[Webinar Recap] Bridging Innovation and Access: A Global Dialogue on Medical Device Reimbursement and Regulatory Pathways
As medical device innovation accelerates globally, mastering the complex interplay of reimbursement and regulation has become essential for turning breakthroughs into accessible healthcare solutions.
As the global healthcare landscape accelerates toward precision medicine, digital therapeutics, and AI-driven care, the success of medical innovations depends not only on regulatory clearance, but also on the ability to navigate complex reimbursement systems. On June 25, over a hundred participants from across the world joined a special international webinar to unpack the evolving strategies behind market access for innovative medical devices.
Titled “Reimbursement & Regulation of Innovative Medical Devices,” this session was organized by the Science & Technology Law Institute of the Institute for Information Industry (III) under the guidance of Taiwan’s Ministry of Economic Affairs, with Anke Media Corp. as the executive organizer. It marked the launch of a global series aimed at connecting Taiwan’s medtech community with international experts and policy insights.
Understanding the Real Meaning of Market Access: Insights from the U.S.
One of the featured speakers was Mr. Mark Domyahn, a veteran reimbursement strategist and partner at the JD Lymon Group, a U.S.-based consulting firm specializing in helping medtech companies—from startups to global corporations—develop reimbursement strategies tailored to the highly complex U.S. healthcare system.
Domyahn emphasized that in the U.S., FDA approval is only the first step. True market access depends on a well-aligned reimbursement strategy built on three interconnected pillars: coding, payment, and coverage—often described as a "three-legged stool" essential for commercialization success.
Coding defines how procedures and diagnoses are described, using systems like CPT, ICD-10 PCS, or HIPAA codes. If a new technology lacks an existing code, companies may face a lengthy process—sometimes taking years—to establish one.
Payment refers to how much providers are reimbursed for the procedure. This amount varies widely depending on the care setting (inpatient, outpatient, ambulatory, or home) and the product type (drug, device, or wearable).
Coverage is the most critical element. Even with accurate coding and favorable payment rates, a product cannot succeed if payers—such as Medicare or private insurers—do not consider it medically necessary.
“Reimbursement is a journey,” Domyahn noted. “It’s not linear. And most payers are built to say no—companies need to come prepared with strong clinical evidence, not just health economic models.”
Domyahn illustrated the risks of overlooking reimbursement alignment through a series of practical examples. Even when a product secures both appropriate billing codes and favorable payment rates, it may still fail commercially if major payers decline coverage. This, he explained, is why early engagement with stakeholders—such as the American Medical Association, CMS, commercial insurers, and health technology assessment bodies—is crucial during development.
He also pointed to the strategic benefits of leveraging U.S. programs like Breakthrough Device Designation (BDD), which can accelerate access to reimbursement pathways such as New Technology Add-On Payments (NTAP) and Transitional Pass-Through (TPT). These incentives can significantly ease financial hurdles, especially for high-cost devices with strong clinical value.
In discussing newer categories such as durable medical equipment (DME) and Software as a Service (SaaS), Domyahn noted that reimbursement logic diverges from traditional implantable devices. For wearable or digital solutions, payment models often rely on direct-to-patient transactions or third-party distributors—requiring companies to rethink both pricing and market entry strategies. This is particularly important for international firms aiming to navigate the U.S. system.
Building for Global from the Beginning: A Taiwanese Perspective on Innovation and Access
The second keynote was delivered by Professor Anna Chen, a leading figure in biomedical engineering at National Cheng Kung University (NCKU) and a Stanford Biodesign Global Faculty Fellow. With deep experience in regulatory science and translational innovation, Professor Chen brought a critical local perspective: how Taiwan’s medtech industry can scale globally by embedding international reimbursement strategies into its innovation process.
Given Taiwan’s limited domestic market, Chen emphasized that global commercialization should be the default, not an afterthought. Medtech companies, she argued, must begin R&D with international access in mind—aligning early-stage design with the reimbursement requirements of target markets.
Her talk highlighted trends in FDA De Novo approvals, which have become a preferred route for first-in-class technologies, especially in digital health and AI. Between 2022 and 2025, a noticeable wave of De Novo-cleared devices emerged in areas such as neurology and chronic disease management. Many of these:
Were software-driven, home-use, and non-invasive
Addressed unmet needs like migraines, fibromyalgia, and cognitive disorders
Incorporated AI-powered diagnostics and qualified for Breakthrough Device Designation (BDD)
Chen pointed out that these devices reflect a broader transformation: from single-use tools to continuous care platforms. However, she cautioned that innovation alone isn’t enough. Without early reimbursement planning, many promising products stall in the so-called "valley of death", unable to reach patients or generate revenue.
She reinforced Domyahn’s earlier message that clinical trials should be designed with payer expectations in mind, not just regulatory endpoints. Generating the right type of evidence—from real-world data to comparative effectiveness—is key to convincing insurers of value.
In the final part of her talk, Professor Chen addressed the distinct regulatory challenges faced by home-based and consumer-grade health technologies, including:
Device usability across diverse home environments
Cybersecurity risks and data protection
Caregiver training and readiness
As the FDA continues to formalize these categories, she advised companies to anticipate these factors early, noting that user-centric design and robust safety protocols are becoming critical to both approval and market success.
From Theory to Practice: Real Questions from Real Innovators
The Q&A session offered valuable insights into the complexities of global market access. Key takeaways included:
On reimbursement planning, Domyahn emphasized that delaying this consideration can cause significant commercialization setbacks. Professor Chen stressed that for Taiwan’s startups—especially in AI, semiconductors, and software diagnostics—adopting a global-first mindset is critical from the outset.
Regarding pricing strategies for home-use devices, Domyahn explained that the durable medical equipment (DME) market differs markedly from traditional hospital reimbursement. Companies often need to consider cash-pay or hybrid sales models to succeed in this channel.
On preparing for the FDA’s Breakthrough Device Designation (BDD) pathway, Professor Chen recommended designing clinical study protocols that incorporate standard-of-care comparators, ensuring data robustness to meet regulatory and payer expectations.
The panel also addressed how software updates and label expansions impact reimbursement. Domyahn noted that minor software changes typically do not require new codes, but payer coverage may fluctuate depending on how the device’s indications evolve.
When discussing the differences between drug and device reimbursement in the U.S., Domyahn clarified that devices are reimbursed based on the associated procedure, not through drug formularies, highlighting the importance of well-published clinical evidence to support payer negotiations.
Conclusion: Speaking the Language of Access
Closing the session, Dr. Yuing Huang, Section Manager at III’s Science & Technology Law Institute, reflected on the importance of today’s discussion. She noted that the transformation of the healthcare landscape—driven by AI, precision medicine, and aging demographics—demands that innovators not only develop great technology but also “speak the language of access.”
The Institute committed to continuing its efforts in building knowledge-sharing platforms that bring Taiwan’s medtech sector closer to global best practices in reimbursement, regulation, and innovation management.
“This is more than a webinar—it’s the beginning of a necessary conversation,” Dr. Huang concluded. “Because innovation, without access, is just potential left on the table.”
This event is organized under the guidance of Taiwan’s Ministry of Economic Affairs (MOEA) Department of Industrial Technology, with the Science & Technology Law Institute as the organizer and Anke Media Corp. as the executive organizer. The Medical Device Innovation Center at National Cheng Kung University is an associated partner, with media partners AnkeCare and SourcingCares supporting the initiative
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