MedTech is not a free market. It is a highly regulated, government-controlled industry where compliance is weaponized to prevent new competitors from succeeding. If you're a MedTech founder with a groundbreaking idea, you need to understand one thing: you will not be competing on innovation—you will be competing on compliance.
MedTech is dominated by public sector contracts—meaning that selling into hospitals, healthcare systems, and insurers requires meeting an impossible web of regulatory requirements.
Here are just a few of the compliance barriers that make innovation impossible:
Required for handling sensitive health data
Cash Cost: $50K–$250K (annual audits, security consultants)
Time Cost: 6–12 months
A "voluntary" security framework that becomes mandatory when trying to sell into healthcare
Cash Cost: $200K–$500K
Time Cost: 6–9 months
Required if you want to sell to VA, Medicare, Medicaid, or any federal healthcare provider
Cash Cost: $500K–$5M
Time Cost: 12+ months
Required for EHR and software that integrates with providers
Cash Cost: $250K–$1M
Time Cost: 9+ months
FDA Approvals (For software classified as a medical device)
HIPAA "Audits" (Used as a legal weapon against startups)
State-Level Regulations (Each state has different compliance requirements)
You can read publicly available MedTech contracts—compliance is always listed under the "terms" section. This is how the U.S. government and large corporations legally prevent competition while maintaining the illusion of a free market.
🔴 Reality Check: U.S. decision-makers (e.g., acquisition officers) do not want competition in MedTech. The entire system is designed to force startups to burn years chasing compliance instead of innovating.
🔴 If you are not already wealthy or backed by corporate insiders, you will never pass these regulatory barriers. The system is rigged.
1️⃣ Understand that MedTech is not a startup-friendly industry. If you're not backed by insiders, your company will be crushed before it even enters the market.
2️⃣ Look outside the U.S. Countries with fewer regulatory chokeholds (UAE, Singapore, etc.) may offer a path forward.
3️⃣ Consider parallel industries. AI-driven health optimization tools that don’t require medical classification may have a chance.
4️⃣ Challenge the system. The only way MedTech changes is if decision-makers acknowledge the monopolistic nature of compliance and remove barriers to entry.
🚀 If you want to build AI-driven healthcare solutions without regulatory destruction, let’s talk.
📩 Contact Ian Sharp, PhD
🌐 SharpMethod.org
📅 Schedule a Consultation