• Login
    • Join
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Manufacturing
    • Markets
    • Top 10
    • Buyers' Guide
    • Events
    • Microsites
    • More
  • Magazine
  • News
  • Exclusives
  • Manufacturing
  • Markets
  • Top 10
  • Buyers' Guide
  • Events
  • Microsites
  • Current & Past Issues
    Features
    Departments
    Columns
    Editorial
    Digital Edition
    Subscribe Now
    Advertise Now
    Editorial Guidelines
    eNewsletter Archive
    eBook
    Top Features
    Additive Manufacturing at the Point of Care

    Six Orthopedic Firms En Route to Significant Market Disruption

    The Next Steps for Recovery and Rehab

    Scratching the Surface: A Roundtable on Coatings and Treatments

    Influencers on the Orthopedic Implant Manufacturing Market
    Breaking News
    Certifications
    Clinical Trials
    Device Approvals & Patents
    Financial & Deals
    International
    Market Data & Trends
    OEM News
    Orthopedic Innovators
    People
    Product & Service Releases
    Products
    Quality, Recalls & Risk
    Regulatory & Legal
    Supplier & Contract Mfg.
    Live From Shows
    Top News & Features
    Integra LifeSciences Founder Dr. Richard Caruso Passes Away

    FDA Clears CTL Amedica's Navigation Instrument System

    FundamentalVR Raises $20 Million in Series B Funding

    Bioventus Achieves Strong Growth in Q2 2022

    Bone Void Fillers Market Growing at 6%
    3-D Printing/Additive Mfg.
    Assembly & Automation
    Biocompatibility & Testing
    Clean Room
    Coatings/Surface Modification
    Contract Manufacturing
    Design
    Extrusion
    Finishing
    Forging & Casting
    Instruments, Cases & Trays
    International/Offshoring
    Laser Processing
    Materials
    Machining & Tooling
    Molding
    Packaging & Sterilization
    Prototyping
    Research & Developement
    Software & Quality
    Staffing, Training & Prof. Dev.
    Supply Chain

    The ODT 2022 Top 10 Orthopedic Device Companies

    Additive Manufacturing at the Point of Care

    Six Orthopedic Firms En Route to Significant Market Disruption

    The Genetic Risk for Joint Replacement Failure

    The Case for Using Historical Control in Clinical Trial Design
    Biologics
    Bracing/Prosthetics
    Extremities
    Imaging
    Instruments
    Large Joint
    MIS/Robotics
    Spine/Neurology
    Trauma/Sports
    Top Markets
    Orthopedic Device Evolution is Driven by Precision Technology

    mdHACM Allografts Demonstrate Potential in Treating Knee Osteoarthritis

    Radically Improving Medicine & Surgery with Light Field Technology

    A Call to Action in Orthopedics: We Need to Personalize Every Single Hip and Knee Surgery

    Giving Knee Replacement Surgery a Much-Needed Update
    Companies
    Categories
    Company Capabilities
    White Papers
    Add New Company
    International Buyers Guide Companies
    Tiodize

    Modern Plastics

    Braxton Manufacturing

    Life Science Outsourcing Inc.

    AV&R
    Industry Events
    Webinars
    • Magazine
      • Current & Past Issues
      • Features
      • Editorial
      • Departments
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • eBook
    • Breaking News
    • Buyers' Guide
      • Companies
      • Categories
      • Company Capabilities
      • White Papers
      • Add Your Company
    • Manufacturing
      • 3-D Printing/Additive Mfg.
      • Assembly & Automation
      • Biocompatibility & Testing
      • Clean Room
      • Coatings/Surface Modification
      • Contract Manufacturing
      • Design
      • Extrusion
      • Finishing
      • Forging & Casting
      • Instruments, Cases & Trays
      • International/Offshoring
      • Laser Processing
      • Materials
      • Machining & Tooling
      • Molding
      • Packaging & Sterilization
      • Prototyping
      • Research & Developement
      • Software & Quality
      • Staffing, Training & Prof. Dev.
      • Supply Chain
    • Markets
      • Biologics
      • Bracing/Prosthetics
      • Extremities
      • Imaging
      • Instruments
      • Large Joint
      • MIS/Robotics
      • Spine/Neurology
      • Trauma/Sports
    • Top 10
    • Online Exclusives
    • Slideshows
    • Videos
    • Webinars
    • Events
      • Industry Events
    • Live from Show Event
    • About Us
      • About Us
      • Contact Us
      • Privacy Policy
      • Terms of Use
      • Advertise With Us
    Columns

    Automated Data Analysis: Making the Case

    Shifting to automated data analysis for process qualification activities can improve the effort for manufacturers and their customers in several ways.

