Resources

Working in Regulated Industries

Build confidence that you can navigate added complexity.

Purpose

If you’re working in a regulated industry, the best thing you can do is not be afraid of regulatory requirements. Ignore doomsayer consultants and lawyers –and learn where regulations have gray areas that can be nudged, and where safety and trust require firm lines that shouldn’t be crossed.
Working in regulated industries can be great – you get a moat and customers who respond to specific selling points. Don’t underestimate the competitive advantage you can create through regulatory expertise.
Using a responsible innovation lens means less chance of existential risks that come from conflicting with the hard boundaries of regulatory frameworks.
Demonstrating awareness of regulatory issues establishes credibility with investors, customers, and other partners.

Method

Map environment
Map your regulatory environment comprehensively. Identify global, federal, state, or local regulations that apply to your product, service, and business model across target market. Leverage AI tools where possible.
Note precedents
Study regulatory precedents in your space. Research how similar companies have navigated compliance, what approvals they needed, and how long processes took.
Proactive engagement
Build relationships with regulatory bodies early. Regulators can provide valuable guidance and prevent costly product redesign later.
Inform product roadmap
Include approval processes, licensing requirements, and compliance timelines in your product roadmap.
Shape sturdy foundation
Build compliance into your product architecture from the start; retrofitting compliance is exponentially more expensive. Build a culture of regulatory awareness so engineering, product, sales, and marketing teams understand how regulations impact their work.Be intentional with early-stage decisions about data handling, record keeping, and operational procedures which will impact your ability to scale efficiently.
Scale your knowledge
Use industry associations and working groups to scale knowledge quickly. Join organizations that advocate for your industry and provide regulatory updates and best practices.
Maintain good information
Recruit advisors with regulatory expertise in your specific industry who can provide ongoing guidance.
Demonstrate to customers
Before launch, develop compliance-focused customer education to help customers understand how your solution meets their regulatory requirements.

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Trap Doors

Pattern recognition for potential pitfalls.

Don’t forget to…
Don’t forget to budget for compliance costs. Include legal fees, consultant costs, application fees, and ongoing compliance expenses to make sure you don’t run out of runway.
Document early..
Create systems to track product development decisions, testing results, and compliance activities for regulatory submissions. Having to recreate the past is a waste of time and puts you at risk in an audit.
Many underestimate…
Many founders underestimate regulatory scope or believe their innovative approach exempts them from existing rules. While "ask for forgiveness, not permission" works for some companies, in healthcare, for example, this approach can be catastrophic.
Time and money both…
Time and money both matter for startups. Don’t underestimate regulatory timelines. Approval processes often take 2-3x longer than initial estimates, and delays can kill startups with limited runway.
Build some internal..
Build some internal expertise on regulatory frameworks to guide day-to-day decision-making. Too many companies rely solely on external consultants who simply aren’t always available when you need them.

Founders + Operators

Participate in workshops and learning experiences that help you survive and grow. Connect with values-aligned peers. Shape how startups impact society.

Founders + Operators

Participate in workshops and learning experiences that help you survive and grow. Connect with values-aligned peers. Shape how startups impact society.

Don't assume regulatory approval equals market success.

Meeting regulatory requirements is necessary but not sufficient for building a successful business.

Cases

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Tools

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Coming Soon!

Who to Enlist

Advisors familiar with the industry can provide guidance

Talk to other founders working in the space to learn from their experience. They will likely have tools, contacts, and some battle scars to share.

Investors often join the cap table of companies where they have some industry expertise. In investor updates, ask if anyone has relevant experience.