WHITEPAPER

Future-proofing
your digital health
regulatory strategy
Key considerations for biopharmaceutical
and medical technology companies
Table of Contents
3 Executive Summary

4 Introduction: New regulatory challenges for biopharmaceutical and

medical technology companies

6 The Digital Health Regulatory Maturity Curve

7 Overview of the BrightInsight Platform

8 How BrightInsight reduces risk, cuts costs, and saves time

9 Future-proof your digital health regulatory roadmap

Overview of BrightInsight, a Flex Company

BrightInsight, a Flex Company, provides the leading global regulated digital health
platform for biopharma and medtech. Our medical-grade Internet of Things (IoT)
platform is built under a Quality Management System to support and optimize
regulated drugs, devices and software through integrated data and actionable
insights to enable customers to drive increased patient adherence and engagement.

Our mission is to make digital health innovation easy for our customers through
our end-to-end digital health capabilities and scalable, medical-grade platform.
Together, our leadership team brings over 85 years of combined digital health
experience in the biopharma and medtech industries.

Our parent company, Flex, helps their customers transform ideas into intelligent
products for a connected world. With approximately 200,000 employees in thirty
countries, Flex provides innovative design, engineering, manufacturing, supply chain
insights, and logistics services to a global customer base across every major industry,
including healthcare. For over 30 years Flex has worked with leading healthcare
companies deploying over 100 regulated hardware and software medical products
worldwide.

Whether you’re connecting a medical device or combination product, developing a

companion app or deploying a smart algorithm, we make digital transformation easy
while accelerating your time to market, minimizing your risk and future-proofing your
digital health offerings.
Executive Summary
Many biopharmaceutical (biopharma) and medical
technology (medtech) companies have taken a
conservative approach to digital innovation. While life
sciences companies have developed thousands of health
and medical apps since the first smartphones launched
more than a decade ago, they have allowed a growing
number of startups to take the lead in developing novel
digital therapeutics and combination products.
Given the persistently unclear and complex regulatory
environment biopharma companies face when
considering a more decisive move into digital, along
with the significant regulatory investment such a move
requires, their reluctance is understandable. The full
potential of digital health, however, will not be realized
until biopharma and medtech companies move beyond
simple apps to sophisticated digital health solutions
such as artificial pancreas systems, connected infusion
pumps, anticoagulation systems, and more. While adding
digital to these types of solutions moves the product
into a more regulated category, companies can also
unlock tremendous opportunity in terms of automating
interventions and business insights, improving patient
adherence and engagement, unlocking new value-based
care services and improving patient outcomes.
Biopharma and medtech companies need to contemplate
their solution roadmap and what type of regulatory
strategy they need to support their current and future
regulated digital health products. Most medical device
data systems (MDDS) will not offer a sustainable regulatory
infrastructure to support more mature digital health
solutions.
For those reasons, biopharma companies are in need
of a medical-grade Internet of Things (IoT) solution that
would allow them to offload the additional regulatory
burden created by new digital products. This white paper
explores the market need for a medical-grade platform
and managed services offering that goes beyond medical
device data systems (MDDS), that can support biopharma
and medtech companies from simple companion apps
to advanced, clinically-approved Software as a Medical
Device solutions. Readers will understand how a medical-
grade IoT platform can accelerate biopharma and
medtech companies’ digital initiatives while reducing
their risk, cutting their costs, and getting their products to
market faster.
3
Introduction: New regulatory E In June 2017 the FDA issued a guidance document
on how it approaches digital technologies used in
challenges for biopharma and clinical trials.4

medtech companies E That same year the FDA signaled that for lower risk
software products the agency is weighing a move to
Regulatory uncertainty persists around a pre-certification model, which would first focus on
medical software the software developers instead of their individual
products. The program is currently being piloted with
The rapid pace of health technology innovation has a half dozen companies.5
driven the FDA to articulate additional regulatory clarity
for medical app developers and manufacturers of E The agency also announced final guidelines in 2017
combination products. The FDA’s actions in recent years, for how best to determine whether combination
however, suggest regulations for software products will products should be classified as drugs, biologics,
evolve at an increasing pace, adding complexity to or medical devices.6
biopharma and medtech companies’ already demanding
regulatory responsibilities. E In December 2017 the FDA issued a new clinical and
patient decision support software draft guidance,
In the past two years the FDA has issued a number of new which attempted to provide clarity regarding software
regulatory clarifications: used by both clinicians and patients.7

