Private — Steven Ellis Only

Helio Solo Execution Plan

Bootstrapped launch. No outside investment. Step by step from zero to first revenue.

The Strategy Shift

The original plan required $40K from Giann. This plan eliminates that dependency. Instead of paying for donor acquisition upfront, you sell research access first, then use that revenue to fund donor recruitment. Revenue before spend.

The order flips: Researcher → Attorney → Clinic Partner → Donors → Specimens → Revenue.

Core insight: Researchers don't need 500 donors on day one. They need confidence you can deliver 5-10 matched specimens in 4-6 weeks. You can do that with a handful of donors recruited organically in Philly. Prove the model small, then scale with revenue.

Who does what:

STEVEN = You do this. Requires your voice, signature, payment, or physical presence.

CLAUDE = I do this. Draft emails, build docs, research, prep templates, write SOPs. Just tell me to go.

Phase 1: Foundation (Weeks 1-4) — $2,000

Phase 1 — Brainless Execution Checklist

Step 1: Form Helio LLC (Day 1 — 30 minutes) STEVEN

Action: Go to stripe.com/atlas. Click "Get started." Select LLC. State: Delaware. Name: Helio LLC. Pay $500. Done.

Stripe Atlas handles everything: Delaware filing, EIN from IRS, registered agent (first year included, $100/yr after), bank account (with Stripe or Mercury), and operating agreement template. Takes 1-2 business days. You also get $2,500 in Stripe credits.

Alternative (cheaper): File directly with Delaware Division of Corporations ($90) + Northwest Registered Agent ($125/yr). But you handle EIN, bank, and operating agreement yourself. Stripe Atlas is worth the $500 for zero friction.

After formation, immediately:

Step 2: Healthcare Attorney (Days 2-5) STEVEN

CLAUDE I can draft a briefing doc to send the attorney before the call so you maximize the hour. I can also draft the follow-up email requesting deliverables. Just say "prep attorney brief."

Who to call (in order):

FirmWhyContact
Flaster Greenberg (Steven's preferred) Mid-Atlantic firm with dedicated healthcare practice. Strong pharma/biotech IP group. They understand the regulatory landscape for life sciences companies. Offices in Cherry Hill and Philadelphia. Call main line: (856) 661-1900. Ask for a healthcare regulatory attorney. Mention: "I'm launching a biospecimen marketplace and need a 1-hour regulatory consultation + a compliance opinion letter."
Kristen Rosati — Coppersmith Brockelman Nationally recognized biobanking and genomic privacy attorney. Has directly advised hospitals and research institutions on biospecimen repositories, data/specimen ownership, and governance. The most specialized option. Email: krosati@cblawyers.com. Phoenix-based but does this nationally. Expect $400-600/hr but she'll nail it in one call.
Post & Schell (Philadelphia) PA-based healthcare regulatory group. Strong on state-specific regulations (PA Blood Bank Act). More affordable than BigLaw. Call: (215) 587-1000. Ask for healthcare regulatory.
Any healthcare attorney via Avvo or Justia Search "healthcare regulatory attorney Philadelphia" — filter by HIPAA/FDA experience. Many offer free 15-min consultations. Budget option. Book via their website. Budget: $250-500 for 1 hour.

Exact questions to ask the attorney:

Print this list. Bring it to the call. Get answers to every question.

1. Regulatory classification:

  • "Helio is a marketplace that coordinates biospecimen procurement. We never draw, process, store, or ship blood ourselves — we contract with licensed phlebotomists for draws and CLIA-certified labs for processing. Does this marketplace model require FDA blood establishment registration under 21 CFR 607?"
  • "Can you confirm in writing that a marketplace/logistics coordinator that never takes physical possession of specimens is exempt from registration?"

2. Pennsylvania Blood Bank Act:

  • "Section 19 of the PA Blood Bank Act exempts 'commercial establishments whose products are never transfused or injected into patients.' Does this exemption apply to research-use-only specimens sourced through our marketplace?"
  • "Are there any PA state licenses or registrations we need as a marketplace coordinator?"

