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​Recently our company published a poll online offering up the following question for the medical device community:

​“What is the most important factor to consider when developing a medical device product?”

At the close of the poll dozens of people had cast their votes for what they believed to be the factors affecting product development the most.  The poll options included:

• Regulations
• Marketplace Analysis (competitive landscape, problem to solve, needs, etc.)
• Having the Right Team in Place
• Risk Management

If you have been in industry for any length of time you know there are dozens of factors which can and often have a direct impact on the product development process.  While there are dozens to consider, such as PRS (Product Requirement Specification), planning, user experience, DFM, etc. what we know to be true is each of these factors carry varying weights of impact.  They are not all equal in measure or influence.

As our poll launched and picked up steam one of the four factors listed as an option began to take a commanding lead.  The respondents, who are largely made up of medical device professionals and executives, had identified a common factor which stood above the rest in its ability to impact positively or negatively the product development process.

What was this most important factor?

Would you have guessed ‘Having the Right Team in Place’ is the number one factor which determines success when developing a medical device product?
‘Having the Right Team in Place’ was identified by 51% of the respondents as being the most important factor which directly contributes to the success of medical device product development.  The other options broke down as follows:

​Simply put – having the right team in place covers all of the other areas that potentially could produce challenges during the product development cycle.  Whereas the inverse is certainly all too true.  When we have the wrong team in place, or teammates lacking the capabilities to facilitate their job as needed by the company, inevitably problems go arise which hold back otherwise good opportunities and technology offerings.

Jim Collins, celebrated author (books like ‘Good to Great’ & ‘Built to Last’) and business management guru, is quoted as saying “Leaders of great companies start by getting the right people on the bus, the wrong people off the bus, and the right people in the right seats.”

What this means is it’s more about the people than it is the technology or problem you’re solving.  This is an important lesson, especially for first time entrepreneurs and startup executives.  You can have the best product idea in the world, one that is in high demand, but if you don’t have the right team in place you’ll most likely spin your wheels while blowing out copious amounts of money in the process.

We’ve also seen this reality in person dozens of times.  As a medical device consulting firm we work with a lot of companies, both start up and conglomerate alike.  One of the consistent characteristics we see within the companies which are able to drive success, often times repeated success, is their management team is comprised of experts in their particular field who know how to both lead and operate in the weeds.  They both strategic and tactical, able to plan for the long term while addressing todays shorter term needs.  As a result, they know how the job is done and therefore can either lead or delegate those tasks helping to guide their department or team to successful completion. 

When you have the right people on the team (your bus) you will then find opportunities (the medical problem you’ll solve) to move forward with.  Following this process you’ll also have a far better chance of facilitating that opportunity through the development process and into commercialization, or acquisition. 

​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.
 
Action Item:
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.

We've talked on a couple occasions about the importance of planning ahead.  When it comes to your business and the safety of your employees planning ahead for emergency situations is a must for all leaders and business owners, alike. 

Listen in as our Operations Manager, Trisha Aure, shares with us in this two part series why it's so important to have an ERP (Emergency Response Plan) in place and the steps to go about implementing one within your business.

​Part 1: ERP Overview & Initiation

​Now that we're aware of what an ERP can do for us and how to initiate it from scratch, let's look further into the implementation for an ERP.

Did you miss our article on Emergency Response Plans (ERP)?  Access it here: ​​http://www.sqr1services.com/white-papers-and-articles/why-you-need-to-implement-a-business-emergency-response-plan-immediately

Executive Summary:
Businesses of all sizes must make strategic decisions to ensure its operations and outputs are optimized, functioning at an effective level to help them grow, increase speed to market, improve ROI, etc.  One tool which helps to achieve those metrics, and more, is outsourcing.  For the purposes of this paper we’re define ‘outsourcing’ as the act of packaging internal work to be sent outside to an external supplier to facilitate on behalf of the company, now client.  There are many positive attributes of outsourcing, yet there are a bevy of deltas which accompany outsourcing if the client doesn’t carefully vet and manage their suppliers.  Outsourcing, a valuable strategic business tool, is best experienced where expectations are managed while relationships are allowed to develop overtime. This produces fruitful outcomes for both client and supplier.

Author: Travis Smith
Contributor(s): Bill Colone, Achilles Young

​To view the full article click on the download link below:

Marshall Goldsmith, celebrated author and leadership coach, is famously quoted as saying, “What got you here won’t get you there”.  Over the course of my career I’ve been amazed how many times this quote has shown up in my career or the people around me, ringing all too true.

​What go you here won’t get you there.  It means the work, style, approach and effort you did to get you to a certain point won’t allow you to continue succeeding and hitting the next level, promotion or milestone.

I see this happen often in two areas of business: promotions and entrepreneurs.
When we’re striving for a promotion the effort it takes to prepare oneself to get promoted often means we’re upgrading ourselves, our output, overall performance, professionalism, etc.  We’re bringing more to the table in order to achieve something – a promotion.  We do the job to get the job.  However once the promotion occurs, it’s uncanny how often times the approach and effort we used to get the promotion isn’t what is needed to be successful in the new role.

​Take for example getting promoted from an individual contributor role into your first management role.  You’re a staff level (individual contributor) engineer who excels in product development and as a result you start getting noticed by upper management.  You’re consistently hitting your deadlines, solutions oriented, taking on additional initiatives, finding work proactively, helping your peers, etc.  These are some of the characteristics of a high performing staff level engineers.  These very characteristics are what get people noticed for management consideration.

Fast forward, the stars have aligned, and you’ve accepted the promotion.  You’re in management now for the first time in your career.  You’re a bit nervous because you’ve never been in management before but you’re confident you’ll succeed in this role just like you did in the last role.  You’ll do the same thing as before, working hard, and everything will work out.

