Star Wars Saga: How Darth Vader’s Suit Met FDA Approval

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FDA ApprovalDarth Vader’s fearsome black mobile life-support suit was manufactured to compensate for the serious injuries Anakin Skywalker suffered after his duel with Obi-Wan Kenobi.

But precious few knew the luninary’s statuesque, gloom and doom outfit—designed with groundbreaking medical device technology—almost didn’t happen.

If the Galactic Empire had not previously met FDA’s stringent compliance approval, the cyborg system would have never shipped to market…and the most recognizable icon of evil the universe has ever known would have never existed.

Vader's life-support system included a chest-worn, 128 bit SSL encrypted, computerized control panel unit that regulated his respiratory functions with a linked breathing apparatus and embedded heartbeat regulator. A ventilating filter in the distinctive mouth grill doubled as an asthma inhaler.

“Vader would sometimes get so worked up over the Rebel Alliance’s shenanigans that he would stomp his feet and hyperventilate,” remembers Emperor Palpatine. “He would curse and wheeze so hard, we thought he was going to blow a lung. So, we made sure to include a device to monitor his breathing.”

The suit also came equipped with a Fitbit, a state of the art activity tracking device, which enabled Lord Vader to calculate the distance he walked, calories burned, floors climbed, activity duration and intensity. “Lord Vader was into the Dark Side, but he was also into fitness and having great abs,” recalls the Emperor. “In fact, he might have had the best abs in the galaxy.”

Product designs for the suit’s frightening look and revolutionary medical device functionality had existed for some time but had repeatedly failed to meet FDA standards. The problem was the Galactic Empire never formalized design control and change management processes. Without a corrective action/preventive action (CAPA) management system and lack of formal design history files (DHFs), device master records (DMRs) and design processes, the evil empire suffered from severe regulatory delays.

“Since we are the Dark Side, I thought intimidating the FDA to expedite compliance approval would be easy,” said Palpatine. “However, the FDA was tougher than we imagined. Their incredibly impudent rep said to me, ‘Listen you overly modulated, breathy sequoia, you can stop with all the blah, blah, blah ‘Dark Side’ claptrap — nothing is more powerful than the FDA.”

“Now, how are those hurtful words supposed to make me feel?” sighed the crestfallen Emperor.

To accelerate FDA approval and meet requirements of other galactic regulatory compliance standards, Palpatine knew he had to rectify the Galactic Empire’s missing or poorly maintained compliance handling procedures and outdated auditing procedures. To achieve this goal, he turned to Arena’s product lifecycle management (PLM) solution.*

For the Galactic Empire, Arena streamlined the management of the bill of materials (BOMs), DHF, DMR, and change orders associated with the suit. And Arena Quality, which is linked to Arena PLM with integrated CAPA capabilities, provided a superior empire-wide approach. “This holistic embedded quality solution offers visibility, cross-functional team collaboration, and long-term tracking of quality resolutions that accelerated FDA approval for Lord Vader’s suit and allowed us to enter mass production ” says Palpatine.

How did the suit become en vogue across the galaxy?

For three years running the Endor edition of GQ magazine voted Vader’s outfit as “Mobile Life Support Suit of the Year.” The ensemble’s sweeping bold lines, industrial gaged breastplate armament, and stylish accessories—gloves, helmet and cape—became the darling of the Galactic Empire’s Fall collection. The rakish outfit had such flair, it also placed ‘Best in Show’ for form, fit and function at runway shows from Paris to Tatooine.

Palpatine bristles when asked what would have happened if the Galactic Empire had not achieved regulatory compliance for the suit in time. “We were resigned to the possibility that Lord Vader would be forced to ride around on either a mall cop Segway, or an even more humiliating cherry red Rascal with a basket in front,” growled Palpatine. “Even if Medicare subsidized the Segway or the scooter, which was doubtful, imagine how degrading that would be. How does one strike abject fear into entire galaxies while brandishing a front basket?”

Fortunately, the Galactic Empire had Arena PLM, which made audits easier and less time consuming; this enabled Palpatine’s team to meet compliance requirements and go to market fast with advanced medical device technology—all while dressed in a killer suit.

*Important Note: Star Wars historians are quick to point out that the Galactic Empire’s medical device division was savvy enough to understand the compliance value of using Arena’s cloud based PLM and Quality to formalize design processes; however, the larger weapons manufacturing division was too set in its old ways, relying on on-premise solutions or outdated spreadsheet and paper based engineering change orders, to change and adopt new software.

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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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