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
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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.

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February 23rd, 2017
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An expert discusses what medical device manufacturers need to keep in mind as the compliance date for the fourth edition of the IEC 60601-1-2 standard approaches.

Marie Thibault

Manufacturers developing and marketing medical devices have a staggering number of regulations, guidances, and industry standards to master. One such standard is IEC 60601-1-2. The fourth edition of this standard was published in 2014 and the transition date is fast approaching.

To learn more, we asked Lorenzo Cividino, director, Global Applications and Support at SL Power Electronics, a company that designs, makes, and markets power conversion solutions for a number of...

February 22nd, 2017
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Holistic and pragmatic risk management throughout the product development lifecycle can make the development process more predictable.

Doug Boyd

Effective risk management is the single most important activity to achieve a predictable and successful product development program. All medical device development programs engage in safety risk management to ensure the safety of the ultimate product, but too often, development teams do not engage in the holistic, programmatic risk management necessary for a predictable development program.

When there are shortcomings in the programmatic risk management process, they are most often due to either the improper level of technical risk reduction for the project stage, or from not having a truly holistic...

February 21st, 2017
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An R&D manager shares his perspective.

Daphne Allen

Li Jin

Medical device designers are well versed in design controls, but generating design requirements can get a little confusing. At MD&M West 2017, Li Jin, R&D manager for Abbott, clarified a few points about design inputs in “Developing Design Requirements to Ensure User Needs Are Met in Product Development” on February 7.

A design input...

February 17th, 2017
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The annual college basketball bonanza is right around the corner, and that means it's also time for MD+DI's Medtech Startup Showdown In our competition's third year, medtech startups will face off against each other in brackets. Enter your startup now!

It's already time for the MD+DI's third Medtech Startup Showdown. In this contest, medical device startups compete against each other to determine who has what it takes to succeed in the industry.

Here’s how it works: We’ll organize startups into a tournament bracket, and each week give our readers the chance to vote for their favorites. The team in each bracket that gets the most votes will move on to the next round.

To be considered for the tournament,...

February 17th, 2017
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As Allergan and Hologic announce big acquisitions in the medical aesthetics space, Syneron Candela discusses its strategy for competing against these bigger players.

Marie Thibault

This was a big week in the medical aesthetics technology space, with two major medtech companies—Allergan and Hologic—making bids for two different medical aesthetics companies. The proposed acquisitions are clear evidence of interest in the rapidly growing field, but the potential purchases are also likely to impact market dynamics and current players.

One such medical aesthetics player is Syneron Candela. The company offers products used for body shaping, hair removal, and vascular lesions, among other treatments....

February 16th, 2017
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A specialty chemical company publicizes a four-step protocol to test materials for resistance to disinfectants, drugs, and the other chemicals found in the hospital environment.

Marie Thibault

In the medical device industry, the importance of choosing materials that can stand up to repeated exposure to harsh chemicals is becoming clear, as MD+DI has reported in the past. The use of strong disinfectants and rigorous sterilization procedures has intensified with healthcare reform and the focus on reducing hospital-acquired infections. Some plastics can crack, change color, become sticky, or even fail in these hospital environments,...

February 14th, 2017
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The chief scientist at IBM Commerce Research offers insight into the elements that keep people using their wearables—and the practices that lead to abandonment.

Marie Thibault

Ah, wearables—they grab our attention with their good intentions and slick looks. But all too often, they end up in the wearables graveyard, a drawer with all the other gadgets that failed to become a permanent fixture in our daily lives.

Of course, this isn't the fate of all wearables, but it is a notable challenge. As medical wearables gain steam in the medtech industry, how can designers and developers increase the chance of long-term adoption?

An industry expert, Chandra Narayanaswami, chief scientist and senior manager at IBM Commerce Research, shared lessons learned from IBM...

February 10th, 2017
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Follow these tips if you’re trying to land your first job in medtech or transitioning from another industry.

Jamie Hartford

 

It’s not hard to see why medtech is a great industry in which to stake out a career. Medical device and diagnostics companies pay well—median salary tops $118,000—and job security and job satisfaction among workers is relatively high, according to MD+DI’s 2016 Medtech Salary Survey. But getting your foot in the door at a medtech company isn’t always easy.

At the MD&M West expo in Anaheim, CA, on February 9, three...

February 10th, 2017
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