Medical Design Briefs - October 2023 - 24

Show Preview: Biosensors for Medical Wearables
The Future of the Digital
Therapeutics and Medical
Wearables Market:
Q&A with Tim Callahan, VP, Scientific
Affairs, Philips Pharma Solutions, and
with Janet Nikolovski, New Venture
Lead, Johnson & Johnson
The digital therapeutics and medical
wearables market has matured greatly
over recent years. What key differences
have you noticed in the last year regarding
significant developments?
Tim Callahan: We are now understanding
the regulatory guidance more
and trying to conform clinical trials to
meet the guidance and collect better
data. Clinical trials, especially late phase,
are looking to wearables as a viable alternative
to traditional collection methods.
Janet Nikolovski: The COVID pandemic
has accelerated the adoption of
remote patient monitoring. We have
also seen more clinical studies adopting
digital technologies.
What do you see as the greatest challenge
facing the industry at the moment?
TC: Standardization. Clinical trials
are predicated on collecting data to
meet safety and efficacy endpoints.
These can be statistically driven. Unless
we standardize the data collection
method (including precision and standardized
software), we might be in
danger of missing these endpoints.
JN: One challenge is the need for
generating robust clinical evidence to
support the efficacy and safety of digital
monitoring solutions and therapeutics
and doing this inclusive of underrepresented
populations typically addressed
in clinical trials.
Janet Nikolovski
Tim Callahan
What current hot topic will you be
addressing in your presentation, and
what would you say makes it relevant
to 2023?
TC: Using wearables in clinical trials
and how the data can be analyzed
(compared to
traditional methods).
This will include how AI will be important
in the future.
JN: The use of smart phones and
wearables in clinical trials can allow us to
access broad, large populations, not be
limited by need for clinical sites, reduce
costs, and complexity. However, lack
of sustained patient engagement and
complete follow-up can be a significant
challenge. Several remote digital health
studies using mobile applications and
wearable devices have been successful to
retain high participation in short term,
or with high touch. But long term, digital
studies requiring engagement over
years has proven challenging. We will
share our design process for the Heartline
Study, an app-based, large, siteless
clinical trial lasting two years, comprised
of an Apple Watch and a custom digital
engagement program. The high rates
of sustained, longitudinal engagement
achieved in that study, and the insights
we gained, we hope can inform the design
of future trials.
How would you like to see the market
develop in the future, and where do
you think the biggest growth area will
be in 2023?
TC: Wearables will fill a niche in
clinical trials. We will need to start
with later phase trials and then move
the collection of data to earlier phases.
However, we need to start with widespread
surveys with these devices. This
usually happens in postmarketing surveillance.
Concurrently, we should be
able to seed Phase 3 trials with remote
data collection using wearables to collect
more, real-life data.
JN: I'd
like to see greater convergence
of clinical and consumer
devices that are easy to use but deliver
on patient expectations and
outcomes. While there are opportunities
in each in each space separately,
the biggest opportunity is to
demonstrate outcomes that matter
to payers, providers and ultimately
patients/consumers.
And on a final note ... Why do you
feel it is important for the industry to
join this year's Biosensors for Medical
Wearables conference?
TC: The industry is growing and
changing rapidly. Keeping up with
these changes, including benchmarking
of your own projects, in crucial to
stay current in this field.
JN: To hear the latest challenges and
exciting opportunities in this industry
and the broad ways different groups
are addressing them.
24
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Medical Design Briefs - October 2023

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