✓ 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 Team
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.
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.
Jill Bagdasarian
Clinical Operations & Regulatory Support
Jill is a senior level leader with over 25 years of business experience. She has been focused since 2009 on building clinical programs and leading US and global clinical trials in the Biotech, Pharmaceutical, Medical Device and Tissue Industries. Her specialties include strategic planning, clinical trial development, protocol design, trial execution, data management, building clinical infrastructure, implementing quality processes and preparation of regulatory submissions.
Lee Springer
Lab Operations, Product
Lee brings executive experience in clinical diagnostics, laboratory medicine, healthcare regulations, and FDA regulatory and compliance. He has worked extensively in laboratory, hospital, and health system operations, including process improvement, service line development, strategic initiatives, and growth strategies. Lee also has served in executive roles for medical device manufacturers leading new product and service line development in conjunction with bioassay/device research and development and sponsored clinical trials and investigations. Lee also has designed, developed, and led organizational change strategic initiatives for physician practices, corporations and health systems that were focused on collaboration, culture, and quality. In addition to his significant industry experience, he has served in various capacities in higher learning from lead faculty, program director to course and online learning environment development.
Michael (Cappy) Cappillino
Strategic Advising,
Systems Development, &
Program Management
With 25 years of business experience and 15 years in the biotechnology industry designing, developing, and launching medical devices and diagnostic products, Michael (Cappy) Cappillino has helped numerous companies deliver value faster while improving their ability to effectively manage risk and investment. Teams leverage his expertise as a strategic business leader, product and assay developer, data scientist, Project Management Professional, Lean Six Sigma Green Belt, and graduate of the Isenberg School of Management to help teams efficiently plan and execute all manner of projects, including organizational design, strategic planning, new product introduction, process improvements, regulatory affairs, quality management, operational excellence, and more.
Josh Beckmann
Design Engineering
Josh Beckmann combines a diverse background in small scale manufacturing, public health research, and prototyping. He currently specializes in applying simple technologies to novel medical device applications. His technical skills include: CAD design/rendering, digital fabrication, and electronic prototyping and fabrication. He holds a Masters of Public Health and Masters of Social Work from Boston University and a Bachelor of Arts in Sociology from University of Minnesota.
Jeffrey Budd, PhD
Biostatistics
WIth over 40 years of experience in medical diagnostics, the last 20 as a principal biostatistician in the in vitro diagnostic industry, Dr. Jeffrey Budd has helped companies across the globe to develop hundreds of products and file their successful submissions to FDA, EU and other national regulators. As an ongoing leader and key contributor in multiple organizations (Clinical and Laboratory Standards Institute, International Organization for Standardization, International Federation of Clinical Chemists) he remains at the forefront of the IVD industry with respect to standardization, product development, and validation.
Bryan Bothwell
Strategic Advising
Bryan is a proven executive covering high-tech and medical device biotech C-suite functions with 23 years
across high tech verticals, focusing on entrepreneurial programs with success in identifying new opportunities
and obtaining consensus with key decision-makers.
As a co-founder of Qorvo Biotechnologies, Bryan spent the last 10 years growing it from conception into a
fully operating revenue-generating company with 95 employees, including a recent business sale. As General
Manager, Bryan led the establishment of asset acquisitions, IP licensing, development of world-class technical teams, global high-volume manufacturing establishment, government funding engagements, and go-to-market strategy.
Bryan holds Masters Degrees in Business and Electrical Engineering from Babson College, and Oregon Health
and Science University respectively, and undergraduate degrees in Biology and Biochemistry from the
University of Portland.
Kaela M. Leonard
Clinical Operations & Regulatory Support
Kaela is an experienced clinical research & operations manager. Before this work, she spent almost a decade in microdevice design and fabrication, biological sample handling and experimental design. Her specialties include clinical research, clinical trial design and management, analysis of clinical data, microdevice fabrication via soft photolithography, dielectrophoresis, human erythrocytes, electrokinetics, lab on a chip devices.
Lucius (Tad) Fox
Assay Design & Development
With nearly 30 years of service in the In-vitro Diagnostics industry, Lucius (Tad) Fox, PhD, has developed over 75 IVD products for use in both human and veterinary medical applications. His experience spans all aspects of the product design and manufacturing process development including technology innovation, design, and manufacturing process development. His contributions to the IVD industry span a broad range of applications including new and existing diagnostic markers in Clinical Chemistry, Therapeutic Drug Monitoring, Drugs of Abuse, Proteins, Diabetology, Kidney Injury, Infectious Diseases, Hormones, Lipids, Liver Markers and Hemostasis (Coag). Tad has broad experience leading and developing R&D organizations in both startup & large scale companies. With a passion for design efficiency and product integrity, he uses systems engineering approaches across all projects to ensure the creation effective product designs and robust manufacturing processes. He has served on several ISO and CLSI initiatives to create new industry wide standards and has solid experience interacting with regulatory agencies. Tad holds a PhD in Physical Chemistry from the California Institute of Technology is active both as an expert medical device consultant and university instructor.
Josh Buser
Device Integration
Dr. Josh Buser is a scientist, engineer, and toolmaker focusing on biomarker quantification solutions for the past 15 years. He specializes in early-stage medical device technology development and transfer to manufacturing. His innovations have resulted in 8+ patent applications. His technical skills include microfluidics, supply chain development, laminate manufacturing for point-of-care diagnostics, fluid dynamics in porous media, non-electric precision temperature control, along with microscopy and quantitative image analysis. Josh performed his PhD and postdoc work at the Univ. of Washington Dept of Bioengineering, and holds a B.S. in Mechanical Engineering from the Univ. of Wisconsin-Madison.
Neil Spooner
Bioanalytical Support & Tech Innovation
With over 20 years of experience in leadership positions in the pharmaceutical industry working with groups providing bioanalytical support and technological innovation for the quantitative determination of drugs, metabolites and biomarkers in biofluids, Neil has successfully applied his knowledge and skills to helping companies to integrate biological fluid microsampling and patient centric sampling and analysis into workflows. He also works with innovator companies to develop technologies and introduce them to the market. Neil also assists organisations with their understanding of emerging trends in the pharmaceutical industry and bioanalysis.
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.
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.