Source: Playbook team analysis

Sensor

Person/Patient Data Platform

Person generated data flow

Person generated data flow

In this Section on Operations, we’ll discuss elements of validating the digital measurement system

The Playbook / Build the shared foundation / Operations

Algorithm & Data Science Platform

Digital Measurement

System

This is the combined technologies: the sensor, the algorithms, and the platforms used to manage the system.

Preparing and validating the digital measurement system will include:

• Authenticating, configuring, and provisioning the technologies
• Training staff
• Preparing User Acceptance Testing (UAT)
• Distributing the technologies to the patients

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1

Source: Expert interviews, Playbook team analysis

2

PRO TIP

• You don’t want to train clinical teams until the IoMT products have been configured (e.g., don’t draft patient guides and site manuals until product is agreed on)
• These materials should be clear around who is handling additional tech support when issues arise
• These training materials may be used during the UAT testing process

The Playbook / Build the shared foundation / Operations

Train the teammates who are setting up the patients

Jobs to be done

• Develop processes for onboarding and consent processes for patients using these products
• May want to consider looking into Cybersecurity informed consent (CIC), a new paradigm that raises cybersecurity considerations for connected medical technology as related to informed consent discussions between patients and clinicians
• Create training guides, these could include: patient/participant facing guides (material)
• Clinic/site manuals (e.g., likely in PDF from, more comprehensive than what’s shared with patients with step-by-step guide. More specific about the technology)
• Training slides. Could be Slides, e-learning, or part of a virtual training. An overview for staff, which combines the tech and the implementation

2

2

Source: Expert interviews, Playbook team analysis

3

PRO TIP

• May consider working with one of the industry logistics subcontractors (e.g., Integron, Stefanini, C3i Solutions) to manage these processes
• In many cases you’ll want to ensure that ‘receipt’ of delivery is trackable

The Playbook / Build the shared foundation / Operations

Distribute the technologies to the patients

Jobs to be done

• Prior to distribution, ensure that training associated product metadata (e.g., serial numbers) is complete
• Deliver the products into the regions (note: states and countries may have varied requirements)
• Maintain what regions are the products registered
• When working internationally, apply for and maintain import licenses (e.g. Coordinate the Importer of Record (IOR) and associated customs impacts for getting devices and sensors into countries)

3

3

Source: Playbook team analysis

Let’s dive into Stage 3: Post go-live

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The Playbook / Build the shared foundation / Operations

Post Go-Live

Close Out

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2

3

4

Procure digital measurement products

Prepare product-level ecosystem

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Go Live

‘Close out’ processes look different across research, care and public health, though exist across all contexts

• Monitor and serve the population
• Provide alerts, software updates, maintenance
• Tech support as needed

• Authenticate, configure, and provision the tech
• Integrate tech into broader platform
• Prepare User Acceptance testing (UAT)
• Train the staff

Patients start using digital measurement products

Go Live

Acquire access to the needed technologies

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4

Source: Expert interviews, Playbook team analysis

5

PRO TIP

• May consider working with one of the industry logistics subcontractors (e.g., Integron, Stefanini, C3i Solutions) to manage these processes
• Third parties can help scale your edge devices/IoMT products, connectivity options, and network design if internal teams lack experience

The Playbook / Build the shared foundation / Operations

Manage products and monitor the target population

Jobs to be done

• Mange the IoMT products for their entire lifecycle (e.g., from validating, securing, connecting and tracking the products)
• Manage inventory, data plans and IoMT product pairing
• Provide tech support for patients and clinics/sites (e.g., Help Desk / “Geek Squad” to support with issues like bluetooth connectivity)
• Provide alerts, software updates, maintenance as needed
• Track vulnerabilities in devices (e.g., Common Vulnerabilities and Exposures (CVEs))
• Develop tools for operational and patient-level insights (e.g., administrative tools, dashboards, and operational and person-level analytics)

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5

Bandwidth issues are related to speed:

• You might not have access to high speed all day, which would impact services like software updates
• May vary between the patient’s home and the clinic/site
• Some software development kits (SDKs) have bandwidth requirements

PRO TIP

You need a plan for connectivity, data, bandwidth, updates, and firewall related issues

Source: Expert interviews, Playbook team analysis

6

Connectivity and data (e.g., WiFi, data, Bluetooth):

• How do you know the WiFi is set up in the home where you need it? (e.g., what if person is in backyard)
• How do you communicate with the product if you don’t have WiFi or it’s dead?
• If goes offline, how will you save the data? (e.g., store & cache data)
• When collecting lots of data, what happens if the IoMT runs out of local data storage?

Updates to software:

• When are they happening?
• Who is ensuring that updates happen? Are patients notified?
• If there’s a security incident what happens? (e.g., call center contact, if no remote update how will the patient ship the product back)

Firewall issues are related to who gets access to data and when:

• Whitelisting URLs
• Considering solving these issues at scale (e.g., proxy server)

The Playbook / Build the shared foundation / Operations

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