Regulatory Planning In Early Medtech Development Is The Recipe For Success

This article, “Regulatory Planning in Early Medtech Development is the Recipe for Success,” was originally published in Med Device Online, written by Sheila Gwizdak, VP, Strategic Consulting Solutions at Halloran, and Meghan Patterson, Principal Consultant at Halloran Consulting Group. Permission to republish has been granted.

In today’s environment, medtech companies can no longer build their strategy around regulatory timelines alone. With market dynamics shifting, regulatory expectations evolving, and business continuity becoming more complex, aiming for clearance or approval is no longer a sufficient endpoint.

While regulatory, clinical, and quality considerations remain central to any forward-looking strategy, today’s competitive market demands the integration of pricing, reimbursement, and market access be prioritized from the outset. These elements are not optional but, instead, are foundational to managing risk, driving differentiation, and remaining competitive in a fast-moving market.

This article explores the strategic shift required across both pre- and post-market activities, challenging outdated approaches to regulatory planning, and presents a more integrated pathway to achieving long-term regulatory and commercial success.

It’s Time To Evolve Our Regulatory Approach

Historically, many medtech companies have engaged with the U.S. FDA in a conservative and transactional way, providing only the minimum required to obtain clearance or approval, often without considering what comes next. That mindset is no longer enough.

The medtech industry is at a turning point. Emerging technologies, such as AI-powered diagnostics, connected home-use devices, and other novel innovations demand more than a checklist approach. Regulatory strategy must move beyond tactical execution aimed at satisfying investor milestones and instead evolve into a comprehensive, holistic, forward-looking plan that incorporates clinical value, market access, and patient adoption elements.

This shift also redefines the role of regulatory professionals. No longer just compliance gatekeepers, they must act as strategic integrators, connecting science, business, policy, and patient needs to shape both innovation as well as long-term product value.

In parallel, regulators are also undergoing significant change. The FDA is under pressure to evaluate increasingly complex technologies with fewer resources, all while maintaining public trust and accelerating review timelines. This dual challenge, doing more with less, makes proactive and strategic engagement with regulators even more critical.

Now, more than ever, regulatory affairs professionals must serve as the bridge between innovation and implementation, ensuring products are not only approved but positioned for real-word success.

From Compliance To Competitive Advantage

Regulatory planning must start early and run in parallel with product and clinical development, health economics, and commercial strategies. A cross-functional approach from the outset is essential to ensure alignment across value, access, and adoption goals.

By embedding regulatory insights into early decision-making, organizations can shape development plans that meet the needs of regulators, payers, and patients simultaneously. Engaging with regulatory agencies proactively allows for greater flexibility as expectations evolve, reducing risk and enabling faster paths to approval.

When regulatory is treated as a strategic partner, rather than a downstream checkpoint, it can help guide evidence generation, strengthen go-to-market planning, and help ensure that compliance efforts also support business continuity.

As digital tools and AI become more integrated into the regulatory landscape, early adoption of technology-enabled solutions can further enhance transparency, scalability, and submission efficiency. Ultimately, treating regulators as a value driver, not just a gatekeeper, can offer a true competitive advantage.

A real-world example of this strategy can be seen with Medtronic’s InPen – a smart insulin pen that tracks dosing history and connects to a mobile app. The company aligned early with the FDA on combination product classification and, based on agency feedback, incorporated cybersecurity safeguards to support digital interoperability. It also began reimbursement planning with value-based payment models in mind and prioritized human factors testing, especially for adolescents and older adults. This holistic regulatory-commercial approach helped the product stand out in a competitive diabetes market and enabled safer self-administration across diverse populations, according to the FDA’s 510(k) summary¹ for the InPen and a company announcement.²

Early Integration Of Market Access And Reimbursement

A strong regulatory strategy doesn’t operate in a silo. Consider the case of a diagnostic company developing a smartphone-connected device for blood level detection in children. While technology was novel, the real challenge lay in:

• adapting Current Procedural Terminology (CPT) codes that were not designed for home use
• pursuing Clinical Laboratory Improvement Amendments (CLIA) waiver status to permit non-laboratory use
• demonstrating real-world usability and safety to regulators.

This wasn’t just a regulatory exercise; it was a complex, multidimensional effort requiring coordination across the Centers for Medicare and Medicaid Services (CMS), payers, and patient engagement strategies. Strategic planning had to reflect the full landscape of clinical, regulatory, reimbursement, and user adoption challenges from the start.

