Jun 30, 2015

Why Medical Device Companies Must Get Serious About Cybersecurity

Device makers aren't doing enough to
protect their data or devices, experts agree.

by Lisa Weeks, Marketing Communications Specialist, MasterControl

The Anthem data breach should be a wake-up call to the health care industry, according to security experts. On February 5, 2015, hackers stole the social security numbers and personal information of 80 million Anthem members and employees, leaving them vulnerable to identity theft and blackmail.1 While the insurer may be one of the biggest health care companies to suffer a breach, it certainly isn't the first. 

Editor’s Note: This post is an excerpt from the white paper “Five Trends Transforming the Medical Device Industry in 2015.” 

In October 2014, the Department of Homeland Security investigated more than 20 suspected cases of cyberthreat in hospital equipment and medical devices, bringing some well-known health care giants under scrutiny.2 That same month, the FDA published a cybersecurity guidance for medical device makers, outlining the security measures developers should build into their products when seeking approval for a new device.

Jun 25, 2015

4 Reasons Why Document Review is Crucial to Compliance


When was the last time you reviewed 
your quality documents?
by Cindy Fazzi
Editor, MasterControl Insider

When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.

“For organizations using a paper-based or hybrid system, a common problem is lack of document review,” said Jackson. “They have internal policies that require them to review their SOPs, work instructions, and other critical quality documents on a regular basis, but they fail to track them down. When that happens, they are violating their own policies.”

Jun 23, 2015

Study: mHealth Will Soon Be the New Normal in Health Management


More than half a billion smartphone users 
are expected to be using mobile 
health apps this year
by Lisa Weeks, Marketing Communications Specialist, MasterControl 

Mobile health, or mHealth, has gained significant momentum over the past couple of years, and it will continue to influence product development in 2015. Millennials raised on technology are providing device makers with the unprecedented opportunity to sell directly to consumers in the form of wearable devices and mobile health applications that allow patients and physicians to interact clinically from different locations. The popularity of mHealth tools has been fueled by the growth of the smartphone industry.

Editor’s Note: This post is an excerpt from the white paper “Five Trends Transforming the Medical Device Industry in 2015.”

Jun 18, 2015

Science Fiction Meets Science Fact: How 3-D Printing is Revolutionizing Medical Devices

Scientists think it will be possible to 
print a 3-D heart in 3 to 5 years' time

by Lisa Weeks, Marketing Communications, MasterControl


Imagine a time when a clinician can modify and manufacture an implant sized for a particular patient on-demand in a health care facility—or print a human organ as easily as a paper document. As futuristic as it sounds, that time is not far off, according to scientists who continue to find new and truly mind-blowing ways to apply three-dimensional (3-D) printing techniques to the medical field.

Jun 16, 2015

7 Ways to Reduce Human Error on the Drug and Device Manufacturing Floors

President of Ginette M. Collazo, Inc.
Human Reliability Consultancy

As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of failures and defects.  Sadly, little is known about the nature of these events mainly because the quest for answers ends where human error investigations should begin. This situation has become very evident to regulators and GMP enforcement agencies are being more critical of the approach, result, and effectiveness of corrective and preventive actions or CAPAs when dealing with human performance issues. In order to successfully achieve this goal, we have to understand how to improve the way we deal with these types of situations.

Jun 11, 2015

FDA Regulation of HCT/Ps – Impact of New Guidances on Manufacturers and Users


Axinn, Veltrop & Harkrider LLP

What does the Food and Drug Administration (FDA) consider to be “minimal manipulation” and how are human cells, tissues and tissue-based products (HCT/Ps) made from adipose tissue regulated by FDA?  These questions were addressed in two draft guidances issued by FDA in late December of 2014.  The first, Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations (1), focuses on how adipose tissue is defined and thus how adipose-based HCT/Ps are regulated by FDA.  The second, Minimal Manipulation of Human Cells, Tissues and Tissue-Based Products (2), focuses on the types of cell and tissue processing that would be considered more than minimal manipulation, resulting in the regulation of the cell or tissue-based product as a drug, biologic or medical device.  Although they are not yet final, these guidances shed light on FDA’s current thinking and may signal that FDA will make it more difficult for products to be regulated solely under Section 361.  Not only will such a position by FDA impact development of new HCT/Ps, but it could threaten the regulation status of currently marketed HCT/Ps. 

