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​Are you ready to electrify your QMS system?
 
If you’re at a point where you’re finally ready to consider bringing in an electronic Quality Management System (eQMS) tool, or perhaps you’re looking to re-evaluate better options on the market, there’s naturally a litany of things to do and consider BEFORE you decide which tool to move forward with.
 
This article covers most of the steps and considerations you’ll need to think through as you evaluate different electronic Quality Management System (eQMS) for your medical device company.  I’ve had the good fortune to help dozens of clients select eQMS tools and scale them to operational status.  Here’s what I’ve seen from a decision-making perspective, and of course some learned lessons along the way.
 
WHAT IS AN EQMS:
The folks at Praxie did a superb job defining what an eQMS is, so we’ll borrow their definition: “An eQMS is a technology-driven solution designed to manage and monitor quality standards across an organization’s manufacturing processes. It replaces traditional paper-based systems, offering a centralized platform where all quality-related data and processes are stored and managed digitally. The primary role of an EQMS is to ensure consistent quality by automating and standardizing processes such as document control, audit management, and training management.
 
KNOW YOUR WHY:
As you look to bring in a QMS, including eQMS, one of the biggest considerations is to know your why – what’s driving the need.  What’s the reason you’re thinking of bringing in a tool in the first place?  Do you really need the tool or is it nice to have? 
 
PRO-TIP – if you’re a pre-clinical startup there’s a good chance you might not need an eQMS just yet.  The old-fashioned traditional paper-based approach, while simple and cost effective, can be a realistic option.  That said, the manual paper-based QMS isn’t a long-term solution as it can bring about complications with time-consuming processes, human error and traceability.    
 
Most startups typically think about bringing in a QMS once they reach the design phase of the product development lifecycle as at that point implementing design controls becomes critical. (image credit: Medical Device Quality Management System (QMS) - SimplerQMS)

From there, the next thing your WHY will help you understand is how robust a system you need.  Read section ‘System Functionalities’ for further insights.
 
REGULATORY REQUIREMENTS:
A good QMS ensures compliance with standards such as ISO 13485, FDA 21 CFR Part 820, and EU MDR, and helps maintain product quality and safety.  Is your company seeking to go outside the US (OUS) or remain domestic?  While you can certainly pick a QMS without knowing 100% what your regulatory strategy will be, it’s advisable to know that ahead of time as different tools offer different modules and layouts which may work more efficiently with a domestic strategy vs an OUS one.  The reality is you must still be compliant to FDA regulations if operating in the US due to site registration requirements.
 
Secondarily, I’m of the opinion if I’m looking for a tool to support medical device QMS related needs I’m only going to look for tools which are largely, if not exclusively, designed for this purpose.  Trying to appropriate a tool which was initially designed for another industry, even pharma, into your medtech space is more of a band aide than a real solution.  Buy the right tool for the right purpose.
 
ORGANIZATIONAL NEEDS:
Inevitably we may be splitting hairs here as some of this information will be similar in thought and approach to ‘Know Your Why’.  Picking the best QMS tool relies on you also knowing what you need out of it.  Things to consider are your company size (# employees and product lines), growth plans (scaling strategy and how a tool would need to grow in parallel with you), budget (what can you afford now, while taking into account setup costs, maintenance fees, licensing fees, etc.).  You’ll also want to think through the complexity of your technology as the more complex a product is the more advanced your QMS functionality needs to be in order to appropriately address areas like risk management and product/ process traceability.
 
SYSTEM FUNCTIONALITIES:
QMS tools, like any other software tool, offer a variety of different features and user experiences.  No two tools are the same, or so they say.  When we’re considering a software tools functionality, we first need to be able to answer our WHY (why we need the tool) and what we’re hoping to do with it.  This will then help you determine if the functionality of a tool you are evaluating is appropriate.  For example, a popular QMS tool in the medical device industry is Greenlight Guru.  It does it all, and has a modern user interface experience, but it isn’t cheap and could be overkill for a pre-clinical startup.  Think about it like this – if you’re buying a car just to get you to the office 15 miles away, strictly for commuting, do you really need a car that has every bell and whistle on it?  Think about QMS tools this same way.  If you only need the basics you might want to stay away from the flash and glitz that comes with the bigger tools.  To further complicate things, and to play both side of the fence, robust tools like Greenlight Guru offer starter packages that allow you to add on modules as your company scales.  Is a starter package the right route?  You’ll need to read on to decide.
 
