This primer will help medical device manufacturers that are already familiar with RoHS gain a better understanding of the European Chemical Agency’s REACH legislation.

Nigel Syrotuck

The Importance of Understanding REACH

In February 2017, the European Chemical Agency (ECHA) released a draft guidance on requirements for substances in articles under REACH (Registration, Evaluation, Authorization, Restriction of Chemicals, Regulation (EC) No 1907/2006). REACH is an extremely important (and complex) piece of legislation to understand, but just like RoHS (Restriction of the use of certain Hazardous Substances, Directive 2011/65/E), meeting its requirements is a must to sell products in Europe....

March 23rd, 2017
0

Material selection for medical devices is of critical importance for reducing risk of a failure and hinges on many factors.

Jeff Ellis, PhD

Medical device material failures are common and costly. Fortunately, the risk of these failures can be greatly reduced through better understanding of materials science earlier in the product development cycle, preventing both delays and postmarket issues.

Using data found on the FDA website, our team of researchers concluded that materials were either a major or possible cause of more than 30 percent of medical device FDA recalls in 2013 and 2014. Whether they incite FDA recalls or development setbacks, many of these material failures can be avoided by gaining a better understanding of the materials’ properties and...

March 22nd, 2017
0

Internet of Things-enabled medical devices have great potential, but it's important for device developers to have a strong understanding of value creation in IoT-enabled medical products.

Shawn Oreschnick

This is a story you may be able to relate to. A medical device organization saw the potential of its medical-grade, in-hospital wearable device for a broader consumer audience. Certainly, changes were needed, the most significant of which included adding smartphone connectivity to allow for ongoing service and data collection. The engineering was not difficult. Even marketing the device through consumer pharmacy chains proved easier than expected; pharmacy technicians could easily explain the device and its intended use. It sold well. In fact, it...

March 20th, 2017
0

Silicon technology is one of the most promising solutions for low-cost, sensitive, and specific measurements of a large number of biomarkers. 

Liesbet Lagae

Chip technology has given us ever-faster and smarter computers, smartphones, sensors and will keep on doing this in the future. We will need further scaling of chip building blocks for faster and better data communication, computation, and storage in large server plants. Finally, chip technology will enable a revolution in healthcare. 

The healthcare arena is on a clear path toward preventative and personalized medicine. Measurements of health status are essential in advising patients and healthcare professionals on the most appropriate preventive or curative measures. However, our...

March 20th, 2017
0

Medical device manufacturers must ensure their suppliers are consistently delivering high-quality parts and materials. Here are five signs that a supplier’s quality system or processes may be slipping.

Terrance Holbrook

 

As medtech OEMs’ supply chains grow longer and more complex and regulatory bodies such as the FDA place more focus on upstream activities, manufacturers must know whether their suppliers are reliably producing high-quality parts and materials. But if a manufacturer doesn’t know what signs to look for, it will struggle to know if a supplier’s quality system is failing, let alone be able to keep the...

March 17th, 2017
0

What’s in a name? A lot more than you might think.

Mike Pile

One of the occupational hazards of being a professional namer—yes, there is such a job—is that you notice then analyze the brand names you sees while out and about. A simple errand becomes an endless exercise in analytics when surrounded by vans delivering home meal kits from Purple Carrot, Blue Apron, PeachDish, Just Add Cooking, Sun Basket, Hello Fresh, HomeChef, and Plated.

...
Get more expert product development advice at the BIOMEDevice Boston Conference, May 3-4, 2017.
March 14th, 2017
0

Been there, done that. These medical device entrepreneurs reflect on the lessons they've learned building medical device companies.

Marie Thibault

Starting a medical device company can be a daunting undertaking. Between the lengthy regulatory timelines, clinical testing, and large amounts of capital needed to bring a medical device to market, many innovators shy away to other fields.

But a group of entrepreneurs gathered at the South by Southwest Conference and Festivals this week to discuss “No More Apps: Why Reinventing Devices is Key” have taken on the challenge of a medical device startup and are able to share lessons learned firsthand. Panelists included Janica Alvarez, cofounder and CEO of Naya Health, a company...

March 14th, 2017
0

For more promising medical technologies to cross the so-called valley of death, development teams need to rethink their approach.

Bruce W. Lichorowic

As the convergence of high tech and medtech continues, ask most medical professionals if there's a better way of bringing new medical technologies to market, and they'll likely all agree that there is. However, most of these professionals can’t devote the time needed to develop a new medical device or improve an existing one.  Most often, they use devices and techniques they've learned in medical school or fellowship.

...
March 13th, 2017
0

A clinician details the development of the electronic brachytherapy field and the design and engineering aspects that make the technology unique.

Rakesh Patel, MD

High-dose rate electronic brachytherapy systems have a wide range of applicator sizes, allowing the radiation to precisely target cancer cells while sparing healthy tissue.

Each year in the United States, clinicians treat more than 5.4 million cases of nonmelanoma skin cancer (NMSC), including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). Rates of NMSC have increased dramatically in recent years, highlighting the need for advanced treatment options to improve...

March 9th, 2017
0

MD&M West speaker shares success story on engaging patients.

By Daphne Allen

Amy Cook

Each night millions of patients use continuous positive airway pressure (CPAP) devices to manage their sleep apnea and other chronic conditions. While CPAP is considered the gold standard treatment for sleep apnea, many patients still struggle with consistent adherence, explained Amy Cook, director of Healthcare Informatics for ResMed, at the MD&M West 2017 conference. Despite advances in device...

March 3rd, 2017
0