December 12, 2018
By Alex Butler, Manager of Medical Device Solutions, MasterControl
This blog post is the first of a series of three articles on the need to modernize the FDA’s 510(k) clearance process. Part 1 discusses key points of the ICIJ investigation on the medical device industry, the FDA’s response, and the implications of this hot-button public debate in the near future.
December 6, 2018
By Sarah Beale, Staff Writer, MasterControl
When you’ve got a hard deadline, efficiency is everything and no one knows this better than Santa. While he has the entire year to prepare for December 25th, he’s also preparing up until the last second to ensure he’s got everything ready for the big day. To pull this off, he needs a reliable digital production records solution.
December 5, 2018
By Beth Pedersen, Staff Writer, MasterControl
Artificial intelligence (AI) offers unprecedented opportunities for productivity and economic growth in manufacturing and other key industries. Manufacturers are already leveraging AI on the factory floor in highly innovative ways and seeing measurable results.
December 4, 2018
By Arvilla Trag, RAC, Consultant, BioProcess Technology
New drug development is Sunday drive, especially for startups. There can be costly mistakes and unanticipated roadblocks that pop up when you least expect it. Learn how to steer clear of hazards, what to do and who to talk to.
November 29, 2018
By Jean-Christophe Gourmanel and Tifany Desprez, Apsalys, a MasterControl Partner, and Tifany Desprez, Apsalys, a MasterControl Partner
Regulatory change is a near constant in the medical device industry. One of the newest systems to the international medtech scene is the Medical Device Single Audit Program (MDSAP). Find out what is required to implement MDSAP in this first of a three-part series
November 27, 2018
By David Jensen, Staff Writer, MasterControl
In the epic good vs. evil paradigm in superhero movies, supervillains could actually improve their odds if they used the right technology. This article looks at three noted supervillains and discusses how their nefarious agendas might have been more successful had they used a digital manufacturing operations solution.
November 15, 2018
by PricewaterhouseCoopers Health Research Institute
PwC’s Health Research Institute recently issued a report on the U.S. midterm election that analyzes policy issues that may well impact the American health care industry for years to come, particularly those in the pharmaceutical and life science industries. Learn what this means for manufacturers.
November 8, 2018
By Sarah Beale, Staff Writer, MasterControl
Nutraceutical companies have never been required to conduct clinical trials. However, many are now voluntarily taking on this endeavor to show that their products work as advertised. This adds legitimacy to nutraceuticals and provides a better value for consumers, but the complexity of clinical trials presents a significant hurdle.
November 1, 2018
By Robert M. Wolfarth, Chairman, RAPS Utah Chapter
Based on recent economic study and the establishment of the Silicon Slopes technology corridor, Utah has one of the fastest-growing life sciences communities in the U.S. Learn about the Regulatory Affairs Professionals Society’s (RAPS) new Utah Chapter and what the organization is doing to attract more regulatory affairs experts to life sciences careers.
October 30, 2018
By Sarah Beale, Staff Writer, MasterControl
The protein supplement category is no longer exclusively for hardcore athletes. The general population is now full of people who are concerned that they’re not getting enough protein in their diets. These consumers are increasingly turning to supplements to fill the void.
October 25, 2018
By David Jensen, Staff Writer, MasterControl
There are many pathways to bring a medical device to market. The 510(k) and premarket approval (PMA) are the most common, while the de novo pathway is less popular. Advances in technology and changes in regulatory standards are making the de novo a more attractive option.
October 23, 2018
By Dan Vuksanovich, Regional Sales Manager, Schlafender Hase
Because there are potential but invisible risks inherent in labeling artwork documents of life science companies that can’t be detected through manual proofreading, it’s important to be thorough and to know the tricks to detect and prevent these snags from causing unnecessary delays in the manufacturing process.
October 18, 2018
By Stephanie Christopher, Program Director, Medical Device Innovation Consortium
We all seek quality in goods and services, but how can that quality be assured? The U.S. Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH), as part of its Case for Quality initiative, last year launched the Voluntary Medical Device Manufacturing Product Quality pilot program based on a maturity model as an alternative to the traditional path of a routine FDA inspection. Find out if the program might be the right step to boost your company’s quality and compliance.
October 16, 2018
By David Jensen, Staff Writer, MasterControl
One trap regulated startups should try to avoid is having unrealistic assumptions about what it takes to achieve compliance. Part 3 of this article series features several members of the BraveHeart team discussing their views and expectations for quality throughout the Wearable Life Sensor’s life cycle.
October 11, 2018
By Rai Chowdhary, CEO of KPI System (Key Performance Improvement)
Failure modes and effects analysis (FMEA) is a particularly effective tool in risk management. But its use is often accompanied by fear or pain because practitioners struggle to apply it. Learn how to effectively use FMEA without trepidation to improve your company’s risk management operations.
October 10, 2018
By David Jensen, Staff Writer, MasterControl
Before any aircraft leaves the ground, it undergoes a preflight check. Part 2 of this series on BraveHeart features Steve McCalmont performing an aircraft preflight check to illustrate how this critical part of flying equates to the importance of incorporating quality in the design of a medical device.
October 9, 2018
By Sarah Griffin, Principal Consultant, Brandwood Biomedical (Australia)
Australia is increasingly an attractive market for medical device manufacturers. But medtech companies need to know the complexities of the country’s blended public and private hospital systems to avoid confusion and fully profit from its device reimbursement opportunities.
October 4, 2018
By Sarah Beale, Staff Writer, MasterControl
The nutraceutical world is constantly evolving to meet consumer needs and the search for alternative delivery forms is a prime example of this. To combat pill fatigue, supplements now come in liquids, powders, lotions and sprays, but companies embracing innovation need to be aware of the challenges they face.
October 3, 2018
By David Jensen, Staff Writer, MasterControl
Startup ventures are the embodiment of innovation – often hitting the ground running with little more than an idea and a vision. Part one of this three-part series introduces startup medical device company, BraveHeart Wearable Life Sensors, and how it is uniquely inspired by aviation.
October 2, 2018
By James Jardine, GxP Lifeline Editor, MasterControl
This examination of quality guru Ken Peterson’s proven corrective and preventive action (CAPA) innovation techniques provides strategies and sequential principles for refining transformative CAPA innovations, avoiding half-baked solutions and obtaining organizational buy-in of revolutionary quality event management ideas.
