OTC medical device commercialization is rapidly becoming a key growth strategy for connected device and biosensor manufacturers. As regulatory frameworks evolve and consumer demand for proactive health monitoring surges, forward-thinking MedTech companies are exploring how to bring regulated products once available only by prescription directly to market.
Recent launches like Dexcom’s Stelo and Abbott’s Lingo illustrate the opportunities and challenges of this transition. In this article, we examine these two high-profile examples to uncover what device makers, biosensor developers, and mobile medical app innovators can learn about regulatory pathways, platform integration, and market positioning when shifting from clinical use to over-the-counter availability.
Industry Shift: Why OTC for Connected Devices?
The MedTech landscape is undergoing a rapid transformation, with OTC medical device commercialization emerging as a powerful strategy for expanding market reach and accelerating adoption.
Driven by advances in biosensor technology, mobile medical apps, and consumer health awareness, more connected devices are moving beyond traditional prescription channels. This shift is not only opening new revenue opportunities but is also reshaping how medical device companies design, regulate, and deliver their products.
Regulatory Changes Enabling OTC Pathways
In recent years, regulatory bodies such as the FDA and EMA have introduced more explicit guidance and expedited pathways for certain connected medical devices, including biosensors and continuous glucose monitors.
For devices with proven safety profiles, simplified user interfaces, and strong post-market surveillance plans, achieving OTC clearance is now more feasible than ever. This is because:
- SaMD regulatory pathways are evolving to accommodate hybrid clinical-consumer use cases.
- Devices that integrate with secure, device-agnostic platforms can more easily meet compliance requirements for data privacy and interoperability.
- OTC classification can often be pursued in parallel with prescription indications, allowing companies to serve both markets.
These changes have lowered the barriers for connected medical devices and mobile health apps to enter the consumer space without sacrificing regulatory rigor.
Benefits of Going OTC for Connected Devices
For manufacturers of biosensors, wearables, and mobile medical apps, the shift to OTC distribution offers significant advantages, including:
- Expanded Market Reach – OTC status opens access to consumer markets far beyond clinical patient populations.
- Faster Adoption Cycles – Direct-to-consumer sales reduce dependence on physician adoption and reimbursement policies.
- Brand Visibility and Loyalty – Early consumer exposure helps build brand recognition that can influence clinical adoption later.
- Data-Driven Insights – OTC use increases data volume, which can inform product improvements, clinical research, and personalized care strategies.
As devices like Dexcom’s Stelo and Abbott’s Lingo demonstrate, OTC readiness depends on more than just consumer demand. It requires strategic planning across regulatory, technical, and commercialization dimensions.
Dexcom Stelo
Dexcom’s Stelo represents one of the most notable examples of OTC medical device commercialization in the continuous glucose monitoring (CGM) space.
By shifting from a prescription-only model to an over-the-counter offering, Dexcom has opened new doors for consumer adoption while setting a precedent for other connected medical device manufacturers.
Target Audience and Intended Use
The Stelo system was initially designed for individuals seeking proactive glucose monitoring without a diabetes diagnosis, primarily health-conscious consumers interested in optimizing diet, fitness, and metabolic health.
This broader wellness audience differs significantly from Dexcom’s core clinical base, which traditionally comprised people with type 1 or type 2 diabetes. The device’s intended use in the OTC market is focused on wellness monitoring rather than direct disease management, which positioned it for a different regulatory and marketing approach.
Regulatory Pathway Taken
Dexcom leveraged recent FDA guidance to bring Stelo to market as an OTC continuous glucose monitor. Instead of requiring a prescription, the device was cleared for consumer purchase based on:
- Demonstrated safety in non-clinical populations
- Simplified usability for self-installation and operation
- A robust post-market surveillance plan to monitor real-world use
This approach illustrates how a manufacturer can adapt its regulatory strategy to expand beyond clinical care, making OTC approval a pivotal part of connected device commercialization.
Technical Features Enabling OTC Viability
Several technical design choices made Stelo suitable for OTC distribution:
- BLE Connectivity – Bluetooth Low Energy integration allows seamless pairing with mobile devices for real-time glucose readings.
