Dec 29, 2016

Protect Your Investments!

Preventive equipment maintenance
and accurate documentation of this activity
are important parts of FDA compliance.

by Dr. Christopher Joseph Devine


Devine Guidance International

Failure to maintain and inspect equipment can get a device establishment into big trouble.

This article first appeared in the August 31, 2016 edition of MedTech Intelligence.  Reprinted with author's permission.

Did you miss old doctor? Dr. D is back from a two-week hiatus that included some drinkin’ and thinkin’, and is again ready to continue with the dispensing of guidance for solving the day-to-day challenges associated with the medtech industry. Helping Chief Jailable Officers (CJOs) navigate the often treacherous regulatory waters associated with compliance to quality, regulatory and statutory requirements has always been one Dr. D’s salient goals, along with providing a few chuckles. Besides, there is no better forum than one that allows the readers to laugh and learn at the same time.

Dec 27, 2016

5 Ways Artificial Intelligence Is Changing Health Care and What It Means for Quality Management

Artificial intelligence is the future of
health care, and the future is here.

by Beth Pedersen

Marketing Communications


Health care data is expected to reach a staggering 2,300 exabytes (one exabyte is equal to one billion gigabytes) in 2020. We all know knowledge is power, but the amount and complexity of data in existence has long since outpaced the human mind’s ability to access and process it. Enter artificial intelligence (AI). Since its inception over half a century ago, AI has experienced an ebb and flow of attention, investment, development and scrutiny but one idea persists: the promise of making human lives significantly better.

Dec 22, 2016

3 Principles You Must Adopt to Keep Pace With Future Trends in QA

by David Jensen

Marketing Communications


It’s impossible to know what the future holds, but a Bristol Myers Squibb executive shared some insights at the recently held PDA/FDA Joint Regulatory Conference to help you compete better in the future.

Donna Gulbrinski, senior vice president at Bristol Myers Squibb, talked about quality assurance at the conference held in Washington, D.C., from Sept. 12-14. She identified some strategies for how your quality management practices should function going forward. 

Dec 21, 2016

Love it or Hate it, the 21st Century Cures Act is a Big Step Forward

The 21st Century Cures Act is an
ambitious initiative that deserves
public support.
by Cindy Fazzi

Editor, MasterControl Insider

The 21st Century Cures Act is a massive piece of legislation (996 pages) with an equally tremendous ambition. The life science industry heralded it as a victory, while critics expressed some concerns. Everyone agrees, however, that there’s a need to support medical innovation and advance regulatory compliance. The reform-minded law unites all sides to that extent.

The legislation is estimated to cost $6.3 billion upon implementation (1). Signed into law by President Obama on Dec. 13, it generated buzz primarily for Vice President Joe Biden’s Cancer Moonshot initiative, which will receive $1.8 billion in funding under the act, and for providing $1 billion over two years in the fight against opioid abuse.

Dec 20, 2016

Santa Claus Is REAL but He Requires an EQMS!

by Marci Crane

Localization Manager


Once upon a time your parent or some “responsible” adult decided to be a big dope and tell you that Santa Claus wasn’t real. You, always the awesome kid on the block, took the news with grace but nevertheless it carved a scar onto your tender little heart.

Parents can be such miserable wet blankets.

Let’s not wax too dramatic, however. Of course you’ve moved on with your life, and frankly you’ve been a great success, but perhaps---just maybe---some small childlike part of you is still mourning the loss of Santa-Claus-like innocence, wonder, and joy. After all, believing in Santa Claus allows people to enjoy the very act of BELIEVING, which can be fun! In fact, aren’t there times when you wonder if no longer believing in Santa Claus has blocked your ability to believe in the possibility of……well…. everything?

Dec 15, 2016

Lean Thinking: A Roundup

Lean thinking is a better way of organizing, 
managing and thinking about enterprises.

by Tom Ehrenfeld

The Lean Post

Editor's Note:  This article ran first on September 27, 2016 in The Lean Post. It is reprinted with permission.

