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.
How to Solve Your #1 Business Challenge
One of the biggest business challenges I run across today impacting both large and small companies alike is bandwidth issues – too much work, not enough ‘resources’ to get the job done.
A lack of resources in any business is a problem, indeed. Whether those resources are people, materials or relationships (supply chain), having the right number of resources to handle your needs while also being able to get a head requires both strategic forethought and action.
It can be a daunting task to get beyond the fire fighting stages to then be able to actually start focusing on longer term strategic plans. For this reason its smart to get help.
Despite the back and forth about the health and standing of our present economy, employment remains strong as the US unemployment rate as of December 2022 was at 3.5% according to the Bureau of Labor Statistics. For professionals in a technical setting the unemployment rate is estimated to be closer to 1.7%. This means if you need technical help most of the good resources are already in use elsewhere.
When resources are constrained, yet work is plenty, this is where the consulting industry comes conveniently into play.
The consulting industry has grown since 2011 by close to 5% YOY on the coattails of increasing supply and demand. With a multitude of options now available to companies looking for help one of the biggest challenges afflicting buyers seeking additional resources to solve their bandwidth issues is how they will find the right support while ensuring the money they’re paying for it results in a positive outcome.
A Lesson in History
Consulting isn’t new by any means, we’ve just reframed it to fit our present marketplace. Henry Ford, the USA automotive tycoon, used consultants prior to the 20th century to help build out his automotive empire ultimately creating what we know today as the Ford Motor Company. Consultants like Oliver E. Barthel are credited as key contributors to Fords success by developing combustible engines for commercial use which could be scaled for production. Needless to say consultants like Barthel and their associated contributions are immeasurable to the success of their industries.
As with all things, time has a habit of bringing about change. The consulting industry is no different. One considerable difference today versus even 10 years ago is many people who are in the practice of consulting are doing so as a means to uphold a particular lifestyle. This is relatively new to the consulting game as its initial pioneers worked around the clock perfecting their art, driven by a passion to create, help and succeed on their own accord. Even as late at the early 2000s traditional consulting firms like EY, Deloitte, etc. offered excellent top notch service albeit for a hefty price. Their employees worked tirelessly to execute, the idea of a work life balance wasn’t even on the horizon.
Today thousands of people go into consulting for the work flexibility. With these changes along came a fractured approach to the consulting business. The way one goes about their work (the process, focus, communication and execution) is often not the same as the next company or individual, especially when dealing with stand alone solopreneur consultants. As a result, I’ve witnessed palpable discord between consultants and their customers as an increased sensitivity between service (value and experience) and cost (time and monetary investment) unfolds.
The age old discussion of value versus price isn’t new, what is new is the approach many consultants take today to justify their pricing and how they deliver their service without correlating their price to the actual value garnered by the client from the experience. I’ve witnessed, more times than I can count, consultants indicate their pricing model is based off of what is required to keep their current lifestyle in good measure, not necessarily what they’re delivering. When pricing is done without consideration of value, we may be able to gain some work in the interim, however we run the risk of leaving behind us a wake of clients who feel like they’ve been overcharged and undoubtedly under delivered. This is what I refer to as a 'consulting dilemma'.
Fixing the Consulting Dilemma
Pricing is important, but so is a positive outcome. While the two of these are not necessarily mutually exclusive, they do tend to have a comingled relationship. When buyers are looking for additional support price will always be a factor however it should never be the leading indicator for a decision. If you’re in a situation where you’re maxed out with your current bandwidth and you’ve determined getting consulting support is a viable option to get ahead, consider the following leading up to your buying decision:
Once you can answer these five (5) questions then you can address the pricing component of this new potential resource relationship.
In order to effectively solve a customers problem a consultant must provide a service which delivers the intended results at a cost which is in alignment with the problem being solved.
Long term successful consultants know and understand the importance of leaving customers feeling good about their decision to hire them for work. In fact, Salesforce, one of the largest sales CRM software companies in the world did a study with their clients where they discovered 67% of their customers said “their expectations for good experiences [with sales people] are higher than ever”. This same report revealed 76% of customers report it’s easier than ever to take their business elsewhere. This means it’s no longer about having a great tool or the best consultant qualifications, you have to provide a good experience, complete the work successfully while ensuring the price paid is in alignment with the work performed.
