At first glance, the processes of human pregnancy and medical device submission management belong on separate planets even more than tacos and french fries belong in different ethnic food categories. But consider this quote from medical device expert Alex Butler:
“When I worked as a product development manager in a medical device company, dossier management and product registration were a source of constant anxiety and tremendous pressures for regulatory, submission and quality professionals.”
Doesn’t “constant anxiety and tremendous pressures” sound a lot like what an expectant mother (and father) go through during the gestation, labor and delivery phases of a baby?
The truth is that it’s surprising to see how many pains these two forms of labor have in common.
First off, let’s get down to “brass tacks” as the saying goes. The most obvious similarity between pregnancy and medical device submissions management is that they are hard and painful. In fact, both require a great deal of labor. Some of the labor involves waiting, studying, planning, documenting and preparing, while the rest of the labor includes acting quickly, making life-changing decisions and enduring intense amounts of pain.
Not to veer too far from the subject, but in the United States, citizens celebrate “Labor Day” every September. The holiday came as a result of the labor movement in the U.S. and acts as a reminder of the accomplishments of the U.S. labor force1.
The day, though designated a respite from labor, reminds us of the millions of hours that Americans have used to accomplish what it is they set out to do.
As we get closer to Sept. 3 (this year’s Labor Day), it might be interesting to consider that labor doesn’t always have to be painful. Sometimes the labor can be broken down into simpler processes.
This is — perhaps — the case for the processes of pregnancy and medical device product registration. These labors are typically painful, but it is possible that some of the pain could disappear after making a few important changes.
There are definitely techniques that can reduce the amount of labor required to complete a pregnancy (i.e., have a baby) and successfully manage a product’s dossier or medical device premarket submissions across various economies and regulatory environments.
Listed below are a few common concerns of both pregnant individuals and med dev professionals as well as techniques for reducing pain.
During pregnancy and after a child is born, parents often complain that a kid should come with a user manual. You can read all the parenting books that are available and watch every YouTube video, but you still have to look at those little cheeks, little eyes and little hands and wonder how you are ever going to make the decisions that will build a healthy human adult.
The “no single source of truth” mantra applies to medical device submissions regulatory managers and their teams as well. Often, teams are spread throughout the globe and using disparate systems. How are employees supposed to streamline dossier management and verify the latest design changes while satisfying dozens of regulations?
Even though an up-and-coming parent may have done her research, there is only one person that can funnel that information for a child. That one person is, of course, the parent. When all is said and done, it’s the parents who decide what the research means for their child. In other words, mothers and fathers have to learn to trust their own gut after they’ve done their due diligence.
When it comes to the medical device industry, one source of truth amounts to a centralized web-based system that keeps track of all a product’s design changes and streamlines the dossier management process (including full document management capabilities) from start to finish. The system should also be localized into relevant languages, as many medical devices could be sold in dozens of international markets.
From the moment a couple gets pregnant that little embryo-about-to-turn-human is a moving target. It’s growing and growing and growing, and nobody’s sure what to name it yet! Although the gestation process can seem drawn out, there’s nothing slow about the development of a child. It happens quickly, and parents get stressed out wondering how they can best prepare for the labor and delivery (not to mention the 18 years following) so as to help the baby start off with a strong foundation.
From the medical device side of things, it’s the product expirations, registration deadlines, and compliance requirements across multiple markets that are the moving targets. Regulatory managers in the med dev space have so many shifting management and compliance variables that the pain can seem debilitating and can slow down premarket submissions. Their duties are huge in scope and can prove to be “overpriced” if submissions aren’t handled in a timely fashion. In other words, the moving targets need to be hit with as much precision as possible!
Many soon-to-be parents, especially first-timers, may not have the true picture of their baby’s health or future health. There’s a lot that goes on in the womb in only nine months’ time.
For a regulatory manager in the med dev space, there is a need for reporting capabilities. If he or she doesn’t have them, there’s no big picture available. Without that “bigger sense of things,” a regulatory manager can’t utilize product information that’s already available, which again, could result in delays to premarket submissions or submissions related to products already on the market.
While pregnant, getting tested for possible genetic anomalies or additional characteristics can be valuable for planning purposes. As the saying goes, “knowing is half the battle.” For pregnant couples, to get the “data” they need can help point them in the direction of good parenting.
For medical device companies, the big picture equates to having a centralized system where data is consistently gathered, routed to the correct users, and reviewed for use. Many companies have data but fail to set aside the time necessary to review and act on it.
It isn’t uncommon for an expectant mother to find herself experiencing inconsistent symptoms. One day she will sleep, and the next she’ll hardly be able to rest at all. She’ll have nausea one morning and not the next. These inconsistencies can be aggravating emotionally because they don’t allow a soon-to-be mother to plan her day in a way that a non-pregnant woman could.
Then there’s your regulatory managers and their pains. For example, inconsistent filings on behalf of a new or updated medical device are common. Many medical device companies have disparate systems across geographies and even have varying systems at one location. Different systems lead to inconsistent filing techniques and documentation prone to errors. These issues can result in submission delays or noncompliance with one or more regulatory/standards bodies.
When your life or submissions process becomes inconsistent, it’s important to add more consistency to your environment. For an expectant mother, consistent healthy snacking and soft music playing around the house can help keep anxiety low even when the sleeplessness or nausea arise. She’ll feel better managing what’s in her environment when she can’t manage what’s going on inside.
Inconsistent filings rarely occur with a centralized web-based system. The system keeps the environment consistent with built-in submissions checklists, document management capabilities, and organization capabilities for multiple products sold in multiple geographies.
It's common for a first-time expectant mother to try to be too independent. When you’re pregnant, there are simply things that become difficult to do (bending over, for example), so it’s important to keep the lines of communication open with trusted friends and family. Asking for help is necessary during this time. Most people are happy to help even though it’s common for expectant mothers to worry that their new pool of hormones is making them clingy.
Every medical device regulatory manager knows that a lack of collaboration (across departments, geographies, regulation requirements and product teams) during the process of preparing for submissions and registrations of one or more products results in wasted time, wasted effort, wasted money and headaches! Even if the product somehow gets successfully to market, there is still a chance that compliance may be compromised in the future.
The fact that an expectant mother is nurturing a growing human being on a full-time basis naturally means she will have to be nurtured even more to keep up with the job! It is OK to be vulnerable and let others know what feelings and “neediness issues” are arising. Emotions and hormonal states are like weather — they eventually move on, so it’s OK to graciously get the most out of the experience while you can.
Across any large or small organization, collaboration is key, and the medical device industry is no different. What any organization needs to collaborate effectively across departments, product teams and geographies is a web-based centralized system that is protected and can be accessed at any time by any approved user.
1) United States Labor Day Holiday https://www.dol.gov/general/laborday/history
Marci Crane is a staff writer for GxP Lifeline and has written on life science topics for over a decade.