Karen Maduschke, Principal of ClinTech Strategy Partners

I've Lived Your Journey

Many health tech founders are brilliant engineers or scientists with limited understanding of clinical research or pharma purchasing.

Or they come from biopharma but don't grasp startup constraints or commercial strategy.

I've been in both camps.

In 2005, I joined a small Maryland startup building what would become the world's first interactive electronic informed consent product for clinical trials—solving a real problem with paper consent forms that were error-prone, tedious, and holding back research.

With a health communication degree and some tech savvy, I did a bit of everything: content entry, client training, product documentation, testing. It took us three years to launch our first study. Three years of regulatory hurdles, pharma skepticism, and learning what "audit-ready" actually means.

But we figured it out. We built trust. We proved the concept. Fast-forward: by 2015, our product was deploying across the US and EU with top-tier pharma.

📍 Meet me at health.tech global summit — Basel, March 3-5, 2026 Schedule a Meeting

The Transformation

After moving to Germany and a brief detour into corporate communications,
I was recruited back to SecureConsent in 2016

The eConsent business was rapidly expanding in Europe and needed someone who understood both the technology and the European landscape. We were also positioning for sale. By the end of 2016, DrugDev acquired the product. I continued to lead customer engagement as we navigated this integration and expansion. Within a year, we took another huge leap, as DrugDev was acquired by IQVIA.

In 2020, I took over P&L leadership of a business unit that was breakeven, operationally chaotic, and struggling with morale after two M&A transitions. The pandemic hit the same month I took the reins.

What happened over the next 4 years:

  • Transformed the business leveraging Lean Six Sigma and Kaizens to identify over 800K in time & cost efficiencies
  • Launched a re-engineered product, migrated a decade of data to a new global hosting infrastructure, built integrations across numerous clinical trial technologies
  • Turned around a struggling P&L from breakeven to tripled revenue with double-digit EBITDA margins
  • Elevated customer satisfaction to a highly positive NPS while restructuring pricing and renegotiating MSAs
  • Elevated employee engagement from under 60% participation to over 90% participation and satisfaction
  • Expanded into Asia hiring Japanese & Chinese-speaking staff in Tokyo and promoting team members in India and the Philippines to meet growing market opportunities in APAC
  • Earned a CEO Award for Operational Excellence for significant business impact and team development
  • Trained 40+ PMDA regulatory inspectors on eConsent audit processes (Japan, 2024)—one of very few Western consultants trusted for this role

The secret? I didn't do it by being the smartest person in the room. I did it by listening attentively, connecting and encouraging isolated teams, and building systems that made excellence the default - all while leading through influence in a matrix organization where I didn't directly control sales, commercial, or engineering.

"I didn't succeed by being the smartest person in the room. I did it by listening attentively, connecting and encouraging isolated teams, and building systems that made excellence the default."

Why I Do This Now

I chose consulting because this is where I do my best work — focused entirely on the strategic and operational puzzles I've spent two decades learning to solve.

I love this work. I love mapping the path to a first pharma pilot when everything feels impossibly complex — and helping ensure start-to-finish customer satisfaction once you're in the door. I'm energized by the problem-solving, not exhausted by it, because 20 years of pattern recognition combined with continual learning and leveraging AI tools, means I get to answers faster than brute-force hustle ever could.

I'll fly to Basel, Boston, or Tokyo when the work demands it. I'll put in long, intense days during critical phases. But I've also learned — the hard way — that sustainable performance requires balance, and I bring that same philosophy to how I advise founders. Sprint when you need to. Recover so you can sprint again.

What you should know about working with me: I lead with questions, not assumptions. I'll push back when your timeline is unrealistic and celebrate with you when you hit a milestone that seemed beyond the horizon. I communicate candidly but always with respect and genuine investment in your success. I've built and led diverse, global teams across the US, Europe, and Asia, and I believe the best strategies come from listening to the people closest to the problem.

I've sat in rooms where I was the only woman, the only non-technical person, or the only one willing to say "this isn't working." If you've ever felt like an outsider trying to break into an insider's game — I understand that, and I can help you navigate it.

"I'll tell you if you're not ready, if your timeline is unrealistic, or if we're not a fit. Because honesty, integrity and relationships matter."

My Approach

A phased, milestone-based model that protects your investment while building the foundation for sustainable market success.

Start with Honest Assessment

I'll tell you if your launch goal is unrealistic—and explain what's actually achievable. Unvarnished candor up front saves you from burning bridges with prospects you're not ready for.

Phased Engagements with Decision Gates

Most comprehensive projects are structured in 2-3 phases. After each phase, you decide whether to continue. This protects your investment and allows you to course-correct based on what we learn.

Milestone-Based Deliverables

Every investment must deliver tangible value. You receive clear, concrete deliverables at each milestone—you know exactly what you're paying for, when you'll receive it, and how to use it.

Evidence-Based Recommendations

My recommendations are grounded in market research, competitive intelligence, and decades of pattern recognition across clinical technology markets. I show you the data, build the models, and help you make informed decisions.

Building Your Internal Capability

I guide strategy and provide expert direction while your team executes. This approach manages costs effectively while empowering your organization to build sustainable capabilities that continue delivering value long after our engagement.

Partnership, Not Just Consulting

Your success is my success. I'm invested in helping you achieve your goals and will bring everything I've learned over 20+ years to help you get there.

Let's Talk About Your Market Entry Strategy

Start with an introductory call. We'll discuss where you are on your unique journey, what's realistic, and whether we're a fit to work together.

Schedule a Call