✓ Senior expertise
✓ Strategic roadmap
✓ End-to-end coordination
Diagnostic products fail in the same places, for the same reasons.
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Regulatory, product, and strategy consultants working in silos, with the client managing the gaps between them
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Clinical studies designed before the regulatory strategy downstream is confirmed
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Manufacturing commitments made before the quality management system is in place
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Capital spent correcting sequencing errors that were avoidable from the start
Vectis coordinates all of it, at every stage.
Venture and Product Readiness
We help early-stage companies build investor-ready plans, map the regulatory path, and structure product development decisions before the expensive commitments are made.
Validation and Regulatory Readiness
We design clinical studies, develop regulatory strategy, and prepare submission packages, with former FDA Branch Chiefs in our network who have worked inside the review process itself.
Build, Approve, and Launch
We prepare validated products for manufacturing, establish quality systems, and build the brand and commercial infrastructure needed to enter the market and scale.
WHAT WE DO
Every engagement is structured around where you actually are.
Healthcare companies at different stages face genuinely different problems. Vectis organizes its work around three stages of the product journey, matched to where you are and what your situation actually requires.
1
Venture and Product Readiness
For founders with a concept or early prototype, preparing to fundraise, and still mapping the regulatory and product path. The work at this stage is turning real science into a credible, investable plan with a realistic path to execution.
At this stage, Vectis works on:
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Business planning and financial modeling
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Market and competitive analysis
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Regulatory pathway assessment
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Investor pitch development
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Initial brand and product positioning
2
Validation & Regulatory Readiness
For companies with a prototype that needs to demonstrate performance and navigate the regulatory process. The cost of a wrong decision here is high and recoverable only with time and capital most companies cannot afford to spend twice. Former FDA Branch Chiefs are part of the Vectis network specifically for this stage.
At this stage, Vectis works on:
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Clinical study design and oversight
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Regulatory strategy and submission preparation
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Coordination with external labs and CROs
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FDA engagement and response management
3
Build, Approve,
and Launch
For companies with a validated or near-validated product ready to become a manufactured, branded, commercial business. The strategic decisions made in the earlier stages compound here. A well-run Stage 1 makes Stage 3 measurably faster and less expensive.
At this stage, Vectis works on:
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Manufacturing readiness and quality management systems
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Design for manufacture
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Brand identity and product messaging
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Commercial launch planning
HOW IT WORKS
You don't need to have it all figured out to get started.
There is no intake form and no pre-qualifying process. A first conversation with Vectis is thirty minutes: you describe where you are, Vectis explains what it can offer, and both sides figure out whether it is a fit. Many clients come in knowing they have a problem and not yet knowing exactly what to do about it, and thirty minutes is usually enough to start changing that.
1
Intro call
Thirty minutes to understand your situation and whether Vectis is the right group to help.
2
Scoped engagement
Vectis recommends a structure based on your stage: a scoped discovery project, a defined deliverable engagement, or an ongoing advisory arrangement.
3
Work product
Reports, regulatory submissions, strategic roadmaps, investor materials, launch plans. Actual deliverables you can act on, reviewed and signed off by people who will stand behind them.
Companies that work with Vectis reach market faster, with the infrastructure to scale.
The clients who get the most out of a Vectis engagement come in knowing they need serious help and trusting the process enough to follow it. They leave with regulatory clearance built on a sound clinical foundation, a commercial operation that was planned before it was built, and a product path that did not require rebuilding from scratch every time a sequencing error surfaced.
The people behind the work.
Vectis engagements are led by Brandon Johnson and supported by a curated network of specialists matched to each engagement's stage and technical requirements. The depth of that network in regulatory and clinical affairs is one of the more significant practical advantages the firm offers.
