The importance of partnerships for clinical strength in digital health

• Proving the efficacy and safety of digital health solutions through rigorous scientific validation is essential for gaining the trust of healthcare providers, patients, payers, and investors
• Partnerships, particularly with pharmaceutical companies, are crucial for digital health ventures to establish clinical evidence
• Partnerships offer essential expertise, resources, and funding, facilitating clinical trials, regulatory approvals, and boosting the credibility and market access of digital health solutions

The digital health landscape is rapidly evolving, with innovative technologies emerging at an unprecedented pace.¹ However, the success of these innovations hinges not only on their novelty but also on their ability to demonstrate real-world efficacy and safety²  —a concept known as “clinical strength.” This document explores the critical importance of clinical strength in digital health, detailing how strategic partnerships and robust clinical evidence are essential for gaining the trust of healthcare providers, patients, payers, and investors. As the demand for proven digital health solutions grows, understanding and achieving clinical strength becomes increasingly vital for ventures aiming to make a lasting impact in the healthcare ecosystem.

As regulatory bodies, payers, and investors demand higher standards of evidence and the amount of evidence being generated by digital health ventures increases, the importance of clinical strength continues to rise.³ Partnerships with biopharma and other industry verticals are crucial for digital health ventures seeking to build clinical evidence, as they provide access to expertise, resources, funding, infrastructure, and established networks for patient recruitment and clinical trials. These collaborations enhance credibility, trust, and market access, enabling digital health solutions to integrate into existing healthcare systems and achieve regulatory approvals more efficiently.⁴

The significance of clinical strength in digital health is immense. Traditionally crucial for regulated solutions, it is now equally critical for earning the trust of healthcare providers, payers, and patients for non-regulated solutions. Clinically validated digital health tools are more likely to be adopted and integrated into standard healthcare practices.² Additionally, corporate partners and investors are increasingly insisting on evidence for clinical efficacy before adopting solutions, selecting development partners, or funding digital health ventures.³ Demonstrating clinical strength is therefore essential for the sustainable growth and acceptance of digital health innovations.

Clinical Strength can be defined as the measure of a digital health venture’s ability to demonstrate the efficacy and safety of its solutions through rigorous scientific validation. This includes clinical trials, regulatory approvals, and publication of results in peer-reviewed journals.³ Clinical strength is not just about having an innovative technology; it’s about proving that the technology can deliver real, measurable health benefits in a controlled, scientific manner. According to this, ventures can be classified as having “proven clinical strength” when their products have been utilized in at least one of the following categories:

1. Clinical Trials: Conducting clinical trials that follow rigorous scientific protocols to test the efficacy and safety of digital health solutions. This is considered one of the most reliable methods for demonstrating clinical strength.
2. Regulatory Approvals: Obtaining approvals/clearance from regulatory bodies such as the FDA, EMA, or other relevant health authorities. These approvals indicate that the solution meets the necessary standards for safety and efficacy.
3. Peer-Reviewed Publications: Publishing study results in reputable, peer-reviewed medical or scientific journals. This provides transparency, requires scientific rigor, and allows the broader medical community to scrutinize and validate the findings. Multiple publications are needed to prove clinical strength.

By focusing on these aspects, this framework offers a method for assessing the clinical strength of both digital health ventures and individual products. It aids investors, healthcare providers, and other stakeholders in making informed decisions about which technologies to support and adopt.

While clinical strength can prove beneficial to patients and users in all areas of Digital Health, certain categories within digital health particularly require proven clinical strength due to their direct impact on patient health and safety.³ These areas include:³

1. Diagnostic Tools: Tools used for diagnosis, such as AI-driven diagnostic platforms or software to interpret medical images, must undergo rigorous clinical trials to validate their efficacy and safety. 48% of ventures in the Medical Diagnostics cluster have proven clinical strength.³
2. TechBio (Research Solutions) and Clinical Trials: Digital tools used by biopharma can support drug discovery, drug development, and clinical trial processes. Such tools need clinical evidence to ensure their safety, efficacy, and regulatory compliance, ultimately leading to better patient outcomes.
3. Remote Monitoring and Devices: Technologies used for monitoring chronic conditions or providing remote care need to be thoroughly tested to ensure accuracy and reliability.
4. Patient Apps and Digital Therapeutics: Digital health apps and software for patients must demonstrate clinical benefits to be considered trustworthy by users and healthcare providers.

Global data on digital health ventures that have reached Series A and beyond shows a direct correlation between the number of partnerships announced, the average funding raised, and the clinical strength of a venture.³ When a venture increases its clinical evidence, the number of partnerships also rises. Additionally, funding increases with clinical strength, with a significant surge in funding required for ventures to generate the evidence needed to achieve proven clinical strength.

Partnerships with pharmaceutical companies are critical for digital health ventures aiming to build clinical evidence and provide several key advantages to digital health ventures:²

1. Access to Expertise and Resources: Pharmaceutical companies have extensive experience in conducting clinical trials and navigating regulatory landscapes. Digital health ventures can leverage this expertise to design robust clinical studies and achieve regulatory approvals more efficiently.
2. Funding and Infrastructure: Pharma partnerships often come with financial support and access to necessary infrastructure, such as clinical trial sites and patient recruitment networks. This support is crucial for startups that may lack the resources to conduct large-scale trials independently.
3. Credibility and Trust: Collaborating with well-established pharmaceutical companies can enhance the credibility of digital health ventures. It signals to investors, healthcare providers, and patients that the digital health solution has undergone rigorous evaluation and meets high standards of efficacy and safety.
4. Market Access: Pharmaceutical companies have established relationships with healthcare providers, payers, and regulators. Partnerships can facilitate the integration of digital health solutions into existing healthcare systems and expedite market entry.

Across all industry verticals, more than 5175 partnerships have been announced since 2020 with digital health ventures having proven clinical strength.³ Venture-to-venture collaborations are the most prevalent, capturing 21% of all partnerships. Health systems and hospitals (healthcare providers) have established the highest share of partnerships for industry partners, with 19%. In a healthcare setting, evidence of safety and efficacy to patients is paramount, making these partnerships essential. The pharmaceutical industry follows closely, accounting for 15% of the partnerships. Academia and Big Tech complete the top five, demonstrating the interest in collaboration across different sectors in ventures with proven clinical strength to enhance healthcare outcomes.

Investors in digital health are increasingly focusing their funds on ventures that can generate evidence of their solution’s effectiveness. Analyzing funding trends from 2020 through the first half of 2024, the proportion of ventures demonstrating proven Clinical Strength rises with each successive funding stage.³ On average, among ventures that have secured at least Series B funding, 46% have achieved proven Clinical Strength. These ventures, however, secured on average 58% of the funding value deployed, significantly exceeding their proportional share.

In conclusion, clinical strength is a fundamental aspect of digital health that underpins the credibility, adoption, and success of new technologies. Strategic partnerships, especially with pharmaceutical companies, and a focus on generating credible clinical evidence are key drivers for the adoption and trust of these technologies. As the digital health landscape evolves, these elements will remain fundamental in ensuring that digital health solutions are not only innovative but also safe, effective, and reliable, thereby securing their place in modern healthcare systems.