Arena Blog

How Kona Medical Reduced ECO Approvals from 6 Months to 48 Hours

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Heart Hour GlassDear Readers, I know many of you are involved in the development of innovative medical device and other compelling life science products. I know how hard life can be considering the strict compliance mandates, and an increasingly competitive market. So let me ask you a question, and please answer honestly: Does your company suffer from any of the following manufacturing challenges?

  • Miscommunication amongst dispersed supply chains
  • Inability to organize product information
  • Change order confusion/conflict
  • Tight budget and resource constriction
  • If you said yes to any of the challenges mentioned above, then you need to read how Kona Medical—with the help of a cloud-based product lifecycle management (PLM) solution—was able to:

    • Reduce lost ECOs from “3-5 per month to 0”
    • Increase ECOs fourfold
    • Accelerate ECO approval from 6 months to 24-48 hours
    • Arena helps some of the largest medical device companies in the world streamline their extended supply chain efficiencies, reduce costly errors and accelerate their desired business results. Kona can certainly testify (can I get an “amen”) to the power of PLM to heal even the most dire product development ailments.

      Founded in 2009, Kona Medical is a privately held biomedical start-up developing an innovative non-invasive treatment of soft tissue structures throughout the body. The first clinical application of their flagship device addressed severe high blood pressure (hypertension) through non-invasive ablation of the renal nerves without radiation or the cost or complexity of MRI and other technologies.

      Despite the company’s innovative vision, Penny Dalton, Kona Medical’s document control specialist, admitted the medical device company struggled with the organization of paper documents, change order completion time, and collaboration of different operational functions. She confesses that the cross-functional management of the product and all of its parts through the lifecycle were difficult to manage using spreadsheets and file folders.

      “The biggest challenge we faced was organization of all of our bills of materials (BOM) and managing the different lifecycle of parts and sub-assemblies,” said Dalton. “Our system has thousands of parts from screws to software to panels to PCAs. Managing all that on paper and spreadsheets was impossible. The changing of the lifecycle of parts within the BOMs and the parent assemblies created a paper trail nightmare. We would sometimes have six banker boxes full of drawings for one release.”

      According to Dalton, Kona Medical’s next big challenge was managing where the engineering change orders (ECOs) were during the process of routing. “We didn’t have visibility into who was left to approve, why so-and-so didn’t sign, and of course, the hold up of hundreds of parts in an ECO when one of the parts had drafting issues or part number issues.”

      Business Solution

      Who did Dalton call when she needed help? Ghostbusters? No. Dalton turned to Arena PLM to eliminate the time-consuming complications of managing unwieldy change order packages by formalizing the engineering change request (ECR) and engineering change order process with an intuitive, highly scalable, multi-tenant cloud-based solution.

      In the movie “A Few Good Men” Tom Cruise demands he’s entitled to answers and wants the truth. Some of you can’t handle the truth. For most medical device companies reading this blog, you too are entitled to the truth. And who better to hear the truth from than your medical device peer. In Dalton’s words, here is a list of the many benefits Arena PLM provided Kona Medical:

      • Management of each part and BOM lifecycle
      • Snapshot of an assembly lifecycle
      • Electronic routing made easier for travelling approvers. Not to mention the ability for them to view the entire ECO package (including PDF copies) of drawings
      • No more paper and filing. The need for a file clerk resource just went away
      • Compliance traceability. This can make or break a class III medical device company
      • And once again, a fourfold increase in ECOs (see reference graph below)
      • Kona ECOs


        You still want the truth about how PLM helped Kona? Can you handle the truth? Then download your copy of the Kona Medical case study today and discover how Arena can offer your medical device company real, measurable ROI.