Real-world evidence (RWE) captures health data from outside controlled clinical trials, such as wearable devices, patient forums, electronic health records, and symptom tracking apps. It reflects the daily realities of individuals managing chronic conditions, navigating medications, and seeking answers when the system fails to provide clarity.

As Yael Elish, one of the founders of the mega crowdsourcing transportation platform WAZE and now CEO and Founder of the patient RWE platform StuffThatWorks, has said, “Patients will never have a seat at the table until their data is considered part of the navigational guide for new medicines, devices, and indications of use.”

She’s right, but perhaps we must push ourselves to a new level of acknowledging why we are pursuing new approaches to care. This is not just about offering patients a seat at the allegorical table. It’s about acknowledging that the table of discovery and development exists for their benefit. The science, systems, and research all exist to serve their needs. Their voices and their lived experiences must inform the path forward.

A Silent Majority Speaks: The Data We Ignore

A recent survey conducted by StuffThatWorks, which gathered insights from more than 15,000 patients across 145 medical conditions, revealed a staggering disconnect. 92% of patients expressed a willingness to participate in clinical trials. Yet, 84% said they had never been asked, never invited to the table of health innovation.

This isn’t a communications oversight—it’s a justice issue. The system is failing those it claims to serve. Patients are ready to contribute. Some are out of options and want concrete action steps. They are waiting to be seen, heard, and engaged. Their personal care and experiential data they offer doesn’t just enrich our understanding—it recalibrates it.

“The Pharma Industry’s efforts to include patient voices have been a step in the right direction; however, they remain on a very small scale today,” notes Caroline Redeker, chief strategy officer at Advanced Clinical, a leading clinical research organization. “Interacting with a minimal number of patients without scale does not accurately represent the full patient population with the condition.  Using available static data (claims, EMR) detached from the patient covers the ‘what’ of patients – how many, where, with claims or treatments of a condition, and mostly in the US.”  

Redeker adds: “The more important factors in trial design include the ‘why,’ including most bothersome symptoms, effectiveness of treatments, regional differences, comorbidity considerations, and other valuable information to accurately design the right trial.  The ‘why’ information can only come directly from the patients.  The future will bring patients and their organized data to the table and include patient insights from all over the globe.”

Real-World Realities: Lessons from Ehlers-Danlos Syndrome

Consider Ehlers-Danlos Syndrome (EDS), a connective tissue disorder with 13 recognized subtypes, ranging from the more common hypermobile form to the rare, life-threatening vascular subtype. Each type carries a distinct constellation of symptoms and risks. Some people face chronic dislocations and mobility challenges, while others live with the daily fear of spontaneous organ rupture.

A single disease name masks and encompasses a spectrum of experiences. Standard clinical trial models often can’t keep up with that complexity. But thousands of patients with EDS are documenting their treatment responses, flares, and management strategies across RWE platforms such as StuffThatWorks—building a picture of this disease that’s as varied, inclusive and individualized as the people living with it.

“The StuffThatWorks survey expands the usual definition of real-world data to include this novel direct patient-inputted database,” says George Sands, MD, FAAN, FAHA, FACC, a former senior director at Pfizer and noted advocate for collaborating with patient communities  “Patients and patient advocacy groups want to partner with sponsors, whether pharma or academia, and to be fully represented in research endeavors. This is very different from sponsors looking to recruit and retain research participants more fully. This is about collaborating.” 

Dr. Sands adds, “Additionally, it is important to have all different patient populations, including people of color, so their data is included in the trials and can be used for clinical care. Otherwise, clinicians have to extrapolate based on those included in the trials; it doesn’t always work exactly.” 

That kind of data, born of day-to-day life, isn’t just complementary to clinical trials. It completes a fuller picture essential for developing effective treatments. Without it, we risk designing therapies that help in theory but fail in practice.

From Inside-Out to Outside-In

Much of medicine’s traditional approach to research is inside-out, starting with what companies aim to prove and working outward through the trial process. That’s not inherently wrong—it is how rigorous science is structured—but that is not enough.

