Navigating the Challenges of Med-Tech Quality Management

Time and costs can soon rack up in a med tech device design and development cycle. But those who have installed a robust Quality Management System early on in the process will be better able to ride the waves of testing, iteration and regulatory scrutiny that each new phase entails.

Meanwhile, those who don’t have these vital quality mechanisms in place from the start will likely find themselves overwhelmed as the stresses and demands being made of them and their plans gradually mount up.

Getting started

The boundaries between drugs, medical devices and software are blurring. There are now more opportunities than ever before for startups to breakthrough in the sector with new ideas, and non-traditional competitors to bring existing technology and sidestep into the marketplace.

However, the intricacy of the med tech design and engineering challenge, can lead developers new to the sector to underestimate the time needed to perfect their efficacy and bring them to market.

The need for detailed research, user-centric design, exhaustive testing and iteration as well as the fundamental requirements to ensure the absolute safety and comfort of end users in often stressful and unpredictable conditions - can all cause delivery timescales to spin far out into the future.

The realities of medical device regulation

And no matter the strength of their innovation, new entrants to this market will inevitably butt up against the time and resource hungry realities of the industry’s regulatory demands - demands that are, with good reason, among the most rigorous in the world. After all, faulty and substandard manufacture or design of medical devices can cause injury or death. There is a high burden of proof required to show regulators that your product is of sufficient quality to be effective and safe for end-users.

The complexity of all these challenges, can tempt those new to the sector to design and build prototypes first - and turn their attention to regulatory requirement at some future date. But that will likely be too late.

Unique demands to minimise risk of quality failures

When it comes to medical device development there are many, mandatory requirements for defining and documenting all your processes - from ideation and design, through to prototyping and manufacture. They are all necessary to demonstrate compliance and secure the CE marking or FDA license necessary to trade legally in Europe or the US, and they cannot be neglected or assembled retrospectively.

Medical device development makes demands unlike any other, it may seek to borrow cutting edge technology, agile innovation and ‘fail fast’ dev techniques from other disciplines but it cannot ignore the demands of the inspectorate for a rigorous, phased design and build process, documented by an auditable quality management system.

Experienced medical device developers are acutely aware of these tensions and the freedom developers in other sectors have by comparison. Take, for example, Sebastian Liedtke of Roche Diabetes Care who says:

“In the field of industrial design, we see growing demand for products to become smaller, more integrated, more discreet and more connected. That’s a trend that started in fast-moving consumer goods. But unlike that industry, producers of medical solutions must comply with regulations, and it will be challenging for us to keep up with the pace they set”

Quality Management Systems bring efficiencies

But regulatory demands are not designed to inhibit the natural flow of a developer’s work or prevent them getting to market with vital and groundbreaking products. Instead, they are intended to draw a developers’ focus on planning as early as possible, in order to minimise the potential for the replication and amplification of errors throughout a project. This approach ‘bakes in’ risk based thinking to their every process so that development, testing and manufacture can proceed safely and with maximum efficiency.

Why a QMS must be flexible and process driven

A quality management system doesn’t have to be inflexible or monolithic in its structure. It doesn’t have to take months to install and work out how to use. Indeed, the best QMS, can give you competitive advantage, by providing the tools for swift development and commercial decision making within a digital framework driven by process. Get this right and you can fulfil an objective shared by med tech enterprises both large and small.

“Many med tech companies could benefit from moving their development processes beyond the traditional V shaped water fall model. But that doesn’t mean descending into chaos. You still need robust stage-gates with clear “pass or fail” criteria and strong leaders who don’t let weak projects progress. However, for in-between stage gates, it’s important that designers can work fluidly, iteratively and creatively rather than ticking boxes in a bureaucratic process.”

Steve Eichmann - Johnson and Johnson.

Wave after wave of opportunity and challenge

It is not uncommon for medical devices to take between 6 and 10 years to develop, and cost anywhere between $2 and $10 million in the final reckoning. Companies need to acknowledge these realities while finding the tools that can help them navigate these complexities in the most efficient and scalable way possible.

The phases of medical device delivery are precipitated by waves of ideation, funding, development and regulatory activity. These are the waves of activity that can accelerate your progress towards a final launch date, or overpower you with their demands for testing, validation and evidence of compliance.

With a flexible, lightweight, digital Quality Management System, though, you can more easily ride these waves of activity and stay on top of the pressures they bring.

A QMS can streamline your approach to development from the outset, preparing your business for the audits and the documentation requirements to come. The right solution can help you maintain the confidence of investors and colleagues and ensure you are equipped to meet the commercial and regulatory challenges ahead.

It can give you the tools you need to attain ISO 13485 and the approvals necessary to bring your product to market.

Stay afloat and ride the wave of the medical device development cycle:

• Understand from the outset what your regulatory obligations will be
• Meticulously plan your product and the quality management system you will use to bring it to market
• Choose an approach to delivering on quality goals that is flexible, robust, scalabale and cost effective
• Implement your QMS as early as possible in the process