Tess’ Top Takes from this Month’s Meetings in Digital Health: September 2023
It's been another month of great events at HealthXL, with topics ranging from Pharma 3.0 and how to do digital health better, to the role of medical affairs in the age of digitalisation.”
To make sure you don't miss the top insights from our community meetings, here are my top six takeaways from HealthXL meetings that took place over the past two months:
1. Digital Biomarkers in Neurology: Early Diagnosis & Disease Management
In this roundtable led by John Cohen from Johns Hopkins Applied Physics Lab, participants discussed how digital biomarkers could revolutionise neurology by providing authentic insights into patient daily activity and fostering patient trust for self-management.
Passively collecting data from patients using wearable devices and smart sensors is a reliable way to understand their daily activities. This method reduces the chance of patients changing their behaviour when they know they are being monitored. To use these digital biomarkers in clinical trials, it is important to validate the accuracy and effectiveness of the sensors and tools before life science companies start using them. In the field of neurology, the adoption of digital biomarkers in clinical care has been limited because there is no established way to get reimbursed for using them.
For patients with psychiatric or neurodegenerative disorders who may experience heightened paranoia or anxiety, it is critical to build trust in monitoring technologies. Additionally, digital biomarkers have shown promise in detecting and managing diseases in neurology. For instance, new tools like eye-tracking and facial biomarkers can assess the risk of developing a disease early on and analyse how effective the treatments are.
In the future, a combined approach that includes both passive and active data collection is expected. The ultimate goal is to empower patients to manage their conditions on their own.
Read the key discussion points here!
2. Masterclass: Multi-Condition SaMD: Regulatory Requirements and Future Implications
In this masterclass, Arrash Yassaee and Mani Shanmugham shared their experiences and challenges with getting Huma’s platform approved as the first agnostic SaMD platform. They emphasised the importance of approaching SaMD from an agnostic perspective, structuring and presenting data effectively, and navigating regulatory landscapes with an evidence-based strategy.
Why consider an agnostic problem?
- Versatility: An agnostic platform allows software to not be tied to a specific condition or device.
- Go-to-market strategy: Having an approved platform structure accelerates the go-to-market strategy for potential partners.
- Meticulous planning: For multi condition SaMD complying with regulations, anticipating future implications and developing adaptable solutions that meet stakeholder needs.
Building a robust technical file submission:
- Clear delineation: Having a clear technical file that spells out exactly what the product is and how it operates simplifies the regulatory process.
- Chunking: Organising data effectively and clearly using a modular structure ensures clarity for external stakeholders and showcases the platform’s flexibility.
Evidence generation requirement:
- Generating robust evidence is critical for agnostic solutions to establish regulatory trust.
- The requirement for evidence generation emphasises elements such as usability, feasibility, and proxy or process monitoring for SaMD.
- Building trust in the overarching platform, its foundational components, and the expertise behind it.
Geographical differences in regulation:
- EU regulations generally satisfy global standards, making them a good reference point.
- The FDA has released guidelines that outline requirements for evidence generation (available here), which assists in cross-comparison.
- Early consultations with clinical teams and regulators, and understanding regional distinctions, can expedite regulatory processes.
Dive deeper into this topic here.
3. MedTech : New revenue opportunities with digital, data and connectivity
MedTech has the potential to shape the future of healthcare by leveraging data, relevant skills, shorter product iteration cycles, software technology, physician touchpoints, and trust profiles.
Smaller, agile MedTech companies may have a more influential role compared to traditional players, transitioning from vendors to enablers by connecting devices and leveraging data. Overcoming challenges in infrastructure and aligning buyers and users require investment infrastructure, skills, and innovative business models.
Sharing real-world information and making evidence-driven decisions are crucial in healthcare, addressing the issue of information silos and prioritising solution and outcome-centric approaches. AI and ML play a significant role in driving better product development and outcomes in healthcare, with challenges in monetising healthcare data.
Differentiating between analytics, AL and ML in healthcare is important, addressing data quality, trust, and regulatory challenges. Concerns around adoption, usability, value creation, data integration, legal considerations, and reimbursement were highlighted as key factors for successful implementation.
Dive deeper into this topic by reading the key takeaways here.
4. Pharma's Role in Remote Patient Monitoring in Oncology
Remote patient monitoring (RPM) solutions in oncology offer immense benefits for patients, health systems, and the pharmaceutical industry. These solutions can enhance treatment accessibility and improve medication adherence for patients. They also play a vital role in driving patient retention and improving risk profiles in clinical trials.
However, the successful adoption of RPM tools depends on effective engagement with healthcare providers and patients. Additionally, RPM systems can expedite patient discharges and reduce readmission rates, thus benefiting healthcare systems. Despite their potential, implementing RPM solutions outside of clinical trials poses challenges related to regulation and commercialisation strategies.
It is worth noting that the return on investment (ROI) of RPM solutions may primarily favour healthcare systems rather than pharmaceutical companies. Nonetheless, RPM offers opportunities to decrease the need for physical presence in clinical trials and support diverse patient populations. Moreover, pharmaceutical companies can leverage RPM data for drug discovery and research. However, ethical questions arise regarding patient consent and their willingness to participate in data collection endeavours.
Discover other key takeaways and strategies to effectively navigate RPM in the digital landscape here.
5. Masterclass : Effective Strategies for DTx Clinical Trial Design
Proving clinical efficacy is crucial for digital therapeutics (DTx) companies to gain support from prescribers, users and buyers. Here are some key strategies discussed in the masterclass session on DTx clinical trial design:
- Align Evidence Level with Business Model: The evidence package design should match the chosen business model. Different models, like reimbursements, employer channels, and direct-to-customer (D2C) approaches, require varying levels of evidence. Reimbursement and prescribing models need rigorous randomised control trials (RCTs) to demonstrate clinical benefits.
- Approach DTx like a pharmaceutical product: Prescription DTx (PDT) should meet the same standards as traditional pharmaceuticals. Trial design and therapeutic approaches must focus on treating the disease itself, not just managing symptoms. Consider internal validity (unbiased study design), external validity (applicability to different contexts), and ecological validity (generalisability to real-world settings).
- Alternative Strategies for Clinical Evidence: Innovative strategies can overcome challenges in establishing clinical evidence. If funding doesn’t align with the business model, design early-phase studies to demonstrate efficacy signals to investors. In limited patient populations, in silo or simulated research can provide valuable results.
By implementing these strategies, DTx companies can enhance their clinical trial design and effectively demonstrate the efficacy of their digital therapeutics.
Dive deeper into this topic here.
These are just a few top takeaways from some of our discussions this month. Apply to attend an upcoming HealthXL Community event and get all the insights first hand.
Join the HXL community, where members can revisit, rewatch our webinars, read the key takeaways from virtual and in-person events and rewatch our webinars., and more.
To round out our spotlight series on medical affairs in digital health, we’ve launched our latest HealthXL report: Pharma Medical Affairs: Digital Health’s Next Strategic Enabler.
See you in a HealthXL meeting soon!