3. HIPAA obligations:

  • "We collect donor health information (conditions, medications, demographics) to match them to research studies. Is Helio a covered entity or a business associate under HIPAA?"
  • "We anonymize all health data before sharing with researchers — donors are identified only by a random Helio ID. Does this de-identification meet the Safe Harbor standard under 45 CFR 164.514(b)?"
  • "Do we need to sign BAAs with our phlebotomy partner and processing lab? What about the researchers?"
  • "Can you draft or review a BAA template we can use with all partners?"

4. Informed consent:

  • "Can you draft an informed consent template for donors that covers: purpose of donation (research use only), types of specimens collected, compensation disclosure, risks of venipuncture, data usage and anonymization, right to withdraw at any time?"
  • "Does this consent need to be IRB-approved before we use it, or can we operate under a general research consent until we engage an IRB?"
  • "Can donors provide electronic consent (e-signature), or do we need wet signatures?"

5. IRB requirements:

  • "Do we need our own IRB approval, or can we operate under the researcher's IRB protocol? Many biospecimen companies operate under the researcher's IRB — is that an option for us?"
  • "If we need our own IRB, what's the process and timeline for a commercial IRB like Advarra or WCG?"
  • "For specimens collected for general research use (not a specific study), does this qualify for IRB exemption under 45 CFR 46.104(d)(4)?" (secondary research use of identifiable biospecimens with broad consent)

6. Compliance opinion letter:

  • "Can you provide a 1-page opinion letter on Helio letterhead confirming our regulatory position? Specifically: marketplace exemption from FDA registration, HIPAA compliance approach, PA state compliance. This is our credibility document for research institutions."
  • "What's the cost for the letter on top of the consultation?"

7. Liability and insurance:

  • "What types of insurance do we need? General liability, professional liability (E&O), or anything specific to biospecimen handling?"
  • "Do we need to be named as additional insured on our phlebotomy partner's malpractice policy?"

8. Website credibility — listing you as an expert:

  • "Can we list your name and credentials on our research website? We'd like to show researchers that our regulatory framework has been reviewed by qualified counsel."
  • "The format would be something like: 'Regulatory framework reviewed by [Your Name], Esq. — specializing in FDA blood establishment regulations and PA Blood Bank Act compliance.' Is that acceptable?"
  • "Would you prefer the title 'Regulatory Advisor' or 'Of Counsel' — or something else?"
  • "If listing your name isn't possible, can we reference the firm name instead?"

9. IRB via partner clinics:

  • "Our draw partner clinics already operate under IRB protocols. Can Helio operate under the partner clinic's existing IRB coverage rather than obtaining our own commercial IRB?"
  • "If yes, can we state on our website: 'Specimen collection conducted under partner clinic IRB protocols'?"

Expected deliverables from the attorney:

  1. STEVEN Get written answers to all questions above (email follow-up is fine)
  2. STEVEN Informed consent template ($300-500 additional) — attorney drafts, you review
  3. CLAUDE BAA template — I can draft a standard one for your attorney to review ($0 vs $200-300)
  4. STEVEN 1-page compliance opinion letter ($200-400 additional) — must come from the attorney
CLAUDE What I can prep before your attorney call:
  • 1-page business summary for the attorney (what Helio does, the marketplace model, your questions)
  • Draft BAA template based on HHS model language
  • Draft informed consent template for attorney review (saves them billable hours = saves you money)
  • Data security architecture summary (already exists — I'll format it as a PDF-ready doc)
  • Comparison research on how iSpecimen/Sanguine handle regulatory (precedent for your attorney)

Just say "prep attorney package" and I'll build all of this.

Total attorney cost estimate: $800-1,500 (consult + deliverables). If Flaster Greenberg is too expensive for a single consult, ask if they offer a "startup package" or fixed-fee engagement for regulatory setup.