The agency should be lauded for keeping up with the

E In February 2015 the FDA released a new risk-based
fast- moving digital health market by issuing its constant
approach to regulating mobile medical apps. The
stream of regulatory updates, but keeping tabs on the
guidance notes the agency plans to use regulatory
agency’s current thinking has proven to be a regulatory
“enforcement discretion” to leave lower-risk medical
challenge in its own right.
software alone.1

E Additionally, the agency down-classified medical As companies consider their global expansion, it’s
device data systems (MDDS) from a Class III to Class I important to keep in mind that launching digital
device. A year later, however, the 21st Century Cures Act health solutions outside of the United States and
changed the definition of “medical device” to exclude the FDA’s purview compounds the complexity and
certain medical device software, including MDDS.2 regulatory burden.

E In 2016 the agency and its international counterparts

around the globe announced a new effort to harmonize
regulatory paradigms, including guidelines for Software
as a Medical Device and combination products.3

“Mobile Medical Applications, Guidance for Industry and Food and Drug Administration Staff,” Food and Drug Administration, February 2015,
1 

https://www.fda.gov downloads/MedicalDevices/.../UCM263366.pdf Accessed November 2017.

“Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” Food and Drug Administration, February 2015,
2 

https://www fda.gov/downloads/ medicaldevices/deviceregulationandguidance/guidancedocuments/ucm401996.pdf Accessed November 2017.

“Software as a medical device (SAMD): Clinical Evaluation,” Food and Drug Administration, August 2016,
3 

https://www.fda.gov/downloads/ medicaldevices deviceregulationandguidance/guidancedocuments/ucm524904.pdf Accessed November 2017

“Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers, Draft Guidance,” Food and Drug Administration, June 2017,
4 

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM563785.pdf Accessed November 2017.

“Digital Health Software Precertification (Pre-Cert) Program,” Food and Drug Administration, September 2017,
5 

https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/Default.htm Accessed November 2017.

6 
“Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff – Final Guidance,” Food and Drug Administration, September 2017,
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM258957.pdf Accessed November 2017.
“Clinical and Patient Decision Support Software: Draft Guidance for Industry and FDA Staff,” Food and Drug Administration, December 2017,
7 

https://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/UCM587819.pdf Accessed January 2018. 4

Reconciling dramatically different
There are significant costs associated with
regulatory cycles
operationalizing to support additional QMS audits
Another challenge facing biopharma and medtech and regulatory filings for connected medical device
companies embracing digital is the clash of regulatory or combination products.
cycles for drugs, devices and software. Take the product
cycle of a molecule that typically spans 10 to 15 years.8 Biopharma and medtech companies face impacts
Medical devices are moving toward a two-year regulatory on headcount to build software regulation
cycle, as consumers come to expect their glucose meters expertise, as well as delays in getting the digital
to be refreshed as often as their smartphones. Finally, solution to market that can result in revenue loss.
because it typically lives on those same consumer devices,
software regulated as a medical device demands update
cycles measured in months or weeks. Healthcare’s culture vs. digital innovation’s
rapid, iterative approach
The FDA requires review of design documentation on
Healthcare companies that have seen early success in
each component of a combination product – the drug/
digital recognized that software requires an iterative
biologic, device and/or software – which is accomplished
approach once a product enters the market, much like the
by presenting a master file for components that are not
consumer technology industry. Drug and medical device
developed by the manufacturer. A medical device master
development take the opposite approach: Innovation
file, for example, is similar to a premarket submission that
occurs up front, and once a drug or device enters the
includes detailed information about the requirements,
market, it is locked down to minimize any variability.
design, testing, processes and articles used in the
Thinking like a consumer company requires healthcare
development, manufacturing, processing, packaging
organizations to frequently update their digital offerings
and storing of the device. Given a drug’s 15-year cycle,
based on what works and what needs to be improved to
life sciences companies will be updating the hardware
help their patients.
a number of times, and the software frequently, over the
course of the drug’s time in the market. As biopharma While biopharma companies have launched thousands
companies move from products that are solely drug- of health apps since the advent of the smartphone, as
based to product lines that include tech-enabled services, a group, biopharma companies are less successful at
these “beyond the pill” business models carry with them an driving app engagement than the typical health app
array of new and challenging regulatory implications. developer. A recent survey found that on average the top
12 biopharma companies have each created 153 apps to
Moving into digital brings with it additional date. Biopharma companies’ app portfolios have doubled
QMS audit exposure and significant costs in size over the past two years, and yet these apps have
attracted an average of just 3,300 annual downloads
One clear implication for biopharma’s move into software apiece.10
and medical devices is an increase in QMS audits. Large
biopharma companies are intimately familiar with the Notably, just one biopharma company offers a medical
Center for Drug Evaluation and Research’s (CDER) frequent condition- focused app that has broken into the millions
audits and the FDA’s medical device division, the Center of downloads. However, this biopharma company did not
for Devices and Radiological Health’s (CDRH) inspections develop this successful app; it was the flagship product
of medical device facilities. In fact, a recent analysis of of a startup it acquired.11 This example points to a related
the FDA’s database of inspections actually shows that challenge: software and medical device design expertise
CDRH conducted 6,000 more inspections over the past are in high demand. Outside of Silicon Valley, finding
nine years than CDER.9 When deploying a connected this specialized expertise has proven to be an ongoing
combination product, new QMS audits for the software challenge for biopharma companies.
development function are introduced.

