Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, November 22, 2016

The Rise of Smart Wearables

The wearable technology market is one of the fastest growing global industries. Intelligent watches allow you to read emails without checking a mobile phone display, while fitness monitoring bands keep track of the steps walked and the calories burned, seamlessly connecting with a smartphone app.


Smart wearables are not just an extension of smart devices. They are marketed as an invaluable extension of oneself in ways that a smartphone alone cannot do. 

Smart wearables are a key component of the rapidly expanding web that is the Internet of Things (IoT). IoT is hyped for its ability to improve our health, lifestyle, finances, and many other areas. 

The Healthcare Sector: 


The healthcare sector has identified the potential of using smart wearables to take pre-emptive action. The cost of healthcare in the US is mounting every day and, but it is predicted that mass use of wearable technology can mitigate these increases. Wearable watches can allow people to monitor their key health metrics and give healthcare providers remote access to health data, leading to reduced doctor and emergency room visits and better health outcomes. 

Smart wearables geared towards the healthcare sector are set to grow at an annualized rate of 13.6%. Venture capitalists are betting their money on this hot niche, pouring in $2.1 billion over the last three years. 

From parameters like heartbeat and breathing rate to ECG, EEG, EMG, blood pressure and blood glucose monitoring, a great deal is possible, leading to more accurate and timely diagnosis. 


Mark 10’s Contribution to Smart Wearables: 


Smart wearables, like mobile phones, are designed with relatively simple interfaces and ease of use, masking the massive amount of engineering required to develop them. From the materials sourced for the housing and strap, to the torsion- and impact-resistance of the case, to the touchscreen itself, proper testing by device manufacturers is essential in ensuring a successful product.  

Mark-10 equipment can characterize the quality of the strap by measuring tensile and elongation properties, measure the force required to activate the touchscreen, and measure how much force is required to shatter the glass. With a legacy that spans almost 40 years, turn to Mark-10 for testing solutions in the packaging, food and beverage, healthcare, electronics, springs, aerospace, and many other industries. Contact us for more information.

Tuesday, June 3, 2014

New FDA Proposal to Expedite Approval Process for Medical Devices

At Mark-10 we’re always closely watching medical device trends and recently the FDA has proposed a new program to help speed up the approval process for devices that treat or diagnose patients with serious conditions whose needs aren’t met by current technology.

The new program would have more interactive engagement with FDA staff and unlike other existing programs, this one focuses on reducing the time associated with product development and not just reducing the time to market.

According to the FDA, to be eligible for participation, a medical device must:
“Be intended to treat or diagnose a life-threatening or irreversibly-debilitation disease or condition, represent one of the following:
1.       No approved alternative treatment/diagnostic exists, or
2.       A breakthrough technology that provides a clinically meaningful advantage over existing technology, or
3.       Offers a significant, clinically meaningful advantage over existing approved alternatives, or
4.       Availability is in the patient’s best interest
And have an acceptable data development plan that has been approved by the FDA.”

At Mark-10, we’re happy to play a helping role for medical device manufacturers to meet their quality objectives. Our line of force and torque measurement systems may be used for numerous applications, including fastener torque, needle sharpness, catheter torque, tube terminal pull tests, peel testing, tensile testing, and more. Visit our website to learn more.