Our managing director Travis Smith covers five (5) key questions anyone in a buying position should be asking a consulting firm or individual consultant to better qualify them prior to making the buying decision.
Read the full article at www.sqr1services.com/white-papers/how-to-solve-your-1-business-challenge
The results are in from our Square-1 Engineering online poll...."What are the top 2 most frequent reasons warning letters/ citations are issued by the FDA?"
Listen in as our managing director, Travis Smith, covers the results of he poll while sharing commentary from the medical device community.
Need help dealing with an audit or warning letter? Learn more about our support capabilities at https://lnkd.in/g7NX_8pw
#poll #fda #capa #complaints #regulatory #quality #medtech #square1engineering
Our LinkedIn poll concluded with some interesting findings and a fair amount of debate. It's estimated 75% of medical device start-ups fail or never make it to the market. Understanding the primary factors which drive these outcomes makes or breaks the difference in a start-ups success.
As our respondents weighed in it was clear the primary factor which gets in the way of a start-up meeting up with success is in fact its own people. 48% of voters identified this as the primary reason for failure, many of which current have or have had in the past direct experience operating in a management role within start-ups.
The debate ragged on within the poll as some people felt like the product (ie technology) played a larger part in the failure of the company as it's ability to meet a core, and perhaps large, clinical need drove a variety of things including funding, market acceptance, etc.
In the end the old saying still rings true - the people we surround ourselves with makes all the difference.
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:
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
Imagine a life that is totally different from the one we know today. A life where disease and medical disorders are not commonplace. A life where medical afflictions no longer claim lives. It’s a wild thought, we know. It is our utopia!
Now think about this utopia in comparison to where we are at today. In 2019, roughly 58 million people died worldwide of which 74% of those deaths (or 43 million people) were the result of noncommunicable diseases like heart disease, stroke and COPD.
Imagine what the world would be like if all of those people, our family, friends and colleagues, were still with us.
It’s a sobering and certainly emotional thought! But how could we ever achieve such a utopian life existence?
Enter Square-1 Engineering and the greater life science industry.
As I write this I’ll humbly admit there will inevitably be people who read these statements and think we’re absurd or even delusional for thinking we could ever achieve a life without disease and medical disorders. That said, it would also be prudent to note the purpose of this statement is not about our company, it’s not a sales pitch or a ‘look at what we’re doing’ ploy. It’s about an unrealized opportunity we need your help with as we believe it to be our responsibility to spread the word. Our utopia is indeed possible and it will take all of us, both within the life sciences industry and outside, to work together towards a greater goal.
This greater goal, which we’ve defined by Square-1’s company vision, is to achieve a life where ‘medical technology has created a new quality of life empowering people to live fearlessly’.
Our company, like many others, is on a quest to change the world as we know it for the better. How are we going to do this you ask? We’ll achieve this through the advancement of medical technology. Along with many other companies in the life science industry, our focus is to drive change and innovation so that we can continue to inch closure to a state in the future where the way we live as people is better than today. Hopefully without disease and medical disorder.
Imagine again if all heath care afflictions were in fact eradicated. The fear many of us live with as a result of the daily health issues we struggle with would also cease to exist. Rather than harboring fear we could spend our time focused on a life filled with optimistic gratefulness.
We know our ambitions are colossal, even unimaginable at times yet this is exactly what keeps us going.
It’s for this reason we’ve made it our mission to put all our time and energy into advancing medical technologies to improve patient lives today so we can in the future meet our utopia, a world rid of disease and disorder.
Could you live fearlessly?
Join us on our mission and learn more about some of the great companies who are pushing the boundaries of what’s possible in order to create a better tomorrow. A fearless tomorrow. Our utopia!
Edwards Lifesciences: https://www.edwards.com/aboutus/credo#
Staar Surgical: https://staar.com/our-mission
Square-1 Engineering: http://www.sqr1services.com/vision-mission.html
Axonics Modulation Technologies: https://www.axonics.com/about-axonics/who-we-are
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.
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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.