^{Figure1: Uses of Digital Companions and Digital Therapeutics in consumer health (Source: IQVIA Consumer Health)}

Regulatory consideration on digital companions and digital therapeutics

Regulatory frameworks for digital companions and digital therapeutics varies depending on the country/region-specific jurisdiction, and regulatory agencies worldwide are continuously working to adapt and update their frameworks to keep pace with the rapidly evolving digital health landscape.

Digital health tools, including digital companions and digital therapeutics, are subject to different regulatory classes based on factors such as their intended use, risk level, and interaction with users. General wellness products, which focus on promoting a healthy lifestyle without diagnosing, treating, or preventing specific diseases or conditions, typically do not fall under regulatory oversight (e.g., fitness trackers, meditation apps, and nutrition apps).

On the other hand, digital health tools that qualify as medical devices have a specific medical purpose, such as diagnosing, treating, or preventing a disease or condition. Depending on the risk level, these devices may require regulatory oversight and premarket clearance or approval (e.g., wearable glucose monitors).

Another relatively new category, Software as a Medical Device (SaMD), encompasses software products intended for medical purposes without being part of a hardware medical device. SaMD products, which might diagnose, treat, or prevent medical conditions, typically undergo regulatory review based on their level of risk (e.g., skin diagnosis).

Prescription Digital Therapeutics (PDTs) form a subset of digital therapeutics that needs a prescription from a healthcare professional. PDTs generally involve software-driven interventions to treat medical conditions and are subject to rigorous clinical trials and regulatory approval processes (e.g., substance use disorder treatment app, special insomnia tools).

A holistic shift in healthcare and self-care

The future of consumer health lies in integrating such digital health tools to foster more holistic approaches to healthcare. Solely building a future pipeline on traditional remedies like tablets, pills, and capsules could see ‘traditional’ industry become obsolete.

Consumers are increasingly seeking more holistic health products with integrated digital health tools as opposed to standard “pills and capsules”. Holistic products with digital tools offer a personalized and proactive approach to health management, empowering individuals to take control of their well-being.

These solutions provide real-time feedback, enabling users to monitor progress and make data-driven decisions about their health. Additionally, digital health tools can enhance adherence to treatment plans, provide valuable insights into lifestyle modifications, and facilitate better communication with healthcare providers.

This shift towards holistic, digitally-integrated solutions represents a desire for more comprehensive, individualized, and engaging healthcare experiences that address both physical and mental well-being, involving a multidimensional sequence of "Inform – Advise – Diagnose – Treat – Prevent – Manage" interactions that emphasizes consumer autonomy and personalized care.

Bridging the gap between traditional and digital health

Despite the availability of numerous digital health tools, the majority remain disconnected from the consumer health industry. While some traditional consumer health companies are beginning to explore digital health technologies, their adoption has been comparatively slow due to issues around core competencies and focus, regulatory complexities, organizational inertia, financial considerations, competition, and data privacy concerns. However, the growing demand for personalized, holistic healthcare solutions is prompting these companies to explore digital health technologies, invest in innovation, and adapt to the evolving healthcare landscape to improve consumer health outcomes.

Digital companions and digital therapeutics now

Digital health tools already support consumers across several health areas and are revolutionizing consumer health and self-care by providing support across various health areas. Specifically, areas such as diet and nutrition, lifestyle and stress management, fitness, mental health, women's health, pain management, and sleep are well-suited for self-care digital health interventions. By leveraging innovative technologies, data-driven insights, and user-friendly interfaces, digital health tools in these areas enable consumers to proactively manage their health, leading to improved outcomes and increased satisfaction.

Across categories, we are slowly seeing the emergence of self-care digital health tools:

Pain management

• Virtual reality systems like EaseVRx provide immersive, therapeutic experiences that help manage chronic pain by reducing stress and promoting relaxation.
• Digital health platforms, such as Omada Health, combine digital coaching, behavioral interventions, and support from healthcare professionals to create personalized pain management programs.
• Mobile apps like Kaia Health and Curable guide users through exercises, pain education, and cognitive behavioral therapy to better manage their pain.
• Wearable devices, like Quell and Sana Health Mask, use neuromodulation and light stimulation respectively to offer drug-free pain relief.

These digital companions and therapeutics make pain management more accessible, personalized, and holistic, leading to improved outcomes and increased patient satisfaction.

Sleep issues

• Wearable devices, such as Philips SmartSleep, enhance slow-wave sleep for better restorative sleep.
• Guidance apps like Sleepio offer personalized CBT-I programs that help users develop healthier sleep habits.
• Sleep tracking devices like Fitbit monitor sleep patterns and provide insights for users to improve their sleep quality.
• Meditation apps, such as Headspace and Calm, guide users through relaxation techniques and mindfulness practices that promote better sleep.
• Sound and noise apps like Noisli and White Noise Lite create soothing environments using customizable ambient sounds and white noise.

