INDUSTRY OVERVIEW

Realizing the promise of digital medicine
ZS Digital Medicine

How pharma, medtech andhealthtech can use digital medicine
to improve patient outcomes andtransform care

• Will be adopted by clinical opinion leaders• Generates regulator-required clinical data on safety

Applying clinical rigor to digital solutions can leverage
low-cost mobile devices, internet connectivity, connected
devices, patient data portability, AI and machine learning,and other innovations to help diagnose and treat patients.
This represents a tremendous opportunity to deliver better
outcomes at a scale never before possible.

different clinical workflows, patient behaviors andregulatory regimes

Delivering on this promise, however, is challenging as
it requires both building great solutions and achieving
commercial scale.
Building a great digital medicine solution starts withselecting the right medical challenge to address, as well
as designing and building a solution that:• Provides a demonstrable clinical benefit while
delighting users

and efficacy• Abides by other regulatory requirements• Demonstrates financial value• Does all the above across multiple countries withAchieving commercial scale includes:• Building the solution in an efficient and timely manner• Generating the additional, even ongoing, evidence,
required by the market’s various stakeholders• Navigating the currently fragmented, immaturelandscape to find a viable path for distribution, payment
and adoption

By embracing innovative strategies to address theserequirements, companies have an opportunity totransform healthcare.

INDUSTRY OVERVIEWCREATING REAL-WORLD IMPACT
We help deliver on the potential of digital medicine—wherever clients are on their journey. We help clientswith such things as:• Upfront strategic planning• Product discovery and concepts• Design and development• Evidence planning and execution

Our approach
ZS understands the challenges to design and build
digital medicine solutions that delight patients, improve
clinical outcomes and achieve widespread adoption andreimbursement. In 2022 alone, we worked with more than
70 clients on their digital missions.
The complexity and rigor of digital medicine often requires
taking a best-of-breed approach, leveraging not only ZS’s
capabilities but those of other ecosystem players, includingZS’s portfolio of pre-qualified partners.

• Go-to-market planning and deployment

ZS provides end-to-end support across the life
cycle, including:• Ongoing quality and data management Business• Strategic advisory: We have a dedicated team of experts

Process Outsourcing (BPO)

500+
Digital health and digital medicine projects delivered
since 2012130+
Clients in biopharma, medtech, retail health and more

210%
Increase in digital patient engagement inchronic programs+15M
Lives managed in largest engagement program

Top 20 pharma

focused on digital medicine. Whether you’re looking tomake, buy or partner, build foundational capabilities,create market opportunities, manage your productor commercialize an asset, our team can provide key
experience-based expertise.

• Product design and development: Our productmanagers, UX researchers and designers, technology
architects and engineers can build a range of custom
solutions and integrate them with third-party systems.
Through the ZS SaMD Factory, an affiliate of ZS, and its
ISO 13485-certified quality management system (QMS),
we can execute your SaMD’s design and development.

• Solution modularization: Many digital medicine

solutions involve two types of components: nonSaMD (designed and built in a fully agile manner) andSaMD (subject to design control and validation). Our
modularization strategies reflect both initial productconstraints and future roadmaps.

ZS helped design a digital therapeutic (DTx) for COPD
patients, incorporating behavioral change techniques.
We built a prototype used for observational studies
in two geographies (indicating a 50% readmission
reduction potential).

• Compliant technology platform: We leverage

Medical devices• Healthcare partnership network: We leverage

ZS helped a client evaluate their consumer technology
for cardiac arrhythmia screening through clinicalsupport, market and regulatory research andquality management.

Providers
ZS developed a software as medical device (SaMD)
to better manage COVID-19 patients post-discharge,
leveraging our HITRUST-certified Connected Health
Platform for compliant data management.

our engagement and data platform to accelerate
development of novel digital medicine solutions.
ecosystem and technology partners to augment
development, evidence generation and last-mile
deployment—not only for one market solution but alsolocalized versions for multiple markets.

• Embedded regulatory, quality and compliance SME:
Whether helping clients establish their own SaMDspecific QMS and software development life cycle or© 2023 ZS | 2

INDUSTRY OVERVIEW

incorporating regulatory strategy into product definitions
and rollout plans, our subject matter experts (SMEs) can
support responsible innovation throughout the process.

