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External vs Implantable CGMs: A Deep Dive for Medical Device Companies

A continuous glucose monitoring patch on a woman's arm
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    Introduction

    The Continuous Glucose Monitoring (CGM) market is experiencing rapid growth, due to increasing prevalence of diabetes, as well as mainstream acceptance of medical wearable devices. But for medical device companies in the CGM market, what’s a better space to operate in between external and implantable CGM patches?

    In this blog, we’ll explore and compare the growth trajectories, return on investment (ROI) and manufacturing considerations of both external and implantable CGM patches.

    Growth Trajectories & Return on Investment

    External CGM patches, which adhere to the skin, have long been the foundation of the CGM market, and have gained mainstream acceptance due to their ease of use and non-surgical requirements. Furthermore, improvements in sensor accuracy, battery life and wireless connectivity have made external CGM devices significantly more appealing. These conditions have led to a stable and predictable ROI associated with external CGM patches making them an attractive option for medical device companies. The recurring revenue from disposable sensors and device replacements further contributes to their favorable ROI.

    In contrast, implantable CGM patches represent a more recent innovation in the market. These devices offer continuous glucose monitoring through a sensor inserted under the skin, which can appeal to patients seeking a more seamless and less obtrusive monitoring experience. Despite their potential, implantable CGM patches are still in the early stages of market adoption. Innovations in biocompatible materials, miniaturization of sensors and extended battery life are driving their development, but widespread acceptance and market penetration will take time.

    Another important factor to take into account is the higher initial development costs associated with implantable CGM devices, due to the complexity of ensuring biocompatibility and long-term stability. These factors suggest the ROI for implantable CGM patches may take longer to realize than external CGM patches.

    Manufacturing Considerations

    When it comes to manufacturing, the production of external patches can be scaled more efficiently than implantable CGM patches due to established manufacturing techniques, processes and supply chains.

    By contrast, manufacturing implantable CGM is more complex. Materials need to be biocompatible and safe for long-term implantation, making the production process more complex. In addition, the need to miniaturize components while maintaining sensor accuracy and battery longevity should not be overlooked.

    On top of the increased manufacturing complexity, the regulatory pathway for implantable devices is more stringent, requiring extensive clinical testing and validation to ensure safety and efficacy. Whilst still rigorous, the regulatory framework for external CGM devices is more straightforward.

    Conclusion

    Whilst there are definitely benefits and specific use cases for implantable CGM devices, it is clear that external CGM patches offer a more stable and predictable path to growth. Their established market presence, lower development costs, and more straightforward regulatory framework make them an attractive option for CGM brands. It’s important to remember that implantable CGM patches serve specific use cases and could see significant growth in the future. However. the current market dynamics favor external CGM patches as a more viable product offering in the immediate term.

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