6 Best Practices from Six Sigma that Medical Device Companies Should Follow

    Let me tell you the secret to turning your medical device company into the market leader in your category: You have to build a quality-driven culture—not a compliance-driven culture.

    Whether you become a blackbelt in Six Sigma or not, just a few of the best practices behind that framework can make a big difference for your company and build that kind of winning culture.

    YMCA implemented Six Sigma teachings to improve the culture of their summer day camp. George Chemers, the owner of Perfect Formula, worked with the YMCA as a consultant.

    He helped them customize and implement a training program to provide training on Six Sigma. The course allowed participants to create and complete real projects to put their learning to the test.

    “Once they got their hands dirty and started working with this in the training, they realized it wasn’t really doing work differently, but organizing and documenting in a new way.” — Erin Reuland, Manager of Administration for Youth Development and Social Responsibility for Y-USA

    The YMCA’s project team were able to exceed their goals in the first year—all thanks to Six Sigma tools and techniques.

    Ready to make your company better too?

    Check out the six best practices from Six Sigma medical device companies should look at and consider implementing.

    6 Best Practices from Six Sigma Medical Device Companies Need to Explore

    Qualio is an eQMS solution that was created with medical device companies in mind. Our software is simple to use and scalable. It’s perfect for teams of up to 500 employees. With Qualio, you can:

    • Automate your workflows
    • Streamline communications
    • Create and approve documents with ease
    “I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us to reduce workload and paper trail in a cost-effective and easy manner that is flexible to grow with the company.” — Paul Maguire, CEO, and Co-Founder of Arann Healthcare

    Discover all of Qualio’s features and test out the demo here: Qualio: The leading quality management platform for young and growing life sciences companies.

    1. Track problems with a Pareto chart

    Pareto charts are bar graphs you create so you can analyze data about the frequency or identify what's causing problems in a process. You can even use them to take a look at specific components and analyze broad causes.

    Pareto charts make it easier to share your data with others, and you can focus on the most significant cause of a specific problem.

    To use Pareto charts effectively, you’ll need to decide:

    • What categories to use for grouping items
    • What measurements to use
    • What period of time you want your chart to cover

    Making Pareto charts is not a complicated process. Follow the steps on the American Society for Quality website and use their pre-built templates to start creating your own Pareto charts.

    Related Reading: Reviewing the Best Medical Device Risk Management Consultant Options for 2020

    2. Reduce variation

    Variation is a lack of consistency in your business processes. You should measure variation to increase reliability and to reduce the costs caused by multiple variations.

    Discrepancies in your business processes are what cause variations to occur.

    Discrepancies happen when:

    • Machines have considerable wear and tear.
    • You make changes to your processes.
    • You input incorrect measurements.
    • The quality or makeup of your materials varies.
    • Changes occur in the environment.
    • The quality of an employee’s work is unpredictable.

    Identify variations by using run charts to look for common causes or control charts to look for special causes. Follow the steps on this website page to create run and control charts.

    3. Refine your business process map

    A process map is a tool you can use to show actions, inputs, and outputs of a process graphically. Process maps allow you to visualize every step of your process closely so you can improve decision making.

    You’ll be able to pinpoint all the strengths and weaknesses of your current processes so that you can see what's working and what isn't and make improvements accordingly. A process map should illustrate all the steps, inputs, outputs, workflows, and communications that occur.

    The two types of process maps are process and deployment flowcharts. Process flowcharts provide visuals of each step and their points of decision. Deployment flowcharts show communications between the departments of your organization.

    Use this guide to create your first process map for your business.

    Related Reading: The 8 Essential Elements of Quality Management for Pharmaceutical Companies

    4. Aim for real results

    Create attainable business goals that can be tracked and measured with tangible results. Examples of tangible results include measurements of money saved, profit increases, or other mathematical data you can track and compare.

    Create goals for all three types of business processes.

    • Transformational processes: changes in the physical or virtual inputs that produce outputs
    • Decision-making processes: input parties communicate about the objectives to reach decisions.
    • Transactional processes: inputs produce specific outcomes by interacting with each other.

    Monitor your processes closely and keep meticulous records so you can track your progress. Qualio is perfect for creating and storing all of your important documents.

    Find out more about how Qualio is the perfect eQMS software for medical device companies.

    5. Push for 70% improvement

    Stretch goals are a 70% improvement over current performance. Kaizen is one option (incremental), but aiming for significant improvements may be better depending on your organization.

    Kaizen involves focusing on standardizing production processes and using small, incremental changes to improve efficiency and eliminate waste. The improvements gained by utilizing Kaizen tactics won’t be as significant, and it will take more time to achieve results.

    Benchmark yourself against your competitors to create stretch goals for your organization. Six Sigma tools and techniques will help you reach the stretch goals you set for your business.

    Related Reading: 4 Examples of Continuous Improvement in Quality Management in Life Sciences Companies

    6. Explore Taguchi methods

    Dr. Genichi Taguchi created the Taguchi methods that help engineers improve productivity. Robust design is another term used to refer to the Taguchi method.

    Robust design allows companies to improve product quality, reduce product costs, and speed up product development processes.

    Design directly influences more than 70% of the product lifecycle cost; companies with high product development effectiveness have earnings three times the average organization's earnings, and companies with high product development effectiveness have revenue growth two times the average organization's revenue growth. Believe it or not, 40% of product development costs are wasted.

    The Six Sigma approach to design focuses on value-based management and increasing productivity. Robust design and Six Sigma tactics combined can have your business seeing real results faster than expected.

    Exceed Your Goals and Improve Your Medical Device Quality

    Increasing productivity is a great goal; you can do more in less time and get closer to dominating your market.

    However, you don't want your quality to suffer as your productivity levels increase. Six Sigma approaches help you scale, and our free guide can help you avoid potentially damaging quality issues while you do.

    Read the guide to learn strategies that will help you:

    • Improve review processes
    • Find areas where quality standards are not being met
    • Establish and utilize feedback loops
    • Ensure that your documents are in order
    • Guarantee that your team is trained appropriately

    Grab your copy of 7 Things You Can Do Now to Leverage Medical Device Quality as a Competitive Advantage and start your journey towards outpacing your competition this year.