Medical devices · Diagnostics · Regulated hardware

You have a prototype and a grant.
What you need is first revenue.

Regulatory pathway, reimbursement, IP, and go-to-market are not four separate problems to hand to four separate vendors. They are one decision, and getting the order wrong costs you a year. I have made that decision before, from inside the company and from the outside.

Book a 30-minute call
PROTOTYPE ENGAGEMENT FIRST REVENUE
Step response Ideal step input A step function does not ramp. It changes level.
Who this is for

Small teams with real money and no commercial leadership

Most of my clients are one to fifty people. They have non-dilutive funding or a seed round, a working prototype, deep technical talent, and nobody whose job is getting the thing sold.

That is a solvable problem, and it is almost always solved in the wrong order. Companies lock a regulatory pathway before they know who pays, or build a sales model around a billing code that does not exist yet. The sequence is the strategy.

  • NSF and NIH SBIR awardees writing a Phase II commercialization plan
  • Device and diagnostics companies choosing between 510(k), De Novo, and PMA
  • Teams who need a reimbursement answer before they finalize a design
  • Founders told to hire a VP of Sales who suspect that is premature
  • Regulated hardware outside medtech with the same prototype-to-revenue problem
Engagements

Three ways to work together

Fixed fee, scoped up front, priced in public. You will know what it costs before you get on the phone with me.

Level 01 · Start here

Path-to-Revenue Sprint

$18,000 – $25,000

Fixed fee · 3 weeks

One document that sequences regulatory pathway, reimbursement strategy, IP position, and first-market entry into a single plan with dates and owners.

  • Pathway and predicate analysis
  • Coding, coverage, and payment route
  • Beachhead market and first ten customers
  • Budget and hiring sequence

Doubles as the commercialization plan an SBIR Phase II application requires.

Level 02 · Ongoing

Fractional CPO / CCO

$10,000 – $16,000/mo

2 days per week · 3-month minimum

Senior commercial leadership on your team without the search, the equity, or the fully loaded cost of a full-time executive.

  • Own product and commercial strategy
  • Run pricing, positioning, and launch
  • Board and investor materials
  • Build the team that replaces me

Most engagements run three to nine months and end with a hire.

Level 03 · Compounding

AI Operating Layer

$25,000 – $40,000

Fixed fee · 4 to 6 weeks

I install the AI workflows I run my own practice on inside your company, and train your team to keep them running after I leave.

  • Regulatory and literature research pipelines
  • Clinical and device data analysis
  • Competitive and reimbursement monitoring
  • Documentation and submission drafting

For teams who keep hearing they should use AI and have never been shown how.

Fixed fee, never hourly. Hourly billing penalizes speed, and speed is the thing I am actually selling.

Track record

Twenty-five years of getting devices to market

CompanyYearsWhat I did
Smart Human Dynamics 2014 – 2026 Founder and CEO. AI-enabled remote patient monitoring and wearables. Mayo Clinic partnership and investment, NIH SBIR with the University of Michigan, IRB clinical trials, four issued patents.
Bespoke Innovations / 3D Systems 2012 – 2014 Senior Director, Marketing and Business Development. Built a national direct and distributor channel from zero.
Spiracur 2009 – 2012 Wound care. Office-based go-to-market built on reimbursement codes that already existed, which is the fastest revenue path a device company ever gets.
Guidant → Abbott 2001 – 2006 Endovascular and vascular intervention, then the bioabsorbable stent program that carried into Abbott.
Advisory Selected Materna, Volcano, Abbott, Amaranth, Innospine, Luma, HX Diagnostics.
25+Years in medtech
4Issued patents
NIHSBIR awardee, not just an advisor
HaasMBA · MS BME, Michigan
Who you are hiring

Steve Dugan

I have been the founder writing the SBIR application, the executive presenting to the board, and the marketer standing in an operating room at six in the morning. I have raised money, run trials, prosecuted patents, and closed first customers.

I am also unusually far along with AI tooling, and do the majority of my work through it now. That is why I can sell fixed-fee engagements at speeds that used to require a team. It is a delivery advantage, not a product pitch. I am a commercialization operator who happens to be AI-native.

Based in Lafayette, California. Bay Area companies in person, everyone else remotely.

Next step

Tell me where you are stuck

Thirty minutes, no charge, no deck. Bring your situation and I will tell you what I would do first, whether or not you hire me.

BEFORE THIS GOES LIVE — two links still need real values:
1. Booking button → your Cal.com or Calendly URL
2. Email button → mailto: address, once the domain is registered