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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
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 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.  Could You Live Fearlessly?2/15/2021  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’. 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! Medtronic: https://www.medtronic.com/us-en/about/mission.html 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 Diality: https://www.diality.com/diality #fearlessmedtech Get Your Boss to Approve Your Idea12/8/2020  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:
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:
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.  Technologist, including engineers, are often unfairly labeled and stereotyped as lacking soft skills when it comes to interacting with other people. Words like ‘quirky’, ‘introverted’ and ‘rambling’ are often used to describe technologists and how they interact with others. After more than 15 years in the medical device field working side by side with my engineering colleagues I’m convinced these adjectives unfairly characterize many technologists, yet the use of these descriptions continues to permeate conversations rather consistently. Whether you’re a technologist or not, the simple truth is we all could use a little help in upgrading ourselves professionally. Continual improvement is a cornerstone for a good professional and so is proper business etiquette. If you’re looking for a way to improve how you show up, including how those around you perceive you, consider the following nine steps to boost your business etiquette: 1. KISS (Keep It Simple, Stupid) A wonderful acronym to say the least. Those of us who like to tinker and develop products have a tendency to overcomplicate the outcome, as well as our communication. When we ‘over engineer’ our ideas, products or conversations it shows a lack of understanding for the true need as well as our ability to hold back personal interest before company needs. Good business etiquette in this area is when we build awareness around the importance of keeping things simple which focuses on driving greater realized value for the end user. “Simplicity is the ultimate sophistication.” – Leonardo Da Vinci 2. Understand the Big Picture Technologist can be stereotyped as not understanding the company’s bigger picture and its goals as a business. Its important engineers slow down to take the time to understand how their role impacts the business, especially how their decisions impact things downstream. When we understand the big picture we’re able to remove ourselves from our preconceived notions and think like business professionals, not just technology developers. This becomes crucial when we’re making decisions early in the product development process on product needs versus how that need supports the company’s mission and the needs within the marketplace. Just because something is a great feat of engineering awe doesn’t mean it is necesary for the product, the company and or the customer. 3. Be Proactive With Your Communication Engineers live a life of projects. They go from one project to another in their day to day work and as such they’re often embroiled in deadlines. There’s nothing more frustrating to have someone on your team report the day of the deadline that they are going to miss it. That’s unacceptable. When we have good business etiquette we respect the other people on the team by communicating proactively so the team is prepared, especially in a situation where we may be missing a deadline. Don’t wait to communicate. 4. Understand Your Cross Functional Colleagues It’s poor business etiquette for engineers to only stay in their lane and not get to know, interact with, or understand their colleagues in non-technical roles. Why is this the case? Read #2 on this list. When we don’t understand the bigger picture of the business, how it runs and operates, how decisions are made and why they’re made, our ability to be a productive employee is reduced to chance. Ever seen someone come up with an idea which they claim to be amazing or revolutionary to be shot down shortly thereafter from another person in the company? More often than not that idea infringed on #1 or #2 within this list. For example, if you make a suggestion to add a feature to an existing product without taking into consideration the cost to manufacture it or if the companies sales people can actually sell it to their customers you’ve singlehandedly shown that you can come up with ideas which have little merit in their ability to be executed. 5. Good Enough Vs. Perfect Confucius said, “Better a diamond with a flaw than a pebble without.” When we chase perfection we often find ourselves on a never ending journey where we’re busy as can be without accomplishing much. Its important engineers build awareness around the idea that nothing is ever finished therefore it isn’t settling if perfection isn’t achieve. We should expect it and build product updates into our process down the road. Apple, Inc. does this all the time with their new releases and they still have people lining up around the block to buy their products, regardless of the initial glitches and bugs associated. 