MedTech Lifecycle Excellence: Out of the Dark and into the Age of Enlightened Quality

During a less-than-heroic time in history, humans suffered through the Dark Ages with a lack of new technology and scientific advances. It was the Renaissance Period that proposed change - challenged the status quo - and transformed society from darkness to The Age of Enlightenment . And as they say, history seems to repeat itself. 

In the same way today, the MedTech industry now stands at the precipice of a new era of work for MedTech professionals. We have new technologies, new expectations, and new opportunities to deliver cutting-edge devices and innovative solutions that improve people’s lives. 

And yet, bringing life-changing products to patients is still harder than it should be. Many MedTech companies struggle to balance compliance efforts with the speed of innovation and execution. 

The source of MedTech’s growing pains are varied. Some point to ever-changing global regulations for creating challenges in documentation, traceability, and risk management. Others say it’s because teams are remote and siloed, with 78% of MedTech professionals opting for a hybrid workplace following the pandemic, according to 2022 State of Medical Device Report data. Ultimately, though, all the factors come down to one thing: a failure to establish quality-as-an-asset rather than a cost center for baseline compliance. 

But what if there was a different way? Market-leading MedTech companies have figured out the secret. Recent data shows most market-leading companies (67%) view quality as an asset to the organization, a rate 50% higher than moderately competitive companies. Doing so allows them to:

• Maintain strong visibility into quality data
• Design feedback mechanisms to support quality excellence
• Reduce the cost of risk and compliance issues

• Empower entire organizations to take ownership of quality throughout the device’s entire lifecycle

To move the MedTech industry out of the dark age of quality and into the period of rebirth and enlightened quality, we need to embrace an entirely new approach, one which we humbly call MedTech Lifecycle Excellence. 

MedTech Lifecycle Excellence (MLE) is an approach for medical technology and device companies that focuses on delivering high-quality products to patients by connecting disparate teams, processes, and data throughout the entire product lifecycle.

First, let’s examine the current approaches and tools holding us back from achieving True Quality and Medtech Lifecycle Excellence.

Today’s Dark Age of Compliance 

In the past decade alone, massive advancements in technology have radically expanded the possibilities of global healthcare. Since 2010, our industry has seen the birth of new concepts like advanced robotic surgery tools, remote patient monitoring apps, and 3D-printed organ transplants. 

However, we’ve also faced significant obstacles. Healthcare’s digital revolution has disrupted the traditional patient-provider roles, resulting in more empowered patients with higher expectations than ever before. The technological leaps have also resulted in rapidly shifting regulations across the globe. And of course, ongoing global health crises like COVID-19 have permanently altered supply chains and remote patient care.

Keeping up with these changes has been a struggle for MedTech companies. Many are stuck reacting to changes and have continued to approach quality with a policing mentality, chasing down signatures and halting production phases all in an effort to ensure compliance. With little perceived value and a perception as bureaucratic hall monitors, medical device companies have equated quality with compliance, putting teams under nearly constant pressure to reduce costs surrounding quality. These anxieties are understandable, too —  issues related to adverse quality cost medical device companies come in at an estimated $5 billion per year. 

But the fact is that this mindset has shaped quality systems, product lifecycle management, and team dynamics for years. And when new digital technologies known as “smart technology” came around, it unsurprisingly caused MedTech companies to squander in investing in them in search of quick cost-cutting tools instead.

Legacy, single-point tools have left MedTech companies reactive and flying blind

Of all the tools birthed from the Renaissance-era, few gave as much insight as the telescope. With a few glass lenses placed carefully in a leaden tube, scientists like Galileo and Johannes Kepler progressed astrological knowledge further than ever thought possible —all thanks to having the right tool to grant vision into the stars. Kepler famously said, “Telescope, instrument of much knowledge, more precious than any scepter!”

So, when MedTech companies are relegated to using the generic tools —or non-industry specific tools —they have been given to ”leverage” quality and provide insight into their data, it can be a little tough to stomach. These tools often take the form of paper, just in digital form. Beyond that are single-point, general-purpose solutions that lack visibility, traceability, and connectedness of data, processes, and teams. 

Teams are left managing disconnected systems, processes, and records. Each disparate system and process serves a different purpose or different team - with no visibility into one another - or continuation across the value chain of bringing devices to market.

The reliance on legacy solutions creates data silos that make innovation incredibly difficult. The problem is pervasive, too —just over 1 in 4 medical device companies say employees have “high visibility” to access and review quality problems, and nearly 1 in 5 say visibility is low or non-existent. It also means that quality has been event-driven, full of lagging indicators, corrective actions, and an inability to be proactive rather than reactive. And as research shows, the average MedTech company uses 3-5 point solutions exceeding costs of $200k annually to solve all of these problems across the entire product lifecycle. Because of this dark age approach, there hasn’t been a single, all-inclusive ecosystem that contains every touchstone in medical device lifecycle management.

