How can I justify the costs of implementing medical device specific quality management software at my medical device company? What potential revenue can be lost or gained? How much time can be wasted or saved? Learn how to build an effective business case for quality with easy to follow use cases.

How to Implement a World-class Medical Device QMS using the 5 Phase S.M.A.R.T Methodology

In this playlist you'll learn how to establish a world-class medical device QMS using our proven 5 phase S.M.A.R.T methodology designed to help you through each stage of your product life cycle. This is the final episode of this playlist brought to you by The Greenlight Guru YouTube Channel with Jon Speer.

 

Episode 7 Transcription:

Hi everyone, welcome to the seventh and final episode of our playlist on how to implement and maintain a world-class QMS at your medical device company using the S.M.A.R.T Methodology. 

I’m Jon Speer, founder and VP of QA/RA at Greenlight Guru and we’ve discussed a lot in the previous episodes, so here’s a brief recap:

Our S.M.A.R.T methodology is fueled by three main components: people, processes and technology. We’ve discussed how to leverage these three core tenants during each of the 5 phases of our methodology: 1) Scope, 2) Make, 3) Approve, 4) Release, and 5) Track. And the final result is your world-class medical device quality management system. 

We also discussed how the importance of using your QMS to initiate processes early on, establish plans for initial production and regulation strategies, and prepare your product for market.

This episode will conclude this playlist, but we’ll be bringing you many more valuable videos to help you in all areas of your medical device. So make sure you’re subscribed to our channel to be the first to know about new videos we publish.

In today’s episode, I’ll teach you how to Build the Business Case for Quality. You’ll learn why it’s so important to have a world-class medical device QMS, namely for your bottom line, time to market, and company culture. I’ll even share some real use cases about how Greenlight Guru’s world-class medical device QMS software solution has helped companies around the world improve all three of those things. 

Many companies still use a paper-based system as their QMS. Although you can get away with using this type of system for a period of time, there are a number of reasons why you shouldn’t. It dampens teamwork and collaboration, as well as the fact it does not scale.

The medical device industry certainly has some catching up to do in terms of embracing technology, but most companies are already using some form of electronic system without realizing it. For example, when you send an email attachment, you’re creating an electronic document. When you scan a document with a signature, that information is now in a system with little to no security or validation.

There are many risks and hidden costs associated with using general-purpose systems, such as Excel or SharePoint. Regulatorily speaking, QMS software validation is required in nearly every market around the world. General-purpose tools do not come validated, so you should expect your validation efforts to be ongoing, constant, and expensive, as well as place a strain on your resources.

Let’s talk about the business costs associated with quality. First, let’s consider the cost of internal labor. On average, a team can expect to lose roughly 179 hours over the course of an 18 month medical device project. This time comes from zero value-add activities like coordinating, updating documentation and maintaining traceability. Using the US industry average of $150,000 as an annual cost per project manager, you’re looking at a cost of about $12,600.

The cost of a consultant is also significant. Between hours spent collaborating, travel, design reviews, maintaining traceability, updating documentation, compiling design history files and more, you can expect about 676 consulting hours on average per medical device project. At a rate of $150 per hour, you’re looking at a cost of about $101,400.

The opportunity cost of time to market can also be a significant expense. Let’s say you have an average expected deal size of $950, and your sales forecast calls for 415 scheduled units to be sold per month. This represents nearly $395,000 in lost revenue in just one, single month.

We’ve already been able to identify 855 hours of saved project time. While this certainly does not mean that the project will finish 855 hours earlier, we can reasonably estimate - and verify through case studies - that 2 months could be shaved off the product timeline... That’s 2 months earlier to market, with more features, and ahead of the competition. To put that in perspective using our earlier example, a 2-month delay would cost your company $790,000 in lost revenue! And that doesn’t even include the additional cost of burn rate!

The potential cost of errors must also be considered. This can be tricky to calculate, but given that 69% of 510(k) submissions are rejected the first time, and the FDA takes, on average, at least 1 month to provide a submission response, you’re looking at another month of lost revenue, on top of burn rate. This represents an additional $395,000 in lost revenue, at minimum, if your 510(k) is rejected.

And finally, you need to consider the cost of noncompliance, which can be most painful to your bottom line. What if you get a citation for a product already on the market? Well, you’re looking at a minimum of $100,000 to address a 483 observation and that could be up to $1M to remedy a warning letter. If you’re a startup or early-stage company, a warning letter could easily put you out of business. VC or angel investors won’t invest, and it could bankrupt your company.

The value of true quality can have a huge impact on the future of your business, as well as serve as a competitive advantage for driving enterprise value.

Building the Business Case for Quality shows that when you prioritize quality in your QMS, those deliberate efforts will produce a medical device with the same level of quality. 

The number of regulations that medical device companies are required to follow can seem overwhelming. And to make it worse, a lot of these requirements are not written in a vernacular that is easily understood by most people. This is a huge reason why it’s so important to build trusted partnerships with industry experts who do understand this regulatory language, and have experience guiding companies through them for compliance.

With Greenlight Guru, you’re completely covered – our world-class medical device QMS software has specific workflows built-in that are based on regulatory requirements across global markets. We have a team of medical device Guru experts to help guide you through anything. And our software even comes fully validated with 21 CFR Part 11 compliant IQ protocol/checklist and completed OQ and PQ reports.

We are the only QMS solution provider in the industry that integrates design control and risk management. We’ve witnessed a great deal of evolution with design controls in the past two decades since the original regulation was published, but the changes in risk management have and continue to be revolutionary. And for medical device companies, it’s not just the regulators we have to worry about - it’s the litigators as well.

As medical device professionals, we have a shared goal of producing medical devices that save or improve lives. Your end-users deserve a device that has undergone the most diligent of quality and regulatory processes. This can be accomplished with accuracy and simplicity through your new world-class medical device quality management system. 

To learn more about how you can implement your world-class medical device QMS leveraging Greenlight Guru’s easy to use and scalable software, head over to www.Greenlight.Guru and request your free, personalized demo.