- Simple User Interface – Minimal setup steps and intuitive prompts reduce the need for professional training.
- Mobile App Integration – The Stelo app delivers visualized glucose trends, personalized insights, and optional data sharing with coaches or healthcare providers.
- Device-Agnostic Compatibility Potential – The data structure and transmission protocols can be integrated into broader platforms, enabling research, clinical trials, and multi-device data aggregation.
These features not only meet consumer usability expectations but also align with compliance requirements for connected health devices in regulated markets.
Market Positioning and Launch Strategy
Dexcom’s launch strategy for Stelo was distinctly consumer-focused while still retaining clinical credibility. Key elements included:
- Brand Leverage – Building on Dexcom’s established reputation in the diabetes space to assure product quality.
- Retail and Online Distribution – Making Stelo available through e-commerce platforms and potential retail pharmacy partnerships.
- Educational Marketing – Framing CGM use as part of a broader wellness and performance optimization trend.
- Cross-Segment Messaging – Appealing to those concerned about their blood glucose levels, nutrition-conscious consumers, and early adopters of health tech.
This combination of technical readiness, regulatory agility, and strategic positioning has made Stelo a model case study for manufacturers pursuing OTC medical device commercialization.
Abbott Lingo
Abbott’s Lingo is another standout example of OTC medical device commercialization, this time aimed squarely at the wellness and metabolic health market.
While Abbott has long been a leader in the clinical CGM space with its FreeStyle Libre systems, Lingo represents a deliberate pivot toward the consumer segment, offering a biosensor solution that can be purchased without a prescription.
Target Audience and Intended Use
Lingo was developed for a non-clinical audience seeking deeper insights into personal metabolism, energy management, and fitness performance.
Rather than focusing on blood glucose management, Abbott positioned Lingo as a metabolic coaching tool, targeting health enthusiasts, athletes, and individuals pursuing lifestyle optimization. The device is intended to provide feedback loops for nutrition choices, exercise impact, and recovery patterns.
Regulatory Pathway Taken
Abbott pursued a regulatory pathway that enabled Lingo to enter the market as an OTC connected biosensor.
While leveraging its prior expertise and regulatory track record with the Libre platform, Abbott tailored Lingo’s intended use, labeling, and companion app features to fit within the parameters for OTC clearance. Key regulatory elements included:
- Restricting claims to wellness and lifestyle benefits rather than diagnostic or treatment declarations
- Ensuring consumer-friendly labeling and training materials
- Demonstrating device safety and ease of use without professional oversight
This approach allowed Abbott to reduce time to market while avoiding the clinical trial requirements of a new prescription-only device.
Technical Features Enabling OTC Viability
Lingo incorporates several design and technical elements that made its OTC pathway possible, including:
- BLE Connectivity – Enables continuous, low-energy data transmission to paired smartphones.
- Custom Mobile App Experience – Their mobile health app offers personalized metabolic insights, trend tracking, and behavioral prompts aligned with lifestyle goals.
- Wearable Comfort and Usability – Slim profile and discreet adhesive design encourage everyday wear.
- Data Security and Privacy Compliance – Meets HIPAA and GDPR requirements for handling health-adjacent data in consumer markets.
These features ensure the product is both appealing to consumers and compliant with regulatory expectations for connected wellness devices.
Market Positioning and Launch Strategy
Abbott’s market strategy for Lingo was built to differentiate it from traditional CGM devices while still leveraging the brand’s established authority. They accomplished this through:
- Wellness-First Messaging – Positioning Lingo as a personal performance tool rather than a clinical monitoring device.
- Lifestyle Partnerships – Collaborating with fitness influencers, sports nutrition brands, and wellness programs.
- Global Multi-Channel Rollout – Launching in select markets with strong consumer demand for wearable health tech.
- Educational Content Marketing – Using blogs, videos, and app-based tutorials to explain metabolic health concepts to the average consumer.
By combining consumer-oriented branding with proven biosensor technology, Abbott has expanded its market reach while setting a strong example of how connected device makers can successfully execute an OTC commercialization strategy.
