Issue 2 – The FDA’s ‘least burdensome’ approach applies to your start-up. Yes, YOURS

Doing more doesn’t mean reaching your milestones faster, you may feel like you’re making progress but you’re really just running to stand still. In this issue, I explore lean thinking through the lens of what most assume is a very un-lean organization, the FDA. Welcome to BIG talk.

Carlo Odicino, CEO at One TEAM Partners

October 11, 2023

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There’s a reason the FDA’s Least Burdensome provision exists…

(link: The Least Burdensome Provisions: Concept and Principles)

For those who are unfamiliar with the guidelines, it recommends that FDA personnel ask for exactly what is required to answer a question or resolve an issue, and no more.

This guideline simplifies the device approval process to achieve one of the FDA’s primary goals: providing patients with timely access to high-quality, safe, and effective medical devices.

A strategy like this – one which exists to resist corporate bureaucracy – enshrines a number of strong business principles that all businesses, but especially start-ups, could learn from.

From only tackling what is necessary now (rather than what might be required in three milestones’ time), to using your mission to guide strategic decisions, to working hard to find simplicity, the least burdensome approach is how all start-ups should be operating.

Let’s unpack why.

Lesson 1: Invest in exactly what is required, and no more

I see it all the time. A start-up builds out infrastructure and processes for the organization they hope to become, not the organization they are right now. Typically, it’s because they think it’s a hack to achieve profitability faster than the rest.

The mindset is “If we go big early – if we hire someone with a big company background to implement a big company strategy, we’ll get there faster.”

It’s these start-ups that most often find themselves in hot water because they’ve grown prematurely.

Start-ups should be embedding least burdensome thinking into investment decisions; they should build for where they’re at now, and no more.

Life sciences start-ups in particular are slightly irregular in that they typically see a larger investment up front. But just because you have the money, doesn’t mean you need to spend it. Of course, have a strategy to scale in your back pocket in case success comes quickly, but don’t act on it until the data tells you to (and that means more than one positive data point). This will de-risk your growth and avoid creating a cycle of doubt if/when milestones are missed.

On why start-ups are tempted into jumping two steps ahead, Kristina Kenney – a Principal Consultant at One TEAM Partners – explains…

“Efficiency is the start-up buzzword of the decade. Many believe – largely because of the boom of tech – that efficiency paves a path to success. They think that if you can fit more into a day/month/quarter, you will arrive at your desired destination faster. This kind of thinking can be very dangerous in a start-up. It can lead C-Suites to invest in solutions that promise to improve efficiency, possibly very expensive solutions when the organization isn’t ready for them. Or simply doesn’t need them yet.”

Lesson 2: Trust your people and your mission

The Least Burdensome provision is the FDA’s attempt to side-step bureaucracy, to allow itself the best chance of achieving its mission. There’s a lesson for start-ups in this.

In my experience, bureaucracy happens when an organization tries to funnel all decision-making through a centralized point (and often high up in the organization). Organizations, especially start-ups, should instead be asking themselves who the best person to make a decision is and allowing them to do so. Of course, there should be checks and balances, but you want to minimize them and drive decisions to the lowest appropriate level that is closest to the day-to-day work. In most cases, the subject matter expert should be empowered to make the call.

“This is also a prime example of an organization allowing itself to be led by its mission,” adds Melissa Fackler, One TEAM’s Marketing Lead. “The unique responsibility of the FDA to deliver safe innovations to the public in a timely manner (its mission) has forced it to be better than the status quo; that is, becoming bureaucratic like many organizations of that size often do.”

Start-ups should take a page out of the FDA’s book and think creatively – innovatively – about their processes. Is it helping you achieve your mission? Is there a smarter, safer AND less burdensome way of achieving it? If so, why aren’t you doing it?

Lesson 3: Simplicity over complexity

This brings us to the final lesson: prioritizing simplicity over complexity.

Folks use the excuse “It’s very complex” too often. So what? That just means it’s going to take more effort to simplify. Simplicity is how you become a better operating organization. It’s quite easy to make something complex. It’s actually harder to take something that’s complex and make it simple.

Take an elevator pitch, for example. It’s easier to describe your innovation in 6000 words than 60, but is it as good at starting investor conversations?

Simplification is difficult because, to simplify something, you first need to understand it. You need to know how it works, why it exists, who is involved, and all of the nuance surrounding it. All too often, organizations hide behind – or throw money at – complexity. Start-ups don’t have that luxury, or at least they shouldn’t.

A least burdensome approach is one way to do this. As One TEAM’s Managing Partner, Geoff Parker puts it, “FDA regs aren’t only about safety and efficacy – there are good business principles in there too. Start-ups from all industries have something to learn from this agency’s strategy”.

If what I’ve said in this newsletter resonates – perhaps you’re the leader of a start-up facing some of the issues I’ve described, or perhaps you’re keen to avoid them – feel free to reach out via our website, or here on LinkedIn.

Working with C-Suites of early-stage companies is One TEAM’s niche. In fact, we’ve developed an intensive program specifically for you and your company. The LifeSciences Breakthrough Accelerator drives meaningful and lasting results into your organization in just 16 weeks. The results include:

  • Saving an estimated $1.5 – $3M over the next 3 years
  • Hitting milestones with money and a strategy to reach the next one
  • Better work-life balance for YOU and your people

Learn more here.


BIG talk. How C-Suites of life sciences start-ups get big sh*t done.

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What if C-Suites sidestepped the small talk; the fluff that keeps them busy at being mediocre? What if, instead, they focused on the BIG stuff that’ll make their organization thrive? BIG talk is here for exactly that.

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