7 Hard Lessons: Scaling a Biotech Startup: What Every Founder Should Know
- Donald Munroe, Ph.D.
- Apr 10
- 6 min read
Updated: Apr 15
Donald Munroe, Ph.D.
Edgewater Talent Advisory Board Member & Principal, Stratagem Healthworks, LLC
Scaling a startup isn’t just about growing headcount, raising capital, or hitting revenue targets - it’s about navigating unexpected challenges at every stage.
Whether you’re an entrepreneur preparing for your Series A, a biotech founder aiming for FDA approval, or a senior leader transitioning from startup chaos to corporate stability, the playbook changes as you scale.
At a recent Anchor Ventures panel discussion, held with experienced biotech executives at the newly opened 4 MLK facility at the University of Maryland Baltimore, I listened to honest reflections on what really matters when growing a company and building it for success.
My insights from the conference are the key dealmakers and deal breakers and are highlighted below. As leadership and talent consultant in R&D and a senior leadership executive coach, I submit that these keys and essentials apply beyond biotech; in fact, these pivotal points apply to any high-growth, high-stakes industry where funding, regulation, and innovation collide.
Here are 7 essential lessons every founder should take to heart:
✅ Evolve your leadership style as your company grows.
✅ Master investor storytelling—fundraising is about business viability, not just science.
✅ Prioritize team alignment over raw talent—culture matters.
✅ Understand where you thrive—startups and corporations require different leadership skills.
✅ Prepare for M&Along before it happens—due diligence is grueling.
✅ Have the humility to step aside when the time is right.
✅ Embrace uncertainty—there is no finish line.
1. Scaling is a Leadership Transformation—Not Just Business Growth
Many founders believe that scaling is about adding more people, raising more money, and expanding operations. The truth? Scaling is a complete transformation of leadership.
What works at 10 employees will break at 200—and fail at 2,000.
A great early-stage founder thrives in chaos, but as the company scales, structure and process become essential.
Decision-making must be distributed—if everything still runs through the CEO at 500+ employees, the company will stall.
One founder shared how they struggled to let go of hands-on decision-making. But once they focused on empowering their team, everything changed.
Key takeaway: Your leadership must evolve as your company grows, or you’ll become the bottleneck to your own success.
2. Science Alone Won’t Convince Investors—You Need a Business Model
Founders in deep tech and biotech often believe that breakthrough science will automatically attract investors. That’s a dangerous assumption.
Investors don’t just want great technology—they want a viable business with a clear path to market.
A commercialization and reimbursement strategy is just as important as clinical validation.
A clear regulatory roadmap is critical—FDA approval isn’t a given.
Investors want financial projections, not just scientific potential.
One panelist admitted they initially underestimated how much investors cared about business execution. Once they focused on mapping out revenue models, regulatory pathways, and market adoption, fundraising became much easier.
Key takeaway: You’re not just pitching a breakthrough—you’re pitching a business.
3. Hiring the “Best” People Isn’t Enough—You Need Alignment & Loyalty
Many founders believe that hiring the smartest and most talented people will guarantee success. That’s not enough.
Misaligned teams destroy startups faster than bad technology.
Loyalty and cultural fit matter just as much as expertise.
A team full of “rockstars” who don’t share the vision will tear the company apart.
A founder on the panel shared how misaligned leadership nearly sank their company. They had recruited top-tier executives, but internal power struggles and clashing priorities created dysfunction. Once they rebuilt the leadership team around alignment, growth accelerated.
Key takeaway: Don’t just hire for skills—hire for alignment, trust, and shared vision.
4. Startup vs. Corporate Leadership: Two Completely Different Games
Many founders dream of growing their company into a large, industry-defining player. But what they don’t realize is that big corporations and startups operate on completely different rules.
Startups reward risk-taking, agility, and creativity.
Corporations value structure, predictability, and stability.
The things that make a great startup CEO (breaking the rules, rapid experimentation) will get you fired in a corporate setting.
One former startup CEO described his post-acquisition experience:
“I went from making big, bold decisions every day to sitting in meetings, waiting for approvals, and navigating bureaucracy. My energy just drained.”
If you thrive on autonomy, innovation, and high-risk decisions, a corporate environment may not be for you.
Key takeaway: Know where you thrive, don’t force yourself into a corporate role that doesn’t fit.
5. Acquisitions Aren’t Quick Deals—They’re Long, Grueling Processes
Exits don’t happen overnight. A successful acquisition takes years of preparation, relationship-building, and due diligence.