Core functionalities to look for may include:

• Document Control: Automated version control, electronic signatures, and easy document retrieval.
• CAPA (Corrective and Preventive Action) Management: A robust CAPA system to identify, investigate, and prevent quality issues.
• Risk Management: Integration with ISO 14971 (Risk Management for Medical Devices) for proactive risk identification and mitigation.
• Audit Management: Tools to schedule, track, and document internal and external audits.
• Training Management: Managing and tracking employee training, which is crucial for regulatory compliance.
• Supplier Management: Evaluate supplier performance and ensure the quality of supplied components.
• Complaint Management: Streamlined processes to track, evaluate, and resolve customer complaints.
• Change Control: A well-structured process for managing changes to products, processes, or documents.
• Validation Capabilities: Ensure the QMS software itself is compliant and validated for FDA or ISO regulations.

 
Tool Ownership/ Storage:
Many, if not most, QMS software tools today are offered as an online cloud-based tool.  For smaller companies this may be advantageous as the tool supplier owns, manages and maintains the tool on your behalf.  This of course comes with a cost, but it’s minimal in comparison especially when considering the cost of buy, install and maintain a data center of any size.
 
If cloud storage and access isn’t right for your business most of the prominent tools offer an on-premise option which can offer more control over data. OEMs typically choose this option if data security is a high priority, and the company prefers to keep control in-house.
 
UX AND SUPPORT / TRAINING:
While not everyone is going to care about the user experience (UX) of the tool, I’ll candidly admit I fall in the camp of ‘caring’, and consider this to be a big deal for me.  I was recently evaluating several business operations tools, like an ERP, and outright declined one of the options that had all the functionality we needed, at a price that was good, yet the actual experience using it was stale and 20 years old. If I’m going to pay a healthy subscription fee for a tool, like a QMS, I want it to be modern and easy to use, intuitive, as if it was built by people in the industry.
 
When considering support and training for the tool, this may not be an issue with the larger tools like MasterControl or Arena, it may however be an issue with some of the smaller tools like QCBD. (right, you’ve probably never even heard of that one).  My comment here in reality has nothing to do with QCBD as its quite a good tool, however you need to consider the size of the company who makes the tool and how easy or difficult it will be to get support when you need it, not when they can get to you.
 
Take the added step to do some preliminary research on the tools you’re evaluating to see what user forums are saying, how are the tool developers rated, etc.  You can learn volumes of information in short order by doing this.
 
INTEGRATION:
Even if you don’t need it now, it’s advisable to pick a tool that can eventually integrate with other tools your company already has in use this way when the time comes you can increase efficiencies with your operation.  Ideally, your QMS should integrate seamlessly with your existing systems such as ERP (Enterprise Resource Planning), PLM (Product Lifecycle Management), CRM (Customer Relationship Management), and MES (Manufacturing Execution Systems).
 
According to Allan Murphy Bruun with Simpler QMS, “It typically takes 3 to 9 months to fully establish a medical device QMS. Still, medical device consultants suggest starting preparations at least 18-24 months before commercialization.”
 
CUSTOMIZATION:
This may fall into the same camp as the UX comments above, however I would caution you against selecting a tool that has little to no customization ability.  Every medical device company is different as their technology, people and processes all have their own flavor to contend with. Choosing a QMS tool that allows customization based on your company's specific workflows is key. The more adaptable the tool, the better it can cater to your unique processes without requiring excessive manual work. 

​PRO-TIP – while a tool may offer customization many times it can come with at a price.  Ask about this during the evaluation phase so you can manage your own expectations accordingly on the backend as the tool is being integrated into your operations.
 
Regulatory and Quality (RAQA) expert Robert Lahaderne further shares, “Being able to customize your eQMS is a big deal since your QMS must be aligned with the tools and therefore becomes your QMS.  Not being able to adjust things like titles or work flows leads back to the UX considerations within this article.”
 
TOOL DEMO:
Never, ever buy a software tool without first going through an in depth demonstration, to do so otherwise if foolhardy. Request a demo and ask for a pilot test period to evaluate the tool in your actual working environment. During this time, test the core functionalities that align with your company’s key regulatory and operational needs.
 
