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Suttons Creek Expands Technical Expertise to Support Growing Combination Product Demand
As pharmaceutical and biologics companies continue to advance drug–device combination products at an unprecedented pace, the need for experienced, hands-on technical expertise has never been greater. In the second half of 2025, Suttons Creek strategically expanded its technical team with the addition of several seasoned combination product specialists, each bringing deep, practical experience across development, regulatory, quality, and execution.
These hires were not made in anticipation of growth alone; they were made in direct response to client needs we were already seeing across 2025. As more sponsors entered combination product development for the first time, and as existing programs accelerated toward critical regulatory and clinical milestones, our expanded team played a key role in helping clients reduce risk, clarify strategy, and maintain momentum.
As we move into 2026, this depth of expertise positions Suttons Creek to support even more clients with confidence, clarity, and executional rigor.
Strengthening Execution Where It Matters Most
The following technical experts joined Suttons Creek in the latter half of 2025, each contributing immediately to active client programs while helping build the foundation for future success:
Michael Koucky
Principal Consultant | Device Engineering Specialist
Michael brings more than a decade of extensive experience supporting drug–device programs across design, development, and execution, particularly where early technical decisions have downstream regulatory and lifecycle implications. His expertise spans product architecture, verification and validation, and design control implementation for global medical device and combination product programs. Michael’s background enables him to bridge engineering considerations with broader program strategy, helping teams avoid common pitfalls that lead to rework or delays.
In 2025, Michael supported multiple client programs navigating early device definition and design controls, helping teams translate high-level requirements into actionable development plans.
“Michael brings a rare ability to connect technical detail with big-picture program risk. His impact on our client teams was immediate.”
— Konrad Walzer, Technical Director
Sarah Mollo, PhD
Principal Consultant | Regulatory Specialist | Former FDA
Sarah’s addition to the Suttons Creek team brought a particularly valuable perspective: first-hand experience from inside the U.S. Food and Drug Administration. Joining us following her tenure as a FDA reviewer and product jurisdiction officer, Sarah offers clients direct insight into how regulators evaluate combination product decisions—what questions they ask, where risks tend to surface, and how expectations are applied in practice.
Throughout 2025, Sarah supported sponsors preparing for regulatory interactions, strengthening submissions, and pressure-testing development strategies against real-world regulatory scrutiny.
“Sarah’s FDA background fundamentally changes the conversation with clients. She helps teams see their programs the way regulators do—before it’s too late to adjust.”
— Jeff Kim, Senior Principal Consultant & Associate Director of Quality Systems
Jin Kim
Senior Project Manager
Jin brings more than a decade of program management experience spanning the medical device, healthcare, and pharmaceutical industries, with a career focused on guiding complex products from early concept through commercialization. Her work centers on medical devices developed in highly regulated environments, where disciplined execution, cross-functional alignment, and quality-driven decision-making are critical to success.
As a project manager at Suttons Creek, Jin guides multidisciplinary projects through the full lifecycle of combination product development. Her deep familiarity with FDA and international quality system requirements enables her to support project teams in navigating complicated client challenges while maintaining forward momentum.
Throughout 2025, Jin played a key role in helping client teams progress through development complexity by building practical processes, aligning stakeholders, and ensuring that day-to-day execution is moving ahead according to plan, timeline and budget. Known for her collaborative leadership style and hands-on problem-solving approach, Jin helps teams stay focused and maximize project resources.
“Jin brings structure and clarity to some of the most complex programs we support. Her ability to manage stakeholderswhile keeping progress moving is invaluable.”
— Mickey Burg, Associate Director, Program Management
Alex Spivak
Principal Consultant | Systems Integration and Program Management Specialist
Alex brings broad experience across combination product development, with particular strength in cross-functional execution and technical problem-solving. He has led global cross-functional teams in program strategy, vendor oversight, and design history file integration, helping clients streamline execution from concept through market launch. His background enables him to work seamlessly across engineering, quality, and program teams, helping clients maintain alignment as complexity increases.
During 2025, Alex supported multiple fast-moving programs where coordination across vendors, internal stakeholders, and technical disciplines was critical to staying on track.
“Alex thrives in complex environments. He brings structure, clarity, and forward momentum when programs need it most.”
— Albana Thorpe, Technical Director
Parth Kothari
Senior Principal Consultant | Development and Commercialization Specialist
Parth adds strong program leadership and technical depth in the combination product space to the Suttons Creek team, with over thirteen years of experience supporting product development, regulatory compliance, and continuous improvement implementation across regulated environments at global pharmaceutical and medical device companies. His approach helps clients evaluate tradeoffs early, before assumptions become costly commitments.
In 2025, Parth worked closely with client teams evaluating device options and development pathways, helping them build defensible, realistic strategies aligned with clinical and regulatory goals.
“Parth consistently helps teams ask the right questions early. That insight saves time, cost, and frustration later.”
— Konrad Walzer, Technical Director
Looking Ahead to 2026
The addition of these technical experts reflects Suttons Creek’s continued commitment to growing alongside our clients, not just in size, but in capability. As combination product programs become more complex and expectations continue to rise, our expanded team ensures sponsors have access to experienced practitioners who have seen these challenges before and know how to navigate them.
As we enter 2026, this collective expertise will help new and existing clients:
- Make stronger early device and regulatory decisions
- Reduce execution risk across development stages
- Prepare more confidently for regulatory interactions
- Deliver patient-centered, innovative combination products
We’re proud of the impact this team has already made—and excited about what’s ahead.
Connect with us:
Visit the Suttons Creek LinkedIn page to connect, follow our growth, and welcome our newest experts to the team.