MedTech I.Q.

The Cutting Edge of Medical Technology Content, Community & Collaboration

Adam Fleming's Blog (255)

Having a [baby] is exorbitant and befuddling, notwithstanding for a wellbeing approach master

It is hard to believe that it has been just over since five months since our second son, Lukas, was born on Feb. 3. His mother, Hollyanne, is doing well, which is something to be thankful for, given the excessive maternal mortality rates in the U.S. Lukas is also healthy and growing, albeit sleeping little at night. What is…

Continue

Added by Adam Fleming on July 19, 2018 at 8:23am — No Comments

Rebooting Life science industry with Digital (Technology)

Digital technology has been driving change throughout the life science industry for years, however the sector is currently standing on the precipice of revolutionary development – some organizations have already taken the jump towards a more digital future.

Data collection and visualization for decision making to improve the overall performance of themanufacturing supply chain is a huge opportunity for the life science industry, however it’s not about being new – it’s about using…

Continue

Added by Adam Fleming on July 17, 2018 at 5:28am — No Comments

Education Technology’s Machine Learning Problem

From Formula 1 to Yelp, industries across the board are seeking ways to apply machine learning to their work. Even academics and Goldman Sachs analysts tried using it to predict World Cup winners. (Those predictions proved very, very wrong.)

But how is machine learning playing out in education—and how does it impact not just students, educators and parents, but also the businesses building technology tools to support teaching and learning?

At the SF Edtech Meetup, hosted by…

Continue

Added by Adam Fleming on July 12, 2018 at 7:45am — No Comments

Ask the SMXperts — Schema & Structured Data, JavaScript

Do you think Google will use Schema extensions built by experts?

Bill: There are subject matter experts and there are experts on creating Schema, and ideally an extension will involve both types of experts. To read up on extensions to Schema, there is a page on Schema.org…

Continue

Added by Adam Fleming on July 9, 2018 at 6:49am — No Comments

Blockchain Technologies to get Increasingly Powerful and Robust

You may be familiar with blockchain as the technology powering bitcoin cryptocurrency. But blockchain’s potential goes far beyond this, with healthcare being just one of the industries set to be revolutionized. In an editorial published today in the International Journal of Health GeographicsMaged N. Kamel Boulos and…

Continue

Added by Adam Fleming on July 6, 2018 at 4:57am — No Comments

Introduction of the new system is causing some concern over the privacy

A NEW controversial system may soon see welfare recipients required to have their face scanned and analysed before they can access their payments.

The system, which will also affect people trying access Medicare and childcare subsidies, age pension and pay tax online, is part of a new biometric security program that is set to begin in October.

Under the new strategy those trying to access these government services will be required to take…

Continue

Added by Adam Fleming on July 3, 2018 at 5:32am — No Comments

Improving Customer Experience with AI

A myriad of customer service channels exist today, such as social media, email, chat services, call centers, and voice mail. There are so many ways that a customer can interact with a business and it is important to take them all into account.

Customers or prospects who interact via chat may represent just one segment of the audience, while the people that engage via the call center represent another segment of the…

Continue

Added by Adam Fleming on June 28, 2018 at 6:59am — No Comments

What does the medical device/biotechnology auditor look for and why?

Audits -both internal and external -are a vital tool for ensuring that a medical device or biotechnology product and its manufacturing operations meet prescribed regulatory requirements. Medical device and biotechnology auditors have guidelines on how to establish that the manufacturer has met standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820.

Apart from going by these guidelines; the auditor…

Continue

Added by Adam Fleming on June 14, 2018 at 7:18am — No Comments

Food Fraud in the Organic Industry

A recent admission by The U.S. Department of Agriculture’s Office of the Inspector General of its failure to review required documents for products labeled as “organic” indicates a lack of controls at U.S. borders, increasing the likelihood of nonorganic products entering the U.S. under false “organic” labels.

This opens the floodgates for the entry of dubious products into the market and getting passed off as organic, without being that. In fact, many imported products that carry the…

Continue

Added by Adam Fleming on June 5, 2018 at 5:47am — No Comments

When a medical device fails to meet these standards for precision and accuracy

All medical devices have their stated intended use. With time, many of them undergo changes with use. Because of this, they need to be calibrated to retain their effectiveness. The FDA’s medical device calibration requirements have been devised with the same intention.

