“So you have an idea...”
A practical guide to tech and device development for the early-career GI
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11/01/2025
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by Alicia Muratore, MD, MBA , Emily V. Wechsler, MD , Eric D. Shah, MD, MBA
You are in the middle of a busy clinic day and think to yourself: “There has to be a better way to do this.” Suddenly, a better way to do something becomes obvious. Maybe it’s a tool that simplifies documentation, a device that improves patient comfort, or an app that bridges a clinical gap. Many physicians, especially early career gastroenterologists, have moments like this, but few know what to do next.
This article is for the curious innovator at the beginning of their clinical career. It offers practical, real-world guidance on developing a clinical product: whether that be hardware, software, or a hybrid. It outlines what questions to ask, who to consult, and how to protect your work, using personal insights and business principles learned through lived experience (Figure 1).
Understanding Intellectual Property (IP): Know its value and ownership
What is IP?
Intellectual property refers to your original creations: inventions, designs, software, and more. This is what you want to protect legally through patents, trademarks, or copyrights.
Who owns your idea?
This is the first and most important question to ask. If you are employed (especially by a hospital or academic center), your contract may already give your employer rights to any inventions you create, even those developed in your personal time.
What to ask:
Does my employment contract include an "assignment of inventions" clause?
Does the institution claim rights to anything developed with institutional resources?
Are there moonlighting or external activity policies that affect this?
If you are developing an idea on your personal time, with your own resources, and outside your scope of clinical duties, it might still be considered “theirs” under some contracts. Early legal consultation is critical. A specialized IP attorney can help you understand what you own and how to protect it. This should be done early, ideally before you start building anything.
Lawyers aren't optional: They're essential early partners
You do not need a full legal team, but you do need a lawyer early. An early consultation with an IP attorney can clarify your rights, guide your filing process (e.g. provisional patents), and help you avoid costly missteps.
Do this before sharing your idea publicly, including in academic presentations, pitch competitions, or even on social media. Public disclosure can start a clock ticking for application to protect your IP.
Build a founding team with intent
Think of your startup team like a long-term relationship: you're committing to build something together through uncertainty, tension, and change.
Strong early-stage teams often include:
The Visionary- understands the clinical need and vision
The Builder- engineer, developer, or designer
The Doer- project manager or operations lead
Before forming a company, clearly define:
Ownership (equity percentages)
Roles and responsibilities
Time commitments
What happens if someone exits
Have these discussions early and document your agreements. Avoid informal “handshake" deals that can lead to serious disputes later.
You don’t need to know everything on day one
You do not need to know how to write code, build a prototype, or get FDA clearance on day one. Successful innovators are humble learners. Use a Minimum Viable Product (MVP), a simple, functional version of your idea, to test assumptions and gather feedback. Iterate based on what you learn. Do not chase perfection; pursue progress. Consider using online accelerators like Y Combinator’s startup school or AGA’s Center for GI Innovation and Technology.
Incubators: Use them strategically
Incubators can offer mentorship, seed funding, legal support, and technical resources, but they vary widely in value (Table 1). Many may want equity, and not all offer when you truly need.
Ask Yourself:
Do I need technical help, business mentorship, or just accountability?
What does this incubator offer in terms of IP protection, exposure, and connections?
Do I understand the equity trade-off?
What services and funding do they provide?
Do they take equity? How much and when?
What’s their track record with similar ventures?
Are their incentives aligned with your vision?
Academic institutions: Partners or pitfalls?
Universities can provide credibility, resources, and early funding through their tech transfer office (TTO).
Key questions to ask:
Will my IP be managed by the TTO?
How much say do I have in licensing decisions?
Are there royalty-sharing agreements in place?
Can I form a startup while employed here?
You may need to negotiate if you want to commercialize your idea independently.
Do it for purpose, Not payday
Most founders end up owning only a small percentage of their company by the time a product reaches the market. Do not expect to get rich. Do it because it solves a problem you care about. If it happens to come with a nice paycheck, then that is an added bonus.
Your clinical training and insight give you a unique edge. You already know what’s broken. Use that as your compass.
Conclusion
Innovation isn’t about brilliance, it’s about curiosity, structure, and tenacity (Table 2). Start small. Protect your work. Choose the right partners. Most importantly, stay anchored in your mission to make GI care better.
Summary content
7 Key Takeaways
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1
Developed a paper-based colorimetric sensor array for chemical threat detection.
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Can detect 12 chemical agents, including industrial toxins.
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Production cost is under 20 cents per chip.
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Utilizes dye-loaded silica particles on self-adhesive paper.
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Provides rapid, simultaneous identification through image analysis.
