Raise capital faster
A technical and regulatory package a diligence team can verify in an afternoon.
Investor-ready package · IP & competitor map · budget from real quotes
Medtech & innovation intelligence partner
Build your idea. Build it right.
Identify risks early. Make smarter decisions. Accelerate development.
Proprietary research tools and 20 years of product development and technical strategy: an advance radar that surfaces the risks in the first weeks and helps you engineer them out.
SEVEN RISK DOMAINS · SCANNED IN THE FIRST WEEKS
What you get
- Raise capital fasterStronger, de-risked story for investors.
- Shorter time to marketFewer surprises, fewer redesign loops.
- Risk retired earlyCritical risks found and engineered out.
- Portfolio decisions with evidenceBuild, acquire, sustain or exit, on evidence.
What changes when KAMA is on the team
Four outcomes we are hired for
Reach market sooner
Handoffs planned on day one: design to V&V, V&V to regulatory, engineering to manufacturing.
V&V plan at design freeze · fewer prototype loops · transfer-ready docs
De-risk early
A roadblock found in week three costs a meeting. Found in month eighteen, it costs a redesign and a bridge round.
Scored radar report · ranked red flags · quarterly re-scan
Expand the portfolio
Make the Build, Acquire, Sustain or Exit (BASE) decision on each technology with evidence instead of instinct.
BASE scorecard per asset · build-vs-buy analysis · technology due diligence
Start with KAMA
You've been thinking about a device. We'll tell you what it will take to make it.
Two 45-minute calls and a written brief, delivered in two weeks. The same questions a diligence team asks, answered before you spend on design, lawyers or a pitch deck.
DAY 0IntakeA structured questionnaire; we run the radar pre-scan before we talk.
DAY 345-min working callYour device in use, the hardest engineering problems, your constraints.
DAY 10The brief, in writingSent 48 hours before the readout so you arrive with questions.
DAY 1245-min readoutScenarios, our recommendation, your next 90 days.
Credited in full toward any scan or package booked within 60 days.
Built by people who have shipped devices
Catheters, balloons, implantable devices, capital equipment, structural heart delivery systems. Twenty years of it.
The same discipline that gets a device through Edwards, Medtronic or J&J, applied to your first prototype.
KAMA vs. the alternatives
How KAMA compares with the usual options
Most teams stitch together a design firm, a regulatory consultant and a freelance engineer. Each sees one slice. KAMA sees the whole board, from the first week.
| Design & engineering firm | Regulatory consultant | Freelance engineer | KAMA | |
|---|---|---|---|---|
| Starts from a napkin idea, no spec required | ◐ Sometimes, or through partners | — Not typically offered | ◐ Sometimes, or through partners | ✓ Core service |
| Scans regulatory, IP, reimbursement and competitors before design freeze | ◐ Sometimes, or through partners | ◐ Sometimes, or through partners | — Not typically offered | ✓ Core service |
| Designs, prototypes and runs V&V | ✓ Core service | ◐ Sometimes, or through partners | ◐ Sometimes, or through partners | ✓ Core service |
| Writes a preliminary investor-ready technical package | ◐ Sometimes, or through partners | — Not typically offered | ◐ Sometimes, or through partners | ✓ Core service |
| Acts as your fractional CTO | — Not typically offered | — Not typically offered | ◐ Sometimes, or through partners | ✓ Core service |
| Ongoing market, regulatory and competitor intelligence after hand-off | — Not typically offered | ◐ Sometimes, or through partners | — Not typically offered | ✓ Core service |
✓ Core service ◐ Sometimes, or through partners — Not typically offered
Marks reflect typical scopes in our experience; individual firms vary.
In one sentence: a design firm hands you a device. KAMA hands you a device, the evidence around it and the next decisions you will have to make.
Sample output
What a radar report contains
Generated by engineering experts with the help of KAMA's proprietary medtech AI. Built for planning and scenario simulation: run the what-ifs before you commit money. Illustrative example for a drug-coated peripheral balloon.
