Remediation in the medical device industry is often described as a matter of “it’s not if it will happen, it’s when it will happen”.
With so many companies over the years going through major remediation efforts one would think by now most people in the business would have a good appreciation for what success looks like to navigate through FDA remediation projects. Yet, many people will tell you the remediation projects they’ve been a part of were messy, unorganized and a galactic waste of money. Unfortunately, when we’re faced with remediation there is no choice other than to mend our broken wings before flying home for the summer.
This sparks an interesting question – if I have a remediation project ready to deploy what are the things I can do to ensure it succeeds? Regardless of the project size implementing these six keys to success will drastically help increase your ability to successful execute on your next remediation project:
1. Ensure Your Entire Company (Especially Executive Management) is Onboard
Everyone in the organization, bottom up, needs to understand why this project just went to the top of the work list. Everyone needs to be bought in and rowing in the same direction, otherwise you’ll experience cumbersome internal issues as mentioned above, which waste time, money and energy. One can accomplish by using a tactical scorecard as described in #4.
2. Establish Clear, Consistent and Easy Communication Protocols for the Project
Once your entire management team and company is onboard its time to set expectations for communication. This is one of the most overlooked parts of any large scale project. It’s especially important when considering cross functional company divisions and the people accountable to working towards successful completion. When people are misinformed or don’t know what’s going on you can be certain it will slow your project down and cause further product quality and procedural issues down the road.
3. Get a Lobbyist
You’ll need someone acting as the liaison between your company and the FDA. Typically, this person comes from your QA/ RA group, but is that the right person? Don’t assume your de facto executive in QA / RA is the best for the job. Ensure your company aligns itself with a proven individual who has relationships within the FDA and knows how to play the game. If necessary get a consultant to support this effort. This will pay off huge dividends in the end as they’ll know how to navigate delicate situations, get continuances and or leniencies where able.
4. Employ a Tactical Scorecard
Remediation projects can quickly run off the rails if leadership isn’t hyper focused on tangible execution. When projects span an entire organization involving dozens of resources and a multitude of external suppliers its easy for things to get lost in the shuffle causing delays and confusion among the troops. To overcome this challenge utilize a tactical scorecard which everyone in management has access too along with anyone who is in a lead role for the remediation project. It’s a project charter and Gantt Chart combined into one, just simplified. This scorecard should breakdown the project into four or five key areas as necessary, but no more than five. Each of these project areas act as a cost center of sorts for accountability. Within each area you’ll have the activities coming up in the next 30 days, deliverable dates and the people who own the work. A process like this creates transparency while providing clear direction. The key stakeholders should meet at least monthly, if not earlier, to review the status of the project in comparison to the scorecard. SCRUM style meetings offer a good approach for transparency and accountability.
5. Learn How to Manage Cost Early On
Often companies will use a consulting group to lead or help work through their remediation efforts. All too often the selection process for that supplier comes down to a key relationship within the company which basically side tracks any formal vetting process of other possible suppliers. Cost becomes a 2nd or 3rd consideration over a relationship. This can be disastrous as selecting the wrong supplier to help you with a remediation project can end up costing you thousands, if not hundreds of thousands, of dollars extra down the road. Case in point – when you use suppliers that fly in consultants you are literally paying more than double the cost for that service just because those resources weren’t local. Flights, housing, food, per diems, auto, travel, etc. adds up incredibly fast. I’ll admit, sometimes the best solution is an out-of-town supplier, however be sure to do your homework before you settle on the one supplier that’s going to get your company back on track.
6. Know the Difference Between Execution & Strategy
As mentioned above, companies use consultants because it’s a good way to get ahead of a remediation project with people who have been there an done it before. It momentarily expands your bandwidth for as long as you need. While that sounds lovely there is a downside to the consulting and client relationship – the difference between strategy and execution. Some consulting companies bill themselves as experts and charge big prices to boot. What many companies find out the hard way is that these overpriced consulting firms stay up in the stratosphere where strategy is best played and seldom come down to the ground level to get their hands dirty. This means they can put a plan together but executing on it is another story all together. If you’re going to use a consulting firm make sure your contract includes deliverables which focus on execution and completion of work.
Key Take Away:
If you’re heading into an FDA remediation project it is paramount to set up a company wide communication protocol which provides direction and project updates in real time.
Remember – it’s not ‘if’ but ‘when’ you’ll find yourself in a situation where you’re stuck going through remediation. Therefore, you must be proactive. Before you need the help, begin compiling data on suppliers that could help with a possible remediation project. Compare their capabilities, learn how they would approach a potential project, how do they charge, etc. Once you’ve done your homework you’ll then have all the necessary information upfront to make a strategic and informed decision when it comes time to dive into remediation.
Imagine a life that is totally different from the one we know today. A life where disease and medical disorders are not commonplace. A life where medical afflictions no longer claim lives. It’s a wild thought, we know. It is our utopia!
Now think about this utopia in comparison to where we are at today. In 2019, roughly 58 million people died worldwide of which 74% of those deaths (or 43 million people) were the result of noncommunicable diseases like heart disease, stroke and COPD.
Imagine what the world would be like if all of those people, our family, friends and colleagues, were still with us.
It’s a sobering and certainly emotional thought! But how could we ever achieve such a utopian life existence?
Enter Square-1 Engineering and the greater life science industry.
As I write this I’ll humbly admit there will inevitably be people who read these statements and think we’re absurd or even delusional for thinking we could ever achieve a life without disease and medical disorders. That said, it would also be prudent to note the purpose of this statement is not about our company, it’s not a sales pitch or a ‘look at what we’re doing’ ploy. It’s about an unrealized opportunity we need your help with as we believe it to be our responsibility to spread the word. Our utopia is indeed possible and it will take all of us, both within the life sciences industry and outside, to work together towards a greater goal.
This greater goal, which we’ve defined by Square-1’s company vision, is to achieve a life where ‘medical technology has created a new quality of life empowering people to live fearlessly’.
Our company, like many others, is on a quest to change the world as we know it for the better. How are we going to do this you ask? We’ll achieve this through the advancement of medical technology. Along with many other companies in the life science industry, our focus is to drive change and innovation so that we can continue to inch closure to a state in the future where the way we live as people is better than today. Hopefully without disease and medical disorder.
Imagine again if all heath care afflictions were in fact eradicated. The fear many of us live with as a result of the daily health issues we struggle with would also cease to exist. Rather than harboring fear we could spend our time focused on a life filled with optimistic gratefulness.
We know our ambitions are colossal, even unimaginable at times yet this is exactly what keeps us going.
It’s for this reason we’ve made it our mission to put all our time and energy into advancing medical technologies to improve patient lives today so we can in the future meet our utopia, a world rid of disease and disorder.
Could you live fearlessly?
Join us on our mission and learn more about some of the great companies who are pushing the boundaries of what’s possible in order to create a better tomorrow. A fearless tomorrow. Our utopia!
Edwards Lifesciences: https://www.edwards.com/aboutus/credo#
Staar Surgical: https://staar.com/our-mission
Square-1 Engineering: http://www.sqr1services.com/vision-mission.html
Axonics Modulation Technologies: https://www.axonics.com/about-axonics/who-we-are
About the Author
Travis Smith is the founder and managing director of Square-1 Engineering, a life sciences consulting firm, providing end to end technical project services to companies which design, develop and or manufacture products in Southern California. He successfully served the life sciences marketplace in SoCal for over 15 years specializing in engineering services, consulting, project outsourcing and leadership development. In 2019 he was recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA.