With fewer safety risks and a faster turnaround time, VPA sterilization can allow medical device OEMs to sterilize product in house. 

Vicki Lanka 

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Like all manufacturers, medical device companies are constantly looking for ways to optimize their production efficiency. Because patient safety and FDA compliance are top priorities, effective and dependable sterilization is a crucial part of the manufacturing process. However, many medical device manufacturers currently rely on off-site contract...

March 29th, 2016
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A U.S-educated academic returns to India to create a mobile diagnostic device powered my digital health tools to assist rural healthcare workers.

Arundhati Parmar

 

That global health is a puzzle that mobile health technologies can help to solve is not new.

But it's always amazing to see entrepreneurs dream up new applications nonetheless.

This latest story comes from India and a device called Swasthya (Health) Slate that was designed to help rural healthcare workers run diagnostic tests and get results quickly. For the past few years, the device has been used It is a mobile platform that comprises of a hardware device that connects to a digital thermometer, a blood pressure monitor, heart rate sensor...

March 29th, 2016
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Boston Scientific thinks Watchman represents a $500 million market opportunity, but how are physicians viewing the device now that reimbursement is available?

Arundhati Parmar

Boston Scientific's left atrial appendage closure device — Watchman — has had a tortuous path through FDA to win approval and more recently had to navigate difficulty at CMS with respect to reimbursement.

FDA deemed that the device was appropriate for patients who are on anticoagulants like warfarin, and while CMS initially disagreed and recommended coverage for only those who couldn't take anticoagulants, its...

March 28th, 2016
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An agile product development process does not have to conflict with the requirements and goals of regulators and investors.

Blake Alberts

 

This past November, the International Council on Systems Engineering (INCOSE) Healthcare Working Group held a workshop on the agile systems development process for medical device developers. The goals of this workshop were straightforward: bring together a small number of companies in the medical device industry to discuss the application of agile practices within the scope of systems engineering and product development, scaling the agile manifesto to apply to more than just the software discipline. Those in attendance, a mix of...

March 28th, 2016
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An engineering executive from a wearable cardiac monitoring company muses on the future of wearables and remote monitoring in healthcare. 

Arundhati Parmar

 

Wearables and digital health technologies are spurring the remote monitoring of chronic patients, forever transforming the brick-and-mortar model in healthcare and improving its delivery.

These technologies have the power to bend the arc of healthcare costs by reducing hospitalizations, amont other things. That is the firm belief of Brian Kronstedt, manager of hardware product development at Preventice Solutions, which sells the FDA-cleared BodyGuardian, a wearable cardiac and activity monitoring device. 

But when asked what could be the next frontier in wearables development, Kronstedt...

March 25th, 2016
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There are more challenges to the heart failure monitoring device than just reimbursement, according to a new survey of physicians.

Arundhati Parmar

St. Jude Medical had hoped that its CardioMEMS heart failure system would be successfully adopted by physicians keen on preventing costly readmissions of congestive heart failure patients.

However, stymied by coverage rejections from Medicare Administrative Contractors (MACs), revenue of the product has caused revenue declines and a lackluster adoption of the device. Stung, the Minnesota device maker is seeking a national coverage decision from the Centers for Medicare and Medicaid Services (CMS) to relieve its reimbursement woes.

But a small survey shows that there are other reasons besides reimbursement, even though it is the biggest factor, that is...

March 24th, 2016
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ZPower has introduced a high-energy rechargeable battery that can be retrofitted for use with many major hearing aid brands, making it a convenient option for patients.

Marie Thibault

Hearing aids retrofitted with ZPower batteries and customized battery doors can be recharged without requiring users to open the battery doors or remove the battery from the device.

Many hearing aid users rely upon disposable batteries to maintain their hearing and power their devices. It’s a surprising fact in a world where consumers have become accustomed to charging their phones or laptops.

ZPower, based in Camarillo, CA, is trying to change this. It has introduced its rechargeable...

March 23rd, 2016
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Stryker is giving hospitals up to $5 million and additional refunds if its products aimed at preventing the occurrence of retained surgical sponges during surgery fails. 

More than 480 U.S. hospitals are using Stryker's SurgiCount system to prevent the chance of mistakenly leaving behind surgical sponges in patients after surgery

 

Arundhati Parmar

For some time now, medtech companies have been heeding the call from providers to assume more financial risk for the products they make.

Medtronic...

March 22nd, 2016
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An annual survey of medical sales representatives finds that a majority are satisfied with their profession. What do they like most about the job? Hint: it’s not money.

Marie Thibault

It’s not all about the Benjamins.

It might be easy to assume that money is the top reason driving a medical sales rep’s happiness with his or her job. After all, sales reps are incentivized using commission and pull in a healthy average annual pay of $141,464, according to the 2015 Medical Sales Salary Report by MedReps.com.

But results from MedReps.com’s ...

March 22nd, 2016
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MC10's flexible sensors began in the world of sports, but the company's aim to solve broad healthcare problems will eventually bring it within FDA's fold.

Arundhati Parmar

It is interesting to watch the evolution of companies with new technologies moving from unregulated waters toward FDA land.

MC10 with its ultra thin, wearable, biometric sensors, began in the world of sports and fitness with the Reebok CheckLight product. Developed in partnership with the shoe company, it incorporated MC10's flexible electronics into a mesh skull cap to collect head impact data to assist with concussion prevention and diagnosis. But a pivot in 2015 and a new CEO seem to augur the company's slow, yet deliberate path toward being regulated.

Over the past year, MC10...

March 22nd, 2016
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