products—without training sessions or thick instruction manuals.

Amy Schwartz

Patients live in a consumer world. They interact daily with a variety of non-medical devices that are intuitive to use properly and do not require extensive training or detailed instructions.

Yet medical device companies design products that depend on instructions and training to achieve proper use and adherence. Even worse, some of these devices are designed with the expectation that they can mitigate poor design thorough instructions or training.

Poor design leads to usability and adherence problems because basic human factors and an understanding of the actual context of...

April 26th, 2017

A clinician discusses his current approach to tackling sepsis, a challenging condition to identify, prevent, and treat.

Eric Gluck, MD

Around the globe, infections occur in people of all ages. Most of the time, the body can rid itself of the infection without intervention, but when the host is unable to contain the infection, treatment can be required. Pathogenic bacterial infections may require targeted antibiotic therapy aimed at treating the source of the infection. Early administration of appropriate antibiotic therapy is imperative to prevent the infection from spreading to other areas of the body. This may lead to overwhelming inflammation and sepsis if the host is compromised or the infection is left untreated. 


April 25th, 2017

'Intended use' and 'indications for use' are two terms that are often mistakenly treated as interchangeable.

Jon Speer



The medical device industry is chock full of terminology and acronyms that are important to know and understand.

Two terms that are often a source of confusion (and often mistakenly treated as interchangeable) are “intended use” and “indications for use.”

Product development engineers and regulatory professionals, this one’s for you. Recently, I had a...

April 25th, 2017

Have you addressed these four common challenges to sterile packaging for your medical device?

Neil Thompson

Congratulations! You want to sterile package your medical device. Now what?

Here are four issues to keep in mind to make your packaging project a success.

Concern #1—Specifications and Design

Since budget is always a concern, the first question you should ask yourself is, “How many products or product lines do I want to package?” A package that fits multiple product lines or product sizes will drop your costs significantly by reducing the number of validations you need to perform. You can also consider a package scheme that fits two or three sizes and covers all product lines.

Concern #2—Sterilization...

April 19th, 2017

Here's why a medical device manufacturer may want to consider parylene conformal coatings for implantable devices.

Sean Horn

The chemical vapor deposition (CVD) process is unique to Parylene compared to other common conformal coatings.

Parylene provides precisely deposited protective conformal coatings for medical implants, enabling the specific device purpose despite challenging physical configurations. Other performance properties amplify parylene’s ability to withstand operational duress throughout surgical implantation and long-term use in the body:

  • dependable elastometricity,
  • functional stability in the presence of bodily fluids,
  • exceptional biocompatibility, and
  • outstanding...
April 18th, 2017

A recent court decision in a case involving Intuitive Surgical serves as a useful reminder for medical device manufacturers to review their approach to product warnings.

Terry M. Henry, Melanie S. Carter, Lauren E. O’Donnell, and Naomi Zwillenberg

Washington State’s highest court set off a bit of a firestorm recently when it ruled that medical device manufacturers must warn those who buy their products about related risks. The court’s decision in Taylor v. Intuitive Surgical, Inc., seemed to undermine the customary view that a device manufacturer need only provide its warnings to the prescribing physician; the learned intermediary. A broader review of the law shows...

April 13th, 2017

Getting the medical technology industry's commercial model out of the 1980s will pay significant dividends for years to come. Here's what needs to change.

Brian Chapman and Peter Masloski

The 1980s were a time of great innovation for the medical technology industry. The field of in vitro diagnostics was exploding with relevant diagnostic tests being released every month. Self-monitored blood glucose meters were being commercialized, changing how diabetics managed their diseases. Implantable cardioverter defibrillators dramatically reduced the risk of death from ventricular fibrillation. Angioplasty, pulse oximetry, mainstream use of laparoscopic procedures, and more—the list of product innovation is staggering.

In those days, sales and marketing were...

April 11th, 2017

Dreaming up the next digital health disruption can be inspiring, but to move forward, the industry needs to share best practices, take on tangible applications, and collaborate.

Mike Sanders

It may be hypocritical, but I find most articles on digital health distracting rather than helpful to medical device development. That's because most media coverage focuses on the latest company, product, or service, instead of tangible examples of digital health in regulated medical devices.

Admittedly, following digital health technology is fun, but for me, most announcements about new products raise questions. Take, for example, the 510(k) clearance of the Samsung Health App...

April 10th, 2017

Here’s how to cope with new EU Medical Device Regulations requiring unique device identification.

Peter Rose

Back in 2014, the Department of Health started to take tentative steps towards setting a standard for tracking medical implants, supplies, and instruments. Its Scan4Safety program mandated that all 154 acute trusts adopt GS1 identification keys. These keys, used across many industries, provide a unique identification code to any real-world entity making the process of identifying it completely unambiguous, which helps to reduce errors and streamline the supply process. In 2016, a further step was taken to roll out a barcoding scheme for medical implants such as breast implants and hip replacements. Reducing errors is expected to bring benefits to patients and help reduce costs...

April 10th, 2017