8 
“Biopharmaceutical Research & Development: The Process Behind New Medicines,” PhRMA, May 2015,
http://phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf Accessed January 2018.
9 
“Inspections Classifications from 10/1/2008 through 11/15/2017,” Food and Drug Administration, November 2017,
https://www.fda.gov/ICECI/ Inspections/ucm222557.htm Accessed November 2017.
10 
D. Ireland, “Pharma App Benchmarking 2017,” Research2Guidance, July 2017,
https://research2guidance.com/2nd-edition-pharma-report-findings/ Accessed November 2017.
A. Murray, “The Growing Value of Digital Health,” IQVIA Institute, November 2017,
11 

https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-growing-value-of-digital-health.pdf Accessed November 2017. 5

The Digital Health Maturity Curve
Connected
Devices
Simple
Companion Apps
MDDS Solutions
BrightInsight, a Medical-Grade Digital Health Platform
In 2016 there were an estimated 260,000 health apps on
the market. As a group, the top 12 biopharma companies
created 1,060 of the health apps available, up from
just 305 health apps in 2013. While these biopharma
companies increased the number of apps in their portfolio,
growth in downloads across these apps flattened out
between 2015 and 2016.12
Unregulated companion apps typically include
educational and marketing information about a
particular drug or medical condition, and they are
intended for informational purposes only. Sometimes
these apps include simple tracking or journaling features
that require users to manually input data, such as their
medication adherence or emotional state. These apps
serve as a starting point for biopharma companies to
become familiar with ingesting patient data, but from
a user acquisition and retention standpoint, biopharma
companies are facing diminishing returns on their
investment in first-generation health apps.
Digital-savvy biopharma companies see adding new
regulated functionalities as a way to improve patient
engagement, deliver actionable insights to providers, and
provide more value around their products and therapies
Moving up the digital health regulatory maturity curve
brings biopharma companies from developing simple
companion apps, to capturing data from connected
medical devices, to generating meaningful insights
around the data, to building Software as a Medical
Device solutions.
“Pharma and the connected patient,” Deloitte Centre for Health Solutions, May 2017,
12 
https://www2.deloitte.com/content/dam/Deloitte/ global/Documents/Life-Sciences-Health-Care/gx-lshc-pharma-and- connected-patient.pdf Accessed November 2017.
Software as a
Smart Medical Device
Platform
Regulated Solutions
The more advanced regulated solutions include more
robust feature sets, such as controlling connected devices,
drug dosing, decision support, personalized patient
interventions, trend analysis and AI-driven insights.
Introducing more advanced capabilities like these can
create operational efficiencies through automation and
scale, improve patient outcomes through interventions
and engagement, and ultimately optimize the value of
connected drug, device or combination products. To
unlock these benefits and deploy highly regulated digital
health offerings, companies need infrastructure and digital
health regulatory expertise. Building these capabilities
within a biopharma or medtech company impacts their
time to market, increases headcount costs, and introduces
additional regulatory and audit exposure.
As biopharma companies enter the digital health space
and build new offerings, they need to contemplate their
solution roadmap and what type of regulatory strategy
they need to support future products.
Most medical device data systems (MDDS) will not
offer a sustainable regulatory infrastructure to
support more mature digital health solutions. It is
critical for biopharma and medtech companies to
leverage a platform that can support them along
the maturity curve — from simple companion apps
to Software as a Medical Device.
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BrightInsight™, a medical-grade IoT platform