Although the FDA has medical device calibration requirements, many of these medical devices do not have specific measures that need to be set. So, in view of this, the FDA can only require that the…

Continue

Added by Adam Fleming on February 27, 2018 at 4:58am — No Comments

FMEA in medical devices can work better when mated with ISO 14971

Failure Mode and Effects Analysis (FMEA) is a core aspect of risk management and risk analysis in medical devices. FMEA is essentially about analyzing the reasons for which a problem arises and the effects it has on the system. In the field of medical devices, it is absolutely critical to understand the failure mode and effects because the consequences of not doing this can be…

Continue

Added by Adam Fleming on February 23, 2018 at 5:39am — No Comments

Florida capital to press for gun law change

A hundred Stoneman Douglas High School students are busing 400 miles to Florida’s capital Tuesday to urge lawmakers to act to prevent a repeat of the massacre that killed 17 students and faculty last week.

The students plan to hold a rally Wednesday in hopes that it will put pressure on the state’s Republican-controlled Legislature to consider a sweeping package of gun-control laws, something some GOP lawmakers said Monday they would consider. Shortly after the shooting, several…

Continue

Added by Adam Fleming on February 20, 2018 at 5:02am — No Comments

FDA regulation on medical device packaging design

The FDA has regulations on medical device packaging design. This is quite natural, considering that the FDA has several regulations on all aspects of medical devices. However, it needs to be mentioned that the FDA regulation that covers medical device packaging design – Sec. 820.130 Device packaging under Subpart K–Labeling and Packaging Control -is a single liner, which only merely states that “each manufacturer shall ensure that…

Continue

Added by Adam Fleming on February 16, 2018 at 4:46am — No Comments

Medical Device Process Validation is the Key Part of a Quality Process

Process validation is one of the essential functions of a quality system for medical devices. Medical device manufacturers who have to stay compliant with regulatory requirements have to obtain premarket approvals (PMA), as well as premarket notifications for both new and modified existing medical devices. The key to all these is medical device process validation.

The FDA…

Continue

Added by Adam Fleming on February 14, 2018 at 5:04am — No Comments

Medical Devices is aimed at ensuring very high quality assurance standards

Process validation for medical devices is a key ingredient of quality assurance in medical devices. Process validation is the criterion for measuring the effectiveness of a quality system for medical devices. The first step that medical device manufacturers have to take to show compliance with regulatory requirements for new and modified existing medical devices is obtaining premarket approvals (PMA) and premarket notifications. Process validation for medical devices is…

Continue

Added by Adam Fleming on February 6, 2018 at 5:10am — No Comments

CISOs map out their cybersecurity plan for 2018

When Omar F. Khawaja compiled his priority list for 2018, he didn’t include which security technologies he wanted or how many IT staff he hoped to hire.

Instead, the CISO at Highmark Health — a healthcare management and insurance provider whose portfolio includes Allegheny Health Network, United Concordia Dental and Visionworks, among others — articulated an overarching strategy on how the cybersecurity plan should fit within the national organization’s business…

Continue

Added by Adam Fleming on February 2, 2018 at 5:05am — No Comments

What is the purpose of lyophilization & Where it will be applied?

Lyophilization is the clinical term for freeze-drying. In the simplest terms, it can be described as a technical process in which the moisture level of many materials is reduced, most times frozen, for the purpose of creating a new product or an ingredient.

When an injectable drug is freeze-dried -this is the process of lyophilization -its compounds are stabilized. This reconstitution process is…

Continue

Added by Adam Fleming on January 25, 2018 at 5:13am — No Comments

Food Production Is A Modern Agricultural Miracle So Why Is It Under Attack

Agriculture is under attack. Environmentalists label modern farming as unsustainable, blaming farming for polluting the planet and destroying the climate. But today’s food is abundant and nutritious—a modern agricultural miracle.

From 1961 to 2013, world population more than doubled from 3.1 to 7.2 billion. But agricultural output more than tripled over the same period, according to data from the United…

Continue

Added by Adam Fleming on January 24, 2018 at 5:16am — No Comments

How a new technology is changing the lives of people who cannot speak

Last November, Joe Morris, a 31-year-old film-maker from London, noticed a sore spot on his tongue. He figured he’d bitten himself in his sleep and thought nothing more about it until halfway through the winter holidays, when he realised the sore was still with him. He Googled “cut on tongue won’t heal” and, after sifting through pages of medical information on oral cancer, he decided to call his doctor.

The cut was…

Continue

Added by Adam Fleming on January 23, 2018 at 5:05am — No Comments

To ICO or Not to ICO? That Is The Question for Today’s Startups

Aung Kyaw Moe and Jun Hasegawa have a lot in common.…

Continue

Added by Adam Fleming on January 22, 2018 at 5:28am — No Comments

© 2024   Created by CC-Conrad Clyburn-MedForeSight.   Powered by

Badges  |  Report an Issue  |  Terms of Service