Step 3: Insurance (Day 3 — 20 minutes) STEVEN

Action: Go to hiscox.com. Get a quote for General Liability + Professional Liability (E&O). Industry: "Technology / Software." Revenue: "$0-50K." Coverage: $1M per occurrence / $2M aggregate. Expected cost: ~$22-50/month.

Alternative: biBerk.com (Berkshire Hathaway) — similar pricing, starts at ~$27/month. Both are fully online, no phone calls needed.

You need the Certificate of Insurance (COI) — download it immediately after purchasing. Researchers' procurement departments will ask for it. You can add partner institutions as "additional insured" on request (standard feature, no extra cost).

Step 4: Partner Clinic (Days 5-10) STEVEN + CLAUDE

CLAUDE I can research more providers, draft all outreach emails personalized to each company, draft the services agreement template, and prep a comparison sheet. You make the calls and sign the agreement.

Philly mobile phlebotomy services to contact:

CompanyDetailsContact
Unity Mobile Phlebotomy Serves Philadelphia + South Jersey + Delaware. Convenient blood draws at home/office. Already set up for scheduled draws. Book via website or call
WonderStick Mobile Phlebotomy Serves Philadelphia and surrounding area. Privacy-focused, comfort-oriented service. wonderstick.health
We Care Mobile Phlebotomy Philadelphia. Mon-Fri 5am-8pm, Sat 7am-12pm. Yelp listing. Find on Yelp
Magnificent Touch Serves Philadelphia, NJ, Delaware. Homes, assisted living, nursing homes. magnificenttouch.net
PTI Health by DocGo Serves Bucks, Chester, Delaware, Montgomery, Philadelphia counties. $50/visit listed publicly — good benchmark. ptihealth.com
Getlabs Sends phlebotomists to draw labs, delivers to Labcorp/Quest. Tech-forward, API-friendly. getlabs.com

Script for the call/email: "Hi, I run a biospecimen marketplace called Helio. We connect donors with medical researchers who need blood specimens. I'm looking for a mobile phlebotomy partner to do scheduled draws in the Philly area — prepaid per draw, we handle all scheduling and donor consent. Can we discuss rates for a vendor relationship?"

What you're negotiating:

Week 3-4: Academic Core Lab (Processing Partner)

The logistics chain: Phlebotomist draws blood from donor → transports to processing lab same-day → lab processes to researcher's study spec → lab stores short-term → courier ships to researcher. You coordinate all of it. You never touch blood.

The processing lab is the critical middle step. You can't spin blood in your apartment, and researchers won't accept specimens that weren't processed in a CLIA-certified facility. The lab's CLIA number is your credential — it goes on every specimen you deliver.

What the lab actually does (and what they charge):

Processing TypeWhat It MeansTypical Cost
Basic processing Centrifuge whole blood, separate serum/plasma, aliquot into labeled cryovials, refrigerate or freeze $15-30 / specimen
PBMC isolation Ficoll gradient separation to isolate white blood cells (peripheral blood mononuclear cells). More labor-intensive, requires trained tech. $50-100 / specimen
DNA/RNA extraction Extract genetic material from whole blood. Column-based or automated. $30-50 / specimen
Short-term storage Fridge (2-8°C) or freezer (-20°C / -80°C) until shipment. Usually 48-72 hours max. Included or $5-10/day

At 15 specimens/month starting out, you're paying the lab $375-1,500/month — easy money for work they already do every day. They won't bend over backwards for you at this volume, but it's zero-effort revenue for them.

Who to target (in order of preference):

  1. Academic core labs (best option). Penn's Human Immunology Core, Temple's Biospecimen Repository, Jefferson's Translational Research Lab. These labs already process research specimens for internal PIs and have excess capacity. You're just adding volume. They know the workflows, have the equipment, and their CLIA cert covers everything. They're used to working with outside groups.
  2. Independent CLIA-certified research labs. Smaller commercial labs that serve the pharma/biotech community. More flexible on pricing and minimums than the big players.
  3. Quest/Labcorp (last resort). They're set up for diagnostic testing, not research processing. Their systems, minimums, and turnaround times aren't built for what you need. And they'll charge more.

