The Other Half of Innovation

Sep 10, 2026 | Biotech

Image Source: Courtesy of SweetBio
Independent Contributor
Written by: Kayla Rodriguez Graff, Co-Founder and CEO
On behalf of: SweetBio

What does the word “innovation” typically evoke in wound care? For many, it brings to mind a new biomaterial, a novel mechanism, or a breakthrough product supported by promising data and clinical validation. These advancements matter. But they raise a more fundamental question: what value does a breakthrough hold if it never reaches the wound?

Seeing patients not only access a product but experience meaningful healing because of it reshaped my understanding of innovation’s purpose. Innovation is not only about what we create, but whether it reaches the people it is intended to serve.

The Gap Between Invention and Adoption

The wound care industry has historically defined progress by what is invented rather than by what is adopted. We celebrate new technologies and improved clinical outcomes, yet many of the most advanced products never reach the majority of patients who could benefit from them.

Cost, reimbursement limitations, distribution challenges, and constraints within care settings all contribute to this gap. Chronic wounds affect roughly 10.5 million Medicare beneficiaries in the United States, creating an enormous human and financial burden. For patients whose wounds fail to heal after weeks of conventional treatment, advanced therapies such as skin substitutes can offer a critical next step and are widely considered among the most sophisticated tools available in modern wound care. Yet access remains limited. While millions of Americans live with chronic wounds, federal data suggest that only a relatively small number ultimately receive skin substitute therapies, despite their widespread recognition as an advanced treatment option for wounds that fail to respond to standard care.

Even clinically effective solutions can remain out of reach, particularly for patients navigating complex insurance systems or receiving care in under-resourced environments. Invention alone does not determine impact.

Product + Pathway

In practice, innovation is the combination of product and pathway. A breakthrough without a clear route to patients will struggle to achieve meaningful adoption.

This became clear in my experience building a wound care company. We achieved regulatory clearance in 2019, and the product performed as intended. Clinicians recognized its value and were eager to incorporate it into care. Yet adoption lagged. Not because of the science, but because reimbursement pathways were not yet established. From receiving our regulatory clearance to achieving a reimbursement pathway, it took another several years.

As we expanded distribution and built clinical interest, uptake remained limited until we addressed how the product would move through the system. Extending care into the home improved adoption significantly. The core technology itself had not changed, but our approach to the access pathway had.

Reaching patients depends on a series of interconnected steps: reimbursement, ordering, distribution, delivery, and use within real-world care settings. Friction at any point can not only limit uptake, it can halt it.

Designing for Real-World Use

Addressing these challenges requires intentional design well before regulatory submission. Reimbursement is not a downstream hurdle; it is a critical design element that directly influences adoption. In our case, this meant building with a clear understanding of coverage pathways from the outset. Early insight into reimbursement frameworks helped inform key product decisions, accelerating the path from approval to real-world use.

For example, formulation decisions were made with clinical performance as the primary focus. We later gained a deeper understanding of how Medicare evaluates reimbursement for honey-based products, and we were fortunate that our formulation aligned with their requirements, allowing us to secure reimbursement and reduce friction in the process. This kind of alignment is often overlooked, yet it has a measurable impact. Products designed with reimbursement in mind move more efficiently through the system, face fewer barriers to provider adoption, and ultimately reach more patients.

Equally important is designing for the environments in which patients actually receive care. Many underserved populations are not treated in highly resourced hospital systems; they rely on wound care clinics, home health services, or rural facilities with limited infrastructure. Products that fail to align with these settings are unlikely to scale effectively.

Pricing presents another critical consideration. Too often, affordability is addressed only after a product is widely adopted, produced at scale and reaches the mass market. If the goal is broad impact, however, pricing must be treated as another important design element from the outset. Solutions must be clinically effective and feasible to implement across care settings.

Access Is Equity

Access is, fundamentally, a matter of equity. Chronic wounds disproportionately affect older adults, lower-income populations, and communities of color, groups that are also more likely to encounter barriers to advanced care.

In a real-world evidence study of 47 chronic wounds we ran at an urban hospital clinic where over 20 percent of patients were uninsured, the leading driver of non-healing wasn’t the treatment, it was nonadherence, namely missed appointments, not offloading, and dietary indiscretion, the same friction you’d expect from a care model that demands a weekly clinic visit.

When advanced therapies are accessible only to those who can navigate these logistical and financial barriers, they risk reinforcing existing disparities. Access determines whether innovation fulfills its purpose.

Expanding the Definition of Innovation

If the goal is to improve patient outcomes at scale, our definition of innovation must evolve. It is no longer sufficient to ask whether a product works. We must also ask whether patients can realistically access it.

This shift has implications across the ecosystem. Funders might consider access alongside efficacy when evaluating new technologies. Founders might approach reimbursement and distribution as core innovation challenges rather than downstream hurdles. Together, these shifts can continue the momentum of clinicians fighting every day, not only for better tools, but for systems that ensure those tools reach the patients who need them most.

The opportunity is to rethink innovation itself, not as a process that ends with invention, but one that extends through delivery to patient impact. Because at its core, its purpose is to ensure that more patients have the opportunity to recover.

 

Author Bio

    Kayla Rodriguez Graff is a thought-provoking business leader bringing a fresh perspective to the healthcare and wound care industries. As CEO and co-founder, Kayla has spearheaded fundraising to bring SweetBio’s products from product development through patenting, FDA clearance, and early commercialization. Kayla is passionate about policy and advocacy for women, diverse entrepreneurs, and the life science industry. She serves on several boards supporting these efforts and recently presented at the U.S. Senate on Women Entrepreneurship.
    References:
    1. Sen CK (2025). Human Wound and Its Burden: Updated 2025 Compendium of Estimates. Advances in Wound Care. https://pubmed.ncbi.nlm.nih.gov/40660772/
    2. US Department of Health and Human Services, Office of Inspector General (2025). Medicare Part B Payment Trends for Skin Substitutes Raise Major Concerns About Fraud, Waste, and Abuse. Report OEI-BL-24-00420. https://oig.hhs.gov/documents/evaluation/10939/OEI-BL-24-00420.pdf
    3. Centers for Medicare & Medicaid Services. Local Coverage Determination L36377: Application of Skin Substitute Grafts for Treatment of DFU and VLU of Lower Extremities. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=36377&ver=7
    4. Rodríguez I, Alvarez A, Massey C, et al. (2023). Novel Bioengineered Collagen with Manuka Honey and Hydroxyapatite Sheet for the Treatment of Lower Extremity Chronic Wounds in an Urban Hospital Wound Care Setting. Wounds, 35(1):E35-E38. https://doi.org/10.25270/wnds/22034
    The author is co-founder and CEO of SweetBio, a company operating in the wound care sector, and therefore has a commercial interest in the subject matter discussed in this article. All content is published for informational purposes only and does not constitute medical, legal, or investment advice. For more information, see our Terms and Conditions

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