COST & ONGOING FEES:
A large portion of software tools, including medical device QMS tools, operate on the subscription model from a pricing standpoint.  Like it or love it, this pricing model will probably be around for a while.  When looking at the cost associated with a software tool purchase make sure you get the following information upfront of your decision:

• Upfront Cost: Licensing fees and implementation costs. (can licenses be shared?)
• Maintenance Fees: Ongoing costs related to support, upgrades, or additional features.
• Hidden Costs: Consider training, downtime during implementation, and future scalability costs. If you already have a QMS tool and you’re looking to replace it with a new one just know that you may have to run both tools, the new and the old, for several months in parallel while the new tool gets fully integrated and tested.  Running two tools simultaneously naturally adds cost into the grand scheme of things.

 
COMPLIANCE AND VALIATION
In the medical device industry one can’t just buy or use any tool without risks on to your operation on the backend.  If you’re going to consider a formal QMS tool, you’ll want to take it a step further and ensure the tool is compliant with electronic records and signatures requirements. (ie 21 CFR Part 11 Compliance)
 
When selecting a tool, you’ll also want to choose a QMS tool which can be easily validated and offers validation templates or support.  This way if you’re using a simplified tool you can get it up and running and do so with limited additional costs.
 
SECURITY
Since medical device companies deal with sensitive information, the QMS should include data encryption, access control, audit trails, and secure backups.  While not all devices and tools require it, you’ll want to talk with your prospective tool developer, and regulatory folks, about the potential need for Secure Product Development Framework (SPDF) and Quality System Regulations (QSR) as outlined by the Federal Drug Administration (FDA).  It’s always better to be in the know, then have to plead ignorance down the road should regulatory action come about.
 
WHICH TOOL SHOULD YOU PICK:
By now you’ve probably concluded there is a lot to keep in mind when bringing in a QMS tool to your operation.  There is a good chance many different tools can solve your problems while also meeting your business needs.  Below is a quick rundown of QMS tools we often come across in our clients’ operations (note – we are not advocating for one tool vs the other, please make sure you do your own research before you make the commitment):
 
Larger Company Tools:

• MasterControl
• Greenlight Guru
• Arena QMS
• ETQ Reliance
• Qualio

 
Small Company Tools:

• Quality Collaboration by Design (QCBD)
• Veeva Vault QMS
• Intellectt QMS
• QT9 QMS
• QAD eQMS

 
PAST LESSONS LEARNED
If you’ve been in business for any length of time you’ve inevitably made some mistakes along the way, hopefully you learned from them and got better as a result.  When it comes to eQMS, we’ve seen many mistakes made which have translated into lessons learned for future projects and advisory needs.  RAQA expert Robert Lahaderne further shares his PRO-TIPS and lessons learned when evaluating and integrating eQMS:

• Be prepared that success will be tied to resources that are dedicated to the project. Consider what experience the current/future team members have with these tools,
• Don’t be afraid to adopt different facets of the QMS into an eQMS system instead of doing it all at once,
• An eQMS does not eliminate paper from your company, it changes, but an eQMS is the first step in reducing papers,
• It is a big decision; it is hard to change after you have started down one path. As you grow, plan on assessing whether the eQMS can grow with you.

 
 
IN THE END
When selecting an eQMS tool for your medical device company, it is my opinion one must prioritize regulatory compliance, ease of use, scalability, integration capabilities, and robust vendor support as the primary decision factors when evaluating an eQMS.  Opt for a solution that can grow with your company while ensuring compliance with critical medical device regulations.  Remember, no tool is perfect, so if you get most of what you need at a price you can live with then the next step is making sure the tool is used as intended and maintained after implementation.  That’s another article and another read for next time.

​GET PROJECT HELP TODAY!
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 Manufacturing Engineering.  Learn more about how we can solve your work and project problems today to get you back on track!

Would you willingly spend $3,000.00 for a 10% chance your ‘investment’ would produce a good return?
​
While many of you reading this instinctively thought “absolutely not”, there inevitably was a select few who thought to themselves, “depends on what the return is”.  A 10% chance your initial investment produces a positive upside is not a favorable proposition to say the least yet businesses do this all the time, in fact multiple times, if not dozens of times, a year.  I welcome you to the flunky world of ‘corporate training’.

Skillademia, an online training and stats organization, indicates US companies spend upwards of $200 billion a year on training and said training carries about a 10% effectiveness outcome.  The average company spends $3,000 per employee on annual training with dismal results to show for it.