How the handoff works day-to-day:

  1. You schedule a donor draw with your mobile phlebotomist.
  2. Phlebotomist draws blood into the tube types specified by the researcher's protocol (EDTA, heparin, SST, etc. — the researcher tells you exactly what they need).
  3. Phlebotomist labels tubes with the donor's Helio ID (never their name) and transports to the processing lab within 2-4 hours. Temperature-controlled if required.
  4. Lab receives specimens, logs them into their system, and processes per your standing instructions (which mirror the researcher's protocol).
  5. Lab stores processed specimens in their fridge/freezer until you arrange shipping (usually within 48-72 hours).
  6. You arrange cold-chain courier pickup from the lab → delivery to the researcher.

Key requirement: The lab must be CLIA-certified. This is non-negotiable. Get their CLIA number when you sign the services agreement — it goes on your chain of custody documentation and in your compliance materials for researchers.

Budget — Phase 1

LLC formation (Stripe Atlas)$500
Healthcare attorney (1-hr consult + letter)$500
Professional liability insurance (3 months)$200
Informed consent template (attorney-drafted)$500
Domain, hosting, email (already done)$0
Platform build (you)$0
Contingency$300
Phase 1 Total~$2,000

Phase 2: First Research Client (Weeks 5-8) — $1,500

Phase 2

Week 5-6: Research Outreach

  1. Build a target list of 30-50 PIs. Focus on:
    • Penn Medicine — oncology, immunology, diabetes research labs
    • Temple University — Lewis Katz School of Medicine
    • Drexel — College of Medicine, biomedical research
    • Jefferson — Sidney Kimmel Medical College
    • Wistar Institute — cancer research (private, high-volume)
    • Children's Hospital of Philadelphia (CHOP) — pediatric research
  2. Find them on NIH Reporter (reporter.nih.gov) — search for active grants in Philly institutions. Funded PIs = they have budget for specimens.
  3. Send the researcher cold email (see below). Personalize each one with their specific research area.
  4. Follow up at Day 3 and Day 7. Then move on.
  5. Target: 3-5 meetings from 50 emails. Close 1-2 pilot clients.

Week 7-8: Pilot Agreement

  1. Offer a pilot at cost. First 5-10 specimens at $150-200 each (your cost). You're buying credibility, not revenue. The goal is a testimonial and case study.
  2. Draft a simple specimen supply agreement — what you'll deliver, timeline, specimen specs, pricing. 2-3 pages max. Your attorney can review.
  3. Get their IRB requirements. Most likely they need:
    • Your informed consent template (for their IRB review)
    • Your data security/privacy documentation
    • CLIA certification of your processing lab (the lab's cert, not yours)
    • Your HIPAA compliance documentation

Phase 3: First Specimens (Weeks 9-12) — $2,000

Phase 3

Donor Recruitment (Organic)

  1. Recruit 10-20 donors in Philly organically. No ad spend needed yet:
    • Craigslist/Facebook Marketplace posts — "Get paid $50-200 for a blood draw for medical research"
    • Reddit r/philadelphia, r/beermoney, r/sidehustle
    • Nextdoor posts in Philly neighborhoods
    • College campuses — Drexel, Temple, Penn flyers/bulletin boards
    • Word of mouth referral bonus ($25 per referral)
  2. Screen donors via heliorewards.com signup. Match health profiles to the researcher's protocol.
  3. Schedule draws. Mobile phlebotomist comes to donor (or designated collection site). 10-minute appointment.
  4. Process and ship. Specimens go to your CLIA lab partner for processing, then ship to the researcher via cold chain courier (World Courier, Marken, or FedEx Custom Critical).

First Revenue

  1. Deliver 5-10 specimens to your pilot client.
  2. Invoice at pilot pricing ($150-200/specimen).
  3. Collect testimonial and permission to use as case study.
  4. Revenue: $750-2,000 from first batch.
  5. Now you have: proof of concept, a reference client, and revenue to fund Meta ads for donor acquisition.

