White Papers & Articles

​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. 

​Want to get through your remediation project successfully?  Doing these two things helps dramatically increase your chances of success.

#fearlessmedtech #remediation #fda #medicaldevice #medtech #quality #compliance #QMS

​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.

You’ve got an idea!  Maybe it’s to optimize a process, save the company money or to develop a new product.  Many of us at one point or another in our careers will come across this situation where we have a brilliant idea but we don’t know how to implement it.   Once we have the idea what we do after the fact is what makes or breaks our ability to turn into reality.
​
The steps below can help you organize your thoughts in a formal manner so you can further vet your idea while positioning yourself (and of course your idea) for the best possible chance to get approval from the powers that be.

Step #1 – Develop A Business Case

A business case captures the reasoning for initiating a project or task. It is often presented in a formatted written document outlining everything from the reason for the project, problem(s) it solves and the ROI.
 
Components of a business case document may include:

1. Identifying the business need (‘why’ should the company invest in your idea)
2. Expected Outcome & ROI
3. Justifying why the project is necessary
4. High level outline of project goals and objectives
5. What does successful completion look like
6. List of assumptions, things you believe to be true regarding your project
7. What challenges or constraints will you likely encounter?
8. Share what alternatives have you considered
9. Perform a cost benefit analysis to determine the strengths and weaknesses of alternatives in comparison to your idea or project
10. Close with a strong recommendation on why the company should invest in your idea (this needs to clearly articulate why it would be a dumb decision for the company not to move forward with approving your idea or project)

Once you’ve compiled your business case now it’s time to present it.  Set a meeting with your boss, or the appropriate party who would most likely approve your idea and or project.  Inform them ahead of time what the purpose of the meeting is and arrive prepared with multiple copies of your business case both to reference and present from.  Leave the approver with a copy of your business case and an action item to keep them engaged and thinking about your presentation.

Well look at that!  You did such a good job compiling your thoughts and presenting your idea that your boss granted you approval to move forward in the project.  Excelsior!

Now that you have approval, which is a fancy way of saying “we like your idea enough to put money behind it”, you will need to build out the project in detail using a ‘Project Charter’ to ensure it meets a successful conclusion.
Note: What’s the difference between a ‘Business Case’ and a ‘Project Charter’?  A business case comes first as it is an assessment or feasibility study of an idea or task; the sponsor (person who has the idea) pitches their case to the funding stakeholders (typically your boss or people in management). If approved, a project charter is completed outlining the project in detail. The information within the charter is the constraints for which success will be measured.

Step #2 – Develop a Project Charter

As mentioned above, the project charter is a document which clearly defines the project scope, objectives, and participants involved. Components of a project charter may include:

1. A clear statement, or project scope, describing deliverables and the problem or opportunities the project is meant to address along with phases throughout the project
   1. This also includes what’s out of scope for the project, meaning work which isn’t involved in this project
2. How are you evaluating performance via success criteria
3. Objectively and upfront identifying areas of risk, these are ways the project could fail if not addressed properly
4. Detailing out project requirements which are conditions or tasks that must be completed to ensure the success or completion
5. Outlining a schedule for events for the project, this is typically accomplished using a milestones approach or Gantt Chart
6. Describing the project budget, including funding sources and how those funds might be used from a time/ resources and materials perspective
7. Identify team members and project lead(s) as well as what other resources will be used to support the project (cross functional, suppliers, consultants, etc.)
8. Establish communication expectations so the team knows how and when project updates will be given; consider using the SCRUM or Agile methods

 
You’ll note that much of the work that was done initially for the business case can in turn be used in completing the project charter. If your project is big enough it may be worth looking into project management software, like Basecamp or JIRA, to electronically track your projects activities and deliverables.

Now that you’ve got your main documents guiding you through the project out of the way the next step will be to kick off the project and get underway.  I recommend doing the kickoff meeting in person if possible, or via video conference call, where the team can openly talk about the needs of the project and how tasks will be divided up.  All resources involved in the project should have a copy of the project charter along with clear expectations on what their role is and timeframe to deliver those tasks.
Now that you have a basic foundation for what is needed to get your projects approved and kicked off the next step is to look into resources like the Project Management Institute (PMI) and their primary resource guide called Project Management Body of Knowledge (PMBOK).  These resources will help you stay on track while providing vast amounts of information on how to move projects through to successful completion. 

