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Resources in Action

Be Part of the  Community Case Study Hub

The DiMe community is committed to redefining today’s healthcare. Together, by creating and using new digital health approaches and resources – and then sharing these experiences with each other to learn and grow – we are creating a groundswell of change in the field.

Be a part of this unprecedented moment in healthcare.

Browse this case study hub to learn how leaders, innovators, and enthusiasts are using DiMe resources to further the safe, effective, equitable, and ethical use of digital medicine to redefine healthcare and improve human health.

Learn from leaders in the DiMe community, apply some of these ideas to your own organization or project, and then add your “Resource in Action” story to the hub.


Resources in Action: A DiMe Community Case Study Hub

Podimetrics

“When we shift the approach from treatment to prevention, we empower Veterans, improve outcomes, and save lives.”
– Jonathan Brantley, DPM Chief of Podiatric Medicine and Surgery, Richmond VA Medical Center

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ki:elements

“We strive to be pioneers in speech biomarkers and The Playbook provided us with rich and helpful resources to structure our development work towards this goal.”
— Jian Zhao, Regulatory Compliance Manager, Regulatory and Compliance, ki:elements

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LabCorp Drug Development

The Playbook helped us create a team agnostic with the goal of supporting any sponsor looking for digital endpoints in their clinical trials.”
— Ariel Aguilo, M.D., Head of Oncology for the Americas, LabCorp Drug Development

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Winterlight Labs

The Playbook guided our team to prioritize the most important elements of our project and helped us stay focused on patient-centricity.”
— Celia Fidalgo, Sr. Product Lead, Product, Winterlight labs

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Actigraph

“Tools like The Playbook are being adopted by companies of all sizes. It provides a framework allowing you to understand how regulators, sponsors, and vendors can collaborate on the use of novel methods in clinical trials. ”
— Matt Biggs, VP of Applied Science, ActiGraph

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Empatica

The Playbook has been and will continue to be a reference point for our team. It is the resource the industry was missing.”
— Marianna Xenophontos, Director of Marketing, Empatica

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Genentech

The Playbook has helped provide a usable and acceptable framework for discussing the use of digital health technologies with regulators as a primary endpoint.”
— Thomas Switzer, Principal Digital Health Scientist, Early Clinical Development Informatics, Genentech

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Heartbeat Health

“Working with the IMPACT contracting toolkit, we’ve been able to explain key concepts far more clearly and concisely with at-risk entities, leading to faster ramps to execution and successful implementation.”
— Pete Celano, SVP, Business Development, Heartbeat Health

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PhysiQ

“Using the VA-DiMe value-driven framework, the VHA and physIQ deployed a virtual-care solution providing early identification of worsening heart failure enabling timely intervention and reducing readmission.”
—Karen Larimer PhD, ACNP-BC, FAHA, FPCNA VP of Clinical Development, PhysIQ

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Aural Analytics

“The bar for clinical grade speech analytics has to be high given what’s at stake. The V3 framework allows us to provide evidence to ourselves and our customers that our metrics clear that bar.”
— Julie Liss, Co-Founder, Aural Analytics

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Aural Analytics

“V3 established a common language around evaluation of digital biomarkers that was grounded on familiar terms. This made its adoption in digital health natural.”
— Visar Berisha, Co-Founder, Aural Analytics

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Aural Analytics

“V3 has been transformative for us as it’s served as a guiding framework for how we operationalized validation internally, and how we communicate with partners externally.”
— Visar Berisha, Co-Founder, Aural Analytics

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Duke University

“Developing V3 with DiMe & concurrently running the very first V3 study provided a chance to combine theory and practice – it was thrilling!”
— Jessilyn Dunn, Assistant Professor, Duke Big Ideas Lab

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Byteflies

“As a company working on every aspect of the virtual care value chain, having a common internal product and regulatory development language is very important. The V3 framework provides that language.”
—Benjamin Vandendriessche, CMO at Byteflies

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Family Health Centers of San Diego

“Robust and independent evaluation of the analytical validity of BioMets is necessary in order to extract their full potential to better understand and improve human health.”
— Job Godino, Scientific Director of Laura Rodriguez Research Institute

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DiMe Alzheimer’s Disease and Related Dementias Project

“We believe pre-competitive collaboration is essential and are looking forward to working with like-minded innovators within DiMe to accelerate this important work in the fight against Alzheimer’s disease and related dementias public health epidemic.”
— Martin DubecHead of Biogen Digital Health

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DiMe Nocturnal Scratch Project

“The work that has been undertaken has already made great strides in understanding the significance of nocturnal scratching to patients and caregivers, how to make this endpoint a reality operationally, as well as alignment of terminology regarding this novel digital endpoint.”
— Carrie Northcott, PhD, Director & Research Lead for Digital Endpoints, Pfizer

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3D Printing at VHA

“3D printing is a great method to address unique Veteran needs through innovative rapid prototyping and custom solutions, both quickly and in a cost-effective manner.”
—Kaila Grenier, Clinical rehabilitation engineer, Eastern Colorado VA Health Care System

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VA Pride Program

“Since coming to the group, I no longer want to kill myself. I have found others who support me.”
—Veteran Patient, Hampton VA Medical Center

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MADE

“I love the (infographic). It has changed my life. I finally understand how to use these socks.”
—Veteran, User of PSMT during pilot testing