Lessons Learned for Medical Device and App Developers
The launches of Dexcom’s Stelo and Abbott’s Lingo illustrate that OTC medical device commercialization requires a coordinated strategy that spans product design, compliance, marketing, and post-market engagement.
For medical device and mobile medical app developers, these case studies highlight several critical lessons for successfully navigating the OTC pathway.
Lesson 1: Prioritize Regulatory Pathway Planning Early
The most successful OTC launches start with a regulatory strategy that is embedded into product development from day one.
- Engage with regulators early to understand classification options, labeling restrictions, and safety requirements for consumer use.
- Consider SaMD regulatory pathways if your solution combines a connected device with a mobile app.
- Where possible, explore parallel prescription and OTC indications to maximize both clinical and consumer market potential.
Lesson 2: Design for Consumer Usability Without Compromising Compliance
OTC devices must be intuitive for non-clinical users while meeting strict compliance standards.
- User Experience (UX): Clear onboarding, minimal setup steps, and intuitive mobile app navigation.
- Data Handling: Maintain HIPAA/GDPR compliance even in consumer markets.
- Device-Agnostic Integration: Ensure compatibility with various platforms to facilitate multi-device interoperability and secure data management.
Lesson 3: Align Technical Capabilities with Market Expectations
Technical readiness is a determining factor in OTC viability.
- BLE connectivity and real-time data display enhance user engagement.
- App-driven insights tailored to lifestyle goals increase perceived value.
- Scalable architecture allows your product to evolve with market demand, from wellness tracking to research or clinical applications.
Lesson 4: Build a Dual-Focused Commercialization Strategy
An effective OTC launch balances consumer appeal with industry credibility.
- Brand Positioning: Leverage existing reputation or clinical heritage to inspire trust.
- Multi-Channel Distribution: Combine e-commerce, retail pharmacy, and direct partnerships.
- Educational Marketing: Use thought leadership, tutorials, and data-backed storytelling to explain the device’s value proposition.
Lesson 5: Invest in Post-Market Feedback Loops
OTC markets move quickly. Companies must respond in real time.
- Use consumer analytics to refine app features and device performance.
- Monitor real-world safety and effectiveness through connected platform data.
- Feed insights back into both product development and regulatory updates.
Bottom Line
For medical device and app developers, the road to OTC medical device commercialization is paved with strategic foresight, consumer-centric design, and regulatory fluency. The successes of Stelo and Lingo prove that companies willing to integrate these elements can unlock entirely new growth channels without sacrificing safety, compliance, or product integrity.
The Role of Device-Agnostic Platforms in OTC Success
A critical, and often overlooked, factor in OTC medical device commercialization is the ability to seamlessly integrate hardware, software, and data workflows across diverse technologies.
Device-agnostic platforms like Sequenex’s NEX platform give manufacturers a strategic advantage by enabling rapid integration of connected devices, biosensors, and mobile medical apps into a single, secure ecosystem. This interoperability not only streamlines regulatory compliance for data privacy and interoperability standards but also accelerates time-to-market by reducing custom development work for each new device or app.
For companies pursuing OTC pathways, a customizable software platform approach allows them to scale quickly, adapt to evolving market demands, and maintain a unified consumer experience across multiple product lines.
By leveraging NEX, MedTech innovators can bridge the gap between regulated clinical use and consumer wellness applications, capturing broader markets while maintaining the compliance, reliability, and scalability needed for long-term success.
Paving the Way for OTC Medical Device Commercialization Success
The journeys of Dexcom’s Stelo and Abbott’s Lingo show that OTC medical device commercialization is a powerful path for MedTech companies seeking to expand market reach, accelerate adoption, and deliver consumer-friendly health solutions. Success in this space requires more than regulatory clearance; it demands seamless integration, consumer-ready design, and scalable data infrastructure. That’s where NEX makes the difference.
If your goal is to bring a connected medical device, biosensor, or mobile medical app to the OTC market, NEX provides the interoperability, compliance, and scalability you need to get there faster and with greater impact.
Connect with us today to learn how NEX can help you achieve your OTC medical device commercialization objectives and capture new opportunities in the evolving healthcare landscape.