Sound familiar?

This is the genesis of the statement by Goldsmith “What got you here won’t get you there”.

Now that you’re in management you’ll need to deploy a new set of skills in order to be successful.  Some of these skills you already possess like the ability to hard work, focus on being the best you can be, attention to deadlines, leading by example, etc.  However, now you also need to employ a new set of skills to make this new role work.  Skills like listening, influencing, strategizing resources, planning, holding people accountable, communicating above and beyond to ensure your message and intent is understood by your team. 

The key difference is the skills necessary to be successful in management are different and require more than what was necessary in the individual contributor role.  You’re now responsible for people and the product, not just the product itself.

If you were to use the same approach and tactics you did to get promoted into management now that you’re in management you run the risk of struggling.  Struggle leads to frustration and for some of us discontent.  The snowball effect inevitably for some leads to daydreaming being back in an individual contributor role and out of management. 

The same can be said for entrepreneurs. 

The second area I see this happen is when entrepreneurs get in their own way of being successful.

A talented person filled with passion, enthusiasm and spirit to do something different comes up with an idea and begins to put it into action.  Our entrepreneur, largely due to their work ethic and unyielding mindset to succeed can find themselves in situations where their idea, product and or company suddenly beings to grow.  At times, grow rapidly.

They’ve done an amazing job taking an idea and turning into a viable reality.  Outsiders begin to see the hard work and effort of this entrepreneur and want to join the party.  A team is formed.

Just like that, POOF, a company is born.

In the world of medical devices this plays out as someone having a great idea to improve a patient experience or technology.  They build their idea into a tangle product, secure funding and start growing the company around it.  It’s a thrilling time for the entrepreneur(s) as their dreams begin to become reality.

Up to this point much of the success of the product and new company can be attributed to the founding entrepreneur(s) and their early teams.  Once again, we find ourselves at a crossroads where Goldsmith’s statement ‘What got you here won’t get you there’ comes into play. As the company grows so do the expectations and requirements to hit each successive milestone. 

Products need to be rigorously vetted, tested and refined to meet each new milestone.  External forces,  like the FDA or investors eventually get involved, adding further angst and expectation to the company and the product development process.

Many entrepreneurs find the process up to this point rewarding and exciting, yet the most challenging parts lie ahead.

The two most common goals for an entrepreneur and their start-up company in the medical device space is to either position their company for acquisition by a larger suiter, or build it up as a stand alone organization, commercializing the product for sale.

Both of these outcomes require a similar thing to happen – the company must shift and meet new expectations, new milestones and operate as a sophisticated organization.  It’s no longer the wild west free flowing organization it once was at the beginning.  Rules are in place, processes, procedures and increasing expectations.

Our entrepreneur, who can be credited with the early successes of the company, now needs to make a decision.  Does s/he continue to lead the charge or bring in another person who is more experienced in leading companies to the next stage of life. This is an incredibly tough decision, one many entrepreneurs struggle with.  Why?  Two reasons: ego and the passion they had which got them here in the first place.

It’s incredibly tough to step aside from your baby (the company the entrepreneur founded) to hand off the reigns to someone else.  Most people can’t do it and so they continue to lead the organization thinking they can get it to the next level.  In fact, some people can indeed do this, however many struggle unnecessarily. 

Staying at the helm leading the company for many entrepreneurs is a catastrophic decision.

Many entrepreneurs by their nature can be classified as A-types, controlling, visionaries, big picture thinkers, passionate types.  While these are great characteristics to have, they don’t always make for the right recipe to take an organization to the next stage – mature growth.

​As such, the entrepreneur chooses to stay in the driver seat continuing to lead the company with varying degrees of success. 

Inevitably problems start arising within the company.  The key indicator our original founder/ entrepreneur is having a hard time in the leadership ranks is their organization is flush with people problems.  Attrition is high, employees are discouraged, little effort is put into going above and beyond, leaderships approach is more dictating rather than encouraging and influencing.  As a result of these challenges problems start arising with the product.  Issues plague the organization from all angles. 

Many of us are better off being the founder, the visionary, not the CEO or chief leader growing a company through maturity. 

How do we overcome Marshall Goldsmith’s statement “What got you here won’t get you there”?
We invest early in ourselves by getting a mentor!

Mentors do many things but above all they provide perspective.  Mentors see the writing on the wall long before we do.  Since they aren’t in the weeds and often times have an external perspective it allows them room to see all the angles.

Having a good mentor in place in crucial to anyone, regardless of their professional, but especially important for someone seeking a promotion or operating as an entrepreneur.

How do we deal with Goldsmith’s statement – we change or we get out of the way.

Mentors can help you change, help you elevate yourself, help you grow and flourish.  The trick is you have to be open to the feedback.  Open to change, bringing along a growth mindset.

People who operate in this capacity, open to feedback with a growth mindset, stand a much better chance making the right decisions in these key moment (promotions, entrepreneurship) rather than allowing their ego’s to write checks their bodies can’t cash.

Are you living Goldsmith’s statement today, “What got you here won’t get you there”?  If so, get yourself a mentor and be prepared to face your reality.  You’ll either need to adjust accordingly or get out of the way.

Key Take-Away:
The effort and approach you used to get to one milestone inevitably won’t be what’s needed to help you get to the next milestone.  Are you an entrepreneur?  If so, get a mentor and begin building your growth mindset so you can be prepared to appropriately grow your baby (your company).

Action Item:
Get a mentor.  It doesn’t matter what level of your career you’re at or what your role is.  Spend the time now to invest in yourself for the future, even if your working future is only a couple years away from retirement.  Invest now to be a better person tomorrow.  Check out www.micromentor.org, it’s a free service put on by a nonprofit organization which matches people with mentors.

​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
 
Action Item:
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.