Nicolas Schwenck

I am Dr.-Ing. Nicolas Schwenck, a consultant with over a decade of specialized experience in inhalation devices and drug-device combination products. Since 2024, I have been guiding start-ups and early-stage companies in the development, regulatory navigation, and commercialization of inhalation products. My consulting approach is rooted in aligning technical expertise with strategic business insights, helping companies create market-ready products that meet regulatory standards and align with business goals.

Current Focus: Strategic Consulting for Inhalation and Drug-Device Start-ups
In my consulting practice, I provide a range of services, including:

• Product Development and Market Positioning: I help start-ups identify and translate user needs into clear product requirements, build traceability matrices for regulatory compliance, and enhance operational efficiency with tailored project management methods.
• Business Model and Market Access Strategy: I advise on technology selection (DPI, pMDI, SMI, and smart nebulizers), develop pricing and reimbursement strategies, and build compelling business cases for combination products to attract investors and strategic partners.
• Device Evaluation and Regulatory Strategy for Market Entry: From aerosol characterization for regulatory approval to clinical dose estimation for target populations, I provide data-driven insights essential for successful product launch and regulatory compliance.

Industry Background and Key Roles
Before establishing my consulting practice, I held leadership roles in both the medical device and biotech sectors, where I shaped strategic initiatives and drove product development in the inhalation field:

• Ebenbuild: As Head of Business Development and Strategic Marketing for a digital twin technology applied to respiratory health, I focused on shaping product positioning and market entry strategies for cutting-edge simulation solutions.
• Pieris Pharmaceuticals: At this NASDAQ-listed biotech company in Munich, I was responsible for all aspects of inhalation devices, supporting critical functions such as toxicology, formulation, regulatory, and clinical development for inhaled biologics.
• PARI: I led the Technology Platform Aerosol Physics, pioneering in-vitro and in-silico methodologies to improve respiratory therapies. In this role, I also managed PARI’s nebulizer portfolio based on eFlow Technology, collaborating closely with pharmaceutical and biotech partners to align product innovation with market needs.

Academic and Research Foundations
My technical foundation is rooted in a PhD in Aerospace Engineering from the University of Stuttgart, where I focused on simulation software development for fluid mechanics. I conducted research at KTH Stockholm, TU Vienna, and the University of Bergen, and have held guest lecturer positions at the University of Stuttgart and the German University in Cairo.

I’m dedicated to supporting the next generation of inhalation and drug-device start-ups in overcoming the technical, regulatory, and strategic hurdles they face on the path to market. If you’re interested in learning more about how my consulting can help your venture succeed in the inhalation space, please feel free to reach out.