Entrepreneurial optimism is a powerful force with a view to change the future. Your time is valuable and the cost of bringing new products to market is high. We provide AI-infused tools that deliver structured guidance to enrich your journey through highly regulated markets. Whether an individual entrepreneur, an academic organization or a multi-national organization, the benefits are measurable.
Products
Every product sits on the same drafting rigor, persona model, and source-of-truth data plane. Sold as separate licenses so you take only what you need — Entrepreneur's Journey, Med Journey AI, and Medical Device Educator AI launch August 14, 2026; Clinical Lab AI is in active development.
Dream. Plan. Build. Grow.
The operator-grade companion for solo founders and pre-seed teams — the partner-level advisor you'd hire if you could. Draft a defensible business plan, model three years of P&L and cap-table dilution, prepare an investor pitchbook with a fundraising coach at your elbow, and dial in the brand voice and marketing that make your first conversations land. The artifacts you produce are yours; the personas teach you the craft as you go.
Believe. Achieve. Realize.
The compliance-grade content factory for medical-device commercialization — for the solo founder chasing a first 510(k), the consultancy running dozens of client programs, and the CMO or design-support firm operating hundreds of active devices. Draft a Design History File to 21 CFR 820.30, manage Design Controls and Process Controls, assemble Submissions across the full pathway matrix (510(k) · De Novo · PMA · General & Special Controls · Global), monitor five dimensions of post-market novelty, and keep every artifact in an auditable Document Vault.
Includes the full Entrepreneur's Journey business layer — business plan, financial modeling, investor pitchbook, hiring and marketing coaches — so a device program and the company around it are drafted in one place.
Study. Practice. Prepare.
Med Journey AI reframed as curriculum for universities and institutional medical-device programs. Students build real Design History Files as portfolio deliverables — the same artifact set industry teams ship — while every persona doubles as a citation-first tutor that reads back the regulation behind every recommendation. Faculty license, cross-department roll-ups, per-student workspaces, reviewer/approver primitives for instructors.
Includes the full Entrepreneur's Journey business layer, so students learn business planning, financial modeling, and investor communication alongside medical-device commercialization — the two skill sets they'll actually use when they graduate into a program.
Partner · SME-led verticals
Med Journey AI and Entrepreneur's Journey are the first two verticals on the platform. The next ones aren't built by us — they're built with subject-matter experts who own the depth we can't. Revenue share is real and cohort-based; the engineering, infrastructure, distribution, and go-to-market are ours.
You bring
Two decades of regulatory affairs, quality engineering, clinical validation, food safety, aerospace certification, pharmaceutical GMP, financial compliance, energy siting — the specialist knowledge that clients pay $400–$800 an hour for.
We bring
AI-persona engineering, cross-app auth, Vault + audit trail, billing, Vercel + Supabase infrastructure, distribution across bollong.ai, and the ecosystem plumbing MJAI and Entrepreneur's Journey already run on.
We split
Cohort revenue share — Pioneer, Early, Standard. Real economics for the first partners who bring a vertical live. Terms and cohort assignment are per-vertical and land in the DS&RSA signed after NDA.
First vertical under active build — with an SME partner slot open
Regulatory and quality operations for the modern clinical lab. Method validation, proficiency testing, and competency assessment under CLIA §493, CAP, and ISO 15189. Multi-national from day one — built to scale from a single independent lab to 1,500-cert reference networks.
Looking for a Lab Director or ex-CMS surveyor as our SME partner. clia.bollong.ai →
Verticals we would love to build with you
By the numbers · The ROI
Two costs matter to entrepreneurs: the calendar time they can't buy back, and the specialist consulting invoice that used to be the price of doing the work at all. bollong.ai moves both.
Typical scope of a 510(k) regulatory-affairs consultant engagement, handled by SME personas working alongside your team. Quality, biocompat, and human-factors scope carry similar magnitudes.
Med Journey · showcaseDrafting cycles that used to run three to six months compress into weeks. The rigor stays; the back-and-forth doesn't. First drafts arrive cited and reviewable, not blank.
Both licensed productsOne platform, one version, no email-chain drift. C-suite roll-ups for CMOs; a personal workspace for the individual innovator. Every artifact traceable to a persona's rationale.
Ecosystem-wideRanges cited from published industry benchmarks for medical-device regulatory + quality consulting scope, 2024. Your mileage will vary with device class, novelty, and program discipline.
Free tools · Sample the ecosystem
Each free tool is what the licensed products produce, distilled to a single decision. Real reports, real citations, no watermarks. If the output survives your professional review, so will the products behind them.
Validate today. Impact tomorrow.
Rapid concept validation for a medical-device idea. Regulatory classification, predicate-device pointers, initial risk profile — before you commit to the pathway.
Open MedValidateAI-powered insights.
Decision framework for sourcing. Cost model, capability gap, lead-time trade-off, supplier concentration risk — output structured to survive a supply-chain review.
Open Make vs BuyReadiness at a glance.
Rapid ISO 13485 / 21 CFR 820 gap read against your current practices. Where the gaps are, what closes them, what the reviewer will ask.
Open QMS Gap AnalysisReady when you are
No email required. No shortcuts inside. What you produce, you own — whether you ever license Med Journey or not. See the output before the invoice.
