Learning from OceanGate: Safety and innovation are not mutually exclusive

In June of 2023, many of us waited anxiously for news of the Titan submersible carrying 5 passengers on a voyage to the depths of the Titanic wreckage. While we waited for details, old profiles and news articles featuring Stockton Rush, the CEO of OceanGate, were found and circulated on the internet, surfacing quotes like “You know, at some point, safety just is pure waste.”

It later emerged that warnings from industry experts were purposefully ignored before the Titan took its final voyage and that the company had intentionally sidestepped commercial submarine regulations by operating in areas where they did not have to comply.

“Bringing an outside entity up to speed on every innovation before it is put into real-world testing is anathema to rapid innovation.” Another gem from Mr. Rush.

Instead of following the internationally recognized rules for the design and construction of manned submersibles and certifying the craft through DNV, the company relied on the fact that the Titan had made some (mostly) successful trips over the previous two years as proof that their innovative design was fit for use. 

Rush and OceanGate pitted innovation against safety. And they lost.

Technology’s influence on life sciences

Many industries – not just deep sea exploration – are taking a page from the tech industry’s “move fast and break things” ethos, and the life sciences industry is not immune. There is an inherent tension between the desire for breakthroughs (great outcomes) and the need for safety (processes and regulation), but innovation vs. regulation is a false dichotomy. Regulation does not exist to stifle innovation – it exists to ensure that innovation reaches patients safely. 

The view that regulation stifles innovation is most explicit in MedTech, especially since the rollout of the EU Medical Device Regulation (MDR) in 2017. Companies are calling the MDR a “disincentive against launching medical device innovation in the EU,” perhaps forgetting that the MDR was established because of patient-impacting issues with defective medical devices. 

Similar arguments are made about the FDA – that the agency moves too slowly and is keeping innovative and life-changing products from patients. But when you start to look beneath the surface of these claims, you see the delays were caused by the companies’ attempts to take shortcuts, adding unnecessary risk.

Think polarity, not conflict

The bad news: there is no easy fix, no checklist of things to tick off. Operating in life sciences today means CEOs have to shift their mindset. Companies must stop viewing safety and innovation as mutually exclusive and start understanding how to incorporate safety into their innovation. 

Innovation and safety are a polarity – two seemingly opposed concepts that need to be balanced so that you gain the upsides and limit the downsides of both. It’s both/and, not either/or.

Once your company culture incorporates this mindset, more benefits may appear. While counterintuitive, there are multiple studies showing that constraints actually improve innovation. When there are no constraints, two things can happen: 1) products get overly complicated, or 2) people follow the path of least resistance, picking the first idea that comes to mind.

CEOs have to reframe the constraints of regulation and a safety-first, process-driven approach as creative challenges. The fact is that the only way to get repeatable outcomes is through the process because these approaches encourage the learning and depth of understanding that improve the quality and consistency of outcomes. 

When companies are able to use constrained innovation to their benefit, they will drive to long-term success.

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