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Winterlight

“The V3 framework has helped set an industry standard for evaluating digital measures and has guided our rigorous research and development of novel speech-based measures.”
— Jessica Robin, Director Clinical Research, Winterlight Labs

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UCB

“The V3 framework was invaluable in helping UCB and our partners navigate the complexity of building a robust corpus of clinical evidence underpinning the core features and functionality planned for our upcoming smartphone based application.”
— Emily Kunka, Global Digital Transformations Lead, UCB

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Takeda

“Validation of a novel device intended for remote clinical monitoring is essential to determine if the device is fit-for-purpose for the specific patient population.”
— Ariel Dowling, Director of Digital Strategy, Takeda

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WKD.SMRT

“If you’re interested in learning more about #remotemonitoring across #clinical research, clinical care, and #publichealth – with a specific focus on connected #sensor products – DiMe Playbook is your one stop shop.”

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Winterlight

“The measurement checklists provide a framework for best practices in developing and validating novel digital measures. These will help bring consistency and scientific rigour to the field!”

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Winterlight

“Patient-centricity is critical to novel biomarker development. The Playbook establishes best practices for patient engagement, including a practical how-to for the industry to follow.”

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VivoSense

“The fact that these tools were collaboratively developed by a diverse group of experts with various stakes has made it an invaluable resource that we can confidently reference.”

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VivoSense

“Having a common language from which to operate regardless of background or expertise has helped improve efficiency and project outcomes both internally and externally.”

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Takeda

The Playbook provided a useful reference and a single place where we could find the answers to many questions as well as credibility to our work.”

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Merck

The Playbook provides a practical ‘how to’ guide for trial teams on coordinating the multi-functional efforts involved in implementation of digital measures in clinical trials

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Medable

The Playbook will become a well trusted reference for academics and commercial entities alike.

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Medable

“If we truly aim to be patient-centered, we must take a measured & patient-first approach to sensors.  The technology will follow.

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koneksa

“We are extremely proud of our involvement in the development of The Playbook, and wanted to promote The Playbook while demonstrating how our work exemplifies the principles it sets out.

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HumanFirst

The Playbook is driving the industry towards a consistent language and framework for remote monitoring that leads to more productive conversations and empowered decision making.

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Bayer

The Playbook provided a comprehensive and well-structured information resource that helps our organization to build a common language and establish a common knowledge baseline for different functions to be able to engage in a more constructive and streamlined fashion.

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Actigraph

“The Playbook is a great “toolbox” when working with a diverse team. It allows for a clear level set on current situations, understand client needs, expand on education, and use technology successfully in a clinical trial.

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Eli Lilly

“This model has been an effective tool to communicate the types of value to be achieved, and then to aid internal regulatory communications about the progress of ‘intended use’ as a digital measure develops.”

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Eli Lilly

“These considerations have been a useful aid in developing an internal checklist we can use in progressing operational readiness of digital clinical measures.”

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Eli Lilly

“This graphic aided our understanding of novel digital measures internally and encourages us to get specific in the definition early in a project.”

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Critical Path

“If we are ever going to get a handle on Parkinson’s we must consider the breadth of impairments and use digital techniques to collect data continuously. The CPP team has done a remarkable job in constructing a viable approach.”
— John Crawford, Biotech executive living with Parkinson’s, Critical Path Institute

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TNO

“Early patient involvement is key to develop digital outcome measures that matter. It will lead to outcomes that truly support value-based healthcare for diabetes and chronic diseases in general.”
— Willem van den Brink, Scientist, TNO

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Wellinks

“Using the DiMe IMPACT Guide to V1C Payment Models, we were able to internally train our commercial team, and also explain V1C to investors.”
— Geoff Matous, President and Chief Commercial Officer, Wellinks

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Wellinks

“DiMe’s toolkit served as a valuable translation tool and allowed us to clearly articulate the business goals and priorities, saving precious (and expensive!) time and cutting likely back-and-forth of drafts in half.”
— Geoff Matous, President & Chief Commercial Officer, Wellinks

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Visana

“The contracting toolkit helps us accelerate our sales cycles and reduce our contracting times.”
— Joe Connolly, Co-Founder & CEO, Visana Health

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DiMe Research Committee

“The EVIDENCE checklist provides a clear process for authors to follow throughout study design, data collection, analysis, and reporting.” 
— Jessie Bakker, MS PhD, Executive Vice President of Medical Affairs,  Signifier Medical Technologies Ltd

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Human First

“The EVIDENCE Checklist is like a one stop shop for new teammates looking to understand our evaluation framework and power their decisions.”
— Max Gaitán, Research Lead, HumanFirst

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DiMe Nocturnal Scratch Project

“Digital measurements must become another element of the overall clinical outcome assessments used for assessing effectiveness of potential new therapeutics.”
— Brian E. Winger, PhD., Senior Advisor for Digital Health, Eli Lilly

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Smart Heart

“What surprised us was how well Veterans embraced the technology. Our work showed us that it’s feasible to utilize smartphones and digital tools to engage and coach this population effectively.”
—Dr. Arash Harzand, MD, MBA Senior Innovation Fellow, VHA Innovation Ecosystem Director of Digital Cardiology & Vascular Medicine, Atlanta VA Medical Center

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ActiGraph

“V3 is a very helpful framework, clarifying the evidence required to support the digital measures we provide and leverage the benefits of multidisciplinary collaboration.”
— Christine Guo, Chief Scientific Officer, ActiGraph

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