This month marks the 20th anniversary of the publication of Lean Thinking, the book that helped popularize what many of us today know as “lean.” Over the next two days on the Lean Post, authors Jim Womack and Dan Jones will discuss how their thinking has evolved since its publication. Keeping in spirit with past roundups of other lean topics, here’s a recap of the book, as well as a look at several resources giving context to this thing called lean.

Dec 13, 2016

Rogue Documents: A Standard Story

Failing to maintain control over critical 
documents -- say, blueprints of a moon- 
sized space station -- can be devastating.

by David R. Butcher

Marketing Communications


When Rogue One: A Star Wars Story arrives in theaters this week, audiences will finally learn how the Rebel Alliance got their hands on the Death Star plans, an event referenced in the opening crawl of the original 1977 film. The space station schematics were central to the plot of A New Hope, ultimately enabling the Rebellion to uncover the key weakness that Luke Skywalker exploited to destroy the Empire's ultimate weapon. 

For the Empire, failing to secure its critical information – the Death Star plans – was catastrophic. For an organization working in a regulated environment, failing to maintain control over all of its critical documents and data can also be devastating.

Dec 8, 2016

Top 8 Ways to Reach Regulatory Compliance

Companies that live in regulatory 
environments have come to 
understand that compliance is
 actually a tool that can give
 them a competitive advantage.

by Matt Lowe

Executive Vice President


Many companies doing business in regulatory environments treat compliance like another obstacle to success. However, companies that live in regulatory environments have come to understand that compliance is actually a tool that can give them a competitive advantage. Statistics show that 72 percent of senior executives at regulated companies say that ensuring compliance with regulatory requirements is one of the most important challenges in their company.

Instead of kicking against regulations, smart companies embrace them and – like a judo expert – leverage their weight to find success. An organization that is more efficient in achieving and maintaining compliance can get a high quality product to market faster than its competitors.

Dec 6, 2016

CLIA-phites vs. Quality-noids: Who Will Win the LDT Debate?

Can't we all get along? The fight for 
regulatory oversight of lab developed tests 
is far from over.

by Lisa Weeks

Marketing Communications Specialist


The FDA’s proposed guidance for laboratory developed tests (LDTs) continues to create conflict between Quality-noids, those in favor of greater FDA oversight, and CLIA-phites, those who are not. Historically, the FDA has exerted little oversight of LDTs (e.g., no premarket review or quality system requirements) but that’s changing, largely because today’s LDTs are far more complex than the LDTs of the past. Both sides agree that more oversight is needed. Which federal agency should provide it, however, has sparked intense controversy.

Dec 1, 2016

Better IT Tools Mean Better Results

IT, through their choice of employee tools, 
plays a  critical role in the retention and 
motivation of the workforce. 

by David Cornwell


PleaseTech Ltd

An essential and growing component of the workforce, knowledge workers are those individuals whose primary role is the creation or management of information.  Document collaboration is an increasingly common component of these workers’ daily tasks.  In fact, research conducted for PleaseTech by Osterman Research reveals that during a typical month, knowledge workers create an average of 36 documents on which they will need to collaborate with others, while also being asked to collaborate on a further 34 documents. That total of 70 documents a month equates to an average of more than three documents a day.

Nov 29, 2016

GCP Compliance: Eliminating Silos between Clinical Quality and Clinical Operations

 Organizations overlook benefits that 
can be achieved by applying the same tools 
and methods in the clinical space that they 
are already using for quality management.  

by Patricia Santos-Serrao

Global Pharmaceutical, Blood & Biologics Segment Manager


In a classic episode of Seinfeld, George Costanza is terrified of the potential ramifications of his “worlds colliding” when his fiancée, Susan, becomes friendlier with his dubious pals Elaine, Kramer and Jerry. “Everybody knows you’ve got to keep your worlds apart,” George rants (but when does George not rant?) “If Susan is allowed to infiltrate this world then George Costanza as you know him ceases to exist. If Relationship George walks through this door, he will kill Independent George! A George divided against itself cannot stand!”