• Digital-centric study planning and evidence

generation: Our offerings can be used for various
purposes across the life cycle, from concept testing tohuman factors and regulatory clearance to clinician
adoption and pricing negotiations. We specialize inplanning and execution of “digital-first” decentralized or
hybrid studies best suited for many digital solutions—providing speed, higher participation
and representativeness.

• Commercial launch support: We help pilot, integrate,partner and scale, leveraging the decades of experienceand relationships that ZS has in healthcare ecosystem.

Our clients can leverage our experience, best practices andaccelerators in a range of modalities:• Consulting: Supporting your internal teams withexperience, insight, creativity and rigorous analysis.

• Outsourcing: Taking on product development andoperational responsibilities, before or after launch.

• Capability building: Helping plan, resource and traininternal teams for clients who want to use our consulting
or outsourcing only on an interim basis.

EXPERTISE AREASZS SaMD Factory: We help clients
master the combination of agility andregulated design controls.
Clinical decision support: We help
clients productize algorithms built
in-house; by third parties; or by ZS’s AI,
data science and analytics group.
DTx: We design, develop, validate anddeploy DTxs targeted at improving
patient outcomes.
Make, buy and partner: We help clientsassess the roles and capabilities coreto their business versus those that canleverage others’ expertise or
market penetration.
SaMD-specific foundational
capabilities: We help clients set up theirfirst ISO 13485 capabilities as well as
help medical device veterans to develop
SaMD-specific QMSs and SDLCs.
Connected devices and systems:
We support development of connecteddrug delivery devices and theircompanion experiences to ensure
engagement, data analytic andcommercial success.
Behavior change: Our ZS cognitive andbehavioral science team can help design
digital solutions that impact patient
behavior for improved adherence andclinical outcomes.
Last-mile integrations: Leveraging
a variety of partnerships, we ensure
solutions can integrate with theelectronic health records (EHR), picturearchiving and communication systems(PACS)/radiology information systems(RIS) or other systems needed for dataacquisition and end-user adoption.

© 2023 ZS | 3

INDUSTRY OVERVIEW

Why ZS
End-to-end support

Best-of-breed approach

From strategy through design, development,launch and scaling, ZS can support digital medicine
initiatives across the entire life cycle.

While ZS does offer a platform and various
accelerators, our experience is that the rigor of
digital medicine requires a best-of-breed approachfor the given clinical scenario. We are comfortable
collaborating with our network of partners as well as
those of our clients.

ZS SaMD FactoryVia our ISO 13485-certified SaMD Factory, we
can design and develop regulated SaMD’s as
a contract manufacturer, leveraging our agile,
purpose-built QMS.

QMS accelerators and BPO
We offer pre-audited templates and tools to help
clients stand-up their own QMS rapidly, and also an
outsourced quality team to help manage the QMS,
pre- or post-market.

Flexible and collaborative partner
Whether as advisor, subcontractor, manufacturer,
operations support or platform provider, weunderstand different clients have different in-housecapabilities, legacy vendors and future plans that
require us to play different roles indifferent situations.

Digital Health Technology Accelerators
We leverage a suite of technology accelerators that
optimizes the development and deployment ofinnovative, scalable digital health solutions (including
non-SaMD digital medicine components) througha common stack of configurable accelerators and acompliant digital core.

Strong partner network
We bring together a broad suite ofpartners, including:• Healthcare ecosystem partners to accelerate
evidence generation and validationof solutions• Technology partners to leverage tech innovations
to augment client programs• Compliance and certification partners to ensure
trust-based engagements with patients, HCPs,
payers and regulators

The most complete offering set
In collaboration with our clients and ecosystem
partners, the ZS SaMD Factory helps ensure anintegrated, end-to-end approach to get the right
SaMD designed, built, validated anddeployed rapidly.

Learn more: www.zs.com

About ZSZS is a management consulting and technology firm focused on transforming global healthcare and beyond. We leverage
our leading-edge analytics, plus the power of data, science and products, to help our clients make more intelligent decisions,deliver innovative solutions and improve outcomes for all. Founded in 1983, ZS has more than 12,000 employees in
35 offices worldwide.

www.zs.com | © 2023 ZS050923