All Features
Alex Morris, Jon Speer
In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain documentation.
We’re talking documentation to demonstrate you have a compliant quality management system, that you design and develop products to meet design controls, and that you’re addressing…
Michael Causey
We, and others, like to take the FDA to task for missing deadlines or behaving in ways that are sometimes difficult to fathom. So it’s only fair to give equal space to something when they seem to get it right. Take the agency’s Unique Device Identification System (UDI).
Readers of this column…
Alexandra Brown
Being a hospital leader is more difficult than ever in today’s changing healthcare environment. It can be easy to stray off course while dealing with regulatory compliance and financial constraints. It’s vital that a leader remembers he is responsible for one of the most precious and fragile…
Russ King
IEC 62304, the international standard that defines software development life-cycle requirements for medical device software, was developed from the perspective that product testing alone is insufficient to ensure patient safety. It provides a common framework for medical device manufacturers to…
Akhilesh Gulati
The dynamics of the healthcare environment are changing rapidly. Small primary care practices are confronting a host of regulatory, technological, and practice challenges, not the least of which is patient expectation and evaluation. The challenges are all exaggerated by social media, where…
Jim Bevier
A simple calculation—available time divided by demand—known as takt time, is a fuzzy concept for many people in healthcare. That’s understandable when you consider a hospital is open 24 hours a day, and you never know how many people are going to show up at the door. Let’s look at two concepts…
Thomas Prewitt Jr.
One of our major problems with healthcare reform is that we are doing it from the top down.
At the top, a bloated bureaucracy works in an environmental context of regulations and finance that seems to be focused on what is best for government and payers. The perils of out-of-control costs have…
ASQ
Strengthening communication between caregivers and patients should be a top priority for reducing healthcare costs and improving patient experience, according to a new poll of U.S. healthcare quality improvement professionals conducted by ASQ, the world’s largest network of quality resources and…
Alexandra Brown
Physician alignment is vital to driving the changes necessary in our shifting healthcare environment. On the hospital side, physicians are the frontline experts needed to increase quality and decrease cost. It’s impossible for a hospital system to take on important projects like fall prevention,…
Patrick Stone
The U.S. Food and Drug Administration (FDA) has a “Plain Jane” version of its Pharmaceuticals FY 2015 Action Plan. In this article, however, let’s look at some interesting wrinkles not necessarily contained in the document.
This “Plain Jane” action plan, taken straight from the document, reads as…
Jon Speer
When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a lot of emphasis on inputs and outputs, verification, transfer, and the design history file. All good things, of course; without them, you won’t meet FDA requirements for your design controls. The…
Alexandra Brown
Why is it easier for many hospitals to justify investing in capital equipment, new buildings, and service lines rather than in quality improvement? There are three major reasons.
Many hospital systems don’t know their real costs
It’s been said that the first step in fixing a problem is realizing…
Larry Spears
If you’ve been in the life science industry for awhile, you know it never gets easier but instead more complicated year after year. For example, unique device identification (UDI) requirements, combination product rules, and updated electronic medical device reporting (eMDR) requirements add to…
Kelly Kuchinski
Nestlé USA has officially announced its plans to replace the artificial flavors and colors in its chocolate candy products with natural ingredients. This decision will affect more than 250 chocolate bars across 10 brands. The first three modified candy bars—Baby Ruth, Butterfinger, and Crunch—will…
Alexandra Brown
Hospital leaders are feeling increasing pressure to find ways to thrive in our changing healthcare system. A C-suite that is removed from daily hospital operations is a liability in this era of process improvement and hands-on progress.
Here are four characteristics hospital leaders need to move…
The QA Pharm
At the risk of sounding like a pharmaceutical quality assurance heretic, standard operating procedures (SOPs) often don’t work as intended. In fact, they can do more harm than good by giving a false sense of security: “We must be OK; we have procedures for that.”
Having procedures is certainly…
Alexandra Brown
A big challenge facing academic medical centers is how to maintain a focus on patient care in an artificially divided environment.
Most academic medical centers were developed in a system with abundant resources, cost-based reimbursement, and a traditional academic departmental structure. This…
Thomas Prewitt Jr.
As we begin the journey to value-based healthcare, the relationships between a hospital and its medical staff are changing. For decades, these relationships were straightforward: Doctors admitted patients to the hospital, performed procedures and delivered therapies, and at some point, sent the…
Michael Causey
Sometimes it’s nice to be told what the U.S. Food and Drug Administration (FDA) isn’t going to do. The agency issued a guidance last month that should make anyone building or working with a medical device data system (MDDS) happy and relieved. Can you hear the collective sigh?
FDA defines MDDS as…
Dawn Keller
Juvenile idiopathic scoliosis. That was the diagnosis given to my then 8-year-old daughter last January. In short, it means that she’s young (under 10), she exhibits an abnormal amount of spinal curvature, and there’s no identified cause (aside from some bad luck).
Emilia’s X-rays indicated an S-…
As more physicians are integrating their patient electronic medical records (EMRs) with third-party patient portals, they’re looking for clarifications on many issues to stay within the various regulations boundaries and to be meaningful use-attested. It can be difficult to differentiate fact from…
Michael Causey
Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the 5th century B.C. and the 16th century A.D. The Great Pyramid of Giza took about 20 years to construct, according to ancient historians, but it must be remembered…
Michael Causey
The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Basically, anywhere but the United States of America.
Almost across the board, the United States ranks at the bottom (“regressive”) for produce traceability programs as…
Tripp Babbitt
In my last column I wrote about the seven perspectives that pollute customers and culture. These perspectives rule the design of our organizations. They are inherent to our work cultures and thinking. They put us on autopilot as we toil in our everyday work. The first step to change that is to…
Michael Causey
A
s expected, the FDA is shifting more of its regulatory focus toward medical device reporting (MDR). In an Oct. 1, 2014, letter, the agency’s Baltimore district office hit Baltimore-based Electronic Development Labs for not having a MDR procedure. Bad idea. The company may not have recovered very…