We must also embrace outside-in realities as part of the innovation journey, where patients’ lived experiences inform what we explore, how we measure success, and who we prioritize.

Craig Lipset, founder of Clinical Innovation Partners, and co-chair of the unifying NGO/research industry Decentralized Trials & Research Alliance, and former Head of Clinical Innovation at Pfizer, has long championed a rebalancing of power in clinical trials.

“To earn and maintain trust, research participation must become a symbiotic relationship powered by a bidirectional flow of data and learnings, says Lipset. As patients share insight into study design, bring real-world data into trials, and share experience that shapes new endpoints, sponsors must commit to ensuring that study data and results are flowing back.”

That vision is becoming increasingly possible. With technologies that enable decentralized trials, remote monitoring, and electronic patient-reported outcomes, we can now collect real-world data at scale. However, that only matters if we respect what the data tells us and are willing to let patient experiences guide the research agenda. We give lip service to the importance of patient voice in biopharma research and marketing, but do we see them as “customers” of innovation?

The Science of Listening

Real-world evidence is the patient’s language—a narrative built not in labs but in lived experience. It’s not peripheral to science—it is science when equity is the goal. When patients share their stories, whether on online platforms, through wearables, or in digital symptom trackers, they are offering far more than an anecdote. They are offering insight. They contribute to the science of what works, for whom, and under what conditions.

And when we listen, we don’t just become better researchers. We become better healers.

We stand at a pivotal moment. Innovation can either deepen the divide between patients and science or bridge it. Real-world evidence is the support structure for that bridge. It offers us the opportunity to democratize discovery and reimagine research collectively.

Reflects StuffThatWorks Elish, “The current methods of involving patients in the clinical and health spaces are doomed to failure.  Patients’ voice will be heard ONLY when turned into organized data, at scale.  Because no one can argue or ignore organized data at scale. Once that’s accomplished, the integration of patient voice will proliferate and become easily accessible to everyone in multiple forms, including a simple AI-based chat question.  We are doing that at StuffThatWorks; it’s core to our mission and vision.” 

Ultimately, the patient wants to be invited to the table—but not as a token guest. Without them, there is no table worth setting. The patient is not a peripheral player in this system—they are the system’s purpose. They are not guests in the system. They may not be the core customer of the health system, a universe that centers around its economic viability. Still, in the world of health system kinetics, where we examine the relationship and priority of the sector pieces, they are the reason we unite to invent solutions to confront disease, despair and death.  And the future of medicine depends on how well we recognize that truth.

The future of medicine hinges on one choice—do we continue treating patients as passive subjects, or as co-creators of the care that might save their lives? That’s not philosophy. That’s leadership.

Interested in this topic – here is more to explore:

Aman Gupta: Patient Inclusivity: The Missing Piece In Pharma’s Global Innovation Strategy

The Need for High Quality, Reliable Information that is Data-Driven – A Conversation with Yael Elish

Gil Bashe: Real-World Evidence Unlocks Consumer Voice to Improve Care

The post How Real-World Evidence Proves the Power of Patient Engagement appeared first on Medika Life.

For too long, “AI” has been the abbreviation for “artificial intelligence.”  Reject that label!  It’s not only limiting – it’s incorrect.  The information gathered and parsed comes from real-world sources – patients, payers, product innovators, policymakers, and providers.  It is composite data, once called “big data,” sliced and diced through machine learning and then applied to good, sometimes life-sustaining use.  It’s time we acknowledge how “AI” has become a practical source for talent and organizational enhancement.

Health Enters the Age of “Augmented Implementation”

Here’s a dive into 10 transformative examples of how “AI” enables people to tap into their significant potential to heal and accelerate care delivery.  Change is always hard, even when the advantages appear evident, as it requires revamping processes and policies.  However, as innovation theorist, AI philosopher and Nosta Lab Founder John Nosta reflects: “Culture crushes innovation.” 