Jun 9, 2015

Tales from the Front


Sometimes it’s your company that forces 
a new direction during the inspection, 
sometimes it the auditor. Sometimes it’s both.
Adventures of a seasoned inspector. Really, what could go wrong?

By Morris Sherwood
Director, Regulatory Affairs and Quality Assurance
Isolite Systems


So far in my 26 years of working in medical devices I have had many an adventure when it comes to FDA and Notified Body Inspections. I love inspections. I know it sounds crazy but there is this Zen place you get to during an inspection. You must practice patience. You must not think you know exactly what your inspector is thinking. At the same time, it is this amazing game of psychological chess whereby you watch your opponent’s moves and think five moves ahead, only to have your strategy thrown out the window when the inspection zigs rather than zags.

Jun 4, 2015

EU vs US: What are the New Track and Trace Requirements?

The European Commission and the FDA are fighting 
counterfeit medicines through traceability 
requirements in the pharmaceutical supply chain.
by Wolfgang Schmitt
Director Operations
CONCEPT HEIDELBERG GmbH 


In 2011, the European Commission published Directive 2011/62/EC, the so-called Falsified Medicines Directive (or FMD).One goal was the fight against counterfeit medicines through serialization and verification. In 2014 the technical characteristics of these key ideas were defined, the unique identifier (UI), delivering the possibility of verification of the authenticity of single folding boxes. The unique identifier contains information on the:


  • Manufacturer product code
  • Serial Number
  • National reimbursement number, if present
  • Batch Number
  • Expiry Date

Jun 3, 2015

Don’t Call Me Jim Cramer but Here are My Top 5 Pharma Trends

Pharmaceutical production costs are rising 
because companies have more hurdles 
to pass during the testing phase.
by Lane Hirning
Product Management Director, MasterControl Inc.

Judging by a recent report forecasting future growth, the pharmaceutical industry is thriving despite the recent economic downturn. A market research firm is estimating a 30 percent increase in global medicine spending by 2018, which is great news for the industry (1). The same report cited the anticipated launch of 200 new revenue-boosting drugs within the next five years.

Amid this robust growth, what are some of the things that you can look forward to in the near future? I was asked this question recently. Short of sounding like Jim Cramer of CNBC’s “Mad Money” fame, I picked the following trends as likely to influence pharma in the near term. They all have one thing in common—they reflect the impact of technology on medicine and the health-care process.

Do you agree with my picks? What would you add to the list? Leave a comment for me below.

Jun 2, 2015

CAPA and Root Cause Analysis for the Food Industry



Can you find the root cause for the chaos in this kitchen? 
Unless you identify the root cause of a problem, you cannot resolve it.  
By Dr. Bob Strong
SAI Global Assurance Services

A thorough and effective CAPA can provide many benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections.

Why do a root cause analysis (RCA)? Because unless you identify the root cause of a problem, you cannot resolve it. You need to find out what went wrong, how the problem was not detected, or what has changed.

May 28, 2015

Change in Pharmaceutical Manufacture

Change, planned or unplanned, 
is imperative in pharma manufacturing.

by Peter Murray, 
C
onsultant


1. The concept of change

Within the pharmaceutical industry, the concepts of validation, change, change control, deviation and out of specification (OOS) are often treated as distinct activities which operate with a significant degree of independence.

All these activities are related to change, whether that change is planned or unplanned. While separate terms can usefully serve to focus attention on detail in particular activities when dealing with the consequences of change, treating them as isolated activities can lead to confusion and inconsistency of approach to what are logically very similar and/or closely related processes.

May 26, 2015

5 Tips for Winning Executive Buy-In for a New QMS


These five strategies will help convince 
the executives and departments in your 
organization to support your proposal for a 
new EQMS or an expansion of your current system.
by Matthew M. Lowe
Executive Vice President, MasterControl Inc.

If you’re facing executive or organizational resistance to your plan to automate your quality system, you’re not alone. There are many quality and IT professionals who are in the same boat. They have the toughest time convincing senior management not just about the merits of an electronic quality management system (EQMS) but about the real value of quality.

My colleague, Marc Vandenbulcke, and I facilitated a group discussion at the recent Masters Summit to explore common problems when proposing a new EQMS or expansion of your existing EQMS (1). We had a lively discussion with MasterControl customers who come from highly regulated companies.

With valuable input from participants, Marc and I came up with five strategies that will help convince the executives and departments in your organization to support your proposal for a new EQMS or an expansion of your current system.