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:
The world of startups and small business can indeed be an exciting place to be.  Its commonly characterized as highly collaborative, fast pace, less bureaucratic and wildly innovative.  While this sounds great in theory, in practice the world of a startup can be rife with challenge, including heavy amounts of stress and uncertainty.  It’s vital we as professionals analyze our personalities and professional behaviors to assess whether or not we would do well in the startup world - before we actually jump in. Knowing what you’re up against before you dive in will allow you to determine if it’s appropriate for you to consider the startup space, small business and or entrepreneurship.

​Author: Travis Smith

​Read the full article by downloading the below PDF attachment

Growth in hiring is typically a good thing.  Why thank you Captain Obvious.  While growth in hiring may very well be a good thing, successfully navigating the hiring process is an entirely different story.
Successful hiring can make or break the performance of a company.  Unsuccessful hiring on the other hand creates all sorts of fun challenges for folks like you and me.  In fact, Harvard Business Review identifies 80% of employee turnover is due to bad hiring decisions.
​
What does this mean?  First, let’s look at the potential tangible repercussions.

According to Dice, one of the larger online job boards, a poor hiring decision for a candidate earning $100,000 per year could cost, on average, $250,000, and that expense comes right off the bottom line.  That’s scary stuff!  Basically, if the hiring decision you made ends poorly you can expect that mistake to represent 2.5 times the cost of whatever the salary is of the person you are hired.

Rather than fearing the hiring process, or having it work against us, we should approach it with a strategic and open minded process to ensure success.

Want to improve your hiring practices?  Employee (pun intended) these 15 tips:

1. Why Would Someone Pick You/ Your Company? 
No longer is it realistic for employers to have the notion that just because you are in the drivers’ seat administering the interview means you have all the power.  In fact, it’s quite the opposite as the current market is more in favor of the job seeker as they have plenty of options to choose from, you being one of them.  If you want the best of the best you have to be able to speak to WHY people should consider you and your company.  Your story must resonate with your interviewees.
 
2. Character Over Competency
The best leaders use this philosophy – hire people who will bleed for your cause and will make the right decisions even in the darkest of hours.  Competency in most jobs can be taught, character is what the person has developed well before you came around so don’t think you can change it easily, if at all
 
3. Behavioral Based Interviewing
A great tactic while interviewing is to ask people what they would do in certain situations.  This causes people to have to think and adjust in the moment.  You aren’t trying to catch someone doing something wrong here, more or less understand their thought process and how they handle certain tasks or situations
 
4. Know What You Want Before You Interview
All too often I hear people say, “we need to interview some people first to better understand who we are looking for”.  You should never need to interview someone in order to help you understand who or what you are looking for.  If you use this practice most often what it means is you don’t know what you’re doing from a leadership perspective.  Tough love I know but it’s highly important you know what you want and need before you go looking for it during interviews.  Wasting people’s time so you can figure out your direction with hiring isn’t advisable and it’s unprofessional.
 
5. Consult Others
Before you go about the interview process speak with other managers about their experiences and your plans for your hiring process.  The best advice typically comes from those who have been there and done it before that way you can learn from their successes and mistakes
 
6. Make Sure You Know And Understand Your Vision
Somewhat similar to number #1 however this focuses on you and your specific team.  Put yourself in the shoes of the person interviewing and think “Why would I want to work for her/ him?”  “Does this vision excite me?”  “What is my role in the future of this company?”
 
7. Best Foot Forward
A helpful reminder if nothing else, remember when people are interviewing you are witnessing their ideal self, seeing them at their best.  Asking questions which will give you better insight into who they are day-to-day, not just during your interview, are always good ways to get a better glimpse into who they are in a very day setting.
 
8. Tell Them Your Leadership Philosophy
This is especially important if you are hiring the person to join your team.  This is also very different than #6 which talks about the vision for your team or company.  Here you are sharing with your interviewee how you lead and what you believe in.  A great precursor question to this is asking the candidate what type of leadership they like and want in their next career
 
9. Interview Tests
It’s a great practice to test candidates on their abilities on the spot, so long as the test is directly relatable to their core job function.  If you are interviewing a Mechanical Engineer, for example, it is highly suggested you test them on the exact work they would be doing for you (ie Solidworks modeling)
 
10. The Reference Trick
I personally think references are a waste of time.  Why?  Because the people on the other end of the phone are doing nothing but singing the praises of the person you are interviewing.  In over a decade I can name on one hand the number of reference checks I’ve performed which brought about a poor review.  Here’s how to get around it – when you are on the phone with the reference which was provided by your interviewee ask who else the interviewee worked with and then try to phone that person.  This person won’t be prepared for your call and may provide you with more realistic insight into the persons’ work ethic and behaviors.
 
