Walking Before You Run: You'll Need "Precursor Elements" Before Using an eQMS.

You'll Need "Precursor Elements" Before Using an eQMS.

It's a cool, sunny Tuesday. I've just finished my second cup of morning coffee when I get a call from a medical device startup.

"We just purchased an electronic QMS (Quality Management System) for ISO-13485 compliance," they say, enthusiasm palpable in their voice.?

"Great," I reply, "Do you operate under any QMS currently? Are you selling products yet?"?

They respond, "Well, no QMS as of now, but yes, we're already in the market with some non-monographed products. But, we will need to use FDA-monographed active ingredients soon to acquire more business."

My next step is usually a gap analysis. It's a fancy term for understanding where an organization is versus where they need to be for ISO standard compliance.?

Their response is something I've heard before. "We lack formalities because we are so entrepreneurial and busy. Just tell us what to upload in the eQMS (the "e" stands for electronic), and just so you know, we want to be ISO certified in three months.

You can't purchase an eQMS and expect to go from 'no formalities' to ISO compliance in three months.?You need structure and systems - what I call "precursor elements."

Walking Before Running

At this point, I take a deep breath and get ready to explain the concept of "Precursor Elements." These "elements" are the foundations that need to be in place before introducing a Quality Management System (QMS) or an electronic Quality Management System (eQMS). I'll use both terms interchangeably in this article.?

Just as you must master walking before running, ISO-13485 compliance requires patience, care, and an understanding of the intricacies involved, with an investment into scientific, technical, and business basics before use.?

Commitment to Good Scientific Method

Underpinning ISO-13485 and the development of a compliant QMS is a commitment to the scientific method, arguably the most crucial of all precursor elements. ISO-13485 is not a standard any organization can afford to shortcut or compromise; it's the cornerstone of everything you will do in the medical device field.??

The scientific method demands meticulousness, rigor, and consistency. It underscores the importance of having data-driven, replicable processes that can withstand scrutiny.

Conversely, hurried, poorly planned work is the antithesis of the scientific method. It's a temporary bandage solution that often leads to gaps in logic, incomplete validations, and shaky justifications.?

While this might offer a temporary illusion of progress, it undermines the essence of ISO-13485, which needs to be built on a foundation of robust, repeatable, and scientifically sound procedures.

"...even if you are inspired by the lean startup methodology or other entrepreneurial management techniques, business structure and scientific discipline must always be addressed."

There Are Still More "Foundations"

In addition to a commitment to sound science, there are more foundational systems, such as accounting systems, inventory control, data filing methods, and risk mitigation strategies, which are essential business elements that often exist before a company even contemplates a QMS. Yet, strangely, not every medical device startup understands this in their rush to the next great invention.

Let me illustrate this with a cringe-worthy encounter. I once considered investing in a tiny startup. Along with some other potential investors, we asked to see examples of their ISO-13485 process. I'll never forget the embarrassed owner confessing that they follow the "spirit" of ISO-13485 and use a popular off-the-shelf accounting package as their QMS. Mind you, the software had no provision for the crucial elements of ISO-13485 compliance, so we excused ourselves from the meeting as politely and quickly as possible.

Here's my clarion call to all fledgling medical device businesses: Before you dive headfirst into an eQMS or any QMS, ensure you have established certain 'precursor elements.' These foundational systems underpin your operations, providing a backbone for document control, quality records management, product lifecycle management, training records management, supplier management, risk management, auditing, and CAPA (Corrective Action) management, and more.?

The eQMS Is Only as Good as the Systems It's Controlling.

The objective of this "precursor" approach is that it builds a strong base for your eQMS, or QMS, ensuring that when it's time to implement, you're not making a castle on sand.?

Remember, an eQMS is designed to manage and enhance these existing systems, not create them from scratch.

Try a "Dry Run"

One technique I've found particularly helpful with startups is a "dry run." It's a practice QMS implementation where the team grapples with the realities of required behaviors, discussing appropriate tests, risks, production, and specifications. This process allows the team to gain insights and identify gaps, instilling a quality and continuous improvement culture.

ISO-13485 and a successful QMS implementation are not sprints; they're marathons. They require preparation, practice, and patience.?

Not a Design Charrette

Even if you're inspired by the lean startup methodology or other entrepreneurial management styles, structure and discipline cannot be overlooked in the field of medical devices. While these management styles can bring dynamism and innovation, medical device design and development is not a 'design charrette.' It requires a rigorous, meticulous process that ensures safety and efficacy, balanced with the creative problem-solving spirit of entrepreneurship.?

So, even if you are inspired by the lean startup methodology or other entrepreneurial management techniques, business structure and scientific discipline must always be addressed.

Scaling for Success

ISO-13485 is more than just a professional standard to tick off a checklist. It's a testament to accountability, a badge of assurance that you're ready to deliver high-quality medical devices consistently and safely - even before you sell your first product.?

It's about a shared context, an understanding that everyone is in this together, striving for a quality that transcends the ordinary.

Let's assume an organization wants to comply with the requirements of "Product Realization." Precursor elements include design and development, which require an organization to understand "risk" comprehensively. You need a system for supplier management. You'll need a traceability system, an inventory system, and so much more.

It's tough to think about everything if you schedule a one-hour meeting to try to input something into your brand-new eQMS. There are better ways to make progress than that.

It's Up to the Organization to Understand the True 'Deliverables'

Understandably, there's a desire to see tangible results in your eQMS, assuring stakeholders that their investment is worthwhile. However, working on essential precursor elements outside your eQMS also constitutes substantial progress.

Leadership and stakeholders, don't misinterpret 'deliverables' as merely inputting data into the eQMS. Constructing robust systems and processes that underpin eventual ISO-13485 compliance is critical and paves the way for successful eQMS utilization.

Creating a Quality Culture

ISO-13485 is more than a compliance requirement; it's a mindset, a commitment to quality, and a testament to your unwavering dedication to providing safe, effective medical devices to those who need them. So, take the plunge, and lay down those precursor elements!

Your Business Accelerator

At Adhesive Tape Label LLC, with the majority of our work now occupying the medical device R&D and Operations areas, we meet you on the ground zero of your business, where the hustle is real, and the dreams are big.

We understand your vision but also know what you need to do.?

Our hands-on approach marries your aspirations with our expertise, turning compliance requirements into a business accelerator.?

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Thanks for reading! Similar experiences? Thoughts?