How to Solve the Top 3 Medical Device Quality & Compliance Challenges

August 20, 2019
February 3, 2020

Most quality leaders don’t work in businesses with a quality first mindset. Surveys and research show that certain roadblocks are common for quality professionals across industries. Building awareness of the major challenges you’re likely to face and using a few clever strategies to handle them will help you dodge compliance risk and keep quality standards high.


Here are 3 of the most common quality challenges -- and a few tips for getting around them:


1. The perception that quality is a single department’s responsibility - and a potentially costly one.

The challenge:

Today, most medical device manufacturers (and most organizations in general) don’t think of quality as an aspect of company culture. It is seen as one department’s responsibility. For some, the only time leadership dives into questions of quality is when there’s a problem. Especially a problem that could impact market reputation or increase attention from regulatory bodies.

This can leave quality professionals feeling like they’re working in a silo, separately from the rest of the organization. Driving true quality and convincing peers and executives of its importance beyond just cost can feel like an uphill battle.

The organizations that stand out in the medical device industry and truly dominate their markets are the ones who recognize that quality should be top of mind for the entire organization -- starting with leadership and extending all the way down. Quality is not just about technology and guidelines. It's about driving it as one of the core values that define your organizational culture. Creating a true quality minded culture starts with the people. Many companies start with this concept but fall short when it comes to implementation.


The workaround: 

Changing your culture is a major task to take on. It certainly can’t be done overnight and may seem impossible to achieve at all. But quality professionals just like you are taking this challenge on and finding that they can make a real difference in the way their organizations view quality.

How are they doing it? Visit our blog How to Inspire Your Organization to Put Quality Systems First to learn strategies for improving your organization’s flawed perception of quality.


2. Lack of data literacy, skills, and technology.

The challenge: 

Many organizations suffer from poor measurement metrics, which is a difficult problem to identify if you don’t already know to look for it. Most businesses don’t. Data analytics experts have the skills to choose the best metrics to measure, but many businesses don’t have this skill set in-house. This is where most companies in the medical device industry need improvement. It’s rare to see companies spend the time and resources to improve the way they collect, analyze, and present important quality systems performance data. Many have access to large amounts of data but don’t feel the data is helpful or reliable.

When irrelevant or useless data is provided, and no success is gained from using it, people quickly stop using it -- especially when it’s coming in mass amounts and takes days or weeks to analyze. By the time insights are gained, the data is old and irrelevant, and it’s time to start again. In these organizations, the goal of finding value or hidden insights to support decision making and innovation seems unreachable.

The ideal situation with regard to systems and technology is also rarely reached. Most businesses try to make new software work with legacy applications, but they don’t have the expertise on hand to make it work for their needs. And getting useful data from suppliers is often extremely challenging -- especially for the life sciences industry where visibility into all aspects of the supply chain is necessary to maintain compliance. 


The workaround:

Before implementing a new data analytics technology like Tableau or Power BI, find a partner who understands the technology front to back and can help you retrofit it with existing systems effectively. Look for partners with verifiable data analytics experience within your industry, so they can help you determine which data is useful and identify the most useful metrics to measure against. 


3. Unexpected audits that reveal unforeseen quality system issues.

The challenge:

Most businesses don’t prioritize compliance until it becomes a problem. A business that isn’t fully prepared for a compliance audit risks serious penalties when the FDA inevitably appears, especially since these audits can take place at any moment. Without a plan to handle the situation and a proactive, detailed understanding of your organization’s compliance status, the business can suffer:

- Remediation must be crunched into a short time frame, diverting resources toward a sudden unexpected need and away from other high priority business activities

- Remediation can also be costly, in the millions of dollars depending on the number of issues identified

- Without help solving compliance issues, the company may be forced to shut down operations and put a halt on exports, creating a major impact in terms of brand reputation

Most importantly, even without an FDA audit, if something goes amiss in the quality process, consumers’ lives can be put in jeopardy.


The workaround:

If you can use your data to create visualizations that continuously monitor key metrics around high-risk issues within your organization, then you can get a crystal clear understanding of compliance risk and address those issues before they cost you money in penalties and remediation. When you work with us, for example, we start with an exhaustive assessment of the current state of your quality system, visualizing your data to diagnose the health of the system and help you make better decisions that provide early treatment options for any symptoms detected. Here’s a look at an example visualization dashboard:

Example quality and compliance visualization dashboard

Beyond saving you money in penalties and remediation, investing in a greater understanding of your compliance health is wise because it can lead to an increase in time to focus on your long-term business goals. In fact, your business goals and expectations are built directly into the treatment options we offer, to establish solutions to your compliance needs that are sustainable through time.

With more than 2 decades of experience in Life Sciences, a special focus on FDA requirements and quality systems, and the ability to create simple, easy to read dashboards, we can provide an extraordinary level of expertise with all aspects of quality and compliance. We’ve worked hand-in-hand with hundreds of companies to diagnose, solve, and prevent quality issues by using simple, easy to read dashboards that completely revolutionize the way they share quality data across the organization.

Interested in learning more about how this works? Check out our Quality & Compliance homepage to learn more about us and Download our free FDA Quality Systems Enforcement ebook. You’ll learn everything there is to know about how the FDA handles the compliance inspection process and see how, using specific data points, we can visualize the health of your system, show you exactly what changes are needed, and prioritize those changes so you reach your goals faster.

With information about your organization’s quality systems health available in simple dashboards, creating a company-wide culture of quality first becomes much easier. We’d love to hear about your goals and challenges and help in any way we can -- contact us today.

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