Why is it then companies consistently spend so much money on training for such a poor return.  Answer – companies are missing the connection between information retention and positive reinforcement.

In today’s fast-paced and ever-evolving business landscape, employee training is vital, yet just as important is the methodology and mindset of those involved (trainers, company management and the participants.  This article seeks to shed some light on why training fails more than it helps, and how you can ensure the next time you invest in training you’re getting more of a return on your investment.
 
THE FAILURE OF CORPORATE TRAINING
There seems to be a never-ending list which offers insights into the reasons corporate training fails to meet the mark, therefore improving employee performance. 

The #1 reason corporate training fails is due to a lack of reinforcement:  Hermann Ebbinghaus, a 19th Century German Psychologist, was a pioneer in the experimental study of memory and discovered ‘The Forgetting Curve’ which correlates a learners ability to retain information over a given time span.  Ebbinghaus suggests people forget a large portion of what they learn if there is no reinforcement, as follows:

• Immediate Retention: right after a training session, individuals might retain around 50-60% of the information
• After One Day: without reinforcement, retention can drop to around 30-40%
• After One Week: retention might further decrease to approximately 20-25%
• After One Month: retention rates can fall to about 10-20% if no efforts are made to reinforce the learning

Other reasons training programs fail, include:

• Lack of Clear Objectives:

If the training goals are not clearly defined, participants may not understand what they are supposed to achieve, leading to disengagement and ineffective learning

• Irrelevant Content:

Training that does not address the specific needs and challenges of the employees or the organization can lead to disinterest and low retention

• Poor Delivery Methods:

Using inappropriate or ineffective training methods, such as monotonous lectures or poorly designed online modules, can result in disengagement and low participation.

• Inadequate Trainer Skills:

Trainers who lack the necessary skills, experience, or engagement techniques can fail to effectively communicate the material and motivate participants.

• Insufficient Practice and Application:

Without opportunities to practice and apply new skills in real-world scenarios, employees are less likely to retain and use what they've learned.

• Lack of Management Support:

If leadership does not actively support and participate in the training process, employees may not see the value in it and be less motivated to engage.

• No Follow-Up or Reinforcement:

Training is not a one-time event. Without follow-up sessions, reinforcement activities, or continuous learning opportunities, the initial training can quickly become irrelevant.

• Resistance to Change:

Employees who are resistant to change may not fully engage with the training or implement new skills and knowledge.
 
WHAT HAPPENS IF WE DON’T TRAIN
After reading the above it could be easy for someone to say “why even make the investment in the first place” as it relates to corporate and employee training.  While on face value that may make sense, the reality of the situation is far worse than most of us may realize.  Electing to bypass training for your employees can have disastrous results for the company, its ability to operate successfully and its employees. 

​Below are the common pitfalls, and associated consequences of not training employees:

• Decreased Productivity and Efficiency

Employees who lack proper training may struggle to perform their tasks efficiently and effectively. This can lead to mistakes, wasted time, and a general decrease in productivity. When employees do not have the skills or knowledge to complete their work proficiently, the overall output of the organization suffers.

• Higher Turnover Rates

Lack of training can result in job dissatisfaction and disengagement. Employees who feel unsupported and unprepared are more likely to seek opportunities elsewhere. High turnover rates not only disrupt operations but also incur significant costs related to recruiting, hiring, and onboarding new employees.

• Increased Errors and Quality Issues

Untrained employees are more likely to make errors that can compromise the quality of products or services. These mistakes can damage the company’s reputation, lead to customer dissatisfaction, and result in costly rework or refunds. Consistent quality issues can erode customer trust and loyalty.

• Reduced Innovation and Adaptability

Training fosters creativity and innovation by encouraging employees to think critically and embrace new ideas. Without training, employees may become stagnant and resistant to change. This lack of innovation can prevent the company from staying competitive in a rapidly evolving market.

• Compliance and Legal Risks

Many industries have stringent regulatory requirements that employees must adhere to. Without regular training, employees may not be aware of these requirements, leading to non-compliance and potential legal issues. Non-compliance can result in hefty fines, legal battles, and damage to the company’s reputation.

• Lower Employee Morale and Engagement

Employees who do not receive adequate training may feel undervalued and unsupported. This can lead to low morale and disengagement, negatively impacting team dynamics and overall workplace culture. Disengaged employees are less likely to go above and beyond in their roles, which can stifle growth and innovation.

