RFP configuration tool: Find the right digital health partner • BrightInsight

Phase 1: Initial evaluation

Goal: to ensure potential partners have the core competencies to bring your digital health solutions to market.

Focus on these questions to eliminate respondents without the real-world experience required to operate in this complex industry.

Completed product launches

Do you have top pharma/medtech customers on your roster?
Please provide one to three examples of regulated digital health solutions and/or SaMD solutions (specifically with Class II and/or III) that you’ve helped bring to market. Please include your specific role in the project.
Have you successfully launched patient-facing apps or digital companion solutions for on-market drugs?
What has been your experience regarding the time to market for Class I, II, and III SaMD solutions?

Operational maturity

Do you have experience developing digital solutions in our therapeutic area, or similar?
Have you launched regulated digital health solutions across multiple geographies?
Can you describe your operational and delivery model, from ideation to post-launch?

Necessary certifications

Please list the ISO standards and other relevant certifications for which your development model is certified and how long you’ve had them, such as:
- ISO 13485:2016 Certified Quality Management System
- Master File and Design History File accepted by US FDA • IEC 82304/IEC 62304
- MDSAP
Please share your global security and privacy certifications and how long you’ve had them, such as:
- HITRUST CSF v9.3
- ISO/IEC 27001:2013
- Hébergeur de Données de Santé (HDS)
How do you ensure continued compliance when global privacy and security standards are always evolving?
How often are you audited from a security and privacy standpoint?
Please describe your company’s procedures on governing IT risk management and safety risk management.
Is your platform built to securely capture and host patient identifiable information (PII)?
Which countries is your platform compliant or cleared in?
How do you support and maintain the regulatory filings for its digital platform?

Phase 2: Capabilities and expertise

Goal: to compare strengths and weaknesses of remaining candidates.

Consider assigning numeric weights to these questions based on your programmatic needs and score them to help you compare and contrast your potential partners.

Team member experience

Tell me about your leadership team and their specific experience in regulated healthcare.
How much experience do your team members have in building and launching regulated digital health solutions and SaMD?
Describe the day-to-day team that will be assigned to my project.

Company stability

Tell me about your funding and investors.
How long is your cash runway?
What pharma customers do you currently have?
What is the experience and background of your leadership team?
How many FTEs do you have? How many will be on our delivery team?
What’s the breakdown by percentage of employees focused on product, engineering, delivery, regulatory, security and privacy?

Technical capabilities

Please provide an overview, approach and advantages of your system’s capabilities.
What makes your QMS process superior to your competitors’?
Can you tell me about your approach to product and software development lifecycles, including roles and responsibilities?
How do you ensure scalability in terms of number of users, number of apps and amount of content without impacting performance?
Tell us about your approach to integration, specifically with electronic health record (EHR) systems.
What has been your experience regarding the lead time to file and obtain approval for Class II or Class III (equivalent in international markets) SaMDs?
What are the technological advantages of your solution and how will they impact program KPIs, such as patient engagement?
Can your platform integrate third-party data sources?

Data analytics

Do you provide out-of-the-box customizable dashboards that drive real-time insights?
Are pre-integrated analytics and/or machine learning (ML) tools available to our data scientists?
Does your platform support mobile app analytics?
How will you measure and evaluate the success of the program?

Phase 3: Pricing and references

Goal: to explore pricing considerations and do a final reputation check.

This comparison is not always apples to apples—if one proposal has a larger scope, be sure to examine the cost of the internal resourcing needed to complete the work not included in the competing proposal.

Pricing details

In what ways do you provide flexibility for your pricing model?
Do you offer a phased or milestone-based pricing structure?
Do you have an enterprise license agreement?
How does your model help us achieve economies of scale?

Industry reputation

Can you please provide 2-3 references?
What is your Net Promoter Score (NPS) score?
Describe your thought leadership position and initiatives in the digital health industry.
How have you been involved in defining current and future industry standards for this area, e.g., involvement in working groups and communities or with authorities?
Describe your high-level organizational structure specific to development and deployment of a digital health platform and how the employees are distributed across the different units and geographies (e.g., development, support, operation and sales).