The worlds of clinical and quality share the same collision anxiety. Many companies mistakenly believe that quality and clinical are completely separate departments that should maintain their data and processes in discrete silos. What these organizations are overlooking are the benefits that can be achieved by applying the same tools and methods in the clinical space that they are already using for quality management.  

Nov 22, 2016

Process Validation Habits You Should Quit Cold Turkey

IQ/OQ/PQ is for the birds. 
So why are you still using it?

by Lisa Weeks,
Marketing Communications,

It’s that time again. Time to loosen our belts and get ready to eat ourselves into a food coma feasting on hot, delicious gravy-laden turkey. With turkey on the brain, I started wondering about the phrase “going cold turkey” and how it came to mean the act of quitting something (e.g., substance, behavior or habit) suddenly. And more importantly, when we should do it.
As to its origin, there are many theories out there. Some think the phrase evolved from the older idiom “talking turkey,” which means to speak frankly and directly. Others note the similarities between the physical changes a person goes through as part of the withdrawal process that can leave him or her looking clammy, pale and, well, like a cold turkey (minus the stuffing and cranberry sauce). Everyone seems to agree that “quitting cold turkey” is a pretty unpleasant experience. It also tends to have a lower success rate than the slow and steady approach. So why do we do it? Is the cold turkey technique ever a good option (as opposed to the leftover cold turkey sandwich, which is always a good option)?

Nov 17, 2016

5 Lessons Quality Pros Can Learn from Brad Pitt and Angelina Jolie’s Split

Breaking up is hard to do but so is 
sticking with an inefficient or outdated 
quality management system.

by Lisa Weeks

Marketing Communications Specialist


The Brangelina uncoupling has made headlines around the world—and not just in the tabloids and entertainment publications. “How Will Angie and Brad Split their Real Estate?” asks Realtor.com. A recent Forbes article explains, “What You Can Learn About Divorce & Taxes from Brad Pitt & Angelina Jolie.” Legal blogs are going crazy with posts about prenups; they’re not just for the rich and famous, you know. Yes, the Bradexit is much bigger than the Britexit. It seems like all of us can learn something from their breakup—even those of us who work in the quality industry.

Nov 15, 2016

Process Validation: Life Cycle Approach Beats Crossing Your Fingers

Knocking on wood is not 
effective process validation

by David Jensen

Marketing Communications


“Repetition does not transform a lie into truth.” – Franklin D. Roosevelt

If you do something right three times, you should be able to do it that way always. If this is your approach to process validation, Hal Baseman, chief operations officer at ValSource LLC, begs to differ. Baseman shared some insights about improving process validation at the PDA/FDA Joint Regulatory Conference in Washington D.C., Sept. 12-14. 

Nov 10, 2016

Optimizing Outsourcing Options for Small Sponsors

by Laurie Meehan

Social Media Manager

Polaris Compliance Consultants, Inc.

What can small sponsors do to secure the outsourcing resources they need as large CROs form strategic alliances with Big Pharma?

Partnerships between large pharmaceutical companies and large CROs have become the norm.  The advantages for sponsor companies include shared risk, knowledge transfer, dedicated resources, shorter time to market, and the ability to implement the massive data integration that clinical development requires.  Strategic alliances are arguably as advantageous for their outsourcing partners, providing a steady pipeline of work that’s larger in scope and longer in duration than is typical under traditional arrangements. 

Nov 8, 2016

Factoring Regulatory Strategy into New Product Development

Avoid brick walls by incorporating a
Regulatory Assessment at the beginning 
of new product development.

by Kimberlee Washburn

Regulatory Compliance Associates

The Importance of an Upfront Regulatory Strategy

It is unfortunate that so many new medical devices and new generation product launches are delayed due to the absence of regulatory input at the beginning stages of design control and the new product development process.  

The best way to avoid this problem is to put into place a “Regulatory Strategy” or “Regulatory Assessment” document during your first design control stage.  Some companies may choose to call this document the “Regulatory Strategy” and others prefer the term “Regulatory Assessment”, but for simplicity, I will refer to this as the “Regulatory Assessment” in this article.  The Regulatory Assessment will house all of the regulatory planning information for the new medical device, or the “upgraded” or “modified” device that incorporates design changes.   