A Key Consideration
It is indeed important to give your customers a good experience while facilitating their work, it’s just as important to price work appropriately. This is sound business advice for any professional, regardless of industry or role. A key consideration beyond experience and price, empirically important to a consultants’ success is the ability to successfully execute their work. At the end of the day if a consultant can’t successfully execute a project it doesn’t matter how great their customer service was or how affordable the price because the problem which brought the consultant to the table wasn’t solved in the first place. This is even more exacerbated in situations when a consultant charges a client using the indifference pricing model and yet still fails to successfully complete the project. When prices are high, so too are the expectations and there is often little wiggle room or understanding for anything which falls short of successful execution.
When in doubt, close the project out – successfully!
To solve your business issue of to much work and not enough resources you can’t just bring in a consultant, you have to bring in the RIGHT consultant at the right price who can deliver the goods. While this may sound obvious to some, its vital consultants understand both for their future as well as reputation in the industry they serve.
A Word to Consultants
Davy Greenburg, a content and branding marketing consultant in Los Angeles became famous overnight in 2018 for his comment, “If I do a job in 30 minutes it’s because I spent 10 years learning how to do that job in 30 minutes. You owe me for the years, not the minutes.” When a consultant prices their services based on their ability to do such work in correlation to the problem being solved they’re much more likely to get repeat customers down the road. Lifestyle requirements and emotional decision making have no place in the process to develop your price.
We’ve all experienced it – too much work, not enough time or resources to complete it. Day after day passes, the work doesn’t slow down but your timeframes become shorter and shorter furthering the stress of the looming workload.
All companies, start up to conglomerate, experience this same situation. They’ve got work they can’t get to given the circumstances of their business. Usually it’s…
We can all agree we’ve seen this first hand and very well may be living it now within our current companies. The key question then becomes, “How do we address the ‘too much work, not enough [blank]’ commonality we all share?”
First, we need to assess the work in question and is it mandatory to keep close to the chest? Meaning, are we the only ones who can do the work?
If your answer is:
NO – “the work can be done by someone else”; we should begin looking for alternative means for getting the work done via our supply base or strategic partners. First, review your existing base of suppliers and their capabilities to see where work can be sent out. Second, identify firms which provide outsource services. Many times the word ‘outsourcing’ is used as an all encompassing description for service providers that offer project or work package support, often which can be done onsite with the client just as easily as offsite – which would be the traditional method of outsourcing.
YES – “the work can only be done by our organization”; we should review the matrix of resources versus project loads. Undoubtedly there are resources within the organization that aren’t working at full capacity and or are assigned to projects which aren’t immediate. The trick with this approach is it may not satisfy the situation long term, often times when we try to keep things in house all we do is push off the situation to a later date. If that doesn’t work, test your bias on ‘the work can only be done by us’.
If you are in fact going to consider using an outsourcing or consulting firm to support you in your work projects be sure to follow this simple three step process to ensure you’re picking the right partners:
Key Take Away:
Sometimes the best business decision we can make is deciding what work we want to do [internally] to increase our capacity and efficiencies while outsourcing work to suppliers or service providers which specialize in project work. In turn, this means we can focus on the mission critical work, that we enjoy and are great at doing while giving someone else the work and or projects we can’t handle or don’t want to deal with.
Utilize the below decision tree diagram (yes, it’s overly simplified) to help you determine if the work you have in question should stay internally versus would benefit from being handled by an outside source.
Are you looking for an outside services firm to help you with your projects?
If so, our company Square-1 Engineering, would be happy to speak with you about your needs. Check us out and let us know how we can help by clicking HERE.
Solidworks: Enclosure Surfacing
This full length video showcases the importance of using the sweep and loft functions within Solidworks to create complex shapes. After the console and or enclosure is complete, split the model up into multiple parts to aide in proper DFM and ease of assembly.
Learn more about Square-1's CAD Services at by clicking HERE
Solidworks: Sheet Metal Chassis Design
In this full length video we showcase our approach to chassis design using sheet metal and the importance of working smarter, not necessarily harder, by using advanced tools like Hole Wizard.
For more information on our CAD services check out CAD Services
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
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.
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.
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.