Overcome Intergalactic Medical Device Challenges

Posted in Compliance, QMS
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"It's okay, Qwallo. You'll be fine as soon as we stop the bleeding."

―Skywalker reassures Qwallo while using scissors from his medpac unit.

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In paintings and sculptures, the legendary Jedi Knight Luke Skywalker was frequently portrayed wielding either his blaster pistol or light saber wearing a robe with a black utility belt that housed a pouch-like medpac unit. Sadly, this invaluable medical device kit was often mistaken as a dorky fanny pack.

The medpac medical device kit, over time, saved billions of lives and made its medical device manufacturer Athakam Medtech gazillions of dollars; yet, for those who wore this medpac pouch upon their utility belt, a stroll into a cantina could quickly transcend into sheer humiliation. “My dance partner Walrus Man doesn’t like your fanny pack. And come to think of it, I don’t like your goofy fanny pack much either,” said one gruff cantina regular with a tone of a High Noon dust-up.

Even Skywalker’s own father made fun of him. In the climactic final moments of the Battle of Endor, as Darth Vader lay dying in Skywalker’s lap, he looked up at his son and whispered these final dying words: “Nice fanny pack — nerd.”

That hurt.

Of course the injured victims that Skywalker saved didn’t make fun of him. “I know I said I didn’t like you earlier, but thank you for reattaching my pseudopod,” said Walrus Man. Thanks to the medpac’s emergency field surgical instruments (medscanner, spray splints and bandages, flexclamps, synthflesh, irrigation bulbs, bacta patches), the gruff cantina regular and Walrus Man went on to perform magnificently in several galactic ballroom competitions.

So how did medical device manufacturer Athakam Medtech quickly overcome mandatory compliance and overwhelmingly strict requirements of FDA regulations, ISO quality standards, OSHA, SOC and SOX to deliver such a complex collection of medical device products to the galactic market?

Athakam Medtech’s founder Chancellor Gadon Trammer realized that the only way to manage the entire medical device product lifecycle – from regulatory compliance, to global monitoring, quality assurance, risk management and part non-conformance – was through a holistic approach that brought all these moving parts together into a single, unified view. When quality, design control processes, and risk management are embedded as an integral part of the day-to-day product design and development cycle, OEMs can dramatically reduce supply chain oversight, employee missteps and product errors.

The Chancellor turned to Arena’s all-in-one Quality Management Solution, which includes quality, training, document, change, project, and supplier management as well as collaboration tools and product analytics, to expedite compliance approval and maximize business results. How? One big reason why is because everything is tied to the product record.

“Our company uses all tools in Arena’s QMS to establish a regulatory compliant standard work flow for predictable outcomes,” the Chancellor said. “The quality process is great and the engineering change order (ECO) management capabilities are awesome. Arena allowed me to establish a complete quality and risk management solution with streamlined processes to ensure quality for better business results.

Arena provides the Chancellor a comprehensive quality management solution to answer the rigors of compliance, avoid costly mistakes, and maximize his medical device company’s competitive advantage. The entire cross-functional team, including supply chain partners, can now see quality actions, participate in resolving issues quickly, and view quality history.

Even auditors were impressed with the medical device company’s ability to document processes.

“When an auditor comes in, it’s useful to have quality processes tied directly to project tasks,” said the Chancellor. “You can click and show them exactly where you’re at in the project and how much time you expect to complete the CAPA and which aspects of the system you’re touching. Specifically, Arena Training — used for Training Record Management — simplifies audit compliance with easy access and control of training plans, employee records, and training materials in a single system of record for improved visibility, traceability, and efficiency.

Developing a medical device on any planet has always been a complex problem —particularly so with Earth. Manufacturers must continue to drive innovation while facing ever-intensifying business challenges, including the onslaught of fierce competition, the difficulty of managing universally dispersed supply chain teams and an increasing need-to-address quality risks. On top of this already challenging state of affairs, OEMs must also comply with strict and ever-changing regulatory requirements imposed by governing agencies around the galaxy.

While the medical device industry is defined by a number of high hurdles, such as fierce competition and stringent compliance, companies that can overcome these challenges are promised high margins...and vast riches.

“When we launched our new Medpac unit, our competitors laughed at us saying this medical kit looked like a dorky fanny pack,” shared the Chancellor. “But guess what: we’ve sold millions. I’m laughing all the way to the bank.”

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About the Author

John Papageorge
John Papageorge has worked at some of the biggest names in the high tech industry, launching products and programs for companies, such as Oracle, HP, Cisco, and Microsoft. John's passion ... Read More 

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