5 Major Total Quality Management Principles for Medical Device Startups

    What is total quality management (TQM) as it relates to the life sciences industry?

    A bulletproof TQM strategy outlines the strategies manufacturers follow to improve product quality and, by association, customer satisfaction. Without a quality management system (QMS) in place, the process is highly inefficient and laborious, to say the least.

    Major studies indicate that five total quality management principles have the most significant impact on product quality: 

    1. Customer focus, 
    2. Leadership accountability, 
    3. Employee engagement, 
    4. Supplier relationship management, and 
    5. A process-driven approach.

    Are you ready to improve manufacturing output? Are you satisfied with your organization’s current approach to TQM? Keep reading to learn more about the major TQM principles medical device startups need to be aware of.

    5 Total Quality Management Principles for Medical Device Startups

    TQM places an emphasis on the customer during all manufacturing and quality activities. 

    When you consider the customer-centric nature of TQM, it’s not surprising why this approach has become widely adopted across a variety of industries — including medical device manufacturing, biopharmaceuticals, and even automotive manufacturing.

    When building or refining a TQM strategy, it’s important to engage all stakeholders, like employees, leadership, and suppliers. By taking the time to properly align with your network, teams will have a much better understanding of your quality management objectives, quality assurance protocols, and more.

    With all this in mind, here are the top five total quality management principles for medical device startups.

    1. Customer Focus

    In retail, the customer always comes first. The same is true for healthcare patients.

    Putting the patient first means that your organization will have a much easier time generating positive reviews and improving customer satisfaction.

    To activate a customer-focused quality management process, start by understanding your customers’ needs. What do your customers need right now? What do they need in the future? 

    Next, communicate those needs to all stakeholders involved in the product development/manufacturing teams.

    After marketing your product, measure and monitor customer satisfaction. How are customers responding to your medical device? 

    You’ll also need to make sure you follow the corrective and preventive actions (CAPAs) needed to effectively mitigate quality issues.

    RELATED READING: The 8 Essential Functions of CAPA Management Software

    2. Leadership Accountability

    When your company’s leadership spearheads total quality management, your quality programs and processes will be much better. 

    The first step is to find the right technique to implement a company-wide focus on quality, safety, and effectiveness. The second step is to invest in an effective electronic quality management system (eQMS) to streamline the entire process.

    After investing in an eQMS, many leadership teams follow the Deming Cycle to improve and monitor quality processes. 

    In case you’re unfamiliar, the Deming Cycle is divided into four phases: plan, do, check, and act. This four-step process allows leadership teams to better prioritize the processes and systems that will have the greatest impact on TQM. It also helps to foster a culture of continuous improvement across the entire life sciences organization.

    3. Employee Engagement

    Your TQM plan isn't complete until you bring all of your employees on board.

    To do this, start by activating process-driven policies that bring your quality management vision to life. 

    Employees rely heavily on documentation to guide their quality activities. Unfortunately, without a document management system in place, important quality management documents are bound to go missing.

    Qualio’s powerful eQMS streamlines leadership-employee collaboration. The best part is that our system includes powerful document management features designed to make file organization, editing, and search easy.

    RELATED READING: How to Ensure Your Quality Management System Processes and Procedures are Compliant in 2021

    4. Supplier Relationship Management

    Your suppliers and manufacturers are integral to the long-term success of your growing medical device startup. As such, these suppliers and manufacturers must uphold quality and compliance standards during all phases of product development.

    To find the right medical device supplier, vet their quality management standards. Do they follow industry best practices? Do they have their own QMS in place? How do their quality standards align with our own quality benchmarks? These are just some of the questions you’ll want to ask.

    Remember, your medical device is only as good as the suppliers and manufacturers you use to design, build, distribute and improve your products.

    5. Process-Driven Approach

    TQM principles are difficult to activate and manage without a centralized QMS. Many early-stage medical device companies commit to paper-based processes and systems. Unfortunately, these types of legacy tools cause unnecessary friction during product manufacturing and quality assurance. In many cases, paper-based systems are prone to user errors.

    Investing in an eQMS is one of the easiest ways for your medical device company to improve product quality overnight. The benefits of an eQMS include:

    • Improved operational efficiency
    • Improved cross-team communication
    • Process intensification
    • Increased profits
    • Data-driven decision making

    RELATED READING: Cirris Replaces Paper-Based Systems With Digital QMS to Streamline and Pass Audits

    How to Achieve Total Quality Management Success

    What’s the best way to achieve TQM mastery? With an eQMS, TQM success is almost guaranteed. However, with so many quality management solutions to choose from, finding the right eQMS for your medical device organization is easier said than done.

    To make the eQMS selection process easy, we’ve put together a free guide: 12 Questions to Ask Before You Buy an eQMS. Download it to get a list of the most important questions you need to ask to make an informed purchase.


    Of course, we might be a bit biased when we say that the Qualio eQMS has all the features you need to improve your organization’s quality management processes. However, the results are clear:

    “Without Qualio, we would not have been able to achieve our critical milestone of ISO certification. We are now prepared to take the next steps toward compliance with European regulatory requirements and the CE mark” - Jonas T., Quality Manager.

    How can we help your medical device company achieve its quality objectives? We’re standing by.

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