• Inability to Meet Customer Expectations

Customer expectations are continually evolving, and businesses must adapt to meet these demands. Without training, employees may lack the skills to provide high-quality customer service or adapt to new customer preferences. This can lead to customer dissatisfaction and loss of business to competitors who are better equipped to meet these expectations.

• Increased Operational Costs

Inefficiencies, errors, and high turnover rates caused by lack of training can lead to increased operational costs. The costs associated with correcting mistakes, handling customer complaints, and replacing employees can add up quickly. Investing in training can mitigate these costs by enhancing employee performance and retention.

IMPROVE YOUR CHANCES OF CORPORATE TRAINING SUCCESS
So what you’re saying is “I’m damned if I do, and damned if I don’t”.  While it may seem that way on first blush, there is a silver lining that is well within our reach.  The bottom line is, if you aren’t training your employees you simply aren’t a competitive employer.  So rather than avoid training all together, the better approach is to be smart about how you engage in the practice of corporate employee training.

Below is a quick rundown of the three most important factors to implement to ensure your training dollars are well spent and well received:

1. Build into your company culture a consistent process for information reinforcement.  While Ebbinghaus’  ‘The Forgetting Curve’ identifies the rates at which people lose their ability to retain information without reinforcement, Ebbinghaus also smartly identified how to turn that around in our favor.  It’s all about repetition (the employee going through training) and consistent reinforcement (positive reinforcement by company management).  The graph below, compliments of www.howdoi.com, takes Hermann Ebbinghaus’ theory and puts it into practice showcasing the value of repetition.  After a period of four (4) weeks, with consistent repetition, the learner is able to increase their retention of the newly learned knowledge close to 75%.  That’s huge, considering without repetition and reinforcement, the average person will only retain 10-20% of the learning.

1. Once you’ve incorporated repetition and reinforcement, the next two things we need to do to ensure our training investment and aftermath is successful is to focus on setting clear objectives for training and what relevant content will be discussed.
   1. Setting clear objectives is more than just telling your employees they need to learn and explaining the WHY behind it.  Setting clear objectives needs to happen across the entire organization, top down.  Management must be involved every step of the way, working with the training organization while eliciting feedback from the employees before training actually occurs.  With solid information in hand a steering committee can be better positioned to make good, informed decisions which are based in fact and substance.  These training objectives must tie into the company’s large mission and vision and have a clear statement outlining the expectation for everyone involved, including what will come of the training experience for employees and managers alike.
   2. Once clear objectives for training are established, we need to ensure the trainers, regardless if they are internal or external, are utilizing real world and timely information and examples to amend the training course and its content to the learner audience.  The more your training programs are curtailed to the audience bringing in actual examples of the work they perform the more involved the learners will be and the better their ability to apply said learning after the fact will be.  If your company is in the healthcare industry developing medical products, your training should be focused to that particular technology, regulations and processes/ procedures.  Using case studies and examples from the automotive or consumer products industry is both irrelevant and misguided.  Spend the time dialing in your training content up front so its customized to the learners daily job experiences – you won’t regret it.

 
TRAINING DONE WELL HAS A HUGE UPSIDE
The verdict is in – most of us know training is a good idea, it’s our delivery that needs help.  In fact, about 85% of companies with more than 50 employees provide formal training to their employees, and around 95.8% report offering some form of informal training.  (InDemand Designer)​

If you follow the steps above in IMPROVE YOUR CHANCES OF CORPORATE TRAINING SUCCESS, many companies will find training, when done well, has a big upside, including:

• Boosting Employee Morale and Job Satisfaction

Training programs demonstrate a company’s commitment to its employees’ professional growth. When employees feel valued and see that their employer is investing in their future, their morale and job satisfaction increase. This, in turn, leads to higher retention rates, as employees are less likely to leave an organization that supports their personal and professional development.

• Enhancing Skill Sets and Knowledge

Continuous training ensures that employees stay up-to-date with the latest industry trends, technologies, and methodologies. This is particularly crucial in industries that are constantly evolving, such as technology, healthcare, and finance. By providing regular training, companies can ensure that their employees have the necessary skills and knowledge to perform their jobs effectively and efficiently.

