Xena Innova

Bringing Cutting-Edge Solutions to Life

Clinical research and digital health consulting

Helping pioneering investors and companies transform bold health innovation into scalable, operational excellence

✓ We know the current playbook is outdated.✓ The future of health innovation demands bold thinking — but bold doesn’t mean sloppy.✓ Investors and companies need partners who see the future clearly — and know how to operationalize it today.✓ Data is important — but it’s nothing without execution.✓ The winners in this space will be the ones who bridge bold ideas with operational discipline — and that’s exactly where Xena Innova operates.

Denise Bonet

I’m Denise Bonet, a clinical research and digital health expert who doesn’t just consult—I build, execute, and lead from experience. From securing first-of-its-kind FDA approval for a prescription digital therapeutic to designing the playbook for decentralized trials before they were the norm, I’ve worked at the cutting edge of health innovation—and I’m here to help you do the same.

Services

Expert Consulting at the Intersection of Clinical Research, Digital Health & Operations ExcellenceI offer high-impact consulting services designed for health tech startups, digital therapeutics innovators, investors, and established organizations seeking to optimize their clinical research, product development, and operational workflows.What makes my approach unique is my real-world execution experience—I don’t just advise; I’ve built the strategies and executed them from the ground up, giving you solutions that actually work in practice, not just on paper.

What I Do for Clients

Whether you’re a startup preparing for your first clinical trial, a digital health company navigating regulatory readiness, or an investor evaluating a health tech portfolio, I bring:✓ Clinical trial design & operational excellence✓ Custom regulatory strategies for digital health & DTx✓ Due diligence support for health tech investors✓ Operational audits & process optimization for portfolio companies✓ Digital health strategy & product development consulting✓ Financial oversight & budget guidance for clinical and tech projectsI’m not just a consultant—I’m your hands-on partner, turning strategy into action and innovation into impact.

Are you ready?

Schedule a Call

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© Xena Innova, LLC 2025. All rights reserved.

Services

  • ✓ Due Diligence for Health Tech Investors & VCs

  • ✓ Operational Audits & Process Optimization for Portfolio Companies

  • ✓ Digital Health & Digital Therapeutics Strategy

  • ✓ Clinical Trial Readiness & Execution Consulting

  • ✓ Innovation Advisory for Health Tech Founders

  • ✓ Wellness & Leadership Consulting for Organizations

Due Diligence for Investors

Helping VCs & investors make smarter health tech bets

Before you invest in a health tech startup, you need more than a pitch deck—you need someone who’s actually managed clinical trials, regulatory submissions, and product development to de-risk your investment. I provide deep-dive assessments of clinical trial design, operational feasibility, regulatory readiness, and product-market fit for digital health, medtech, and therapeutics companies.

Operational Audits & Process Optimization

Leveling up clinical & digital health operations for better outcomes

Whether you’re a startup scaling fast or a digital health company refining your clinical workflows, I bring firsthand operational expertise to audit, streamline, and optimize your processes—from trial execution to data collection, compliance tracking, and digital tool integration.

Digital Health & Digital Therapeutics Strategy

From concept to clinical & regulatory success

I guide companies in the end-to-end development and optimization of digital health products, including digital therapeutics (DTx). This includes clinical strategy, regulatory pathway development, digital measure validation, UX/UI refinement, user testing, and real-world evidence planning—all tailored to the evolving FDA and global regulatory landscape.

Clinical Trial Readiness & Execution Consulting

Clinical trials that are efficient, compliant, and future-ready

I work directly with clinical teams to design, prepare, and optimize clinical trials—blending traditional trial management best practices with cutting-edge digital tools like AI, wearables, remote monitoring devices, and digital biomarkers. Whether you’re a first-time sponsor or an established player adopting digital innovations, I help you run smarter, faster, and more compliant trials.

Innovation Advisory for Health Tech Founders

Bridging the gap between clinical, technical, and business success

For early-stage founders building digital health, medtech, or digital therapeutics solutions, I offer expert advisory on:✓ Clinical and regulatory strategy✓ Product development aligned with evidence needs✓ Operational playbooks for clinical integration✓ Startup-friendly processes to balance speed & compliance✓ UX, UI, and UAT guidance grounded in real clinical use cases

Wellness & Leadership Consulting(Optional/Hybrid Offering)

Because health innovation starts with healthy leaders & cultures

As a mindfulness advocate and breathwork coach-in-training, I offer optional workshops, leadership retreats, and wellness programming for companies and teams looking to cultivate resilience, creativity, and well-being—especially critical in high-stakes clinical and health tech environments.

Need something custom?

Every client and every challenge is unique. Let’s design a consulting package tailored to your goals—whether it’s a short-term project, ongoing advisory, or a deep-dive operational partnership.Ready to explore how we can work together?

Are you ready?

Schedule a Call

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About Me

With 12+ years of hands-on experience in clinical research operations, digital health innovation, and end-to-end project leadership, I’m not your average consultant. I’ve executed at every level, conducting patient assessments, leading global trials, directly managing site operations, and integrating cutting-edge digital tools—while also steering high-level strategy, budgets, and regulatory compliance.What sets me apart?
I’ve been in the room where strategy is made—and on the ground where it’s executed. From working with patients to collaborating with sponsors, CROs, startups, and regulators to personally designing frameworks that shaped new industry standards, I’ve done it all—and I bring that real-world, end-to-end experience to every client.

Digital Therapeutics Trailblazer

I was part of the core team responsible for gaining FDA authorization for one of the first-ever prescription digital therapeutics (DTx) to treat ADHD in children—a groundbreaking achievement that helped set the stage for how digital therapies are evaluated and regulated today.As we built the clinical evidence package for this digital therapeutic, I led the development of a custom DTx-specific Trial Master File (TMF) structure—designed entirely from scratch because, at the time, neither the FDA nor the TMF Reference Model had established any formal guidance for digital therapeutics. This bespoke TMF became a cornerstone for successful audits and ultimately supported the regulatory submission itself.Recognizing the future of digital therapeutics would rely heavily on remote data collection and real-world evidence, I also played a leading role in designing and operationalizing decentralized clinical trials (DCTs) for our DTx programs. This included:✓ Creating sponsor-initiated decentralized trial models✓ Writing the SOPs and workflows that governed these remote-first studies✓ Incorporating remote patient monitoring, digital endpoints, and ePRO tools directly into the trial designThis combination of digital product strategy, clinical trial innovation, and regulatory pioneering gives me a deeply unique lens that blends theory and practice, ensuring my clients’ DTx programs are designed not just for regulatory approval—but for operational success in real-world settings.

Digital Health Innovation at Scale

At Johnson & Johnson, I expanded my expertise beyond clinical trials into the evolving world of digital health technology. My work spanned:☞ Wearables and remote monitoring tools to capture real-world data☞ Infrared technology and radio wave-based monitoring devices for novel health measures☞ App-based platforms designed to develop and validate digital biomarkers and digital outcome measures☞ Collaborations with startups to guide their product development, user experience (UX), user interface (UI), and user acceptance testing (UAT)—helping translate innovative ideas into clinically and commercially viable products.This holistic perspective—from clinical operations to product development—means I don’t just advise on what’s possible; I show you exactly how to get it done.