Nosta shares with Medika Life readers: “AI, particularly through large language models (LLMs), is revolutionizing healthcare by fostering ‘learner-centricity.’ This approach places physicians, patients, and healthcare systems at the center of a dynamic, personalized learning process. LLMs provide tailored, context-specific knowledge, enabling real-time insights and deeper understanding. Whether it’s a clinician refining diagnostic skills or a patient comprehending treatment options, LLMs create a collaborative learning ecosystem. This synergy enhances the healthcare experience, empowering all participants through shared knowledge and continuous growth.”

The culture of medicine is storied and slow-moving. Still, these 10 approaches to weaving AI into the health system are piquing people’s priorities and enthusiasm for greater use. The wave of universal acceptance is underway.

1. Revolutionizing Patient-Clinician Interaction

Ambient Listening Technologies (ALTs) are modernizing how clinicians transcribe medical documents – by capturing, recording, managing, and analyzing audio data from the patient exam room. AI transcription tools like the Nuance Dragon Ambient eXperience (DAX) from Microsoft streamline recording tasks that once consumed chunks of a clinician’s day. AI-driven transcription systems record and summarize patient-clinician conversations, enabling providers to focus on patients rather than documentation. The plus for doctors is reduced admin time; for patients, it provides the benefit of ensuring their provider has real-time notes for follow-up care delivery.

2. AI-Enhanced Diagnostics are Challenging the Future of Illness

Technologies like DeepMind AlphaFold provide unprecedented insights into protein structure prediction, accelerating drug discovery and enhancing diagnostic tools for diseases like Alzheimer’s and certain cancers. Anyone tracking the field of AI-empowered diagnostics would do well to keep a close eye on innovation in this space.  The 2024 Chemistry Nobel Prize was awarded to John Jumper, PhD, and Demis Hassabis, PhD, at Google DeepMind in London for developing this game-changing AI tool for predicting protein structures.  The Galien Foundation Prix Galien is often called the Nobel Prize of the Life Science industry.  Viz.ai, a pioneer in AI-powered disease detection and intelligent care coordination, received the 2024 Prix Galien USA Award for its Viz HCM™ (Hypertrophic Cardiomyopathy) module.  Keep an eye on these companies and their advances.

Rob Havasy, HIMSS Senior Director of Informatics Strategy, representing one of the most influence professional communities – the leaders from health institutions and governments worldwide – offered this exclusive comment to Medika Life:

“AI has been part of many radiology workflows for years, but data from our HIMSS Market Insights surveys show one of the fastest growing applications right now is ambient AI and other AI tools to relieve some of clinicians’ documentation burden. These tools either help clinicians capture information from a visit or streamline patient-provider communications by creating discharge instructions or helping to manage overflowing inboxes.”

3. Accelerating Drug Discovery and Clinical Trials

AI is catalyzing innovation in drug development, a process that traditionally spans over a decade. Platforms like Hong Kong-headquartered Insilico Medicine and companies like Exscientia are applying machine learning to design drug molecules faster than ever. Meanwhile, decentralized trials are becoming more accessible through collaborative pathways set by organizations such as the Decentralized Trials & Research Alliance (DTRA), a central gathering point for regulators and industry leaders to shift the conversation from theoretical to operational regarding implementation.

Dr. Amir Kalali and Craig Lipset, pioneers in clinical trial innovation, champion this collaborative model that draws in biopharma-sector leaders, CROs, and FDA and EMA regulators. The DTRA Co-Chairs have long advocated that decentralized clinical trials (DCTs) supported by AI tools broaden access and reduce biases. These collaborations demonstrate how AI unlocks new efficiencies and enables more inclusive participation, particularly among underrepresented populations.