6. Handshakes and Eye Contact Those of us in technical fields can at times get a bad rap for not being social butterflies who know how to engage with others. Let’s buck the stereotype! Good business etiquette tells us it is important to give a firm handshake upon initial interaction with another person. In fact, its common to hear from leaders that a poor handshake can be the difference in someone getting a job. The limp wrist, fish handshake belongs nowhere in business. Same can be said about eye contact. Be intentional with your eye contact when speaking with someone in person. Looking at the floor or down at your lap gives others the impression you aren’t confident in yourself. 7. Ditch the Cell Phone Your cell phone needs to stay in your pocket at all times when you are engaged with others, especially in a business setting, unless you are using it as part of the discussion. If you’re in a conversation, including a group conversation, and you’re simultaneously thumbing through your social media you’re giving off a sign that what other people have to say isn’t important. Put the phone away! Your digital friends, who you’ll never meet anyways, won’t even notice you’re not there to like their cat memes. FOMO no mo. 8. First Impressions Are Actually Important This goes hand-in-hand, pun intended, with #6. The way we show up with other people, especially during a first impression can make or break someone’s perception of you. Greet people, shake their hand, learn their name. Make an effort to engage with them. Be polite and considerate. Lastly, be groomed! If you’re appearance is disheveled or unbecoming of a professional that’s how you’ll be treated. Most technologists make a healthy living in their careers, it’s important you act like it, at least upon first impressions. 9. Respecting Others Lack of Technical Knowledge When you’re talking to a layperson, a non-engineer, do your best to use simple, straightforward language. People who aren’t engineers already are often times giving you the benefit of the doubt that you’re smart. (this is the one time when a stereotype works in your favor) As such, you don’t need to impress people with your technical prowess by using terminology and theoretical concepts which fly over the head of the other person in the conversation. Be mindful of who you are talking to and adjust accordingly as this will ensure the discussion is fruitful for both parties. If the other party wants more information they’ll signal to you to get into the weeds, then its go time! When we’re demonstrating good business etiquette we simultaneously show that we respect others while respecting ourselves. Take the time to build awareness in this area of your career, it will pay dividends in spades over the long haul.  Prepare for the Unexpected10/19/2020  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. Part 2: ERP Implementation Continued 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  How many times have we waited too long to address something to later learn our procrastination ended up creating more work and heartache in the end? This is a daily experience for many businesses pushing off activities which may on the surface seem unimportant or trivial in the moment but lack thereof in the wrong circumstances creates havoc on the business’ leaders and employees alike. Havoc also likes to bring with it a loss of time and funds for what that’s worth. Enter the Emergency Response Plan (ERP); also referred to as an Emergency Action Plan (EAP). If you’ve ever seen an ERP, or been lucky enough [heavy sarcasm here] to be a part of the team putting one together, you know firsthand this exercise is no walk in the park. A thorough and well-rounded ERP can easily exceed 60 pages in length, we’ve seen them over 200 pages, covering everything from natural disaster planning to emergency health services and of course the latest business challenge - pandemics. Many also include Continuity of Operations Plan (COOPs) which address situations like when employees can’t come to the office but the show must go on. Sound familiar? Gosh, ERP’s seem pretty important, right? Exactly, then why is it so many companies, especially companies under 100 employees, don’t have an ERP in place. Not only do they not have a formal document and list of procedures to rely on when the sky falls, little to none of their employees have ever been trained in what to do should an emergency occur. This is business gambling at its finest hour. Without a plan in place we are accepting an incredible amount of unnecessary risk. Why do companies choose to put off business planning which includes ERP related procedures and documents? The survey says the #1 answer is ‘they didn’t think they needed it because it [an emergency] wouldn’t happen to them’. Other reasons why companies don’t have an ERP in place is they didn’t know they need one or they’re fire fighting [bad pun given the context of this article] other business needs which require immediate attention. Whatever the reason may be which has led you to push off implementing an ERP just know this – should the proverbial crap hit the fan putting your business, operations, employees or facility in crisis mode, know that your company and or its directors could be held accountable for a lack of planning or action – especially if lives are at risk. This is certainly a grim reality and one which isn’t fun to think about. Let’s hope you’re in a position where you’ve been lucky enough to not experience any emergency or critical situations and therefore haven’t had to activate an emergency plan. If that’s the case we not so subtly suggest you consider the following:
Given the events of 2020 its understandable for businesses and their employees to be on edge about the unknowns ahead of us. Planning ahead of time for possible risks reduces our likelihood that risk develops into a situation which puts our employees or the company in danger. It’s always better to plan and have the plan never go into action than to be unprepared and regret it later on. In January of this year we were contacted by a company to help create their first ERP as they had just experienced an emergency situation where an employee, we’ll call her Tina, fainted at the office in a common area. Another employee, let’s call him Josh, found her conscious but noticeably shaken up and still on the ground. Josh stayed by Tina’s side and called the paramedics with Tina’s approval. He stayed with her, providing support and comfort until the paramedics arrived; long and short Tina turned out to be okay, she had fainted due to overheating. A couple months later I asked the company’s VP of Ops about the outcome of the situation to which she shared, “we were lucky Josh of all people found her, Josh was an EMT (Emergency Medical Technician) when he was in college and jumped right into action. If it had been anyone else, including me, we would have been unprepared not knowing what to do. We had no plan in place whatsoever to deal with a situation like this. Needless to say we’re lucky things ended without further incident and thankful the situation wasn’t worse for Tina. Interestingly enough, Tina and Josh now officially chair our emergency prep team.” This company got a wakeup call and got lucky the situation wasn’t any worse. Prior to this incident they had no plan in place, no process to deal with crisis’ or emergency situations. Their business and employees were left to chance in dealing with critical moments, moments which can be the difference between life and death. As Denis Waitley says, “Expect the best, plan for the worst, and prepare to be surprised.” The names and situations described above have been changed to protect the identify and privacy of the company and individuals involved. Key Takeaway Don’t wait until it’s too late to get an Emergency Response Plan (ERP) in place. The ERP acts as a guide providing step by step procedures for emergency situations. Not having a plan in place means you and your company are accepting a potential large amount of risk, risk which isn’t necessary. Action Item Put on your activity list for immediate attention to implement step #1 in this article: Get an ERP type plan in place IMMEDIATELY; even if the plan you put in place initially is a couple pages worth of emergency preparedness, you’ll still be better off than a company that has nothing. The bare minimum requirements should include facility evacuation, emergency health and utility dangers protocols; include heavy equipment/ chemical hazard protocols should they apply.  Dealing With Awkwardness in Negotiations6/22/2020 Negotiations can be uncomfortable. How we deal with those moments of awkwardness and discomfort makes or breaks our experience and of course the end result. Here's why...
Visit Square-1 Engineering's Resources Library for additional white papers, articles and videos covering a broad range of content from product design, supplier relationships to leadership. http://www.sqr1services.com/resource-library.html #square1engineering #square1 #engineering #lifescience #consulting #negotiation #advice #business #strategy  Opening Salvo: Consulting, it’s the next big business opportunity frontier. From 2011 to present the consulting industry grew by 4-5% YOY on the coattails of increasing supply and demand. More people than ever on record have transitioned out of traditional career roles in the last 15 years to chase the ‘gig economy’ (increasing supply) while companies themselves have developed a steady dependency (increasing demand) on using external support to ensure their operations run effectively and efficiently. While this sounds encouraging, an unexpected outcome of this growth has left many customers with buyers remorse. As more people enter the consulting game the varying levels of experience, service, costs and related outcomes has left customers in a predicament. With a multitude of options now available to companies looking for help one of the biggest challenges afflicting buyers is how they will find the right support while ensuring the money they’re paying for it results in a positive outcome. Author: Travis Smith To view the full article click on the download link below: 
 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:
About the AuthorTravis 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. Archives
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