Regulatory Strategy Aligned With Healthcare Environment

A successful pre-market strategy today must reflect the realities of a dynamic healthcare landscape. It should:

• begin cross functionally, with input from product development, clinical, regulatory, marketing, and health economics
• anticipate evidence needs for reimbursement and clinical adoption
• evolve in response to emerging data, market feedback, and payer expectations.

As companies increasingly leverage real-world evidence (RWE) from wearables, electronic health records (EHR), and registries to reduce trial costs and accelerate adoption, regulatory strategies should be designed to incorporate and leverage this data from the start.

A compelling example is an AI-enabled cardiac monitoring patch that continuously collects electrocardiography (ECG) data and uses machine learning to detect arrhythmias. The company aligned early with FDA on a predetermined change control plan (PCCP) to support future AI model updates and engaged payers to explore reimbursement pathways under remote patient monitoring codes. It also incorporated RWE to support performance claims and designed the patch with usability across age groups in mind. This strategy allowed the company to accelerate approval while building a compelling case for clinical and market adoption.

Human Factors As A Differentiator

Design and usability can no longer be an afterthought. For home use or patient-facing devices, intuitive design and low risk of use errors are critical, not just for safety but also for user adoption, training burden, and payer acceptance. Human factors should be embedded into the regulatory strategy as a key lever for both de-risking and differentiation.

A notable example is Teva’s ProAir Digihaler – the first FDA-cleared digital inhaler with built-in sensors that capture inhalation data and transmit it to a mobile app. While the underlying drug-device combination was already well established, the integration of digital features added new challenges in usability and human factors validation. Teva conducted formative and summative usability studies to demonstrate that patients, particularly adolescents and caregivers, could use the device correctly, interpret feedback from the device and app, and avoid critical errors. These studies were key to FDA clearance via a supplemental NDA and enabled the company to position the product as both a therapeutic and digital monitoring tool.³

Proactively incorporating human factors into its regulatory and commercial strategy, Teva strengthened its payer value while addressing adoption barriers, messaging around improved adherence, and patient engagement while achieving market clearance. This example illustrates how usability, when treated as a strategic design input, can be a powerful differentiator.

Planning Post-Market From The Outset

Forward-looking strategies don’t stop at approval; they also plan for post-market needs from the beginning. Key elements include:

• building feedback loops to capture safety, performance, and value data
• aligning software and AI-based product updates with evolving FDA expectations (i.e., PCCPs)
• embedding patient experience and preferences into both product design and regulatory evidence.

Take the example of a company developing a fertility device using saliva, urine, and wearable sensors. Rather than relying solely on traditional clinical metrics, its strategy focused on capturing and incorporating the patient’s voice:

• Identifying what physical and emotional indicators matter most to women
• Personalizing algorithms for cycle prediction
• Empowering users to guide product evolution based on lived experiences

By adopting a patient-first approach, the company aims to improve adherence, deliver more meaningful outcomes, and accelerate adoption in a competitive market. The strategy also provided a stronger foundation for regulatory review and payer discussions around real-world value.

The Bottom Line

The medtech strategy of the future is integrated, patient-centric, and built for flexibility. Regulatory professionals must do more than guide products to approval. They must also shape innovation that delivers long-term clinical, commercial, and societal value.

Approval is only one milestone. A robust strategy anticipates what will happen both before and after and the value of how all parts of the organization can come together to build a product that performs clinically, earns payer trust, and meets real-world patient needs.

Some examples in this article reflect composite scenarios drawn from trends across the medtech industry. Where publicly available data exists (i.e., Teva’s ProAir Digihaler), references are provided in the references section.

References

1. U.S. Food and Drug Administration’s 510(k) summary. K200403.pdf
2. Medtronic press release. Medtronic Launches InPen™ with Real-Time Guardian™ Connect CGM Data -- the First Integrated Smart Insulin Pen for People with Diabetes on MDI - Nov 12, 2020
3. Teva Pharmaceutical Industries press release. Teva Pharmaceutical Industries Ltd. - Teva Announces FDA Approval of First and Only Digital Inhaler with Built-In Sensors – ProAir Digihaler™ (albuterol sulfate 117 mcg) Inhalation Powder