CONFIDENTIALCopyright © 2021 BrightInsight, Inc. BrightInsight and the BrightInsight logo are trademarks of BrightInsight, Inc. Other trademarks are the trademarks of their owners.

How MedTech Companies Can Thrive in Digital HealthHOSTED BY:Chris Beeman| Sr. Dir. Global AccountsFerry Tamtoro| CTO & Co-Founder at BrightInsight

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Introductions: Chris Beeman and Ferry TamtoroTwo key team members supporting BrightInsight’s partnerships in medtech

20 years in Life Sciences industry

AmgenDirector, Digital Health

Baxter InternationalSenior Manager, Infusion Systems

GE Healthcare Technical Project Manager

Ferry TamtoroCTO, Co-Founder, BrightInsight

19 years in medical device industryEmergo by UL

Global Practice Lead- Digital Health

UL- Underwriters LaboratoriesHead of Business Development- Connected Technologies

Chris BeemanSr. Dir., Global Accounts, BrightInsight

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Agenda

• The Evolving Digital Health Landscape• 3 Recommendations to Thrive in Medtech 3.0

• Introduction to BrightInsight• Q&A

The Evolving Digital Health Landscape

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The State of MedTech 3.0

In terms of profits, medical device manufacturers who embrace cloud computing are poised to reap big rewards

“The starting line is connectivity. Then it’s about collecting the data and then activating the data — vertically at the episode of care and then horizontally across the continuum of care. Using an open platform allows different medical device companies to collect and share that data among the device makers, as well as with the patient and provider. Breaking down silos will drive higher quality care at reduced costs.”

– Scott Huennekens, Medical Device CEO, Entrepreneur, Chairman, Board Member

SOURCE: https://www.prnewswire.com/news-releases/healthcare-cloud-computing-market-to-hit-55-billion-by-2025-global-market-insights-inc-300839513.html

According to a report by Global Market Insights Inc.

US healthcare cloud computing market is set to hit $55 billion

by 2025

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5 Key Trends as we Enter the Era of Medtech 3.0

1. Recognition that the industry needs to move from developing siloed solutions where the manufacturer tightly controlled all elements of the hardware, software, and user experience to a more integrated ecosystem

2. Medical devices are being commoditized and it’s becoming more critical than ever to think about the system, not just the device.

3. There’s been a lot of buzz around remote care, but we are also seeing an increased focus on enhancing the patient experience at the bedside through digital

4. Healthcare remains the number one targeted industry from a cybersecurity standpoint with a 45% increase in attacks in 2020

5. Regulations across regions are increasing for connected medical devices and Software as a Medical Device

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Regulated Digital Health Use Cases Present a Significant Opportunity for Medtech

Dose management and scheduling

Algorithms and decision support

Dose calculators

Telehealth and remote patient monitoring

Cloud based Centralized Data management

Over air device updates

Digital pharmacovigilance

Connected drug delivery devices

Clinical Workflows

Connected surgical robotics

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To Launch Innovative Digital Health Products, You Need an Underlying Cloud-Infrastructure… but that Presents Challenges

Delayed time to market

It can take years to develop a

homegrown platform, and most medtechcompanies are not

able to develop cloud software in an

agile manner.

Challenging to maintain and scale

Maintaining a cloud-based platform requires significant

(and niche!) engineering resources and integrating your

platform into the broader healthcare ecosystem.

Not a competitive advantage

It is not a competitive advantage for medtechcompanies to build the

underlying infrastructure. You should focus your team on

specific digital health IP that is core to your business and

partner for everything else to drive speed to market.

Complex regulatory, privacy and security

complianceAugmenting and enhancing your Quality Management

System is resource-intensive with the added complexity of

evolving privacy, security and quality regulations.

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DEVELOPMENT TOOLS & LICENSES

MAINTENANCE

CLOUD CONFIGURATION

RELIABILITY, SECURITY & QUALITY DEVELOPMENT

CONSIDERATIONS

ORGANIZATION COMPLIANCE

INFRASTRUCTURE

INSTALLATION & DEPLOYMENT

TECHNICAL DEVELOPMENT

SUPPORT

INDIRECT

There are many considerations from a digital health platform compliance standpoint.