• Improving Performance and Productivity

Well-trained employees are more competent and confident in their roles. Training equips them with the tools and techniques they need to perform their tasks more efficiently, leading to improved performance and productivity. This directly impacts the company’s bottom line, as higher productivity often translates to increased profitability.

• Fostering Innovation and Adaptability

Training encourages employees to think creatively and approach problems from different angles. It fosters a culture of continuous improvement and innovation, where employees are not afraid to suggest new ideas or improvements. Additionally, in today’s rapidly changing business environment, training helps employees adapt to new challenges and technologies more quickly, ensuring the organization remains competitive.

• Ensuring Compliance and Reducing Risks

Many industries are subject to strict regulations and compliance requirements. Regular training ensures that employees are aware of the latest laws, regulations, and best practices, reducing the risk of non-compliance and the potential for costly legal issues. This is particularly important in sectors such as healthcare, finance, and manufacturing, where compliance is critical.

• Promoting a Positive Company Culture

Training can be used to reinforce the company’s values, mission, and culture. It provides an opportunity to align employees with the organization’s goals and objectives, fostering a sense of unity and purpose. A strong company culture not only enhances employee engagement but also attracts top talent, as potential employees are often drawn to organizations with a positive and supportive work environment.
 
Investing in employee training is not just a strategic move, it is a necessity for any organization which aims to thrive in today’s competitive environment. By enhancing skills, boosting morale, improving productivity, fostering innovation, ensuring compliance, promoting a positive culture, and preparing for the future, training provides a myriad of benefits that contribute to the long-term success and sustainability of the organization. Companies that prioritize and continually invest in training will undoubtedly reap the rewards of a skilled, motivated, and forward-thinking workforce.
 

NEED TRAINING SUPPORT?
Square-1 Engineering’s medical device compliance & business operations training courses primary focus is to support the longevity of your operations through knowledge advancement.  Hope, is not a strategy for addressing business challenges like poor team performance and product & system nonconformance.  Learn how Square-1’s training courses in Solidworks, Design Controls, Risk Management and Root Cause Analysis can propel your teams performance to the next level.  Visit us at https://www.sqr1services.com/training.html. ​

​FOR IMMEDIATE RELEASE
 
Square-1 Engineering, Inc. Expands Service via New Office in Twin Cities, Minnesota
 
Saint Paul, MN – 05.21.2024 – Square-1 Engineering, Inc. (Square-1), a leading medical device consulting firm, is excited to announce the opening of its newest office location in the Saint Paul, Minnesota area. This expansion marks a significant milestone for Square-1 as it continues to grow its presence in key markets across the United States, in particular the Twin Cities comprised of greater Minneapolis and Saint Paul (MSP).
 
The decision to establish a presence in MSP comes as a strategic move to better serve clients in the region and meet the growing demand for medical device engineering and compliance work. With its vibrant economy, thriving business community, and talented pool of professionals, the Minneapolis Saint Paul marketplace presents a wealth of opportunity for Square-1 to connect with new clients and partners.
 
"We are thrilled to be opening our new office in Saint Paul to support the MSP marketplace," said Travis Smith, Founder and Managing Director at Square-1. "This expansion underscores our commitment to providing exceptional engineering and compliance consulting services to medtech clients in this dynamic market. We are eager to collaborate with local companies, leveraging our Class II and III medical device expertise to drive success and growth in the areas of new product development, regulatory and compliance and manufacturing engineering."
 
Square-1’s new office will be located in White Bear Lake, Minnesota, situated east just outside the heart of Saint Paul’s downtown business district.  The MSP area, in combination with greater Minnesota, represent a rapidly growing market for medical devices as evidenced in the 2023 designation of the ‘Minnesota MedTech Hub 3.0’ (MMT3.0), one of several dozen tech hubs recognized federally across the country which show potential for significant technology growth.  According to Minneapolis Saint Paul Regional Economic Development Partnership, “Minnesota is home to 15,000 healthcare organizations which employ more than 469,740 Minnesotans, including the presence of the top 15 medical device companies in the world.”  The largest concentration of MMT3.0 can be found within the Twin Cities or Minneapolis Saint Paul (MSP) area.
 
In addition to enhancing client relationships, the Saint Paul office will serve as a regional hub for the Square-1’s project management office, which helped to build the company’s sterling reputation at its headquarters in Southern California.
 
For more information on Square-1 Engineering, Inc and its medical device consulting services and expertise, visit www.square1engineering.com.
 