Nov 7, 2016

Free E-Book: 5 Things to Expect in the Future of Regulatory Compliance

by Cindy Fazzi

Editor, MasterControl Insider

Global health care spending is expected to increase by 4.3 percent until 2019, with biotech drug sales and medical device revenues forecasted to reach $445 billion and $454 billion, respectively, in 2019 (1). Given such growth, what kind of regulatory landscape can you expect? A newly released enhanced e-book offers five forecasts.

Matt Lowe, a mechanical engineer and medical device industry veteran, describes what the future would look like in terms of compliance for life science companies in his debut book, “Convergence of Compliance and Technology.” He also shares compelling anecdotes about the struggles of regulated companies and traces the major developments that transformed the compliance process in the past decade.

Nov 3, 2016

How Frances O. Kelsey Blazed a Trail for Women in Regulatory Compliance

by Jon Beckstrand


MasterControl Inc.

Whether it’s the ibuprofen we take to remedy a headache or the world’s smallest pacemaker approved by the FDA earlier this year, we can rest assured that these medical products passed scientific scrutiny and complied with stringent regulations. We can thank a woman who blazed a trail at the FDA—Frances Oldham Kelsey—for raising the bar in compliance.

While doing research on the history of Good Manufacturing Practices (GMP) for a presentation I made, I came across the extraordinary story of Kelsey, who helped avert a medical disaster in the United States in the 1960s. On her second month on the job at the FDA, Kelsey reviewed the new drug application (NDA) for thalidomide, a sleeping pill widely used in Europe for morning sickness. It was supposed to be an “easy” assignment suitable for a rookie like Kelsey because the drug had been in the market overseas since 1957.

Nov 2, 2016

Retraining and Refresher Training: Aren’t They One in the Same?

What gap are you trying to solve 
with retraining and refresher training?

by Vivian Bringslimark

HPIS Consulting, Inc.

I say no, not at all.  Ask an operations manager and he’ll acknowledge that what it’s called is less important than getting the “assignment” done and entered into the LMS.  He’s usually more concerned about the loss of productivity during the training than the effectiveness of the training at that time.  It isn’t until later when the training may have to be delivered again (repeated), that the comment “training doesn’t really work” is heard.

Oct 27, 2016

5 Nightmares that Haunt Quality Managers

Are corporate zombies, phantom projects
or life-draining QMS processes
keeping you awake at night?

by David R. Butcher

Marketing Communications


There are a number of spooky scenarios that quality managers face in their jobs, from unsupported initiatives and disengaged team members, to ineffective change management and inefficient QMS processes.

The five nightmares below are enough to keep any quality manager up at night – or to make them scream in terror!

Oct 26, 2016

Top 7 Takeaways from AdvaMed 2016

by Lisa Weeks

Marketing Communications Specialist


Last week, I attended AdvaMed 2016, the leading medtech conference in North America. This year’s conference was the biggest yet, with more than 2,650 medtech professionals descending on Minneapolis for three days (October 17-19) of educational sessions, lively panel discussions and inspiring patient stories. As the birthplace of the modern medical device, and home to nearly 1,000 health technology companies, Minneapolis was a suitable host location to celebrate the tenth anniversary of the conference. This year’s programming covered the industry’s most pressing topics including policy, reimbursement, big data and digital health.

Oct 25, 2016

5 Best Practices for Developing Products Within a Highly Regulated Environment

Developing a new device is not as easy 
as it used to be.  You must understand
the entire product development 
process to be successful

by Tom KraMer

President & CEO

Kablooe Design

Do you have a great idea for a new medical device?  It's not as easy to get a product to market as it used to be. Following these five design research steps may successfully bring your device to market.

You Must Think About How Devices Get Purchased

Medical device technology today is fascinating. 3D printing tissue, robotic surgeons, and laser procedures are fabulous technologies that we all get excited about.

All too often however, medical device developers become so enthralled with their technology that they forget to think about how their device will be purchased. Who will make a purchasing decision, and what will the process be? It is good to know the answers to these questions if you want your device to even have a remote shot at success these days.