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• Installation Procedures, IQ/OQ/PQ• Deployment and QC across Dev, QA, Stage, Prod

• ISO 13485 Certified QMS for Class C SW• HITRUST Certification • Maintenance of Certifications

• Sizing and appropriate settings for usage of cloud services• Configuration of security settings for cloud services• Networking and VPC configuration

• Application and components patches to correct issues and vulnerabilities• Updates of Design History File to maintain regulatory compliance• Disaster Recovery Preparedness• Monitor potential new Vulnerabilities, assess, and plan for action• Handling of potential data privacy violation based on policies and

procedures

• Acquisition of expert personnel in Global Medical Device Regulatory, Global Data Privacy, Cybersecurity, Architecture & Design in the context of Cloud Computing

• Delay in product launches due to time to build platform• Higher risk of issues during regulatory submission due to new/unproven platform

• Architecture, Design, and Development of Functionalities• Audit Trail and Logging Capabilities• Verification & Validation

• Application, VM, Compute Costs• Identity Management of Users• Data and Log Storage

• IDS and IPS Capabilities• Auto-scaling triggered by multiple factors• Separation and D—identification of PII• Design of Monitoring and Alerting• Fully Traceable requirements at upper and lower level• Risk management activities• Design History File compliant to medical device regulations,

including any development tools used

• License for development (coding, requirements management, testing, etc.)• License for tools (security, monitoring, other managed services) for each of

the environments (dev, QA, Stage, Prod)

• Call center to handle questions, feedback, and issues• Engineering support to provide detailed investigation into

potential issues and downtime• Training for call center and engineering support staff• Monitoring of key indicators (performance, error, etc.)• Monitor, assessment, and prevention of potential threats• Management, triage, and trending of complaints (as

classified by regulatory bodies)

3 Recommendations to Thrive in Medtech 3.0

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Remote Device Support and Over-the-Air (OTA) Updates Contribute to Large Cost Savings

• Leveraging standardized and scalable technology stacks allows manufacturers to break down the silos within their product portfolios to improve their end user experience

• Gathering real-time operational data (e.g., motor currents, sensor data) can help identify maintenance issues early and schedule proactive service visits

• Having the ability to roll out packaged updates to a fleet of installed units can dramatically increase efficiency and reduce costs

• Predicting device end-of-life and proactively upgrading can reduce operational and patient safety issues

• All of these opportunities have been underscored by the COVID-19 pandemic. It will only become more challenging logistically to get your team members onsite at hospitals and health systems

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Don’t Cut Corners When it Comes to Privacy and Security Compliance

• Adequately consider & document the risk of product security to the entirety of your medical device system, especially as it intersects both data privacy and patient safety

• Understand the complexities and security risk of your medical device supply chain, including the Software Bill of Materials

• Incorporate evolving standards and best practices that are leveraged by international regulatory bodies into your product development lifecycle

• Consider architecture options that deidentifies data and containerizes it based on implications to PHI, PII, along with command & control data

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Take an Integrated Ecosystem Approach

• Integration into the clinical workflow is critical. Care providers only have between 13 – 16 minutes on average with a patient, and their workflow is primarily driven by the EHR

• As we continue to move towards value-based contracts, payers are going to demand real-world device data to inform reimbursement

• Hospital administrators will want to understand device usage to determine future investment

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Introduction to BrightInsight

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Provider of the Leading Global Regulated Digital Health Platform for Biopharma and Medtech

HQ in Silicon Valley with corporate presence in NJ, UK, Switzerland and

Copenhagen

Platform could be available in US, European Union, Canada, Japan, Brazil, Australia (regulatory)Available in 9 additional countries (privacy)

100 years of combined experience in digital health within biopharma and

medtech

Customers include global biopharma and medtech

Others not publicly disclosed; Current customers include five ofthe largest biopharma and medtech companies that account for an

estimated $700B+ in market cap

Recently spun out of Flex with venture backing from top healthcare and

technology investors

Awards and recognitions as the leading regulated IoT platform for life sciences

Global Digital Health 100

CB Insights Digital Health 150

2021 Global Entrepreneurial

Company of the Year by

Frost and Sullivan

Ranked 13 on LinkedIn 2021

Top Startups List in US

Top 20 Dynamic CEO 2021 by CEO

Magazine

Google Partner of the Year

Healthcare and Life Sciences

2018 and 2019

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The BrightInsight Platform Takes the Hard Work Out of Building, Scaling and Maintaining Regulated Digital Health Offerings

ConnectivityBrightInsight offers connectivity

and management for regulated apps, algorithms, devices or

combination products.

Data managementBrightInsight can aggregate data from

multiple sources and can integrate with EHRs and other IT systems.

Analytics and insightsClinical, operation and patient

engagement dashboards provide valuable insights in real-time.