Things become exponentially more complicated as MedTech companies try to combine tools for ideation and collaboration, quality management systems, product lifecycle management, clinical trial management, and employee education. Configuring all these disparate solutions and technologies is a huge undertaking that requires constant monitoring and upkeep just to ensure you’re getting a semi-accurate and up-to-date picture of what’s really going.

Tomorrow’s Age of Enlightened Quality 

In order to pull ourselves out of the dark ages, MedTech companies need to practice self-reflection regarding our current lackluster approaches to total product lifecycle management. We know that the three biggest challenges to the current MedTech approach are:

• Lack of insights: Teams are driving without a single source of truth. They lack visibility and traceability and have no way to proactively identify gaps in execution.
• Lack of capabilities: Teams need to manage the entire device lifecycle while navigating ever-changing regulatory requirements, but only have generic single-point tools.
• Lack of proactiveness: Tools and solutions are used today as a system of record. The data is being housed, but there is no action or accountability. Teams need a system of action. 

As opposed to dark age quality, enlightened quality is about leveraging quality as an asset — and that means using insights, data, and connectivity throughout the entire product lifecycle to improve product quality, increase visibility, and drive good business decisions.

This means pulling together many disciplines, processes, teams, and data sets while operating within an ever-changing regulatory and compliance environment across multiple markets.

We need to look past compliance, go beyond the baseline requirements, and put quality at the heart of everything we do as medical device professionals. We need to focus on the success of people, processes, and products through their entirety. We need a single, purpose-built, end-to-end solution designed specifically for the MedTech industry. 

Say Hello to MedTech Lifecycle Excellence

MedTech Lifecycle Excellence is an entirely new category and approach to how medical device companies build and manage high quality devices across their entire lifecycle. By implementing advanced smart technologies, modern process design techniques, and flexible ways of working, MedTech companies can radically improve their approach to building safe and effective devices. 

A recent study by McKinsey & Company found that this “Smart Quality” approach could lead to:

• 25-35% increase in development efficiency and speed to launch
• 25% increase in impact from quality improvement initiatives
• 25-40% increase in productivity and speed for key quality assurance processes
• 80% decrease in deviations and/or nonconformances 
• 50-100% increase in productivity and speed with optimized testing, paperless labs, process automation and shift to the shop floor

In the same way, MedTech Lifecycle Excellence allows companies to operationalize process excellence to drive measurable impact across the entire product lifecycle. 

But what does this really mean? Let’s cut through the business jargon and look at the individual MedTech lifecycle stages and what companies need to accomplish to achieve actual, measurable excellence at each point. 

• Identify the problem and unmet user needs
• Plan project timeline, costs, regulatory pathway, and potential revenue
• Design high-quality, safe products that meet user needs with a seamless design control process
• Submit for regulatory review with confidence
• Deliver your product with a successful design transfer to manufacturing, distribution network setup, marketing, product registration, and reimbursement strategy
• Monitor the efficacy of your product with postmarket surveillance that unlocks full traceability of quality events, including nonconformances, customer complaints, and CAPAs.
• Improve the quality of life through your product by meeting user needs

Achieving excellence in all these phases will require a new software solution that creates seismic shifts in capabilities for MedTech companies. We need to move away from generic, single-point tools that create data silos and promote baseline compliance, into a new era of purpose-built, end-to-end, single sources of truth and action, that promotes excellence and quality.

Get Ready for the MedTech Renaissance with Greenlight Guru’s MedTech Lifecycle Excellence Platform

For years, Greenlight Guru has brought deep expertise to reaching MedTech Excellence. Our software has been the only QMS designed by medical device professionals specifically for medical device professionals. It was the only purpose-built solution based on the latest FDA and ISO standards with built-in industry best practices to guide medical device companies throughout the entire product lifecycle.

Now, it’s time for us to help bring forth a renaissance of quality with the introduction of our new MedTech Lifecycle Excellence platform, giving medical technology companies a single, end-to-end software platform to bring life-changing products to patients.

The MedTech Lifecycle Excellence platform integrates cross-functional teams, processes, and data throughout the product lifecycle, giving visibility and traceability beyond compliance requirements to proactively overcome execution gaps and accelerate success.

• For Innovation Teams, we provide a solution that enables outcome-driven thinking at all stages of your company strategy.
• For Product Teams, we provide a solution that streamlines product development throughout the entire device lifecycle.
• For Quality Teams, we provide a connected quality ecosystem where every quality process and record is organized, centralized, and traceable.
• For Regulatory Teams, we provide a search and recommendation solution to conduct meaningful, up-to-date regulatory research to support your development efforts and monitor the latest regulatory information.
• For Clinical Teams, we provide a solution for continuous clinical evaluation and trial data management to simplify compliance and reduce costs.

If you’re ready to say goodbye to the dark ages and step into the light of true MedTech excellence, contact us today to learn more →