4. Predictive Analytics for Patient Safety

Predictive analytics powered by AI is transforming patient safety in hospitals. For example, Qventus predicts and mitigates perioperative complications. At the same time, companies like Stasis Labs, Current Health, and Vytrac provide real-time in-patient and at-home monitoring, sending vital sign data to nurses and doctors so they know their patient status and triage care.  Amy Abernathy, MD, PhD, has served in several high-profile roles that cut across the health ecosystem, from Principal Deputy Commissioner at the Food and Drug Administration (FDA) and is now Co-Founder of Highlander Health, a bold new organization advancing clinical research and patient care through learning labs, investments, and philanthropy, comments: “AI is transforming how we approach patient safety by intervening in a proactive measure rather than a reactive one.”

5. Addressing Mental Health Needs with AI

Mental health care is becoming more accessible with AI-driven platforms such as Woebot Health and Wysa. These companies are using AI to provide scalable, CBT-based support for conditions like anxiety and depression, often meeting the needs of underserved populations without ready access to mental health services. Another approach led by GrayMatters Health enables mental health professionals to address PTSD through neuromodulation – an FDA-approved for-use approach designed through years of data aggregation.  Noted digital health pioneer, inventor, and  Founder and Curator for NextMed Health, Daniel Kraft, MD, notes: “AI-powered mental health tools are filling the gaps in traditional care delivery, providing immediate, accessible, and empathetic support when people need it most.”

6. Driving Precision Medicine

Precision medicine, enabled by AI, is bringing targeted therapies into sharper focus. Collaborating with Roche, Foundation Medicine uses genomic profiling to guide cancer treatments. Similarly, Tempus leverages AI to connect molecular and clinical data, accelerating therapeutic breakthroughs. The combination of high tech with high science has enabled scientists with support from private equity and academic institutions worldwide to create companies at the vanguard of the discipline in the UK Golden Triangle, Southeast Asia, and the Cambridge/Boston innovation hub. LABIOTECH author Willow Shah-Neville wrote a concise report of 12 biotech unicorns rated in order of their valuations according to CB Insights. It is worth examining how these fast-moving innovators apply information technology to augment their scientific implementation.

7. Streamlining Hospital Operations

AI tools enhance hospital operations, optimize workflows, and improve patient outcomes. For instance, GE Healthcare Command Centers use predictive analytics to manage patient flow. Other companies, such as LeanTaaS, with its iQueue platform, improve operating room and infusion suite scheduling. Hyro is a much-watched hospital workflow optimizer with services that cut across administrative and clinical departments and add AI to Epic workflows, improving access to care. Edward Marx, a global healthcare consultant and former Cleveland Clinic CIO, emphasizes: “Operational AI is reshaping how hospitals function, eliminating inefficiencies and ensuring resources are used where they’re needed most.”

“Top Trends in Healthcare and Life Sciences” Microsoft video episode titled “The power of information to improve healthcare,” Gil Bashe, Chair of Global Health and Purpose at FINN Partners and Medika Life Editor-in-Chief, joins Tom Lawry, formerly National Director for Artificial Intelligence Health and Life Sciences at Microsoft and now Founder of the AI consultancy Second Century, talk about the opportunities and obstacles in health, AI, and the power of information.

8. Promoting Health Equity Through AI

Medtronic AI-enabled remote monitoring devices are helping bridge the care gap in underserved areas. Similarly, PathAI, in collaboration with Quest Diagnostics, is leveraging “machine learning to improve diagnostics in resource-limited settings, ensuring equitable access to healthcare.  Michelle Longmire, MD, a Stanford-trained dermatologist and founder and CEO of Medable, which offers the research-based biopharma industry an array of research tools with a unified platform, adds: “AI’s potential lies in its scalability, which can extend high-quality care to populations previously overlooked by traditional systems.”

9. Harnessing AI for Population Health

AI is transforming public health by integrating social determinants of health into predictive models. Companies like Epic Health Research Network and Innovaccer are helping health systems anticipate and address population health challenges more effectively. Michael Rosenblatt, MD, with his storied career as a scientist and teacher, having served as Chief Medical Officer at Merck and Flagship Pioneering and now as Co-Chair of the Galien Foundation, notes: “AI-driven insights empower health systems to deploy resources strategically, reducing disparities and improving outcomes across entire communities.”