Privacy Security Regulatory Quality Management System is ISO 13485:2016 Certified

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Pre-built Functionality and Modular Architecture Accelerates Time to Market

Create and configure user accounts and

permissionsObtain and track patient consent

Develop and deploy surveys and

questionnaires

Integration with connected device—

device agnostic

Create and configure notification

type/frequencyCreate and configure

patient care plans

Create and configure therapy schedule

Create and deploy patient specific

assessments (i.e., results from BP monitor)

Setup patient specific reminders and

schedulesCapture and store

real-time logsAssess real-time

performance

SAMPLE BRIGHTINSIGHT APIS

Validated containers for custom code modules

IAM CONSENT EPRO DEVICE INTEGRATIONS

NOTIFICATIONS CARE PLANS

MEDICATIONMANAGEMENT

ASSESSMENTS SCHEDULING LOGGING PERFORMANCEMONITORING

CUSTOM CODE

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Flexible API with EHR Integration Supporting HL7v2 and FHIR Standards

HL7v2

Cloud

CDA

X12

FHIR

4-6 weeks

live deployment

500+pre-integrated

provider networks

19FHIR resources

supported

BrightInsight

API

API

API

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Pre-built Customer Dashboards Provide Real-time Contextual Insights to Optimize your Products

Engagement Clinical Operations

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With our Unwavering Commitment to Security and Privacy, You can Minimize Your Risk

HITRUST CSF® v9.1 Certification GDPR compliant

ISO/IEC 27001:2013 certified

Medical Device Single Audit Program (MDSAP)

HITRUST Certification of the NIST Cybersecurity Framework

CERTIFICATIONS

HIPAA compliant

ISO 13485:2016 Certified Quality Management System

Software development lifecycle process conforms to ISO/IEC 62304

Platform security architected to HSCC Joint Security Plan

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Our Managed Service Model Means Less Stress and Ensures Global Regulatory Compliance

Global regulatory compliance

• ISO 13485:2016• ISO/IEC 62304• Master File with the FDA• EC Certification allowing us

to run SaMD modules on the BrightInsight Platform

Cloud change control

One-of-a-kind cloud change control process to

ensure ongoing compliance

Global privacy & security monitoring

Data localization, policy and procedure maintenance

Platform Performance

• Platform performance monitoring

• Level II and III support for the BrightInsightPlatform

BrightInsight Use Cases

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Medical Device Connectivity and Management

SCENARIODevices without connectivity rely on manual data collection, offering limited insights.

CHALLENGESDeveloping custom IoT platforms are expensive to build and maintain, and don’t scale well.

BENEFITSConnecting devices through one scalable, regulated platform slashes costs, reduces risks and generates valuable insights.

Connected infusion pumps (and renal products)Data can be captured from legacy infusion pumps through an encrypted communications gateway integrated into the BrightInsight Platform.

Data integration, machine learning and analyticsThe platform enables infusion pump registration and can securely push the drug library to the pump. BrightInsight analyzes data from multiple products, integrating with EHRs and Health IT systems.

Proactive medical device managementDevices can be continuously monitored in real-time, with algorithms providing early warnings of any risks. Insights from data analysis improve device management and usage.

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AZ AMAZE (Disease Management Platform)on BrightInsight

Regulated Platform launched in less than a year to manage chronic conditions starting with US patients: Asthma, Heart Failure, Chronic Kidney Disease, & COPD

“Digital can play a huge role in improving patient engagement and therapy adherence for their own chronic diseases, as well as providing their physicians better insights to deliver more personalized care in real-time.

By leveraging the compliant BrightInsight Platform and its pre-built integrations into the clinician workflow, we were able to accelerate our time to market and focus on what truly matters – improving patient outcomes and creating care delivery efficiencies, at scale.”

Karan AroraChief Commercial Digital Officer and Global Vice President, AstraZeneca

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Summary: Value of the BrightInsight Platform

Fast To MarketThe BrightInsight Platform significantly accelerates

time to market with 60-80% of typical functionality out-

of-the-box, and agile development under our ISO

13485 QMS to speed configuration and

customization.

Risk-mitigatedWith the BrightInsight DHF on

file with the FDA, and multiple digital products already on the platform

across therapeutic areas, best-in-class privacy

(HITRUST 9.1, GDPR, HIPAA, HDS) and security (ISO

27001) extinguishes development risks.

ScalableThe BrightInsight

Platform complies with regulatory and privacy law across US, Europe (MDR-ready), MDSAP countries, and more, enabling scale and

speed for global launches.

Cost-savingLeveraging economies

of scale through its modern microservices-

based architecture and repeatable SaMD SDLC best practice under IEC

62304, BrightInsight delivers at a fraction of the cost of building and maintaining internally.

Future-proofedAs a managed service,

the BrightInsight Platform minimizes ongoing efforts and costs by

monitoring changing privacy requirements,

ongoing security threats, evolving regulatory

landscape, etc.

BrightInsight enables customers to focus on their core drivers of competitive advantage versus the underlying infrastructure

Q&A

THANK YOU

CONFIDENTIAL© 2021 BrightInsight, Inc. BrightInsight and the BrightInsight logo are trademarks of BrightInsight, Inc. Other trademarks are the trademarks of their owners.

CHRIS.BEAMAN@BRIGHTINSIGHT.COM