Pediatric Digital Medicine Remains an Underdeveloped Opportunity. There are Tools to Help. 

Jennifer Goldsack, CEO, Digital Medicine Society (DiMe)


Demand for pediatric expertise continues to outpace supply. Pediatric specialists are concentrated in a small number of centers, while many children and families navigate care at a distance, often without consistent access to the right support. Clinicians are working with limited, episodic data. Families are managing complex conditions between visits with few tools that reflect the realities of daily life.

At the same time, the technologies that could help address these gaps are advancing quickly. The question that this PedsMrkt community grapples with daily is how to apply them in ways that actually work for children.

That is what led to our partnership with PedsMrkt and the development of The Playbook: Pediatric Digital Medicine.

We started from a practical place. This community does not need another articulation of the problem. It needs a shared approach to building, validating, and using digital tools that can scale across research and care.

A Playbook You Can Use

The Playbook is a working guide developed with regulators, clinicians, industry leaders, and patient advocates to support decisions that teams are already making.

You can access it here. Inside, you will find:

• Approaches to selecting and validating digital measures that reflect pediatric physiology and development
• Study design considerations that are feasible for children and families while still generating robust evidence
• Insight into regulatory expectations, informed by ongoing engagement with FDA and other stakeholders
• Practical guidance on how to move from research to implementation in real-world care
• A Medicaid guide to optimize access and support commercial success. 

This is intended to be used alongside active programs, not after the fact.

How Different Parts of This Community Can Use It

If you are building products
Use the Playbook early in development to shape how you define and capture meaningful outcomes. It can help you avoid relying on adult-derived assumptions that do not translate and reduce the risk of having to revisit measurement strategies later.

If you are delivering care
Use it as a reference point when evaluating new tools. It provides a more consistent way to assess whether a solution is likely to integrate into your workflows and generate information that is actually useful in clinical decision-making.

If you are investing or supporting innovation
Use it to inform diligence. It offers a clearer view of how teams are thinking about measurement, evidence generation, and regulatory alignment, which are often the factors that determine whether a solution will scale.

Why This Work Started with PedsMrkt

This effort grew out of conversations within this community.

PedsMrkt brings together the developers, clinicians, and investors who are actively shaping pediatric care. What became clear is that progress is happening across all of these groups, but often without a shared foundation.

The Playbook is a step toward that foundation, creating a common starting point that allows different parts of the ecosystem to move with greater alignment.

Extending the Work: Pediatric Rare Diseases

Some of the most immediate opportunities to apply this approach are in pediatric rare diseases, where the need for better measurement is well understood.

Building on The Playbook, DiMe and our partners are advancing work to define core digital measures for pediatric rare diseases. You can learn more and get involved here.

This work is focused on:

• Identifying measures that can detect meaningful change in small and heterogeneous populations
• Supporting composite and multi-modal endpoints that reflect how these conditions present and progress
• Creating a library of tools and approaches that can be used across development and care settings

It is being developed in collaboration with regulators and is intended to support both clinical trials and post-market use.

A Shift in Expectations for Pediatric Care

The ASPIRE model that the Centers for Medicare & Medicaid Services announced just last week reflects a broader shift in how pediatric care is being approached.

The expectation is no longer incremental improvement. It is coordinated care across settings, earlier identification of need, and accountability for outcomes over time.

These are not abstract goals. They require decisions about care models, measurement, data sharing, and implementation that work in practice.

The Playbook was developed with these same challenges in mind.

Start Today

If you are already working in this space, there are a few simple ways to engage:

• Review and apply The Playbook within your current programs
• Work with us to publish your case studies of success, or seek additional support
• Participate in ongoing efforts to define and validate digital measures for pediatric rare diseases

We built The Playbook to support the work this community is already leading tirelessly. I hope it may help.  

The PedsMrkt Team is Preparing for PAS 2026 in Boston

We are gearing up to attend the Pediatric Academic Societies (PAS) Meeting in Boston on April 24th. As part of our ongoing commitment to build a stronger pediatric ecosystem, this event will provide another valuable opportunity to promote PedsMrkt and spotlight the innovative work of our member companies to pediatric hospitals.

Be sure to visit the Events page on our website to stay up to date with relevant dates in the world of pediatric innovation.