Oct 20, 2016

4 Quality Management Tips We Can Get From Time Travel Movies

by David Jensen

Marketing Communications


Ever wish you could have a do-over? Wouldn’t it be nice to be able to go back in time to change or undo some event? Or what about going to a future time? Nothing illegal, maybe just to avoid the lines and hassle of getting a ticket to the next episode of Star Wars.

If you’re in quality management and an auditor hands you a list of inspection observations or a warning letter, the notion of going back in time might seem appealing.

Actually, Jules Verne and H.G. Wells aside, when it comes to quality management, the whole space-time continuum thing might not be so far-fetched. With the changing regulatory landscape and manufacturing processes, manufacturers are exploring more effective ways of managing quality. Companies hoping to sustain productivity and momentum while staying compliant are applying more of a closed-loop approach to quality, which, in essence, is a form of time travel.

Oct 19, 2016

10 Tips for Enabling Better CRO-Sponsor Collaborations

The sponsor-CRO relationship is not 
always a win-win but parties should 
strive for a positive outcome.

by Craig Morgan

Head of Marketing

goBalto, Inc.

By 2020 72% of clinical trials are anticipated to be outsourced, up from just 23% in 2012. Sponsors are seeking cost reductions, access to specialized knowledge, and increased speed and agility. Meanwhile, CROs focus is on business goals related to economic outcomes for their owners, investors and shareholders. Each group is expecting deliverables and timelines to be met or exceeded for potentially different business reasons, leading to a traditional client/vendor-type relationship. Though alliances and partnerships are increasing, there continues to be a client/vendor mentality at the operational and management levels, which perpetuates a lack of trust and empowerment.

Oct 18, 2016

Renowned Physician Patch Adams Urges Techies to Help Build an Ethical World

by Cindy Fazzi


MasterControl Insider

Patch Adams, the physician famously played on the silver screen by Robin Williams, urged IT professionals to help build an ethical and nonviolent world during his keynote speech at the 2016 Masters Summit in Salt Lake City.

“The IT world offers the strongest possibility for a revolution. You’ve made the world your living room. Let’s do something,” said Adams, a family doctor, humanitarian, activist, author, and clown. He spoke to a standing-room only crowd about what he called the “most radical medical project in the world.” 

More than 500 people attended the ninth Masters Summit, MasterControl’s premier annual educational conference for its customers. This year, it was held in Little America Hotel in Salt Lake City, from Oct. 11-13, 2016.

Oct 13, 2016

Ignoring This Overlooked Risk Management Metric Leads You Down The Path To The Dark Side

Planning for disaster will 
keep your supply chain 
from sliding into 
The Dark Side.

by Ed Rusch

Vice President, Corporate Marketing


Hurricanes. Power outages. Socio - geopolitical upheavals. Train derailment. Road closures. Contamination in a supplier facility. Terrorism, cyber-attack, sabotage or industrial espionage. Labor unrest. Global pandemic. Fires, floods and natural disasters. These incidents are not a work of science fiction and the number of them that can negatively affect the supply chain are real and virtually limitless.

Sometimes there are advance warnings; sometimes not. Some events are highly unlikely ever to occur; others are probably just a matter of time. The severity of impact might affect only a small area, or an entire business sector, or it could be (or become) catastrophic.

Oct 6, 2016

How Well Do You Know Your FDA History?

Efforts to promote safe, effective 
products go back 300 years! 

by Lisa Weeks

Marketing Communications


Editor’s note: This is part one of a two-part series.

Fall is officially upon us, and we are settling into a new school year. As a child, I loved the beginning of school. It signified a fresh start—new teachers, new clothes, new school supplies. I'm dating myself here, but was there anything better than a brand spanking new Trapper Keeper®?

For those of you who don’t know, the Trapper Keeper was THE 80s school supply must-have: an ultra-cool 3-ring binder with an outer shell (the “keeper”) that held glossy primary-colored folders (the “trappers”) and featured a fold-over Velcro closure to keep it shut.