Budget — Phases 2 & 3

Donor incentives (15 donors x $50-100)$1,000
Mobile phlebotomy draws (15 x $65)$975
Lab processing (15 specimens)$375
Shipping (cold chain, 2-3 batches)$450
Organic donor recruitment (flyers, etc.)$100
Phase 2-3 Total~$2,900
Total bootstrap cost to first revenue: ~$5,000. Compare to the original plan's $40K. The difference: you sell first, recruit second, and start with organic donors instead of paid ads.

What Researchers Will Require From You

This is the gate. If you can't produce these documents, no legitimate research institution will work with you. Here's exactly what they'll ask for and when:

Document Status When They Ask How to Get It
Informed Consent Template
IRB-compatible consent form donors sign		 Required First conversation Healthcare attorney drafts this ($300-500). Must include: purpose of donation, risks, compensation disclosure, data usage, right to withdraw. Their IRB will review and may request modifications.
CLIA Certificate
Of your partner processing lab		 Required First conversation Your partner lab provides this. It's their cert, not yours. Helio doesn't process specimens — the lab does. Ask for their CLIA number when you sign the services agreement.
HIPAA Compliance Documentation
How you protect donor PII		 Required Before first order You already have the DATA-SECURITY-ARCHITECTURE.md. Turn this into a 2-page "Data Security & Privacy" PDF. Key points: 3-tier architecture, Helio ID anonymization, encryption, no PII shared with researchers.
HIPAA Business Associate Agreement (BAA)
Legal agreement for handling PHI		 Required Before first order Their institution will provide their standard BAA template. You sign it. Have your attorney review first ($100-200). This is standard — every vendor signs one.
Healthcare Attorney Letter
Confirming regulatory position		 Required Due diligence 1-page letter from your attorney confirming: marketplace model, no FDA registration required, PA Blood Bank Act Section 19 exemption, HIPAA compliance approach.
Certificate of Insurance
General liability + professional liability		 Required Before first order Your insurance provider issues this on request. Standard $1M/$2M coverage. Most researchers' procurement departments require this.
Specimen Handling SOPs
Collection, processing, shipping procedures		 Recommended Technical review Write a 3-5 page document covering: venipuncture procedure (defer to phlebotomist's training), tube types used, processing steps (centrifuge specs, aliquot volumes), storage temps, shipping containers, cold chain monitoring. Your lab partner can help with specifics.
Chain of Custody Documentation
Tracking from draw to delivery		 Recommended Technical review Build a simple form/system: donor Helio ID → draw date/time → phlebotomist initials → processing lab receipt → processing date → shipping date → tracking # → delivery confirmation. Can be a Google Form initially.
IRB Approval
For your donor recruitment protocol		 Recommended Some institutions require it Commercial IRB (Advarra or WCG) — $2,000-4,000. Some researchers' IRBs will cover your activities under their protocol. Ask first before paying. Many specimen procurement companies operate under the researcher's IRB, not their own.
Material Transfer Agreement (MTA)
Legal terms for specimen transfer		 Optional Some institutions use these Universities often have standard MTAs. They'll provide theirs. It covers: what's being transferred, permitted uses, IP rights, publication rights, disposal requirements.

Exact Outreach Emails

Email 1: Cold Email to Principal Investigator

Email 2: Follow-Up (Day 3)

Email 3: Follow-Up (Day 7)

Email 4: Partner Clinic / Mobile Phlebotomy

Email 5: Academic Core Lab / Processing Lab

Email 6: Cold Chain Shipping / Courier

Revenue Model — Solo Bootstrap

Pricing (after pilot)

Unit Economics (per standard specimen)

Revenue$300
Donor incentive-$75
Phlebotomy draw-$65
Lab processing-$25
Shipping-$35
Gross margin per specimen$100 (33%)

Note: margins improve significantly at scale. Donor incentives can decrease as loyalty tiers kick in. Lab processing and shipping costs drop with volume. Target 60%+ gross margin at 50+ specimens/month.

