De-Risk and Master Phase Zero | Aaron Joseph & Russ Singleton

LifeSci Continuum with Bill Schick

Work with Bill: https://meshagency.com/lets-connect/
- Aaron Joseph https://www.linkedin.com/in/ajosephprofile/
- Russ Singleton https://www.linkedin.com/in/russellsingleton/
Here’s the link to their blog series: https://www.mpo-mag.com/author/russell-m-singletonrodmaneditors-mpo-com/
00:00 Introduction and guest bios (Aaron Joseph & Russ Singleton)
01:40 Backgrounds in medtech, compliance, and product development
03:40 What is Phase Zero in medical device development?
05:30 Why skipping Phase Zero leads to compliance & product failures
07:00 The physician-inventor dilemma: “I am my own customer”
10:30 Early adopters vs. mainstream market realities
13:00 Phase Zero on steroids: knowledge-building, risk reduction, and planning
19:00 Success through feasibility checks, fail-fast pivots, and market validation
25:00 Jobs-to-Be-Done, customer discovery, and avoiding founder bias
41:00 Practical advice for clinicians and teams starting innovation journeys
50:30 Final thoughts: passion, customer focus, and long-term impact
Medtech veterans and co-authors/thought leaders Aaron Joseph (Sunstone Pilot) and Russ Singleton unpack “phase zero on steroids”—the disciplined, pre-development work that de-risks science, validates real jobs-to-be-done, and sets your regulatory and reimbursement strategy before you write a line of code. Expect war stories, practical frameworks, and the permission to cancel projects early (that’s a win).
Most early-stage device teams rush into development and end up paying for it in rework, delays, or regulatory dead ends. In this episode, I chat with Aaron Joseph—principal consultant at Sunstone Pilot—and Russ Singleton—results-driven medtech executive and company builder. Aaron and Russ show you how to run Phase Zero on Steroids.
Three Tactics to Make Your Phase 0 Worthwhile
Russ and Aaron have three key takeaways for your med-tech journey pre-development, all with the promise of reducing headaches when executed properly.
Front-Load Truth, Not Features.
Begin Phase Zero by naming the job-to-be-done in one plain sentence and testing it with a representative set of users—not just top-5% surgeons. Pair a market-ear with a technology-ear in every interview to capture both desirability and feasibility. Write down kill criteria (technical, clinical, regulatory, economic) you’ll honor. If you hit them, pivot or stop. Canceling early is a success that preserves runway.
Make Science a Workstream with Exit Gates.
Treat unknowns like experiments: define the question, the method, the success threshold, and the next decision. Time-box these studies and document what you learn so results flow directly into design inputs. In parallel, map regulatory strategy (e.g., 510(k) vs PMA), evidence requirements (clinical/usability/electrical safety/sterilization), and reimbursement hypotheses. Often the fastest market path is a tight v1.0 with limited indications that establishes a regulatory baseline.
Design for Adoption Across Four Buyers.
You’re not just convincing a clinician—you’re convincing a system. Quantify switching costs and plan proof that speaks to (1) the user, (2) the hospital/economic buyer, (3) the payer/reimbursement gate, and (4) internal champions. Build your go-to-market around early centers that match your first winning application, then expand indications. Keep Phase Zero lean but funded: small, passionate core team; targeted outside experts; a 5-page plan that a VC—or your own GM—can say yes to.
Want help turning messy early insights into a crisp strategy, message, and launch plan? Bring in a Fractional CMO. https://meshagency.com/fcmo-fractional-cmo-fractional-marketing/
#MedTech #MedicalDevices #healthcareinnovation