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

Here are seven tips on how to attract and secure government affairs talent successfully in the medical device industry.

Robert Hall

The value of business at stake from government and regulatory factors is huge. McKinsey estimates that around 30% of earnings for companies in most sectors is at stake, and in banking the figure is over 50%. Turning these figures into actual dollars, euros, or yuan might cause palpitations in the faint hearted, so I won’t dwell too much other than offer one example: One European life sciences company estimated that the ongoing value at stake from regulation was €1.5 billion, or about €30 million for every employee involved in government and regulatory affairs.

Since there is a lot of money on the table for companies, it's easy...

March 1st, 2017
1

As Check-Cap starts its clinical trial for CE Mark on its prep-free C-Scan imaging capsule for colorectal cancer screening, the company’s CEO discusses the technology’s potential.

Marie Thibault

Good news for—well, all of us. Check-Cap’s C-Scan system for colorectal cancer screening without the need for a bowel prep is ready to enter the clinical performance phase of development.

After being swallowed in capsule form, the C-Scan system’s ultra-low-dose X-ray technology is used to produce a 3-D map of a patient’s colon. The system differs from capsule technology already on the market by eliminating the need for a bowel prep prior to ingestion and examining the colon in its natural state without distention.

In January, ...

February 24th, 2017
0

Cybersecurity is a concern for connected medical devices, but not all risks are apparent—or materialize—until after a product is on the market. FDA therefore expects manufacturers to address cybersecurity “throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device,” the agency wrote in its December 2016 guidance, “Postmarket Management of Cybersecurity in Medical Devices.” 

The guidance clarified FDA’s enforcement plans and urges industry collaboration, but one of its recommendations—participation in an Information Sharing Analysis Organization (ISAO)—wasn’t necessarily available for medical device manufacturers. Until now.

...
February 23rd, 2017
0