This episode covers insights by Quality Executive Robert Lahaderne as he shares his perspective on the impact Root Cause makes to a medical device organization when it is done correct versus when it is done incorrectly.
#medicaldevice #medtech #rootcause
In this episode we cover Medical Device Management Top Grading tips with Peter Nalbach, VP & GM, in Orange County, CA. Listen in as Pete outlines his 3-step process to align and bring in the right people to help move the company forward while simultaneously overcoming product challenges throughout the lifecycle process.
#management #medtech #medicaldevice #people #topgrading #leadership #snapshot
When you’re early in the development process it can seem like there’s a never ending list of activities and projects your R&D team needs to take on. When you’re in this mode its vital R&D leaders assess time, resources and associated risks with the product they’re developing. Medical device product development executive Arif Iftekhar walks us through how to focus your team and address the most important product risks head on at an early stage.
In this episode of Medtech Snapshot we discuss strategic supply chain strategies with medical device supply chain and manufacturing executive Jeff Brown. Key points in this discussion include addressing situations similar to China and Taiwan, solutions to hedge yourself against such global challenges, including but not limited to supplier risk, back-up capacity and vertical integration.
Need help sorting through your supply chain and or contract manufacturing challenges? Learn more about Square-1 Engineering's capabilities as it relates to all things manufacturing engineering: NPI, tech transfer, pilot manufacturing, process development and improvement, supply chain management, etc. Click HERE to learn more.
Not all places of business are one in the same, nor is our ability to succeed in said environments. This, of course, is an obvious statement but for reasons verging on inconspicuous.
In business, working for the establishment (the Bigs, Conglomerates, Strategics, etc) versus being in the start-up arena is a constant back and forth consideration for many of us in the medical device industry. This becomes especially true if we find ourselves looking elsewhere for work at which point the phrase “the grass is greener on the other side” has a devilish way of distorting our worldview.
Fun Fact: the phrase ‘”the grass is greener on the other side” traces back to the Greek poet Ovid, circa first century B.C.; Ovid is credited with saying, “The harvest is always richer in another man’s field.” From there the American folk singers Raymond B. Egan and Richard A. Whiting wrote a song called “The Grass Is Always Greener in the Other Fellow’s Yard” in 1924. And there you have it.
Why is this important?
Simply put – we are not original in our thoughts about our present circumstances and opportunities close to us. ‘The grass is always greener’ is really a tale of fantasy, one which often supposes things are naturally better elsewhere just because it doesn’t define our present reality. Herein lies an important question as it relates to you and the medical device industry – what company size are you best suited for and does this environment present greener pastures? Is your current job the right 'grass'?
Working for big business certainly has its perks, there’s no doubt about it. Stability, direction, benefits, work that is defined – you name it. The medical device industry naturally follows this familiar path while also provide other such commonly held benefits like:
This list represents typical benefits which may come with working at a big company, but certainly aren’t guaranteed by any means. As we all know, just because it’s a big company doesn’t denote excellence by any means, which is perhaps the very reason the start-up world exists.
The start-up world can be an exciting place. I’ve experienced this personally for over a decade in my own business as well as supporting dozens of medical device clients who have new and burgeoning places of business. In the start-up environment its common to hear people describe their experiences as:
The world of medical device start-ups can be an alluring place for work. Is it possible the start-up world is where ‘the grass is greener’? The answer to this question comes down to one thing – how you’re conditioned to operate as a professional.
If you are currently looking for a new career it’s vital you truly understand what makes up the medical device start-up world and whether or not you can be successful in that environment BEFORE you jump in to start work. Take a moment to check in with yourself on how you land with these characteristics which commonly can be found in the start-up world:
Start-ups can be exciting places to work because many times the companies and their respective technology are seeking to disrupt the market by bringing new approaches to tired practices. This excitement comes with a twist – funding. The life of a medical device start-up lends itself to a constant and almost never ending process of fund raising to help the company achieve its next milestones. Some start-ups excel in their ability to raise funds, many struggle mightily. Reportedly more than 75% of device start-ups fail, 50% of which fail in the first five years. As a start-up grows and evolves it’s not uncommon for them to also go through waves where they are flush with cash in one season, to find themselves on the brink of going under the next season. Understanding if you are comfortable in an environment which can be viewed as ‘feast or famine’ is crucial to your ability to be successful in the start-up world.
2.Working Outside the Box
When we work for big companies often times our job and daily output is focused on a certain set of tasks, we’re siloed into a niche function. It’s the opposite in the start-up world as often times the mentality of those who are successful in this space is they’re willing to do whatever it takes to get the job done and company moving forward. This includes taking out your own trash! If you’ve ever said “that’s not part of my job description” in response to work that was requested of you I would recommend taking a hard look at whether a start-up or small company is the right move for your career. Job descriptions are incredibly loose in the start-up world, if they even exist in the first place.
Working 8-5 in a large company can be a nice perk. If you’ve done that for any length of time you may have forgotten how nice it is to mentally shut off at 5PM. With medical device start-ups working 8-5 is non-existent. It’s common to work long hours and or be tethered to your phone around the clock. The statement of ‘work life balance’ is blurred beyond recognition in the start-up world. Those that are successful here know and understand that it takes time and effort to create something. How dedicated are you to making that happen and what are you willing to giving up in the process?
Working in a large company doesn’t necessarily mean that everything is clearly defined and outlined yet it is typical that SOPs (standard operating processes) are at the very least available for workers who choose to use them. Different departments exist handling tasks specific to their function in the larger machine. In the start-up world you may find yourself creating these on your own. Take a moment to think how you would feel about being confronted with a daily situation where you are supposed to be working hard, hell – harder than ever before, and there isn’t a lot of direction or support to help you in that effort. If the thought of that excites you than the start-up world may be a breath of fresh air.
This is one of the most overlooked aspects of a start-up in my opinion. Leadership. If you haven’t worked in the start-up world before you may not be aware that people in leadership still do much of the hands on work. In big business this is hardly the case. Neither camp of leaders are necessarily better than one of the other, it’s just a very different environment. In start-ups every person on the team has to give 150% to the cause which means those who don a leadership title still have to get dirty in the day to day work. The reason you want to consider this as a part of your ‘can I make it in the start-up world’ is because leadership ultimately can have a great or very grave impact on the start-up business. Seems a bit obvious but when someone is doing both daily work and in charge of strategic decision making their influence and involvement has a much greater impact. In big business if a company experiences a failure with one of their leaders it typically can be salvaged whereas in the start-up world one or two costly mistakes by leadership will send the company into a grave six feet under.
Start-ups offer an intimate working experience. It’s a necessity. Working in a start-up everyone knows everything about everyone. It’s close quarters with high amounts of communication, partnering and feedback. Collaboration of course exists in big business but not at the intimate level of the start-up. When we work for a big company we are often a part of a team but doing work independently, even at times on our own little island. If you’ve come to enjoy your island and aren’t interested in having neighbors all over your lawn on a daily basis than perhaps staying in big business is the right decision for you.
A career in the medical device start-up arena can indeed be a rewarding and exciting adventure – for the right person. Once you’ve spent some time analyzing what’s most important to you in your career and the type of company which is most suitable to help you achieve success you will better understand how the medical device start-up world fits in with your next steps.
Learn about Square-1 Engineering's mission and what it means to be fearless!
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
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.