Standards Development

At Lonsberry Consulting™, we believe that true innovation isn’t just about FDA approval—it’s about building systems of trust that accelerate access, reimbursement, and safe adoption. That’s why we lead and support efforts to create formal, recognized standards through the MedTech Innovation Center (MTIC) in alignment with the American National Standards Institute (ANSI).

We are actively engaged in developing the next generation of standards that bridge the gap between product development and payment policy—ensuring that breakthrough medical technologies don’t just get cleared, but get paid for and widely adopted.

ANSI (American National Standards Institute) is the recognized U.S. authority that oversees the development of voluntary consensus standards across industries. In healthcare, ANSI-aligned standards are trusted by:

• CMS and federal payers when evaluating evidence and economic claims
• Accrediting bodies (e.g., Joint Commission, DNV) for hospital and surgical access protocols
• Medical device companies as a framework for scalable, compliant practices

By aligning with ANSI, we ensure that the standards we help build are:

• Transparent and inclusive (multi-stakeholder process)
• Evidence-based and auditable
• Eligible for adoption by regulators, payers, and health systems

• Participate in standards development organizations (SDOs) and working groups
• Lead stakeholder alignment between MedTech, payers, hospitals, and regulators
• Draft consensus-based guidance that can be adopted by accrediting bodies or regulators
• Advocate for the use of these standards in hospital policy, CMS frameworks, and payer coverage decisions

Standards are the infrastructure of credibility. When your product, company, or team operates within ANSI-aligned frameworks:

• Your innovation is easier to adopt and reimburse
• Your strategy is more defensible to regulators and payers
• Your brand becomes associated with trust, safety, and scalability

Whether you’re seeking NTAP, BDD, DRG reassignment, or permanent coverage, aligning your company with emerging standards gives you a measurable competitive advantage.

Lonsberry Consulting™ proudly contributes to standards development initiatives through the MedTech Innovation Center, a collaborative hub for driving evidence-based, patient-centered commercialization standards.

“We don’t just help you succeed within the system—we help shape the system you’ll succeed in.”