Regulatory affairs (RA) professionals in the medical device industry essentially want the same thing: to improve their submissions worldwide for a faster time to market. Alex Butler, an industry veteran, has two words for his peers — global approach. He shares some tips for achieving an effective global strategy.
January 10, 2019
By Ray Sison, VP of Pharmaceutical Outsourcing and Tech Transfer, xCell Strategic Consulting
In Part 2 of a pair of articles on pharma companies having a better and more effective vendor selection experience, it’s clear that a thorough request for proposal (RFP) and well-defined vendor selection SOP are essential. By controlling the vendor selection information, you can control the process and negotiate the best deal.
January 9, 2019
By Sarah Beale, Staff Writer, MasterControl
Stagnation is the enemy of most businesses in most industries, making it hard to keep up – especially when it comes to technology. Managers starting to modernize their manufacturing floor should consider how to use that technology to make more products available more quickly with more advancements.
January 2, 2019
By Jean-Christophe Gourmanel and Tifany Desprez, Apsalys, a MasterControl Partner, and Tifany Desprez, Apsalys, a MasterControl Partner
The Medical Device Single Audit Program (MDSAP) can help give your medtech company an edge in international markets. In Part 3 of this three-part series, find out how to most seamlessly navigate your company through the MDSAP audit process.
December 20, 2018
By Beth Pedersen, Staff Writer, MasterControl
5S, the system of workplace standardization and organization which originated in Japan, has helped countless manufacturers reduce waste and optimize efficiency. Now, a sixth “S” is turning this lean initiative into a centerpiece of corporate culture, making it more about people than profit.
The concept of working robots has come a long way since Isaac Asimov’s science fiction stories circa 1940s. Today, robots work in Amazon warehouses, streamline the manufacturing process at Adidas, and serve amenities in Crowne Plaza hotels. How long will it take before we start seeing wanted ads for chief robotics officers (CRO) to manage a combined human and robotic workforce?
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 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 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.
