Apr 29, 2015

Top 5 Medical Device Trends That Will Dominate 2015

Learn how to navigate the biggest industry trends of 2015.  

by Lisa Weeks

Marketing Communications, MasterControl

More connected and consumer-driven than ever before, the medical device industry is in the middle of a truly transformative year. Three-dimensional printing, mobile health apps, and other disruptive technologies are changing the way providers deliver care and prompting regulators to re-examine their roles. Consumers are demanding more transparency and convenience but are also concerned about the security of their medical information. Investors and stakeholders are paying closer attention to reimbursement policy, which could limit innovation and access to life-saving products. In the midst of it all, regulatory frameworks in Europe and the U.S. are undergoing massive changes. Here are five trends worth watching this year.

Cut through the Clutter: Simplifying Regulatory Compliance

Cut through regulatory red tape to improve
quality, compliance and time to market.

by David R. Butcher, Marketing Communications, MasterControl

For any business, the process of getting a product to market – from concept initiation through release – is often long and arduous. For manufacturers that must navigate the maze of regulatory red tape, hoops and hurdles, the process of bringing an innovative product to market can be even more punishing and the stakes even higher: one wrong step can stall or completely derail the entire product development effort, giving competitors a major advantage in the race to market.

As highly regulated companies’ leaders look to bring their innovative products to market, many consider mounting regulatory pressure a key disruptive issue in their industries moving forward.

Apr 28, 2015

MasterControl Revs Up Improvement

by Craig Gygi
Executive VP Operations, MasterControl

The de facto standard for excellent business operations is Lean Six Sigma. Only five years ago you could not say that. But today, in every industry and in every geography, companies have figured out that the principles and practices of Lean and Six Sigma are the world-class standard for designing, configuring, improving, and controlling business.

Apr 23, 2015

Risk: 2015’s Most Valuable Player?

In 2015, risk may become quality's most 
valuable player and could drive quality to a 
new level of proficiency.
by Marci Crane
Marketing Communications, MasterControl

For quality professionals, and especially those in quality management, there are often quality themes that seem to emerge from year to year. In 2000, the theme of process-driven quality was certainly salient and other various themes--though not necessarily new to quality management—seem to stand out as each year passes.

Chances are high that those reading this blog entry are beginning to see the emerging patterns of quality in their own organizations. Perhaps, even this early in the year, one area of quality already stands out more than others. There are certainly many improvements that can be made and when even one aspect of quality is improved it’s likely that new successes will present themselves organization-wide.

Apr 21, 2015

Fewer Donor Hearts Used

A new study tracked a pronounced decline in the 
use of donor hearts overall in the United States.
by Sheila Yu
dailyRx News

As the waiting list for heart transplants has grown longer, fewer hearts have become available for transplantation in the US in recent years.

A new study tracked a pronounced decline in the use of donor hearts overall in the US.

The authors of this study noted that some US regions used more donor hearts than others. As a result, they suggested the need for updated and standardized guidelines on donor heart use and acceptance.

Apr 16, 2015

Your Biggest End-User Training Problem—Solved!

E-learning makes it easier to 
train your global workforce.
by Donna Cline, Senior Instructional Design Specialist, MasterControl 

According to Forbes magazine, the global e-learning market is projected to reach $107 billion in 2015.(1) What’s driving the demand? Employees work in offices (and at home) all over the globe. Traditional face-to-face instructor-led training (ILT) or classroom learning is often too impractical for today’s geographically dispersed workforce. E-learning, also known as online or Web-based learning, solves what is arguably the biggest challenge training coordinators face: How do I reach my scattered workforce?

Apr 14, 2015

5 Practices for Managing Change When ISO 9001:2015 Arrives

by Terrance Holbrook, Senior Product Manager, MasterControl

Quality management system (QMS) standard ISO 9001:2008 is about to undergo some significant changes soon, with the new ISO 9001:2015 due to be published later this year. As a result of proposed fundamental changes to the structure and contents of the standard, this revision will be important to organizations with, or seeking, ISO 9001 certification and those implementing ISO 9001 systems.

When the revised regulatory requirements go into effect, will your organization be prepared to implement the necessary changes smoothly? Will it be able to look at the requirements in a proactive way and turn the challenges of change into opportunities for success?

Apr 9, 2015

Keep Calm & Go Live: 8 Tips for a Seamless Software Implementation

Learn how to keep your cool 
under go-live pressure.
by Stephanie Jones,
Senior Professional Services Consultant, MasterControl  

Does this scenario sound familiar? You have the perfect software implementation team assembled. Together you’ve configured, tested, reconfigured and reconfigured some more. You’ve written and/or updated your standard operating procedures (SOPs), created your user training materials, validated your new system and trained your user community. Now it’s time to go live, and your knees are knocking. What do you do? 

Apr 7, 2015

Regulatory Tools Go UFO: Useful, Free & Online

Social Media Manager, Polaris Compliance Consultants, Inc.

Despite your best efforts, if you’re active in social media, you’ve been drawn into pointless conversations.  Indeed, that’s why many people stay away.  But if you can tolerate a little noise, I’ve found that the fruitful far outweighs the fruitless.  Case in point:

LinkedIn Member 1: “This looks like a great resource. I just hope they are planning on adding more countries.”
[I bet you wanna know what he’s talking about. Stay tuned.]

LinkedIn Member 2: “Don't you find it encouraging there are more and more online tools available to us?”
[Who is this sickening optimist?]

LinkedIn Member 1: “I do find it encouraging. What's the best way to keep up with all these new tools? Is there a web site keeping track of them?”

Apr 2, 2015

Regulatory Affairs & Regulatory Operations: The Air Traffic Control Tower of Life Sciences

MasterControl's Market Segment Manager
Global Pharmaceutical, Blood & Biologics

When describing the role of Regulatory Operations I have found that one of the best analogies of their role and responsibilities is to be the “air traffic control tower for interactions between a life sciences organization and a regulatory authority.” By no means is that their only role but it is an essential role that involves constant communication with various parties both internally as well as externally. Regulatory Operations personnel coordinate resources and documentation essential for filing of global applications such as INDs, NDAs, BLAs and MAAs for pharma/biotech organizations and of 510k and PMAs for medical device organizations.