Over the millennia, Halloween has evolved from a somber pagan ritual to a day of costumes, parades and treats for children. The merriment also includes ghost stories—mostly revolving around haunted OEMs—that are spooky enough to send shivers up the spine.
One such story is the cautionary tale of Genetic Instruments. The fable of the ill-fated medical device company is chronicled by most folklore historians as a modern day version of the Flying Dutchman—a seventeenth-century merchant ship that can never make port and is doomed to haunt the high seas forever.
As medical device industry lore has it, the company became eternally cursed when its CEO refused to take safe harbor and embrace the benefits of a product lifecycle management (PLM) solution during a storm of treacherous shipping delays, product errors and recurring quality issues.
Despite pleas and the occasional “aaarrrghh” from engineers, the CEO ignored how Arena’s suite of PLM and supply chain solutions could enable engineering, manufacturing and their extended supply chains to speed prototyping, reduce scrap, improve margins and collapse time to market. With PLM, the CEO had the chance to save the sinking company and steer the business off the shoals and out of rough waters. Instead, the CEO's hubris tempted a higher manufacturing power, which spitefully capsized the company with waves of spreadsheets, leaving its crew to perish into the bowels of bankruptcy.
Today, the long-since bankrupted “ghost company” has reportedly been seen at midnight slowly sailing along the lonely backstreets of Sand Hill Road gliding past its old haunts—the smell of rotted seaweed wafting through the air. On some foggy nights, witnesses from nearby medical device companies have been rumored to hear the melancholy voices of Genetic’s ghostly crew of engineers and operation managers chanting, “We could’ve gone public. We could’ve made millions.”
The specter of the company’s hull, rigging and mast that supported tattered sails—comprised of errant spreadsheets, compliance documents, and design specs—is a haunting reminder what happens when medical device companies fail to embrace a modern PLM solution to meet compliance standards and accelerate innovation. Without PLM, Genetic Instruments is cursed to sail the Sea-of-Sameness, never able to accelerate innovation, differentiate and break out as an innovative first-mover.
What makes Genetic Instruments’ story even more tragic is they undertook this never-ending voyage knowing full well in advance that three of the top five medical device companies rely on Arena PLM to succeed.
“Medical device companies need to do more than just comply with quality systems regulations—they need to employ an embedded holistic medical device quality management approach that is tied to their product record. One that includes ‘Design Thinking’ practices and is holistic in nature,” said Arena Vice President of Marketing and ghostbuster Kent Killmer. “Linking quality with PLM is the only way a company can be assured of avoiding such a heartbreaking fate as Genetic Instruments. And frankly, I’m tired of being awakened at night by the creepy heavy breathing from those tortured medical device CEOs pleading for but one more chance to get it right.”
Genetic Instruments is a portent of bad luck for medical device companies when they continue to embrace last millennium's tools to manage this millennium's bill of materials (BOMs).
Don’t get tricked this Halloween. Avoid the sound of rusted chains being drug through your office and the stench of rotted seaweed in your parking lot. Consider a live Arena PLM demo.
Save yourself. While you still can.