10. Empowering Patients with Wearables and Digital Health Platforms

Wearables like the Apple Watch have popularized health tracking. Still, more specialized solutions, such as AliveCor and Biobeat are examples of advanced monitors delivering medical-grade heart data enabling patients to access, manage, and share their data and connect with their physicians. Additionally, platforms like the Belong.Life Dave AI focuses on cancer care by guiding patients with tailored recommendations, educational content, and peer support.  David E. Albert, MD, Oklahoma native, physician, inventor, and serial entrepreneur, is the founder of AliveCor and a long-time AI champion, says, “AI will play a role in reducing data into manageable and actionable information for clinical decision-making.”

Looking Forward: A Future Shaped by Collaboration

AI progress in health settings during the past five years illustrates what’s possible when technology meets the demands of patient care, equity, and innovation.  

Is “AI” still threatening and misunderstood?  Absolutely! The term “artificial intelligence” is a threatening misrepresentation of the idea that people will become secondary to machines processing vast amounts of data (largely) accurately and in a blink. However, technology is continuously called upon to automate repetitive tasks.  It does not alone transform people’s health or the fractured health ecosystem – instead, it’s the human desire to question, collaborate, and generate shared – augmented – wisdom that is core to implementation.  

“Driving measurable value at scale with AI is less about the right technology and more about the right leadership. Is there a sufficient level of AI understanding at all levels of the organization?  Is your culture change-ready or change-resistant,” reflects Tom Lawry, principal of Second Century.  Is AI part of your HR plan? In the end, AI success cannot be delegated. Leadership is the catalyst for unlocking its true potential. This requires vision, strategic alignment, and a commitment to empowering teams to innovate and execute with purpose.”

As more people dip their toes into the tech waters, comfort levels are increasing rapidly. Remember the 15-year time gap between Apple’s failed Newton and the early iPhones? Once the idea of a smartphone caught on, it became a personal must. According to a Pew Research Center Survey conducted May 19 to Sept. 5, 2023, 90% of US adults say they have a smartphone. Soon, AI will be ubiquitous in most health settings.

Say so long to artificial intelligence. Welcome to the age of Augmented Implementation!

The next five years promise even more significant advances, , a thirst to use information to accelerate decision-making, fueled by curiosity and collaborations across sectors and the drive to improve lives globally.

The post AI is Transforming Health Delivery: A Five-Year Reflection appeared first on Medika Life.

The transformation of the digital health ecosystem is marked by consolidation, increased investor scrutiny, a shift in investment strategy, and the dramatic convergence of big tech and big health. Galen Growth has now released its 2023 Year-End Digital Health Global Key Trends Report. Medika Life was provided with an in-depth preview of this world-class authoritative data set and shares the report with readers at no cost.

Recognized globally by life science, health systems, and investors for its in-depth analysis, Galen Growth draws on its proprietary HealthTech Alpha platform, the world’s leading data, intelligence, and insights mining tool to compile its reports. Galen Growth tracks more than 680M data points and 14,500+ digital ventures.  

This comprehensive coverage is curated by Galen Growth’s specialized research team led by Sara Schmachtenberg, who leads a global group of analysts and industry experts in Asia, Europe and the United States. We appreciate Julien de Salaberry, CEO of Galen Growth, for making this report available to Medika Life and Lawrence Wurtz, the Galen Growth US lead, for his guidance. Special thanks to Ritesh Patel, who reminds us, “If it moves, digitize it!”

If you think digital health begins and ends with your smartphone, full stop! Digital health is vast and includes AI, ChatGPT, GenAI, health IT and more.  It harnesses the power of software as a prescription medical treatment for people with unmet medical needs. It is on the cutting-edge of health information technologies, driving smart wearables used to monitor patient vitals and report data back to provides. It ensure precision dosing of medicines.  It’s transforming women’s health and senior care. As its efficacy and safety parameters have morphed, the category demands the same degree of clinical commitment, regulatory oversight, and commercial savvy as any clinical product influencing life and health outcomes. The Galen Growth Trends Report studies 68 categories across 18 clusters. There is no comparative data that provides an overview of this magnitude.