    Automated Data Analysis: Making the Case
    Jack Wieland, Project Manager, Lowell Inc.09.14.21
    Lowell’s manufacturing team needed to start making a customer’s part on a new machine. The newer mill/turn machine was automated and would save a lot of machining time versus the original milling machine, but it required reprogramming the part.

    To confirm the new process wouldn’t impact product results, the team performed several process qualification activities. They ran three lots of 30 parts each, then measured and analyzed the data of specific features. The results proved the new process was at least as capable as the previous manufacturing method.

    This type of process qualification is a critical step for contract manufacturers to build OEM confidence in the manufacturing process. It’s a detailed analysis of raw data to prove a manufacturer can create the medical device or component consistently, even over multiple purchase orders and lots.

    Often, the effort of process qualification is manual and tedious. Column after column of data needs to be copied and pasted into a software program, upper and lower specs are manually typed in, and a specific series of clicks must be followed to graph the data appropriately. This becomes increasingly time consuming—and opens greater opportunity for error—as the raw data grow.

    Shifting to automated data analysis for process qualification activities can improve the effort for manufacturers and their customers in several ways:
    • Improving accuracy: Automation removes the manual, repeated copy/paste exercise, which can increase the risk of errors.
    • Reducing time: Automation can more quickly analyze raw data, up to 98.2 percent faster than manual processes.
    • Increasing customer confidence: OEMs understand their supplier’s process can consistently deliver the needed results.
    • Standardizing reporting format: Automation eliminates the need to hunt for the location of critical charts and graphs.
    Following is a closer look at considerations and benefits of building an automated process.

    Process Validation
    Automated data analysis can be created through scripts or macros that are applied to statistical software, such as JMP or Minitab. At Lowell, Minitab is used for statistical analysis of raw data. We’ve developed a custom macro called PQ-it (Figure 1) to help automate the data analysis for our internal processes and our OEM customers.


    Figure 1: Lowell developed its PQ-it macro to save time on data analysis for process qualification.

    Rather than go through the copy/paste exercise described previously, a script or a macro can allow a user to run detailed analysis on multiple columns of raw data all at once, then generate graphs to present to the customer (Table 1). This can lead to significant time savings depending on the number of data points. It also reduces the risk of error in carrying data over from a spreadsheet to the software program.


    Table 1: Raw data as illustrated in this table needs to be analyzed as part of process qualification. Designing a script or macro for data analysis in statistical software programs can simplify the process and lead to time savings.

    Once the data are analyzed, charts can be generated for use with customers. In some cases, analysis can be done and presented to the customer in the same day, accelerating turnaround time and leading to improved customer satisfaction.

    Time Savings
    Developing a script or macro is likely to be an internal effort, and it’s important to have buy-in and belief it is worth the effort.

    As you consider investing resources toward automation, time savings is an important business and customer benefit.

    For example, imagine a part has six features to measure and inspect. For process qualification, three lots of 34 parts each are manufactured and inspected. That generates 102 points of data to analyze for each feature.

    Each data point needs to be analyzed against lower and upper spec limits, and meet the success criteria given by the customer.

    In this instance, it may take 18.5 minutes for an analyst to copy/paste the inspection data into software, add spec limits, and run the required tests to generate graphs. Automating this analysis can reduce time invested by 17 minutes, or 92.9 percent.

    As the number of features grow, so too can the time savings. In one internal study, there was a 98.2 percent time savings—or five hours and 12 minutes—on a part with 100 features. That gives the data analyst back more than half a day to dedicate to other work (Table 2).


    Table 2: This table shows the estimated time savings Lowell saw in automated vs. manual data analysis for process validation.

    These time savings would also apply to OEM teams that analyze raw data provided by suppliers. An additional benefit for OEMs is standardizing how results are reported across statisticians and suppliers for smoother internal communications.