Team of Experts — Credibility Stack

Researchers won't wire money to a solo founder with a landing page. The findhelio.com research page needs a visible team of advisors and partners. This is the #1 trust gap for B2B research sales.

Current state: About section has two cards — Steven (founder) and Helio (company blurb). No advisors, no credentials, no partners listed. Fix this before outreach.

1. Regulatory Advisor Required

After your attorney consultation, ask:

2. Lab / Processing Partner Recommended

Once a CLIA-certified lab partnership is established:

3. Draw Site / Collection Partner Recommended

4. IRB Strategy STEVEN

Use partner clinics' existing IRB coverage rather than obtaining your own commercial IRB (Advarra/WCG). The clinics performing draws already operate under IRB protocols. Helio coordinates — the IRB obligation sits with the entity performing the medical procedure, not the marketplace. Confirm this with your attorney.

If confirmed, add to the research page: "Specimen collection conducted under partner clinic IRB protocols."

5. Research Page Redesign

Rename "About" → "Our Team & Partners". Card grid:

CardContentWhen to Add
FounderSteven Ellis — bio (already exists)Now
Regulatory Advisor"Reviewed by [Name], Esq." + specialtyAfter attorney call
Lab PartnerCLIA cert + lab nameAfter lab agreement
Collection PartnerClinic name + cityAfter clinic agreement

Future additions: Scientific advisor (if a PI agrees to advise), "Trusted by [X] research institutions" badge once clients are onboarded.

Donor Acquisition — 7 Channels

Meta ads are the primary paid channel, but the donor supply side needs multiple vectors to hit critical mass. Priority order:

1. Meta Ads → heliorewards.com STEVEN

Primary paid channel. "$650 for a blood draw" hook. Broad targeting per city. $500/mo to start, scale with revenue. Your DTC playbook applies directly.

Don't spend on ads until you have:

  1. At least 1 paying research client (not pilot)
  2. A proven draw-to-delivery pipeline that works
  3. Positive unit economics on delivered specimens
  4. At least $2,000 in revenue banked

2. Referral Incentive Program CLAUDE

"Refer a friend, you both get $50 bonus on your next draw." Build into the tier system (Spark → Beam → Radiant → Elite) from day one. Viral loop — lowest CAC channel after organic. I can build the referral tracking into the platform.

3. Campus Partnerships STEVEN

College students = ideal donor demographic. High density, always need money, healthy.

4. Reddit / Community Seeding STEVEN

r/beermoney, r/sidehustle, r/povertyfinance, r/philadelphia. "I made $650 donating blood for research (not plasma)" posts perform extremely well in these communities.

5. Google Ads — High-Intent Search STEVEN

$500-1K/month test budget. Target:

Highest intent channel after referrals — these people are actively searching.

6. City-Specific SEO Pages CLAUDE

Programmatic landing pages on heliorewards.com for each active city:

7. Clinic Waiting Room Placement STEVEN

If partner clinics do the draws, they can also recruit. "Earn money while you're here" signage + QR codes. Zero acquisition cost — people are already in a medical setting and comfortable with blood draws.

Timeline to Revenue

WeekMilestoneSpend
1-2LLC formed, attorney consulted, insurance active$1,200
3-4Clinic partner signed, lab partner signed$0
5-650 researcher emails sent, 3-5 meetings booked$0
7-81-2 pilot agreements signed, compliance docs delivered$500
9-1010-15 donors recruited organically, first draws completed$1,500
11-12First specimens delivered, first invoice sent$500
TotalFirst revenue in ~12 weeks~$5,000

Key Risks & Mitigations

When to Bring in Rob

Don't contact Rob until you have:

  1. A working pipeline (donor → draw → process → ship → researcher)
  2. At least 1 paying client
  3. Revenue that proves the model

Then the pitch to Rob is: "I built this, it works, I have paying clients, I need someone to run research sales while I run donor acquisition and tech. Here's the revenue. Here's your equity." That's infinitely more compelling than "I have an idea."