BrightInsight™ is a medical-grade Internet of Things (IoT) platform built under a Quality Management System to support
and optimize regulated drugs, devices and software through integrated data and actionable insights to enable customers
to drive increased patient adherence and engagement. The BrightInsight™ Platform uses software and services to
capture, transmit and analyze data from CE-marked and FDA-regulated medical devices, combination products, apps
and Software as a Medical Device, in compliance with security, privacy and regulatory requirements. Deployed as a
managed service, the platform accelerates the time to market for biopharma and medtech companies, reduces the cost
of implementation and maintenance versus a custom solution, and scales across products and global markets.

Connectivity Data Management Analytics and Insights

BrightInsight offers connectivity BrightInsight can aggregate Clinical, operation and patient
and management for regulated data from multiple sources and engagement dashboards provide
apps, algorithms, devices or can integrate with EMRs and other valuable insights in real-time.
combination products. IT systems.

Real-time intelligence Scalable and turnkey

Our medical-grade BrightInsight Platform goes beyond
simple device connectivity solutions in the market today
to deliver a new level of intelligence to biopharma and
medical technology companies.
E The platform generates real-time insights from real-
world drug and device data to enable its customers
to improve patient engagement and medication
adherence.
E These actionable insights provide a biopharma or
medtech company with new data to improve a drug or
therapy that they haven’t historically had access to.
E From commercial insights that streamline operations
and unlock additional revenue to automated patient
interventions, the platform will enable biopharma or
medtech companies to continue to optimize their
solutions once they are in the marketplace.
Designing for scale is part of the DNA of our parent
company, Flex. With approximately 200,000 employees
in 30 countries, Flex’s scale helps drive the world’s most
efficient and reliable manufacturing operations, and
software development and deployments. Leveraging
this expertise, BrightInsight’s managed service model
maximizes speed, efficiency, and cost-effectiveness.
E The BrightInsight Platform is designed to scale beyond
single products and regions to support our customers’
market needs whether they be hundreds of thousands,
millions, or tens of millions of users.
E The platform also features foundational capabilities
for rapid development and a modular platform
architecture to support customization.
E BrightInsight is device-agnostic and designed to
reduce capital costs and complexity.

E The platform is designed to eliminate regulatory

bottlenecks that lead to frustration and costly delays.
The BrightInsight team reduces the regulatory burden
so biopharma companies only have to file their drug,
device or combination product with the FDA. We
manage the ongoing master file submissions for the
BrightInsight Platform, streamling the file management
for our customers.

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Medical-grade and secure E The BrightInsight team follows the Security-by-Design
principle and built the entire BrightInsight Platform
BrightInsight has achieved the upmost privacy, security,
software stack with security in mind throughout the
regulatory and quality certifications to minimize customer
software development lifecycle.
risk and protect sensitive health information.
E The BrightInsight security framework is based on global
E BrightInsight is designed to support up to Class III
security standards and frameworks (such as ISO27001,
medical device and combination product intended
NIST 800, HITRUST CSF) and follows Defense-in-Depth
uses.
best practices, managing over 350 technical and
E The platform is built within a robust Quality operational security controls to safeguard customer
Management System which is ISO 13485:2016 certified. data.

E The platform is HITRUST CSF® v9.1 and ISO/IEC

27001:2013 certified.

E HIPAA and GDPR compliant.

E Certified under both the EU-U.S. and Swiss-U.S. Privacy

Shield frameworks.

E We employ a dedicated team of privacy and security

experts who adhere to ongoing operational and
administrative safeguards.