    Realizing Benefits
    Process qualification activities are often a requirement for OEMs working with contract manufacturers. Automated data analysis is a tool these manufacturers can use to improve turnaround times and analysis accuracy.

    By understanding how macros or scripts can support your business goals, it’s possible to craft a solution that builds OEM confidence in your process, while decreasing the effort it takes for your team to analyze results. 


    Jack Wieland is a project manager at Lowell and currently manages Lowell’s New Product Introduction team. He holds a bachelor’s degree in chemical engineering from the University of Minnesota Duluth and a master’s degree in manufacturing engineering from the University of St. Thomas. Since he started at Lowell in 2017, Wieland has worked on several key projects, including the development and validation of a statistical analysis macro for Minitab as well as migrating Lowell’s entire quality management system to a software solution. Wieland is a certified ISO 13485:2016 lead auditor and is currently pursuing a Project Management Professional certification from the Project Management Institute. 
    Loading, Please Wait..

    Trending
    • MdHACM Allografts Demonstrate Potential In Treating Knee Osteoarthritis
    • Additive Manufacturing At The Point Of Care
    • Bioventus Launches DUROLANE In The U.S.
    • FundamentalVR Raises $20 Million In Series B Funding
    • Future Stars Of The Spine Industry: The Companies To Watch, 2021
    Breaking News
    • Integra LifeSciences Founder Dr. Richard Caruso Passes Away
    • FDA Clears CTL Amedica's Navigation Instrument System
    • FundamentalVR Raises $20 Million in Series B Funding
    • Bioventus Achieves Strong Growth in Q2 2022
    • Bone Void Fillers Market Growing at 6%
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • Additive Manufacturing at the Point of Care
    • Six Orthopedic Firms En Route to Significant Market Disruption
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome
    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise
    Omega-3 Fatty Acids Linked to Reduced Episodes of Depression
    Coatings World

    Latest Breaking News From Coatings World

    Nouryon Enters into Exclusive Agreement with Brenntag Specialties
    The BEHR & KILZ Brands Partner with Leanne Ford to Revitalize Her Historic American Home
    IGM Resins Acquires Litian
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    TransMed7 Achieves First-in-Human for Heron Soft Tissue Biopsy Devices
    West Pharmaceutical Services Invests in Latch Medical
    Integra LifeSciences Founder Dr. Richard Caruso Passes Away
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Societal CDMO Inks Land Sell Deal
    RoosterBio and AGC Biologics to Accelerate Manufacturing of Cell and Exosome Therapies
    WuXi Advanced Therapies Enters Licensing Agreement with Janssen
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Johnson & Johnson to Discontinue Global Sales of Talc-Based Baby Powder
    Dr. Squatch To Launch a 2nd Star Wars Soap Collection
    Neopac Wins 2 European Tube Manufacturers Association Awards
    Happi

    Latest Breaking News From Happi

    The Body Shop Canada Continues Expansion of New Concept Stores
    Nutrafol Expands Hair Care with Strand Defender Conditioner
    Climate Change Drives Sustainability in Household & Personal Care
    Ink World

    Latest Breaking News From Ink World

    Leadership Change in ALTANA’s ELANTAS Division
    Nazdar Highlights Ink Innovation at Labelexpo Americas 2022
    Cyngient, Imageworx Partner at Labelexpo for Security Labeling
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    TLMI partners with Convergen Energy at Labelexpo
    FINAT reports decrease in labelstock consumption during first half of 2022
    Color-Logic partners to feature metallics at autumn events
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Because Market Expands into Retail Stores
    Tranzonic Acquired by Private Investment Firm
    Monadnock Earns EcoVadis Gold Rating
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Integra LifeSciences Founder Dr. Richard Caruso Passes Away
    FDA Clears CTL Amedica's Navigation Instrument System
    FundamentalVR Raises $20 Million in Series B Funding
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    SEMI Appoints John Cooney to Lead Global Advocacy and Public Policy
    NMBS/SNCB Improves Security With HID Global’s Real-Time Location Service Technology
    onsemi Celebrates Expansion of Silicon Carbide Production Facility in New Hampshire

    Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login