Oct 4, 2016

Key Regulations & Initiatives that Modernized Compliance for Life Science Companies

21 CFR Part 11 is one of the FDA 
regulations and initiatives that 
helped modernize compliance 
for life science companies.

by Cindy Fazzi

Editor, MasterControl Insider

Not too long ago, regulatory compliance meant color-coded stamps for various documents, gigantic cabinets for storing files, and truckloads of paper documents for FDA submissions. The advent of 21 CFR Part 11 signaled the movement toward automation. It’s one of 16 regulations and initiatives that helped modernize the compliance process for life science companies.

Matt Lowe, a mechanical engineer and medical device industry veteran, describes the struggles of life science companies in the old days of manual processes in his newly released e-book, “Convergence of Compliance and Technology.”

In his first job as a product development engineer at a medical device firm, the change control process for getting a new drawing through the system resembled an obstacle course that required a lot of time, effort, and patience. The simple act of document submission was anything but simple.

Sep 29, 2016

How to Use Postmarket Surveillance Data to Gain a Competitive Edge

There's a treasure trove of PMS 
data you're probably not using.

By Lisa Weeks, Marketing Communications, MasterControl  

Medical device companies are required to conduct postmarket surveillance (PMS) on their devices to maintain high product quality and safety. However, few companies realize the true value of the digital feedback they receive. In this post, we will explore current best practices for collecting and interpreting postmarketing intelligence, and discuss how you can use the information you acquire to gain a competitive advantage.

Sep 27, 2016

Tweet This — If You Want to be Slapped with an FDA Warning Letter

These do's and don'ts will help you
 engage with customers compliantly.

 by Lisa Weeks

 Marketing Communications,      MasterControl

Is the FDA starting to get serious about how medical devices and prescription drugs are being marketed on social media? Many experts think so, citing Kim Kardashian’s highly publicized misleading endorsement of the morning-sickness medication Diclegis® as an example. The offending post, which appeared on the reality star’s personal Instagram page, earned drug maker Duchésnay a warning letter, demanding an immediate retraction. The post was promptly removed—after it had garnered 450,000 likes from Kardashian’s over 42 million followers. 

Sep 23, 2016

Preparing for the Impending Medical Device Regulation

The Medical Device Directive (MDD) 
is being recast as the Medical 
Device Regulation.  It's time to 
learn some new rules.

by Linda Chatwin, Esq, RACUL, LLC Senior Customer Solutions Consultant

It’s coming – and at this point, nothing will stop it. The Medical Device Directive (MDD) is being recast to a regulation – the Medical Device Regulation (MDR). It has been over four years in the making and the EU countries have spent many hours (actually over four years) working to agree on its Consolidated Negotiated Text.

Since the MDR is now a regulation as opposed to a directive, the member states in the EU are bound to abide to it – giving it strength equivalent to the FDA’s CDRH regulations in the US. The EU is the world’s second-largest medical device economic area/region, and the regulation, felt to be long overdue, will regulate devices not only manufactured and marketed within the EU, but also devices that will be imported into the EU.  The regulation includes rules for determining device classification, requirements for quality systems, obtaining pre-market authorization, and monitoring device performance in the field, including reporting of adverse events.

Sep 20, 2016

Identifying and Preventing Common Data Integrity Issues

Data integrity is important to the 
quality control laboratory because poor
practices can allow for substandard 
product to reach patients.

by Joanna Gallant

Owner/President, JGTA, LLC

Because of the multitude of problems being found in regulatory agency inspections, data integrity is a hot issue for regulators around the world today.  Data integrity is critically important to regulators for a variety of reasons, including patient safety, process and product quality.  The integrity and trustworthiness of the data provides a baseline for the regulators opinion of the personnel and the company as a whole.
Data integrity is of particular interest in relation to the quality control laboratory and the handling of OOS results, because poor practices can allow for substandard product to be put into the hands of patients.  But the same holds true for any other area that generates or controls data – including IT, R&D, manufacturing – any data integrity failures from these areas can also impact patient safety, product and process quality effects.