How the BrightInsight Managed service saves time on building new

infrastructure while accelerating lessons learned
platform reduces risk, cuts
Our team saves its customers time in a number of ways.
costs, and saves time First, our managed service allows its biopharma customers
to forgo building software regulation and development
expertise in-house, which results in upfront cost savings
Biopharma companies considering the addition of a
related to headcount. We also manage the FDA filing
digital component may rule it out because they would
and maintenance of that filing – including change control
rather not add more risk to the launch of their billion-dollar
notifications to clients and regulatory authorities -- for the
molecule. With BrightInsight, the burden of managing the
BrightInsight software aspects of its customers’ products.
ongoing regulatory file management is alleviated.
This includes helping them understand how to integrate
Every day that a drug is not in the market because of the digital regulatory package with the overall filing for
development or regulatory delays costs a biopharma their combination product. We submitted a Master File for
between $600,000 in lost revenue for niche products to the BrightInsight Platform to the FDA, which was accepted
an average of $8 million for blockbuster drugs.13 Patent in March 2018.
windows remain fixed and development cycles for
Second, since our team is working with multiple customers
increasingly complex drugs are on the rise.
and therefore, use cases, its expertise will build at a rate
faster than any single biopharma company’s internal team
With the right partner, biopharma companies can could match. Those accelerated findings translate into
add a digital component to a combination product time saved for our customers.
without worrying about regulatory complexity
adding to the delay.

“Accelerating Clinical Trials: Budgets, Patient Recruitment and Productivity,” Cutting Edge Information, 2005,
13 

https://www.prnewswire. com/news-releases/clinical-trial-delays-cost-pharmaceutical- companies-55044607.html Accessed December 2017. 8

The BrightInsight modular technical architecture helps customers
get to market faster

Our platform was built using a highly modular architecture, also called a microservices
architecture, which allows it to more quickly evolve its capabilities without having to
be completely rebuilt. By having full traceability down to every single module at the
unit level, we know exactly what impact to expect at the system level when a change
is made, the potential hazards and risk for our customers, and how those translate
into development and verification activities. It also enables us to easily and quickly
document these changes for regulatory purposes.

By building the platform from the ground-up using this modular approach, BrightInsight
is fundamentally different from other medical device connectivity platforms on the
market. The transparency that the BrightInsight Platform architecture enables allows
it to support Class II and III medical devices, combination products and Software as a
Medical Device. From a regulatory and quality management systems perspective, we
can document changes at the unit or code review level, as opposed to just performing a
verification from an overall system perspective.

Additionally, our platform comes equipped with a number of core functionalities that
biopharma customers can package into their digital products, including patient
preferences management, communicating to the patient through email or SMS, and
medication management.

Conclusion: Future-proof your digital health regulatory roadmap

With few exceptions, biopharma companies’ digital For more than three decades we have been operating in
products have mostly consisted of information-only health regulated healthcare environments, bringing more than
apps with limited utility to patients but also limited risk for 100 regulated hardware and software solutions to market.
the companies that made them. Every major biopharma
company, however, recognizes that progressing their Now, with our BrightInsight Platform, biopharma
digital strategy requires a move into regulated waters. and medtech companies can accelerate their time
to market, reduce the cost of implementation and
Moving up the Digital Health Maturity Curve is the maintenance versus developing a custom solution,
only way to harness digital to unlock the maximum and scale across products and global markets.
value, and to achieve the goal of increasing patient
engagement and improving health outcomes. BrightInsight’s regulatory strategy and managed services
model makes digital transformation easy for biopharma
Biopharma companies may lack the necessary expertise and medtech companies.
in-house to build the regulatory strategy and submission
of digital health products. Instead of courting the risks,
costs, and lost time that developing such expertise would
demand, biopharma companies should invest in a partner
that can manage their digital regulatory needs end-to-
end, freeing them up to focus on their core business.

9
For more information on the BrightInsight
Platform and Professional Services,
email contact@brightinsight.com
or visit brightinsight.com

© 2019 Flex Ltd. AGE OF INTELLIGENCE, INTELLIGENCE OF THINGS, SKETCH-TO-SCALE, FLEX, and FLEX-LIVE SMARTER are trademarks of Flex Ltd.
BRIGHTINSIGHT is a trademark of Flex Ltd. and its affiliates.