Leadership and Operations Team
Brandon T. Johnson
Founder & Managing Partner
Brandon founded Vectis in 2021, leveraging expertise and network built over 15 years of experience in medical diagnostics with a focus on consumer-oriented design. As founder and CEO of Boston Microfluidics (Now Weavr Health), Brandon raised $20M+, built a strategic relationship with Labcorp to developed the first product to enable home collection with gold standard results, and contributed to over a dozen patents.
In addition to his work with Vectis, Brandon currently serves as Managing Partner of Nexus Medical Labs, offering clinical lab services as well as CRO services for home-collection and home-testing providers, and Co-Chair of the Home Testing Special Interest Group of the American Telemedicine Association. Client service specialties include company setup, strategic planning, fundraising & partnerships, design for manufacture, and regulatory approvals.
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Kyle Rosenthal
Consultant and Operations Manager
Kyle brings a background in sustainability, project management, and supply chain operations, with previous roles at Ventas and Target. His work at Vectis spans market research, due diligence, regulatory research, and operational coordination. He also serves as Treasurer of the Board of the Climate Solutions Accelerator, which administers New York State programs across a nine-county region.
Charlie Mace, Ph.D.
Associate Professor of Chemistry, Tufts University
Charlie's research sits at the intersection of microsampling, assay development, and point-of-care diagnostics. He has authored 69 peer-reviewed publications, holds 21 issued patents with more than 30 additional applications pending, and is a Senior Member of the National Academy of Inventors. He received the NSF Faculty Early Career Development Award and completed postdoctoral research in George Whitesides' laboratory at Harvard.
Hollie Chan
Chief of Staff
Hollie works at the intersection of strategy and execution, helping leadership teams build operational structure, implement scalable systems, and drive consistent delivery. She brings experience across healthcare, biotech, and technical environments, including a prior role as Chief of Staff at Nexus Medical Labs, operational leadership at Paterna Biosciences where she led a full laboratory buildout, and executive support at Vault Health. She holds an MBA from Tulane University and a B.S. in Marketing from Louisiana State University.
Anna Simpson
Product Development and Operations
Anna co-founded Lia Diagnostics, where she led product design, regulatory strategy, and supply chain operations for the first biodegradable and water-dispersible lateral flow diagnostic platform. Her background spans the full development cycle for diagnostics startups, from early-stage product design through regulatory submission and commercial operations. She is currently CEO of Ciqura.
Advisors and Subject Matter Experts
David Dalessandro, PMP
Product Development and Manufacturing
David spent more than 35 years at Johnson & Johnson in R&D, project management, and supply chain, working across implantable medical devices, in vitro diagnostics, and consumer products. He is a Certified Project Management Professional with deep experience in design control, risk management, and commercialization at scale.
Tony Lemmo
Technology and Commercialization
Tony has more than 30 years of experience bringing platform technologies to life sciences, diagnostics, and pharmaceutical industries. He was CTO and CEO of Codetta Bio and CEO of BioDot, has authored more than 60 publications, and holds 12 product patents. He currently serves as operating advisor and board member for several life sciences companies.
Lucius (Tad) Fox, Ph.D.
Assay Design and Development
Tad has nearly 30 years of experience in the in vitro diagnostics industry and has contributed to the development of more than 75 IVD products for human and veterinary applications. His work spans product design, manufacturing process development, and regulatory affairs, with contributions to multiple ISO and CLSI industry standards. He holds a Ph.D. in Physical Chemistry from the California Institute of Technology and is active as a medical device consultant and university instructor.
Nate Davis
Finance and Business Development
Nate brings a background in venture capital and investment banking with a focus on life sciences. His work spans due diligence, M&A, financial modeling, and early-stage company evaluation, with previous engagements at RA Capital, NanoMosaic, Ansa Biotechnologies, and Nucleix. He holds a B.S. in Cell Biology from the University of Vermont.
Let's chat.
If you have a healthcare product and you are trying to figure out the right next step, that is a good enough reason to reach out. Vectis works with companies at every stage of the product lifecycle. The first conversation is always just a conversation.