One founder’s first meeting with their acquirer happened a year before the deal was finalized.
Due diligence is brutal—expect months of financial, legal, and compliance reviews.
Bringing in a strong CFO or legal counsel can make or break a deal.
A common M&A mistake? Underestimating how much work it takes. Founders think, “We’ll get acquired, and everything will fall into place.” In reality, the real work starts after the deal is signed.
Key takeaway: If an acquisition is in your future, start preparing today.
6. The Best Founders Know When to Step Aside
One of the hardest, but most important, decisions a founder will face is knowing when they’re no longer the right person to lead.
Early-stage founders are visionaries, but scaling requires operators and execution specialists.
Holding on too long can slow down growth and hurt the company.
A strong leader hires their own replacement when the time is right.
One panelist shared how they stepped down voluntarily after realizing their company needed a different type of CEO to scale beyond 2,000 employees. They focused on ensuring a smooth transition, which ultimately helped the company succeed long-term.
Key takeaway: Being a great founder doesn’t mean being CEO forever. The best leaders build companies that can thrive without them.
7. Uncertainty Never Ends—Get Comfortable with It
Many founders assume that once they raise their Series A, land their first big partnership, or achieve profitability, the uncertainty will go away. It doesn’t.
Uncertainty is a permanent feature of leadership—whether you’re running a 10-person startup or a Fortune 500 company.
The best founders learn to thrive in ambiguity—they make decisions with incomplete data and adapt as they go.
Every major milestone just leads to the next set of unknowns.
One panelist put it best:
“The moment you think you’ve ‘figured it out,’ something changes. The key isn’t eliminating uncertainty—it’s learning how to operate despite it.”
Key takeaway: Uncertainty never goes away -your ability to navigate it improves.
Growing a startup into a high-impact, high-value company isn’t about just working harder. It’s about making the right strategic moves at the right time.
Author’s Disclaimer:
This white paper is based on the author’s personal notes and understanding of a panel discussion featuring industry professionals. The insights, views, and interpretations presented herein are solely those of the author and should not be construed as official statements or positions of any individual panelist, their respective organizations, or the panel’s moderator. While every effort has been made to ensure accuracy, any reference to the panel’s discussions or participant remarks is provided strictly for informational purposes. The author does not claim representation or endorsement by the featured panelists or their organizations, nor is the author liable for any differences between the content provided and actual statements made by these individuals. Any mention of specific products, strategies, or outcomes is illustrative only and does not constitute legal, financial, or professional advice. Readers are advised to seek their own professional counsel when making decisions based on the content of this document.
Donald G. Munroe, Ph.D.
LEADERSHIP CONSULTANT & EXECUTIVE COACH
Dr. Donald Munroe is a distinguished healthcare executive with over 20 years of executive-level experience in diagnostics, life sciences, and AI-enabled clinical workflows. As an Advisory Board member for Edgewater Talent, he also serves as an Executive Coach, playing a pivotal role in mentoring newly placed executives through their critical first six months and shaping strategic talent
recruitment for leading healthcare organizations.
He is the Founder and Principal of Stratagem Healthworks, LLC, an advisory organization uniquely positioned to empower diagnostics, biotech, and AI-driven companies by crafting disruptive innovation strategies and multi-year roadmaps that drive adoption and value realization. In addition, his executive mentoring and fractional (Ad Interim) leadership roles offer critical support
during periods of transformation, ensuring organizations achieve lasting impact in tandem with continued growth and business success.
Dr. Munroe’s expertise in business transformations and turnarounds has consistently driven breakthrough outcomes and operational excellence, delivering multi-year product and technology roadmaps, leading global R&D at scale, and architecting user-centric solutions. He is an expert in defining and executing product strategy, technology roadmaps, and lean-agile development,
while fostering cross-functionally high-performing teams and operational excellence. He has deep experience in building strategic clinical and academic partnerships, with a customer-centric approach that accelerates adoption and drives measurable commercial success.
Prior to founding Stratagem Healthworks, Dr. Munroe held senior positions at Fortune 500 Life Sciences sector leaders, including Becton Dickinson, Roche Diagnostics, Beckman Coulter, and Johnson & Johnson, as well as leadership roles with innovative mid-
cap and micro-cap companies, namely, Invitrogen and Vermillion.
Stratagem Healthworks, LLC
Tel: +1(760) 613-2013
Website: www.stratagemhw.com