11. Put Yourself In Their Shoes
Interviewing isn’t easy.  In fact it can be downright terrifying for some people.  Try looking beyond the interview.  Just because someone’s interview isn’t a glowing success, or they may seem overly nervous, doesn’t mean they aren’t a good catch.  Just because someone interviews well doesn’t mean they will perform well in the job.
 
12. Job Description = Performance Expectations
It’s time we ditch the HR job descriptions and actually write and talk about what the newly hired employee will be expected to do from a performance perspective.  If you’re hiring for sales, interview your candidates based on the quotas and metrics you’ll have in place.  Ask how they will achieve those goals, what their strategies will be, etc. 
13. Know Your Non-Negotiables
What are you not willing to tolerate?  When I’m in a position of hiring my two non-negotiables are attitude and integrity because both of these are things we have 100% control over.  Knowing that I then ask questions around those two to see how they view my perspective on my non-negotiables.  Asking interviewees their non-negotiables will also give you an idea of where their priorities land
 
14. Challenge Your Own Mindset
One of the most common mistakes leaders make when hiring is they select candidates that remind them of themselves or select candidates that are beneath them skill wise.  Great leaders surround themselves with people who are not only competent but will challenge the leader to be better. 
 
15. Don’t Hire If It Isn’t What You Want
I hired an employee that was most of what I was looking for but through the interview I uncovered some things that were less than great.  Up to this point I had interviewed so many people that I just decided to move forward with this particular candidate and did the whole ‘cross your fingers’ bit in hopes they would work out.  From that experience I can tell you it is always better to not hire when in doubt than hire because you need to fill a spot.
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Author: Trisha Aure

It seems nowadays there are no safe places for thoughts, comments or posts.  There will always be someone that will have a negative response no matter what the content is.  I was reading a post on LinkedIn about a company that hired their first woman board member.  This is something that should definitely be talked about and celebrated.  But then I started reading the comments, and it was talking about everything this woman was not:
              “That’s great, but it would be better if she wasn’t Caucasian.”
              “How is she going to stand up to her male counterparts?”

Why can’t we see the actual message here instead of seeing everything that it is not?  What would life be if we celebrated what we should instead of tearing down things that don’t align with our personal goals?  We all have different goals, different paths and different stories.  And this is exactly as it should be.  We should be uplifting and supportive of one another, even when we disagree. 

Having a healthy mindset is not the easiest, and I have come to find out, this is an everyday activity.  I’m sure there are many speculations on why our minds are triggered to see the bad rather than the good.  The news, social media, celebrities, and pure gossip are just to name a few. 

I started thinking about this during a conversation I had with a friend of mine about my road rage.  I realized that I get frustrated when someone would cut me off or drive too slow because I would take it personally.  As though the driver saw me and said to himself “I’m going to cut that girl off…. haha.”  My friend put a bit of perspective out there for me and brought up that this person could be driving their hurt kid to the hospital or frantic because they received some heart wrenching news.  This struck home because it made me sound egotistical as though the world revolves around me; why did I think that? 

What does this negativity do to us?  It creates stress and an unhealthy lifestyle. 

“Emotional stress can weaken the immune system and cause high blood pressure, fatigue, depression, anxiety and even heart disease.”

In fact, it is estimated +75% of the physician office visits which occur in the USA annually are for stress related ailments.  It’s also the leading cause of death.  It’s a wonder why we react the way we do to certain actions is the first step.  We need to change our daily habits in order to begin a healthy lifestyle.  This can include:

• Getting regular physical activity
• Practicing relaxation techniques, such as deep breathing, meditation, yoga, tai chi or massage
• Keeping a sense of humor
• Spending time with family and friends
• Setting aside time for hobbies, such as reading a book or listening to music

Key Take Away
Slow down and live life.  Stop holding yourself back from happiness, success, family or anything else that you are striving to.  Stop worrying about things that are out of your control.  If it is out of your control, you can’t do anything about it, so why worry about it?  Why get upset about it?  Why lose sleep over it?  By taking stress out of your life, things won’t look as dull.  Our minds are so powerful, that if we train it to see things for what they really are it would be full of more rainbows than icy storms. 

Action Item
You don’t know everyone’s story and why people act the way they do.  We only have control over our own actions.  Instead of judging someone, talk to them, lend them a hand, or let them pass.  Humor is a big stress reliever for me.  You can’t stress when you are laughing.  If something works for you, share it.  Sharing is caring people.