About Square-1 Engineering:
Square-1 Engineering, Inc. a medical device consulting firm, provides end to end technical project services to medical device OEMs and their supply chain partners.  Square-1’s services cover projects of all sizes in Product Engineering, Regulatory and Compliance (RAQA) and Manufacturing Engineering.
 
Contact:
Square-1 Engineering – The Medtech Problem Solvers
Corporate Headquarters
6 Morgan, suite 125
Irvine, CA 92618
www.square1engineering.com
[email protected]
844-300-7771

When you need help in your device business how do you figure out where to go to find it?  Just as important, how do you make sure the partner (supplier) you select is the right one for the job?
 
Establishing a medical device supplier selection process (part of your Supplier Management system) is an important and vital process for any size company.  Even though supplier management is mandated by quality management systems globally, its eye opening how many device companies don't have a formal process for identifying and selecting their supply chain partners. Making the wrong decision can lead to countless hours of wasted time and of course money down the drain.  If the situation is grave enough, it could also cost someone their job.

To find the right supplier, a ‘supplier selection' process is key to develop ahead of time.

When considering implementing a formal supplier selection process for a medical device OEM some important steps to consider includes:

1. Consider the Regulations/ Standards:  before you begin building out a supplier selection system make sure you get acquainted, or re-acquainted, with the quality requirements for your given global region. (USA & EU - ISO 13485:2016, section 7.4)  While perhaps not the leading indicator as of 2024, additional insights can be gained by reviewing CFR 21 Part 820.50, subpart E. (purchasing controls)  Chapter 7 of MDSAP can also provide insights in the event your company follows this regulation.

2. Simple Systems: if the idea is to systematize the process of selecting suppliers across a company, regardless of size, it's best to create a simple to follow procedure set as this will encourage adoption.

3. Internal Procedures: start by creating purchasing procedures which align appropriate decisions with justifiable needs.  This is especially important if the supplier in question lands on the 'critical supplier' list.  Outlining who internally can perform supplier qualifications, as well as who can approve suppliers.

4. Formulate Supplier Criteria:   It’s important to know what you want, or most of what you want, before you begin looking for it.  Utilizing a pre-established set of standardized criteria will help you ask the right questions, obtain the right information and compare capabilities across a multitude of supplier options.  This also helps to remove information bias where we tend to make decisions based on emotional characteristics, rather than on sound science or facts. Depending on the supplier you’re looking for a Supplier Questionnaire can be useful in obtain this information, and or utilizing a Request for Proposal (RFP) process.  Typical data you’ll want to obtain may include:

• Product specifications or service offering
• Supportive documentation on the product, service and or the suppliers internal processes (QMS, etc)
• How they manage their own supply chain partners
• Certifications
• The suppliers key capabilities and areas which may be verging in the gray

5. Experience and Expertise: Look for a partner(s) with experience in the area you need help with.  The last thing you want is a company that will ‘figure it out’ or give it the old ‘college try’ while simultaneously billing you the for experience. Referrals and references are key here, especially if the supplier you’re considering falls in that elusive ‘critical few’ supply chain partner list.

The best approach to finding the right supplier is by reaching out to others in your industry, or local industry associations, to learn who they use, and just as important who they don’t use.  Take the time to read reviews, gather intel from people you trust before you start calling potential suppliers. While sites like Thomas.net and Google can provide this information it is likely you will quickly find yourself overwhelmed with information.  In the end the most useful data is those that are unbiased or comes from experience which is best collected from trusted resources.

6. Proactively Learn About Your Suppliers Behaviors
When speaking with a potential new supplier try connecting with the people you will be working with, not just the company’s salesperson.  This is important because once the relationship is established most of your time won’t typically be spent with their salespeople rather those delivering the service or product.  When courting a supplier pay attention to things like:

• What is their communication like? 
• Do they respond quickly?
• How do they handle mistakes they’ve made?
• What is their customer retention rate? (if they don’t keep customers long that should be a big red flag)
• Find out how long their employees have been with the company too.  If the company suffers from consistent turnover that should be a red flag as you will likely have to be much more involved with this supplier helping coach and direct new employees to ensure the work is done properly.  You don't want to be in a situation where you're training your suppliers new employees just so they can turn around and bill you for it. 
• Where are you in the pecking order of the level of importance to the supplier?  Don’t be fooled, not all clients are treated equal, even if they tell you otherwise. 
• Do they have consistent business processes in place or are they like a 5-year-old all over the place while simultaneously trashing the house they live in.  Stay away from companies that seem disorganized or get frazzled easily.

