ISO 13485:2016 rewrites the standard for medical device manufacturing

A risk-based approach to QMS. If you’re a manufacturer of medical devices, including the medical device portion of combination products this is not the first time you’ve encountered this emphasis; the shift towards Quality by Design (QbD) has placed risk assessment and management at the forefront of compliance and regulatory considerations for organizations operating within the life sciences industries. But ISO 13485:2016 and its quickly approaching requirements for certification have brought risk front and center for medical device manufacturers with a renewed urgency. Read more »

Quality by Design paves the way for innovation

For companies in the Life Sciences industry, today’s climate—a mixture of competition, regulation, increasing consumer awareness, and continually evolving knowledge and capabilities—presents manufacturers of pharmaceuticals, medical devices, biologics, and combination products with a choice: maintain the status quo in product design, manufacture, and testing, or join the forward motion of the industry as well as the FDA in embracing the holistic and dynamic approach of Quality by Design (QbD). Read more »

Using the FDA’s data on citations to guide compliance efforts

“It’s a full thickness tear of your right rotator cuff.”

Not words I ever wanted to hear, let alone leading up to a holiday. But this diagnosis gave me the opportunity to consider the safety and efficacy of the medical devices and drugs involved in its treatment on a personal level, from the standpoint of the end user.

My pre-Christmas surgery comprised arthroscopic repair to shave the bone and enable greater range of motion for the rotator cuff, a fixation device and suturing to repair the torn tendon, and drugs to anesthetize, manage pain, and ward off infection. It was followed by six weeks with my right arm in a sling, and 12 weeks of physical therapy.  

For those of us working in the Life Sciences industry, it’s common to view our own medical conditions, or those of family members, through the lens of our work. And that’s exactly what I found myself doing during those months of treatment, recovery, and rehabilitation. “What company made this fixation device?” I found myself wondering. “Do they have any citations from the FDA?” “What about the company that made the pain medication I’m using?” Read more »

Spreading the holiday spirit in the workplace

We are well under way this holiday season! The holidays can mean so many different things to different people; for some, it can be a somber time, remembering the loved ones that are no longer with them. For others it can be a festive time, with gifts, eggnog by the fire and holiday decorations. What do the holidays mean to you? What do you reflect upon or celebrate during the holidays? Read more »

Off-label uses… the Windex of the medical field?

You’ve heard the term, “cure-all”, I’m sure, but as we all know, there is no real “cure-all” in life. If you ever watched the movie, “My Big Fat Greek Wedding”, then you are all too familiar with the father of the bride who believes that Windex is the “cure-all” for everything. As he states in the movie, “from psoriasis to poison ivy, put some Windex on it!” Windex, however is not a magic potion. It is simply intended for cleaning windows, mirrors, glass shower doors, glass top stoves and more as stated on their website. In fact, Windex in high concentrations can be very caustic, because it contains ammonia! Maybe the father of the bride should have done some research before promoting Windex’s unapproved uses!

In the medical field, doctors, like the father of the bride in the movie, use many products for unapproved uses. In our industry, the Food and Drug Administration (FDA) requires that medical devices, drugs, biologics and combination products be used according to its labeling of approved (or “on- label”) uses. Oftentimes, however, doctors end up using products for “off-label” use. With this FDA requirement, how is it that doctors are able to use these products for unapproved uses? Read more »

Is it time for a business check-up?

If you’re anything like me, most days you get a bunch of unwanted mail and usually throw it out without much of a look. Earlier this month, as I was looking through my mail and sorting through the junk pile to throw out, something caught my eye. There was a health magazine that was sent from a local hospital and on the cover read “Top Tips for Healthier Living.” This wouldn’t have normally gotten my attention, but due to some recent health check-ups I’ve had lately, this caught my eye. Read more »

Why is the FDA still finding basic nonconformities in manufacturing?

Every so often, I take the time to catch up on the FDA’s findings that result from the latest audits of drug, device, biologics and combination product manufacturers. It always astonishes me as to how these nonconformities occur, namely because the findings seem like simple issues that can be easily avoided. Throughout my career, I have seen various incidents like these occur, such as while walking through the manufacturing areas on the way to my workstation, conducting internal audits, performing supplier audits, or being audited by the FDA.

It occurred to me while I was reviewing these findings that if I think these issues are a simple fix, my guess is others will too, and by bringing awareness to these issues maybe it can prevent some headaches for the next company to be audited. If you’re looking for some insight into what the FDA is still finding, these are just a few of the findings that I came across. Read more »

The cycle of life

Life, they say, comes full circle. This summer I have seen and felt this to be true.

Earlier this year (the first day of summer to be exact) my good friend had a baby girl. The joy of this event was interrupted, however, because the umbilical cord became wrapped around the baby’s neck and stomach, causing her to aspirate meconium and fight for her life. Fortunately, the neonatologists and nurses worked to save her life, and she was brought home a few weeks later. Just last week my friend and her baby girl stopped by for a visit; I was elated to see them both so happy and healthy. Even though her baby will require some follow up care, she is by all accounts a healthy baby girl and is just starting out in her brand new life.

For a close family friend, the opposite was to be true. Last month her life was tragically cut short due to cancer.  She had been diagnosed too late with the disease and the cancer had spread to most of her organs. She suffered with extreme pain through the end of her life, a life her husband helped her through until the end. I never in my life experienced a disease like this, or had a life experience impact me as much as this did. As I think of her husband and the pain he is enduring, it takes me back to an earlier email I sent in June.  Read more »

If you fail to plan, plan to fail

We’ve all heard this saying, right? Sometimes though, it takes a fail in our lives for us to remember it again and let it sink in!

This time of year many of us are getting in some much needed travel time, hoping for some rejuvenation and fresh outlooks for ourselves and our careers. This past month, I did just that! My family and I traveled to Europe for a 3 week adventure! I was in full planning mode by arranging all the details and planning what we would see in all the places that we traveled to. This wasn’t necessarily a relaxing vacation (when in Europe, you need to see all you can to justify the 24 hour door-to-door travel time), but since planning comes naturally to me as a project manager, I thought I would nail this planning process as “tour director” for our vacation.

Boy was I wrong! Read more »