The 5 Most Important Quality Equipment for Life Sciences Startups

    What does it take to succeed as a life sciences startup?

    It’s a bit of a loaded question.

    Unfortunately, there isn’t a silver bullet to create immediate and sustained life sciences startup success. The most successful (and profitable) startups and scale-ups invest in the right processes and tools to streamline regulatory compliance, internal processes, and in turn, foster operational excellence. 

    However, even with investments in these mission-critical areas, the odds are stacked against most growing startups.

    In fact, recent research indicates nearly 90% of startups failed in 2019.

    There are many reasons why startups and scale-ups fail. But the most damaging are compliance infractions and/or product recalls. 

    For this reason, investment in a quality management system (QMS) should be top-of-mind for early-stage organizations.

    “The medical device industry is approaching a tipping point where the increasing likelihood of a quality event, the rising costs of such events, and the public nature of quality performance will force companies to focus on quality and reliability throughout product design, manufacturing, and marketing,” reports McKinsey & Company’s Ted Fuhr, Katy George, and Janice Pai in The Business Case for Medical Device Quality.

    5 Mission-Critical Quality Equipment for Life Sciences Startups

    Why is quality such an important focus for life sciences startups?

    These products are focused on improving the quality of life of consumers. 

    As such, quality processes and related quality equipment ensure that products are safe and perform as intended. Moreover, major regulatory bodies require life sciences organizations to comply with quality standards.

    The benefits of a QMS are compounding. A best-in-class QMS enables life sciences teams to develop a quality product, enhance internal efficiencies, generate increased consumer confidence, and more.

    However, there are many other types of quality equipment that a growing life sciences startup or scale-up should implement on the path to success. 

    In this article, we’ll discuss the most important quality equipment options that you should consider.

    1. Six Sigma Quality Management Guide

    Six Sigma is a business management strategy popularized by Jack Welch at General Electric. After implementing Six Sigma quality controls, General Mills achieved nearly $12 billion in cost-savings, according to Six Sigma Daily.

    “Welch took many business cues from the Japanese,” reports Six Sigma Daily. “He saw early on that companies in the island nation turned into powerhouses by creating more efficient and effective systems.”

    To date, thousands of startups and scale-ups leverage Welch’s approach to quality management. Moreover, thousands of quality management professionals seek Six Sigma Black Belt Certification CSSBB to better understand major Six Sigma principles.

    RELATED READING: 6 Best Practices From Six Sigma That Medical Device Companies Should Follow

    2. Total Quality Management Guide

    Total Quality Management (TQM) is another quality management methodology used to ensure that products meet both customer and regulatory requirements. 

    Populated by W. Edwards Deming, this approach is also adopted from Japanese business practices.

    According to Lucidchart, TQM follows these eight principles: 

    1. Customer focus
    2. Total employee commitment
    3. Process approach
    4. Integrated system
    5. Strategic and systematic approach
    6. Continual improvement
    7. Fact-based decision-making
    8. Communications

    TQM guides should discuss the primary elements of your QMS and include the charts, graphs, and tools needed to help your company systematize its approach to TQM.

    RELATED READING: The 8 Essential Elements of a Quality Management for Pharmaceutical Companies

    3. Equipment Maintenance Log

    An equipment maintenance log might seem like an obvious quality tool. But even small changes to your equipment will influence product output. 

    By tracking equipment performance, you can better plan and prepare for any future changes that need to be made to your equipment. 

    Additionally, an equipment maintenance log will help you to determine if you need to replace equipment, system, or software.

    As a best practice, LabTech recommends training staff on equipment maintenance.

    “To carry this out on a regular basis, necessary documents such as SOPs, service logs, and maintenance logs should be provided,” reports LabTech in Master Checklist for Lab Equipment Maintenance. “The staff should undergo not just theoretical presentation, but also hands-on training on-the-job for the laboratory equipment use and maintenance,” continues LabTech.

    4. Corrective and Preventive Actions Report

    A Corrective and Preventative Actions (CAPA) report aims to enhance internal quality control processes while proactively addressing issues of nonconformance. The CAPA report can also expose the root cause of recurring problems related to product quality.

    The importance of a robust CAPA report cannot be understated. In fact, gaps in CAPA processes are among the biggest triggers for FDA 21 CFR noncompliance warnings. However, achieving CAPA compliance can be secured through a robust QMS. The best QMS software comes pre-equipped with CAPA best practices, processes, and systems.

    5. Quality Management System

    Finally, a QMS enables improved quality through the standardization of processes used to deliver products that achieve high levels of quality and customer satisfaction.

    A medical device QMS delivers the following benefits to growing startups and scale-ups:

    • Actionizes internal purposes and goals into policies and procedures
    • Serves as a framework for continuous improvement through evidence-based decision-making processes and frameworks
    • Facilitates increased agility, flexibility, and profitability

    The Smartest Quality Investment for Your Growing Startup

    The most successful life sciences startups and scale-ups know that quality can’t wait. 

    Recently, Cirris moved from a paper-based system to Qualio’s electronic QMS (eQMS). Almost immediately, the company started to see the value in adopting a digital-first approach.

    “You go a few months without a quality manager keeping things up to date, and you feel it very quickly, and your company can suffer,” said Cirris Quality Manager Gene Vought in a recent interview on From Lab to Launch. “Now it takes days instead of months to get something approved through the system.”

    Qualio can help improve your quality processes. However, we’re not the only QMS provider available to growing life sciences startups and scale-ups.

    To help you make the best investment, we’ve created a simple guide:12 Questions to Ask Before You Buy an eQMS. Read it to learn the insider-intelligence needed to make an informed QMS purchase for your startup.