Digital companions and therapeutics in sleep management provide personalized, evidence-based interventions that empower users to take control of their sleep health.

Women's health

• Fertility tracking apps like Natural Cycles use temperature readings to predict ovulation, helping users plan or prevent pregnancy.
• Pregnancy, wearable devices like Bloomlife Smart Pregnancy monitor maternal and fetal health, offering valuable insights for expectant mothers.
• Hormone health apps like MyFlo help users identify hormonal imbalances and offer personalized recommendations for optimal hormonal health.
• Menopause support platforms, such as Gennev, provide personalized menopause care, including telehealth consultations and symptom tracking.

Digital companions and therapeutics in women's health cater to the unique needs of women throughout various life stages, enabling them to manage their health effectively and proactively.

The need for strong evidence

As digital health tools gain prominence, emerging regulatory frameworks and competitive precedents are shaping evidence standards. It is crucial for consumer health industry stakeholders to navigate these regulations while developing and deploying digital health solutions.

Independent from the type of the digital health product, it is always recommended to provide strong evidence for its benefit as in the longer term this will help the product to be competitive and increase the credibility. In some cases (e.g. SaMD), there is a regulatory need to provide evidence in the form of clinical trials to demonstrate the safety and efficacy of a digital therapeutic. In any case, it is important to work closely with regulatory authorities and seek their input throughout the development process.

The Win-Win Potential of Digital Health Tools

As the consumer health industry embraces digital health technologies, both consumers and the industry stand to gain. Digital biomarkers and sensors are a core technology for digital companions and therapeutics because they enable the collection of valuable health data, drive personalization and efficacy of interventions, enhance user engagement, support clinical validation, and facilitate better integration with traditional healthcare services when needed.

Consumers can access a wide range of digital health tools to monitor and manage their health, while the industry can innovate with digital products, holistic offerings, and novel endpoints in clinical studies to enable new types of product claims.

To ensure sustainable growth and revenue generation, consumer health companies can adopt a combination of strategies, including freemium models, in-app advertising, data monetization, partnerships with healthcare providers, and corporate wellness programs. By staying ahead of the curve and leveraging digital health technologies, the consumer health industry can tap into the vast potential for innovation and growth.

In conclusion, digital companions and therapeutics are revolutionizing the way we address health concerns in pain, sleep, and women's health. By leveraging innovative technologies and personalized approaches, these solutions offer accessible, effective, and holistic care that empowers users to take charge of their health and well-being.

Final thoughts

Digital health initiatives are progressing worldwide, driven by market forces and increased focus on digital health across the healthcare ecosystem. Consumer health industry players must overcome any hesitation and uncertainties by considering the basic business model aspects, such as market assessment, differentiation, integration, validation, pricing, marketing, data privacy, and innovation.

It is crucial for consumer health companies to partner with digital specialist companies and have internal specialists to foster the development of holistic health solutions by integrating digital companions and digital therapeutics. Partnering with digital specialist companies allows consumer health companies to tap into the specialized knowledge and skills required to develop digital therapeutics, such as software development, data analytics, AI/ML, and user experience design.

These partnerships can help bridge the knowledge gap and accelerate the development process. Collaborating with digital specialists can help consumer health companies innovate more rapidly. Digital specialist companies are often more agile and can quickly adapt to changes in technology, regulations, and market demands.

By leveraging their expertise, consumer health companies can stay ahead of the curve in the rapidly evolving digital health landscape. Having internal specialists in digital health allows consumer health companies to better integrate digital therapeutics with their existing product portfolio. Internal specialists can identify synergies between traditional and digital products, ensuring a seamless and holistic healthcare experience for consumers. Furthermore, internal expertise can help drive a cultural shift within a consumer health company, fostering a mindset of innovation and adaptability. They can act as change agents, encouraging the organization to embrace new technologies, guide its investments, partnerships, and product development and ensure the business stays competitive in the digital health market.

Traditional consumer health products, such as pills and capsules, have been the go-to solution for addressing health concerns for many years. However, they have never been the most effective or appropriate solution for every individual. Digital companions and therapeutics offer the opportunity for a more targeted and personalized approach to healthcare, leveraging data, analytics, and AI/ML algorithms to deliver evidence-based interventions tailored to the individual's specific needs.

By leveraging digital health tools alongside traditional consumer health products, individuals can take a more proactive and empowered approach to managing their health and well-being.

If you don’t do it – somebody else will!