While some “trend” reports cite dramatic numbers – largely pinpointing the dramatic drop in overall sector funding – the Galen Growth 2023 Trend Report offers a comprehensive analysis that guides analysts from industry and investment firms on where the money and where the successive waves of innovation are expected. Digital health as a category is maturing.  Gone are the investment dollars driven by unbridled exuberance and people licking their chops to enter “health’s tech boom.”  Get your hands on the 2023 Year-End Digital Health Global Key Trends Report to learn more. In the meantime, here is an analysis of the data and what it might mean for the category.

An Evolution in Digital Health Investment

2023 saw a tectonic shift in the digital health landscape as investors abandoned former highfliers and sought a more realistic perspective after the boundless enthusiasm influenced by COVID-19 in 2021. Even after more than a decade of maturity, the digital health sector has over 10,000 private companies showcasing varying degrees of innovation and potential. This evolution has led to increased commitments from pharmaceutical companies directing greater investment toward digital health innovation within their research efforts. Simultaneously, health systems are intensifying their focus on harnessing digital health innovation to enhance healthcare delivery and address capacity and productivity challenges.

Wallets seemed tighter in 2023.  The global averages revealed that only 31% of early-stage ventures, 34% of growth-stage ventures, and 53% of late-stage ventures raised funds in the last 18 months. But that’s also because many had already raised successful seed funds in the prior years. The remainder of the ecosystem was left to cut costs or rethink its business model.

A Complex Environment for Digital Health Ventures

Despite a thriving investment ecosystem, digital health faces headwinds. Recent data paints a mixed picture: fewer than 35% of digital health ventures secured funding in the past 18 months. This indicates an overall decline in investor support but a reorientation toward sub-sectors offering less risk and more customer upside. The pace of mergers and acquisitions (M&A) notably slowed, and initial public offerings (IPOs) and special purpose acquisition companies (SPACs) were few. Particularly in Europe, the absence of recorded IPOs underscores that investors retreated, waiting to see what the markets find valuable before reengaging. Less than a handful of years ago, there was significant money available to help scale up companies such as Pear Therapeutics (United States), Olive.ai (United States), and Babylon (United Kingdom). In the wake of their collapse, some investors remain in shock, and others are reflecting on the due diligence questions they should have pursued earlier.

The Rise of GenAI – Practical Need for Health Information Interpretation

GenAI (Generative AI) has emerged as one of the most exciting applications in the health sphere. Its prominence in biopharma and partnerships among health systems and innovators underscore its status as a central focus in 2023 and beyond.  The sector is shifting to address health system pain points – from taking the wash of “big data” found in electronic medical records and “scraping it” for clinical data that can be used to improve patient care – from confirmed diagnoses to better understanding chronic conditions to tracking for service provided requiring reimbursement codes and importantly providing healthcare staff summaries of patient status. 

On a topline, looking only at investor engagement and regulatory filing trends in the digital health domain would say the sector is in retreat. The Galen Growth data show its reorientation and why. The rise of GenAI is the “symptom.”  The disease might be responsible for the most significant part of the cost of care – health provider systems – recognize disruptive digital health technologies as the way to become more effective in operations and, most importantly, patient outcomes.

Increasing Partnerships and Technological Integration

The emergence of AI, ChatGPT, and GenAI has sparked partnerships with health systems that have been pivotal for digital health ventures despite the challenges posed by investor belt-tightening. In 2023, announcements of new partnerships surged 1.2 times from the previous year, with a 3% year-on-year increase in the total number of partnerships globally. Technological integration remains a cornerstone, with 39% of private digital health ventures leveraging Artificial Intelligence (AI) or Generative AI technologies to address this sector’s desire for greater efficiencies.

Big tech companies have long been sitting on the sidelines trying to understand better – to comprehend – how the multi-layered – fragmented – health system operates.  Behemoths like Amazon, Google, Microsoft, OpenAI and Google have all made big plays to partner, acquire and integrate health-specific AI platforms into their portfolios.  Health information – much of it handwritten and transcribed – defines “big data” – simply the ecosystem is awash in data.  GenAI might begin to make sense of the information chaos.

The application of AI is vastly different in health than tech and the giants will find the waters murky. In health-delivery settings, AI deals with sensitive patient data subject to strict privacy laws (e.g., HIPAA in the United States). Compliance with government health regulations is paramount, and data security raises legal concerns. There are ethical hurdles extending to issues like informed consent, patient autonomy, and the potential for AI to affect clinical decisions and treatment plans. Regardless, big tech has the cash to deploy and figure that out and they are eager to deploy in the health sector.

Biopharma All Aboard 

The research solutions cluster claimed 20% of the total funding in 2023.  Biopharma companies seek to “fail early” – to guard parents as we advance medicines in the research clinic and reduce the costs of creating new medicines.  They are embracing the idea and putting it into action, recognizing that information sorted at Lightspeed can better target drug discovery efforts and validate drug development teams’ trial design recommendations. 

Decentralized clinical trials have existed for some time. However, the COVID-19 era that became jet fuel for digital-health investment also paved the way for contract research organizations, life science companies, retail pharmacy chains, academic medical centers, and regulatory agencies to roll up their collaborative sleeves to create pathways and policies for the institutional use of this approach.

Companies that harness varied technologies and AI have sprung up to serve academic medicine and industry.  Long-awaited NGO groups such as the Decentralized Trials Research Alliance came into being, signaling increased opportunities for the sector. Research meetings such as SCOPE are seeing more and more digital health tech leaders step to the main stage.  The Galien Foundation, which once awarded its Nobel Prize like Prix Galien only to biopharma and medical device companies, has now included digital health and incubators, accelerators, and private equity entities among its categories.  Digital health is hard-wired into the ecosystem of science and medicine.

Like hospitals seeking to operate at heightened efficiency, the drug development sector recognizes that it needs to reach a much larger pool of patients – with a long-needed emphasis on diversity and broader geography – conveniently participating in clinical trials and ways to collect and sort added data.  Digital health is finding its seat around this table.  But at the same time, the seats are limited, and companies are choosing partners with caution and clinical data post the investment hysteria of 2022.

Galen Growth 2023 A Microscope and a Telescope

Digital health ventures addressing patients’ therapeutic care needs have a higher bar to leap to address environmental funding challenges.  It is now recognized that a Food and Drug Administration 510K approval is insufficient to secure market success.  Demonstrative proof points – the most critical biopharma sector, like clinical evidence, is essential. The need to show patient-care value – either as a solo therapy or in concert with medications – is needed. The Galen Growth Trends Report underscores that the ecosystem requires clinical and peer-reviewed “proof points” – not enthusiasm.

Investors are navigating stormy seas for improved returns in an extended higher cost of capital environment, grappling with a constrained investment value chain, reduced exits, scarce IPO opportunities, and current valuations.  Plus, let’s not forget, that private equity’s primary responsibility is to their limited partners – often institutions that place endowment funds with the firm expecting solid return on investments. Innovators and entrepreneurs have responded by pushing harder to provide the complex, fragmented health ecosystem with a range of digital health technologies that improve operations and patient outcomes – money and lives saved. 

The belt-tightening of investors has pushed out some who mistook category excitement for a quick pathway to returns. The past 18 months have reshaped the sector and catalyzed the transition from short-term, exit-oriented strategies toward sustainable venture-building approaches.

As the sector adapts and recalibrates, the Galen Growth 2023 Trends Report is a diagnostic of the past 18 months and a vital telescope to a potentially transformative future.

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