-
Reimbursement: no dedicated code for the intended setting
Map the two viable coding strategies before the Series A deck is written. -
Clinical evidence: predicate differs in coating chemistry
Add two biocompatibility tests to the V&V plan now, not after submission. -
IP: one patent family overlaps the balloon fold
Decide on the design-around before tooling is cut. -
Manufacturability: standard process at two qualified CMs
No action. Use it in the investor package.
The KAMA sample report is for planning and scenario simulation. Its outputs are estimates for discussion, not regulatory, clinical, financial or engineering determinations. Scores and findings above show the format, not a real client engagement.
A typical engagement
The medtech path, and where KAMA changes it
The phases do not change. What changes is how early you know.
Program phase Rework loop KAMA radar scan
Illustrative timeline for a typical early-stage Class II program. Your schedule depends on device class, evidence needs and funding. The shape, not the exact months, is the point: fewer loops, earlier launch.
What moves the launch date
Risks found at week 3, not month 18
The radar scan surfaces regulatory, IP, reimbursement and manufacturability flags before design freeze, so the redesign loop never happens.
Design controls and V&V from design freeze
Design controls run to ISO 13485 and 21 CFR Part 820 (QMSR). Test plans are written with the design, not after it, so ISO 10993 biocompatibility and sterilization questions are answered while they are cheap.
Labs and manufacturers booked early
Test labs and contract manufacturers are lined up months ahead, so the calendar is yours, not theirs.
Submission strategy set at concept
Predicate, pathway and reimbursement story decided in month one, so the final stretch is assembly, not discovery.
Pricing
START WITH KAMA
PRICING MODEL 1
PRICING MODEL 2
Pick the pricing model that matches where you are
The "What It Will Take" brief
Anyone with a device idea who wants to know what it will take before committing money.
- Two 45-minute calls, one written brief
- Regulatory, evidence and engineering first pass
- Scenarios and a 90-day plan
- Delivered in two weeks
$785 FIXED · CREDITED TOWARD A SCAN
Start with KAMA →AI-assisted analysis + expert engineering guidance
Founders, physicians and incubator cohorts who want to move fast and keep control of the build.
- Reports produced with KAMA's medtech AI: radar scan, regulatory pathway, IP and competitor landscape, V&V plan. You receive the analysis and reports
- A senior device engineer turns every output into decisions with you
- Fixed scope, known price
How it's pricedFixed fee per scan or package, quoted up front before work starts.
Start with a scan →Ongoing support + intelligence gathering
Funded startups, investors and corporate innovation teams who need a watchtower while they build and raise.
- Everything in Pricing Model 1, running continuously
- Monthly brief with the technical and regulatory updates relevant to your project
- Fractional CTO: vendors, V&V, design reviews, transfer to manufacturing
- Board, investor and due-diligence support
How it's pricedMonthly retainer, scoped to your stage and reviewed each quarter.
Talk about a retainer →Corporate teams: the same first-week brief applied to internal concepts or acquisition targets is scoped as a pilot from the "Request a call" conversation.
Who we work with
Built for the people who carry early-stage risk
- IncubatorsA radar scan for every cohort company in month one.
- InvestorsTechnical diligence before the term sheet, a watch on the portfolio after.
- Corporate portfolio teamsBuild, Acquire, Sustain or Exit (BASE) decisions on each technology, with evidence, plus technology due diligence on targets.
- UniversitiesFrom publication to a buildable, fundable product.
- Physician foundersKeep practicing while we run engineering, vendors and regulatory planning.
- EntrepreneursConcept to prototype to investor package, risks surfaced early.
20+years in regulated device development
US · EU · JPgranted patents
Edwards · Medtronic · J&Jengineering and M&A integration
Irvine, CAOrange County medtech cluster
Who is behind KAMA
Kokou Amefia, Principal & Founder
Biomedical engineer and inventor with 20+ years at Edwards Lifesciences, Medtronic and Johnson & Johnson: neurovascular, structural heart, electrophysiology and catheter-based systems. Patents in the US, Europe and Japan. He founded KAMA so early-stage teams get large-company discipline without a large-company payroll.
Community engagement
Serving our community
We give children engineering skills so they can bring their own ideas to life, and welcome partners on educational initiatives.