Innovation & technology strategy
Decide where to invest and what to partner on.
- Multi-year technology roadmaps
- Technology landscaping and search & evaluation
- Build / buy / partner assessments and technical diligence
Pharma · Biotech · Medtech consulting
From molecule to device to patient, with one advisor who has done all three.
Swinney Innovation helps life sciences teams turn promising science and technology into products patients can use: innovation strategy, drug delivery and combination products, device development, and the decisions that move a program from early feasibility to launch.
- FormulationLong-acting depots, peptides, RNA/LNP, drug–device interactions
- DevicePrefilled syringes, autoinjectors, on-body and infusion systems, sensors
- ClinicPreclinical design, clinical study execution, patient tolerability
- Patient & marketTPPs, patient/HCP/payer insight, launch
20+years across pharma, biotech & medtech
37issued U.S. patents
10+pharma companies united in a precompetitive consortium
<18 moto a startup's first commercial products
70+contributors led through influence on one program
Services
Where I can help
Senior, hands-on support for the questions that sit between science, engineering, and the business case.
New product planning
Define what to build, for whom, and why it wins.
- Target product profiles
- Go/no-go decision frameworks
- Patient, HCP, and payer research; business cases
Drug delivery & combination products
Match the molecule to the right delivery system.
- Prefilled syringes, autoinjectors, on-body injectors
- Large volume subcutaneous delivery and tolerability
- Long-acting injectables; formulation–device interactions
Device development & quality
Get from concept to a manufacturable, compliant product.
- Design controls and ISO 13485 quality systems
- Design verification and biocompatibility
- Transfer to manufacturing
Evidence generation
Plan the studies that de-risk a program.
- Preclinical study design, including large-animal models
- Clinical study design and execution support
- Human tolerability and patient experience
Applied AI for R&D and strategy
Put generative, predictive, and agentic AI to practical use.
- Predictive and generative modeling (IVIVC, PK, depot design)
- No-code AI agents for research and competitive intelligence
- AI adoption roadmaps for R&D teams
Who I work with
Clients
- Pharma & biotechDevice and delivery strategy, platform decisions, external innovation, and new product planning.
- Medtech & drug delivery companiesProduct development, quality systems, and the pharma partner's perspective.
- Startups & investorsTechnical diligence, product roadmaps, and getting quality and clinical foundations right early.
- Consulting & engineering firmsSpecialist depth in formulation, drug delivery, and combination products, added to your team as needed.
How we work
Engagement models
- AdvisoryAs-needed expert input, working sessions, and reviews, billed hourly.
- Defined projectsA clear scope and deliverable, such as a technology landscape, a TPP and go/no-go framework, or a device strategy assessment, at a fixed fee.
- Ongoing advisorA monthly retainer for a standing seat alongside your leadership or development team.
- Embedded supportHands-on, part-time leadership for a program or function while you build the team.
Track record
Experience behind the advice
I have been the client, the developer, and the startup leader.
- 2024 – 2026
Gilead Sciences
Senior Director & Head of Innovation and New Product Planning
Established Gilead's first platform capabilities for prefilled syringes and autoinjectors and won C-suite endorsement twice over. Built a 10-year drug delivery innovation roadmap across virology, inflammation, and oncology, directed all search and evaluation for device, packaging, and process technologies, and founded a precompetitive consortium workstream with 10+ major pharma companies on large volume subcutaneous tolerability.
- 2022 – 2023
LiquiGlide (MIT spinout)
Vice President, Biomedical Product Development
Launched the company's first commercial biomedical products in under 18 months and built an ISO 13485 quality system from the ground up.
- 2015 – 2022
Eli Lilly and Company
Senior Director, Drug Delivery & Connected Solutions Innovation; Chief Engineer
Single point of accountability for the extended-wear R&D arm of Lilly's automated insulin delivery program, leading 70+ contributors from concept through clinical study to a solution since commercialized. Applied generative and predictive AI to formulation design. Lilly Top 100 Innovator, 2020.
- 2010 – 2015
Becton Dickinson
Senior Staff Engineer; Staff Engineer
One of the device development leaders for BD FlowSmart™, BD's first insulin infusion set, from concept to launch, including helping lead its clinical development. Contributed to the BD Evolve™ on-body injector. Wesley J. Howe Award for Technological Innovation, 2012.
- 2005 – 2010
Dexcom
Scientific Manager; Senior Research Associate
Designed membranes for continuous glucose monitors and led design verification, biocompatibility, and preclinical studies, taking products from concept to launch in under two years.
- 2004
Johnson & Johnson, DePuy Mitek
Senior Engineer
Technology scouting and partnership development in orthopedic sports medicine.
Speaking & recognition
Recent industry talks
Strategic Foresight in Drug Delivery Planning for Innovation, Scale, and Patient Impact
Large Volume Drug Delivery
Advancing Technologies and Strategies for Subcutaneous Drug Development and Delivery
Accelerating Innovation in Combination Product Development
37 issued U.S. patents
Lilly Top 100 Innovator (2020)
BD Wesley J. Howe Award for Technological Innovation (2012)
Microsoft Certified AI Business Professional & AI Transformation Leader
Mentor & judge: The Engine (MIT), UMass M2D2
About
Monica Swinney, Ph.D.
Founder & Principal, Swinney Innovation
Ph.D., Polymer Science & Technology, MIT
B.S. Chemistry, magna cum laude, UMass Lowell
Boston, Massachusetts
I'm an MIT-trained Ph.D. polymer scientist and materials engineer who has spent more than 20 years where formulation, device, clinical, and commercial decisions meet. I've led innovation and new product planning at Gilead, run a 70-person program at Lilly, developed devices from concept to launch at BD and Dexcom, and built a startup's first product line and quality system from scratch.
That range is what I bring to clients: the science to see what's feasible, the development experience to make it real, and the decision-maker's view of what earns investment. I'm also an avid applied user of AI, which helps me deliver research and analysis quickly.
Full lists of patents, publications, and talks are at monicaswinney.com.
Contact
Let's talk about your program.
Tell me what you're working on and where you're stuck.
monica@swinneyinnovation.com
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