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Inspired by the mammalian olfactory system for pattern recognition.
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Future developments include a machine learning-enabled reader device.
The guidelines emphasize four-hour gastric emptying studies over two-hour testing. How do you see this affecting diagnostic workflows in practice?
Dr. Staller: Moving to a four-hour solid-meal scintigraphy will actually simplify decision-making. The two-hour reads miss a meaningful proportion of delayed emptying; standardizing on four hours reduces false negatives and the “maybe gastroparesis” purgatory that leads to repeat testing. Practically, it means closer coordination with nuclear medicine (longer slots, consistent standardized meal), updating order sets to default to a four-hour protocol, and educating front-line teams so patients arrive appropriately prepped. The payoff is fewer equivocal studies and more confident treatment plans.
Metoclopramide and erythromycin are the only agents conditionally recommended for initial therapy. How does this align with what is being currently prescribed?
Dr. Staller: This largely mirrors real-world practice. Metoclopramide remains the only FDA-approved prokinetic for gastroparesis, and short “pulsed” erythromycin courses are familiar to many of us—recognizing tachyphylaxis limits durability. Our recommendation is “conditional” because the underlying evidence is modest and patient responses are heterogeneous, but it formalizes what many clinicians already do: start with metoclopramide (lowest effective dose, limited duration, counsel on neurologic adverse effects) and reserve erythromycin for targeted use (exacerbations, bridging).
Several agents, including domperidone and prucalopride, received recommendations against first-line use. How will that influence discussions with patients who ask about these therapies?
Dr. Staller: Two points I share with patients: evidence and access/safety. For domperidone, the data quality is mixed, and US access is through an FDA IND mechanism; you’re committing patients to EKG monitoring and a non-trivial administrative lift. For prucalopride, the gastroparesis-specific evidence isn’t strong enough yet to justify first-line use. So, our stance is not “never,” it’s just “not first.” If someone fails or cannot tolerate initial therapy, we can revisit these options through shared decision-making, setting expectations about benefit, monitoring, and off-label use. The guideline language helps clinicians have a transparent, evidence-based conversation at the first visit.
The guidelines suggest reserving procedures like G-POEM and gastric electrical stimulation for refractory cases. In your practice, how do you decide when a patient is “refractory” to medical therapy?
Dr. Staller: I define “refractory” with three anchors.
1. Adequate trials of foundational care: dietary optimization and glycemic control; an antiemetic; and at least one prokinetic at appropriate dose/duration (with intolerance documented if stopped early).
2. Persistent, function-limiting symptoms: ongoing nausea/vomiting, weight loss, dehydration, ER visits/hospitalizations, or malnutrition despite the above—ideally tracked with a validated instrument (e.g., GCSI) plus nutritional metrics.
3. Objective correlation: delayed emptying on a standardized 4-hour solid-meal study that aligns with the clinical picture (and medications that slow emptying addressed).
At that point, referral to a center with procedural expertise for G-POEM or consideration of gastric electrical stimulation becomes appropriate, with multidisciplinary evaluation (GI, nutrition, psychology, and, when needed, surgery).
What role do you see dietary modification and glycemic control playing alongside pharmacologic therapy in light of these recommendations?
Dr. Staller: They’re the bedrock. A small-particle, lower-fat, calorie-dense diet—often leaning on nutrient-rich liquids—can meaningfully reduce symptom burden. Partnering with dietitians early pays dividends. For diabetes, tighter glycemic control can improve gastric emptying and symptoms; I explicitly review medications that can slow emptying (e.g., opioids; consider timing/necessity of GLP-1 receptor agonists) and encourage continuous glucose monitor-informed adjustments. Pharmacotherapy sits on top of those pillars; without them, medications will likely underperform.
The guideline notes “considerable unmet need” in gastroparesis treatment. Where do you think future therapies or research are most urgently needed?
Dr. Staller: I see three major areas.
1. Truly durable prokinetics: agents that improve emptying and symptoms over months, with better safety than legacy options (e.g., next-gen motilin/ghrelin agonists, better-studied 5-HT4 strategies).
2. Endotyping and biomarkers: we need to stop treating all gastroparesis as one disease. Clinical, physiologic, and microbiome/omic signatures that predict who benefits from which therapy (drug vs G-POEM vs GES) would transform care.
3. Patient-centered trials: larger, longer RCTs that prioritize validated symptom and quality-of-life outcomes, include nutritional endpoints, and reflect real-world medication confounders.
Our guideline intentionally highlights these gaps to hopefully catalyze better trials and smarter referral pathways.
Dr. Staller is with the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston.