Manos Health

The FDA’s new guidance on decentralized clinical trials (DCTs) presents huge opportunities to validate your product faster and more cost-effectively. Telehealth, local healthcare providers (HCPs), and digital health technologies (DHTs) were already permissible, but now the FDA has provided clear, structured guidelines to make these trials easier to manage. 1. 𝐑𝐞𝐦𝐨𝐭𝐞 𝐓𝐫𝐢𝐚𝐥𝐬, 𝐋𝐨𝐰𝐞𝐫 𝐂𝐨𝐬𝐭𝐬 The FDA encourages telehealth visits for trial participants where in-person interactions aren’t necessary. This approach allows you to reduce the costs and logistical complexities of site visits, accelerating trial timelines and cutting down on overhead. 2. 𝐕𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐃𝐢𝐠𝐢𝐭𝐚𝐥 𝐇𝐞𝐚𝐥𝐭𝐡 𝐓𝐨𝐨𝐥𝐬 The FDA has issued specific guidance on the selection, verification, validation, and usability of DHTs. This ensures that tools like wearables and apps can be used to gather real-time data in compliance with regulatory standards, streamlining the evidence generation process. 3. 𝐖𝐢𝐝𝐞𝐫 𝐑𝐞𝐜𝐫𝐮𝐢𝐭𝐦𝐞𝐧𝐭, 𝐅𝐚𝐬𝐭𝐞𝐫 𝐄𝐧𝐫𝐨𝐥𝐥𝐦𝐞𝐧𝐭 Decentralized trials improve recruitment by expanding access to diverse populations, including individuals with limited mobility or restricted access to traditional clinical trial sites. This broader participant pool allows for faster recruitment and more representative data 𝐒𝐭𝐚𝐫𝐭 𝐰𝐢𝐭𝐡 𝐚𝐧 𝐄𝐯𝐢𝐝𝐞𝐧𝐜𝐞 𝐃𝐢𝐬𝐜𝐨𝐯𝐞𝐫𝐲 𝐒𝐩𝐫𝐢𝐧𝐭 “We have lots of data already, but don’t quite know how to credibly translate that into evidence to support sales.” Sound familiar? If you’ve been sitting on valuable data but don’t know how to turn it into credible, sales-driving evidence, our Evidence Discovery Sprint can help. In just a few weeks, we’ll audit all your structured and unstructured data, reports, and studies—published or not. We’ll identify what you can prove, what you should prove, and how your evidence stacks up against competitors. This quick audit is the first step to unlocking your growth potential. DM me, and I'll send you what a sprint looks like. Manos Health Rishab Shah

Picture this: your digital health company, armed with top-tier engineers and developers, is on the cusp of launching a groundbreaking product. The clinical need is validated, and the potential to positively impact patients and providers is undeniable. Excitement is in the air until, in the first week post-launch, a flood of feedback reveals a common issue - customers find the product instructions confusing. Yikes! A nightmare scenario, yet one that can be easily averted through a simple yet powerful practice – observational interviews with customers. Take a look at our 101 on Observational Interviews Part I (link in comments). This one focused on the BUILD phase of our build, prove, launch lifecycle. The Manos Health 101 series is intended to provide basic introductory information to innovators building digital health products. It is meant to demystify critical steps in the build, prove, and launch lifecycle. Manos Health

Appreciate all the feedback on the Evidence Discovery Sprint and its value! Are you struggling to translate your data into credible evidence for sales support? Do you find yourself falling behind competitors in evidence or unsure where to start with closing evidence gaps? Perhaps you have multiple outcomes but are unsure which one to focus your R&D efforts on. If your sales discussions often stall with questions about validity or "does it work" questions, the Evidence Discovery Sprint can help. This sprint is designed to assist you in understanding your data, determining what you can prove, and identifying where you can achieve the most impactful evidence. For more on the report, download the example template shared in the comments. #EvidenceDiscovery #DataAnalysis #SalesSupport Manos Health Rishab Shah Ben Rosner, MD, PhD Andrew Auerbach

What do you get in an Evidence Discovery Sprint?  In short, you get answers to what you can credibly prove with existing data and reports. But the report gives you much more than that. Check out what’s in the report here: + Current State of Claims: What are you claiming now?   + Current State of Data and Evidence to Support Those Claims: What evidence do you have relative to your claims?   + Evidence Assessment LEVEL 1: How are you doing relative to the five areas in need of evidence? (Does it Work > Do People Use It > Do People Like It > Do People Benefit From It > Do Buyers Benefit From It) + Evidence Assessment LEVEL 2: How are you doing relative to your claims? This is done both in terms of “current published evidence” and “potential" based on data availability   + Client and Market Assessment: What do your clients care about most?   + Competitor Evidence: How are your competitors doing with respect to evidence and the Level 1 Evidence Assessment? + Findings: What did we find in doing this assessment? + Recommendations: What actionable steps we recommend you take both at the strategic and tactical level? Our report is designed to provide insights that help you know exactly what to do next. Interested? Contact us at hello@manoshealth.com

“We have lots of data already, but don’t quite know how to credibly translate that into evidence to support sales.”      Is this what you’re thinking? Manos Health offers an Evidence Discovery Sprint to help you understand what you have, what you can prove, and where you might get the most bang for your buck when it comes to evidence.  In just weeks, we review all your structured and unstructured data, all data reports, studies (published or not), and any other sources of data that you’ve collected over the years.  We make sense of what you can prove and what you 𝘴𝘩𝘰𝘶𝘭𝘥 prove. Finally, we compare where you stand in terms of evidence relative to your competitors.  All so you can maximize your growth.  Hear what one of our clients said about the value!  “Manos Health delivered far beyond our expectations and far beyond what we typically get from consulting type engagements. We knew we needed better evidence that our product worked, but wanted to maximize what we had before collecting more data. Manos Health provided the clarity we needed and put us back on track for evidence-based marketing and sales. Thank you Manos Health.” - Co-Founder Mental Health Digital Health Company Manos Health Rishab Shah

Manos Health recently completed a Digital Health protocol for a multinational multibillion dollar manufacturing company. Part of the process was educating them on what needed to be included in a protocol. A good time to reintroduce our 101 series! The Manos Health 101 series is intended to provide basic introductory information to innovators building digital health products. It is meant to demystify critical steps in the build, prove, and launch lifecycle. 𝐌𝐞𝐬𝐬𝐚𝐠𝐞 𝐦𝐞 𝐚𝐧𝐝 𝐈'𝐥𝐥 𝐬𝐞𝐧𝐝 𝐲𝐨𝐮 𝐭𝐡𝐞 𝐟𝐮𝐥𝐥 "Protocols 101" 𝐝𝐨𝐜𝐮𝐦𝐞𝐧𝐭.  Here are the key points from "Protocols 101": + Purpose: A study protocol is the scientific plan for research, ensuring participant safety, data protection, and valid results. + Importance: Credibility in digital health requires research-backed evidence. + Key Protocol Sections: Objectives: Define study goals. Background: Contextualize the study within industry trends. Investigational Plan: Outline study design, participant criteria, and recruitment. Procedures: Provide detailed, step-by-step instructions for consistency and safety. Evaluations & Measurements: Define outcomes, data collection, and privacy measures. Statistics: Detail methods, sample size, and quality control. Safety: Protocols for handling adverse events. Administration: Define staff roles, logistics, confidentiality, and ethics. + Changes: Amendments can be made, but major changes require careful consideration. + IRB Approval: May be needed for ethical oversight. + Authorship: Written by the principal investigator with expertise. Need a protocol? Manos Health can help. Manos Health

Thank you Brian and the rest of the Manos Health team for the amazing opportunity to partner with such an wonderful organization. This, without question, puts us a step further on our mutual journey of driving real impact for patients and healthcare providers by helping develop the best digital health technologies possible. #collaboration Marianne E. Walwema, M.D. Aleksandra Fornal Ritesh Patel Jacob LaPorte Chet Robson, DO, MHCDS, FAAFP

Manos Health and datosX Digital Health Labs Partner to Enhance Provider Network and Elevate Clinical Design Practices for Digital Health Solutions Manos Health is pleased to announce a strategic partnership with datosX Digital Health Labs. Both Manos Health and datosX Digital Health Labs are recognized leaders in the design and execution of research studies for digital health solutions. Manos Health originated as the research arm supporting over 70+ health systems nationwide, while datosX was spun off from Novartis, a Fortune 100 pharmaceutical company. Together, we bring unmatched expertise in conducting studies that leverage academic and biotechnological research across a vast network of health systems. While datosX excels in digital health studies, utilizing cutting-edge research techniques, Manos Health provides solutions to address the most challenging aspects of developing, validating, and launching digital health innovations. This partnership aims to: 𝐂𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐞 𝐨𝐧 𝐁𝐞𝐬𝐭 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞𝐬: Share insights and lessons learned from digital health studies to continue leading the industry in delivering high-quality, cost-effective clinical research approaches. 𝐄𝐱𝐩𝐚𝐧𝐝 𝐏𝐫𝐨𝐯𝐢𝐝𝐞𝐫 𝐍𝐞𝐭𝐰𝐨𝐫𝐤: Grow our network of health providers, systems, and experts to ensure access to the right expertise and clinical sites necessary to support innovative solutions. 𝐒𝐭𝐫𝐞𝐧𝐠𝐭𝐡𝐞𝐧 𝐂𝐨𝐦𝐩𝐫𝐞𝐡𝐞𝐧𝐬𝐢𝐯𝐞 𝐒𝐮𝐩𝐩𝐨𝐫𝐭: Enhance our end-to-end support for digital health solutions, addressing the critical challenges faced by startups throughout the Build, Prove, and Launch phases. We are thrilled to partner with datosX Digital Health Labs in our mission to advance healthcare through innovative, digital-based solutions. Rishab Shah Ben Rosner, MD, PhD Robin Roberts Marianne E. Walwema, M.D.

Had a great conversation with Integrated Growth, Inc. on what it takes to innovate in Healthcare. Check it out. Thanks to Gretchen Reid and her Team for the collaboration opportunity! Manos Health Rishab Shah

Ski towns are good for more than just the pow.  Research opportunities are disproportionately clustered in metropolitan areas or centered around urban medical centers. Not only does this limit access for patients, but it also limits opportunities for providers to be a part of research related to novel techniques and devices.  Great to bring digital health research to a ski town community! Manos Health Rishab Shah