Remediation in the medical device industry often adopts a similar saying you’ll hear motorcyclists say when referencing laying their bikes down [accidents], “it’s not if it will happen, it’s when”.
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 a successful process 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.
One of the biggest issues with remediation projects is many people in the company look at it as a ‘quality’ issue. Meaning, “it’s the quality departments problem, let them deal with it because we have our own projects and deadlines.” Shocking as this may be, I literally was told this several years ago from an R&D Director whose company was going through a sizable remediation overhaul. Needless to say he wasn’t operating as a team player and certainly wasn’t aligned with what was best for the company.
Which sparks an interesting question – if I have a remediation project ready to get underway, what are the things I can do in order to ensure it succeeds? Regardless of the project size, these are the four things you must consider as a top priority in your next remediation effort:
1.Establish clear, consistent and easy internal communication protocol for the project
This is one of the most overlooked parts of a 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.
2.Get a GREAT ‘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. 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.
3.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.
4.Learn how to manage cost early on
Often companies will use a consulting group to lead or help work through their remediation efforts. All to 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 to project work 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 here before you settle on the one supplier that’s going to get your company back on track.
Key Take Away:
If you’re heading into a FDA remediation project it is paramount to set up a company wide communication protocol which provides detail to everyone
Remember – it’s not ‘if’ but ‘when’ you’ll find yourself in a situation where you’re stuck going through FDA remediation. Therefore, you must be proactive. Before you need the help, begin compiling data on suppliers that could help with a possible remediation projects. 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.
[Note] this article intentionally does not cover the tactical approaches to FDA remediation as there are hundreds of articles and sources providing that information. This article covers the intangible parts of projects of this nature, the ones that most often go overlooked.
As we grow in our profession, we naturally pick up things here and there which aid us in operating as a professional. These little nuances of professional life often times can’t be learned in a class room setting or text book, especially when it comes to behavioral tips like how to handle yourself in certain situations, shaking hands and introducing yourself at a networking event, overcoming challenges, etc.
Over the course of my career one of the best sources for information and perspective have come through mentors. I’ve been blessed to have four (4) mentors throughout my adult life, each of them providing a different perspective and approach that I’ve been able to utilize to craft my own personal style of ‘me’. For what it’s worth, I’m grateful beyond words to these four people for instilling in me valuable lessons about life, family, work and relationships.
Through these relationships I’ve learned a vital lesson that I will carry with me throughout my career, which is:
The only person responsible for your career is YOU.
Each one of my mentors have preached this lesson, using their own approach to reinstate the fact that we [you and I] are ultimately in charge of our own careers. No one else. Not our parents, not our teachers and certainly not our bosses. It’s a universal truth I’ve tested now dozens of times and I still get the same outcome – it’s up to us, not them.
When we develop a mindset of self accountability we learn that it is in fact up to us [you] to drive our careers in the direction we want them to head.
When people aren’t responsible for their own careers it shows up sounding like the following excuses: “my boss didn’t do anything for me”, “that’s not my job responsibility”, “I didn’t know I could do that”, “no one told me that was possible”, “that mistake wasn’t my fault” and on and on.
Casting aside the multitude of excuses we can drum up, once we learn it’s our ultimate responsibility to drive our careers it then becomes easier to ask for help while navigating the many facets of a career. Once we ask for help and start getting it we remain in the drivers seat asking questions, following up and initiating conversation. As a result we take responsibility for the outcomes. What comes from this type of mindset and approach is an increasing attitude and desire to improve, learn and grow.
Key Take Away:
Asking for help and guidance is a big step. It means you want to improve yourself, congrats as you’re already ahead of many people around you. When you ask for help from someone, whether that be a mentor, boss, teacher, friend, it’s up to you to drive that interaction. It is your responsibility to drive the communication, follow up and request for direction. Don’t sit back and wait for that person to do the work. They are there strictly as advisors to give feedback and perspective, you must put in the time and effort.
Spend some time in a quiet place thinking about your own career and how you’ve gotten to where you are. Happy with the present circumstances? If you still have more you want to achieve go get yourself a mentor asap. A good place to start is www.micromentor.org. It’s a free service, one I wholeheartedly endorse.
You’ve found yourself in consultant heaven having more clients and projects than you know what to do with. Like a dog chasing the car you’ve managed to catch the car (lot’s of projects to keep you busy) but don’t know what to do with it (how to deliver successfully) now that you have it.
If you have multiple projects, multiple clients and or just more work than you know what to do with consider these steps to improve your day and operating rhythm so you can focus on successfully delivering on your projects while keeping your happy customers:
Communication Protocol – happy customers are informed customers. Customers don’t like to be treated like mushrooms – fed piles of crap while being kept in the dark. Establish a daily or weekly communications agenda which keeps you on track of your client updates and check-in’s. Consider creating a communication checklist via Microsoft Excel to help with consistency. (or see ‘Invest’ for tools to help with this)
Invest – don’t be cheap. Make the investment in a project management tool which will help you stay on track with your projects while giving you a professional interface to use for customer presentations, etc. There are literally dozens of tools you can choose from like Asana, Jira, Microsoft Project, etc. When your work is structured, nice and tidy, your results will reflect it.
Establish Customer Expectations – read this link on how to set customer expectations
Get Organized – everything from your work space to how you spend your time should be constantly reviewed and altered to improve performance. Time management is key to your success, ability to deliver and to obtain more work. Find ways to reduce busy work, unnecessary check ins or onsite visits with clients. Sometimes visits are crucial and needed, but not always. When reviewing your actual project tasks create different to do lists/ project task lists for each client then merge them so you have one list broken down by all of your clients and required activities per day and week. (FYI – most project management tools do this for you while producing Gantt Charts which can be shared with customers – another reason to invest in technology.)
Delegate – Undoubtedly there are aspects of your projects you just don’t like to do yourself. Do you know other people that can help you with some of your work? It pays off to have a small trusted group of allies, other consultants such as yourself, that you can bring in from time to time to help with various parts of the project. This allows you to focus on the work you enjoy most.
Say No – one of the most powerful things any professional can do is to say ‘No’ to things or opportunities which don’t align with their key focus. This goes back to how we choose our time and where we spend it. We can’t be everything to everyone. If a customer makes a request that is outside of your capabilities kindly say ‘No’ then point them in the right direction to a possible solution elsewhere. #gogiver
Key Take Away:
Consider investing in a project management tool to streamline your work while having an organized infrastructure for your consulting business
Review all the projects you have concurrently and make a task and timeline list. Embedded those tasks into your week based on the deliverables then begin working towards fulfillment of those tasks.
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.