Report

Medical Devices Case Study

1.866.937.1438 | arenasolutions.com

Company Kona Medical

Location Menlo Park, California

Industry Medical Devices

Business Challenges • Miscommunication amongst dispersed

supply chains

• Inability to organize product information

• Change order confusion

• Tight budget and resource constricted

Solutions Arena PLM BOMControl

Business Benefits • Eliminated paper-based filing and saved

need for additional resource

• Heightened process visibility

• Lowered change order conflicts

• Electronic routing and approval

processes made easier

ROI Results • Number of lost ECOs went from “3-5

per month to 0”

• A four-fold increase in ECOs.

Friction removed.

• ECO approval went from 6 months to

24-48 hours

Arena PLM Case Study | Manufacturing Success Stories

Arena PLM Case Study

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 adjudicate using spreadsheets and file folders.

“The biggest challenge we faced was organization of all of our BOMs 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 if part number issues.”

Dalton turned to Arena to eliminate the time-consuming complications of managing unwieldy change order packages by formalizing the engineering change request (ECR) and ECO process with an intuitive multi-tenant cloud-based solution. Her engineering team now has easy access to searchable product information from a single sign-on password-protected web-based interface.

According to Dalton, she was influenced to use Arena based on feedback from her team, especially those members who had used Agile and other product lifecycle management (PLM) systems. “My NPI manager said that Arena was much more flexible, easier to use and upload different files than other solutions,” said Dalton. “For me personally, Arena is a one-stop shop. We are not only using Arena to manage lifecycle changes, but we will be using it to make our quality process electronic and also our purchasing process.”

How Did Kona Reduce ECO Approvals from 6 Months to 48 Hours?

BUSINESS CHALLENGES

SOLUTIONS

1.866.937.1438 | arenasolutions.comArena PLM Case Study | Manufacturing Success Stories

Arena PLM Case Study

In Dalton’s words, here is a list of the many benefits Arena provided Kona Medical:

• Management of each part and BOM lifecycle • Snapshot of an assembly lifecycle phase • Electronic routing made easier for travelling approvers. Not to mention the ability for them to view

the entire package including PDF copies of drawings • No more paper and filing – the need for a file clerk resource went away • Traceability. This can make or break a class III medical device company • Four-fold increase in ECOs (reference graph below)

Dalton says one of Arena’s immediate benefits to Kona was a greatly accelerated process for change orders. “Turn around time for lifecycle change from ECO approval to completion (part number/revision updates for entire system) went from 6 months to 24-48 hour turnaround,” she claims. “What that means is when our system was approved for a lifecycle change that included all of our parts and assemblies. In the paper process, it took 6 months to get it all updated and filed. In Arena, since we have the ability to manage sub assembly lifecycle electronically. We would simply change the lifecycle as the project grew and were qualified.”

She continued, “By the time the executive team ‘approves’ the whole system, it now take me only a few hours to complete the process. In addition, the number of lost ECOs has gone from 3-5 per month to 0. The time it took to order parts decreased dramatically now that we have the ability to manage our vendors in Arena, rather than the use of spreadsheets.”

“ ”

Arena is a one-stop shop. We are not only using Arena to manage lifecycle changes, but we will be using it to make our quality process electronic and also our purchasing process. — Penny Dalton, Document Control Specialist, Kona Medical

Find out how Arena can help you achieve success and take your company from chaos to calm. Sign up for a demo at www.arenasolutions.com/plm-demo

BUSINESS RESULTS