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If they are a critical supplier it’s vital you learn about their business continuity plan.  What if their manufacturing facility caught on fire?  Shipping is seriously delayed.  Or a key person leaves the company?  Do they have plans in place in order to deal with serious situations which could impact their business, and yours?
 
7. Determine Risk: Every supplier you interact with must have a risk score associated to their involvement with your product and end user.  Categorizing risk usually falls into two buckets: non-critical and critical.  Greenlight Guru does a wonderful job articulating these categories and risk tiers in its article ‘Ultimate Guide to Supplier Management for Medical Device Companies’, as follows:

8. Perform Audits: while not every supplier needs to be formally audited, especially if you’re looking at a non-critical tier 3 supplier, in particular who is a service provider.  That said, it can be a good rule of thumb to audit all suppliers to keep yourself, procedures and systems honest and consistent.  It is recommended to audit any supplier which provides components, parts or raw materials, regardless of their risk level to ensure you are in compliance with standards such as ISO 13485.  Audits can be done both onsite or offsite; critical suppliers require a much deeper dive into their capabilities and processes to ensure compliance and risk mitigation.  Once an audit is performed its vital to finalize the process showing a clear determination of said supplier, including acceptance or rejection and the justification for the decision.
 
9. Selecting A Supplier: Before you make a final decision which supplier to go with take a step back and think big picture.  Is there an opportunity now, or shortly down the road to be looking at economies of scale?  Meaning – can one of your suppliers in question do more than just one thing?  If so, selecting a supplier who can offer a multitude of capabilities may be the better partner – less points of contacts and companies in your supplier database, opportunity for better pricing if you’re giving them more of your business, increase efficiencies. 

There is a draw back to this idea which is important to be aware of which is it is wise not to have any one supplier dominating a particular part of your business as this gives them leverage.  While single source suppliers aren’t uncommon, it’s advisable to slow the process down and really think through what you need today as well as in the next couple years to determine appropriateness of these kinds of relationships.
 
10. Agreements and Onboarding: There should never be a time where you go into business with a supplier and not sign a contract.  Period.  While there are a lot of things which are covered in a contract some of the key considerations may be product or service guarantees, indemnification, no-change clauses, audit openness, pricing and of course intellectual property agreements.
 
Once contracts are signed its important to onboard the new supplier in a methodical and open arms approach.  You have decided to go into business with this new supplier, treat them like gold.  It may save you down the road.  Schedule a formal meeting and invite all key stakeholders from both companies to the meeting.  Key discussions for the onboard meeting should cover how the two companies will successfully work together, areas of opportunity in the next 6-12 months, points of contact, expectations on both sides, etc.  While this step may seem a bit overkill, it’s important to you look a supplier relationship like they’re now part of the family.  The way you treat them and the experience is inevitably what you’ll get as an outcome.
 
11. Requalifying Suppliers: When creating your supplier selection process it’s considered good measure to include a ‘requalifying process’ to ensure your company is managing its suppliers consistently and diligently.  Using a standardized scorecard to capture performance data will make this process easier to manage and act on.
 
A Closing Note on Cost
 
Most supplier selection programs or processes don’t have a specified approach when dealing with the evaluation and costing of products, materials or services. That said, the bigger the company the more robust their approach and or data will be to work with specific to cost.  Either way, reality often shows us it doesn’t matter how affordable or cost effective a supplier is, or how nice they are as people.  If they can’t perform, and do so consistently, the other two ultimately don’t matter.  In many situations I’ve found paying a bit more for the right product/ service and relationship often is worth the investment in the long run despite the extra cost up front. 

While cost is important, it’s usually not the driving factor when picking suppliers.  For most supplier relationships it comes down to:

• Performance
• Relationship
• Price

As Benjamin Franklin is quote as saying, “The bitterness of poor quality remains long after the sweetness of low price is forgotten.”

Medtech Snapshot presents Rodney Brenneman, medtech start-up exec, who shares his winning strategy on what is needed from a leadership perspective in order to propel a pre-clinical company forward.

Hear how emotional intelligence, adaptability and long-term strategies make the difference!

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