EU MDR/ IVDR PROPOSED PUSH
DID YOU KNOW
On January 6, 2023 the European Commission, a political and regulatory steering committee consisting of a group of 27 Commissioners, known as 'the College', adopted a proposal to give more time to device OEMs to certify medical devices under EU MDR to mitigate the risk of shortages. The proposal, which now needs to be adopted by the European Parliament, could push out MDR requirements several years. Higher risk devices such as pacemakers and joint implants would have a shorter transition period till December 2027, whereas lower risk devices, such as syringes or reusable surgical instruments wouldn't be until December 2028.
WHAT DOES THIS MEAN FOR YOU?
Regardless of EU Parliament's decision to potentially extend MDR, device OEMs should consider the following as we hedge through 2023:
1. Strategies for US product approval and or commercialization will continue to increase as OEMs seek alternative pathways to potentially avoid EU MDR compliance.
2. As a result of #1, support to aide OEMs in their go-to-market strategy will intensify causing a shortage for resources, while potentially lengthening the process to get to approvals (supply & demand constraints - notified bodies and consulting firms experience increases in demand causing support shortages). This will be especially true with remediation work.
3. The idea of putting off or slowing MDR related efforts in the interim to re-focus on other activities may provide momentary relief, however it also creates a long-term liability in the business. This liability comes with a variety of future unknowns: regulatory landscape, inflation, cost of resources, CRO and notified body constraints, etc. If you must achieve MDR compliance our recommendation is to get it done and over with in the present.
4. Work associated with achieving MDR compliance can be easily underestimated, especially if you have legacy product where your CE mark was granted pre mid 2000s. The burden to meet MDR requirements may be steep, which is all the more reason to avoid procrastinating said efforts as outlined in #4.
SOLVING THE PROBLEM
The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast! The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance (and yes - remediation) and Manufacturing Engineering. Learn more about how we can solve your compliance problems while besting your EU MDR beast!
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
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.
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.