Introduction

We have seen the number of digital health-related Requests for Proposals (RFPs) and Requests for Information (RFIs) from biopharma and medtech companies increase by over 200% year over year.

Yet despite the high volume of requests, opinions vary on what exactly should go into a digital health RFP and how the process should be executed.

In addition to the inherent complexities of launching an RFP within a large biopharma and medtech company, digital health teams face escalating privacy and security concerns, ever-evolving regulations and global scalability challenges. Needless to say, the process of selecting a digital health partner shouldn’t be taken lightly.

Here at BrightInsight, we’ve received a number of inquiries from our biopharma and medtech customers, asking for help crafting the RFPs and requesting guidance with the overall RFP process. So, we’ve developed and are sharing this comprehensive guide to help you find success in your digital health RFP process.

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Think of this guide as an expertly designed “shopping list” to help you determine the main capabilities you need to explore and the criteria you should use to find your digital health partner. By selecting the right criteria and approach, you’ll set your digital initiatives on a path for long-term success.

A three-phase approach to identify the best partners

Completing a digital health RFP is no small feat. That’s why we recommend a multi-step strategy to narrow your potential partners and find the best fit.

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PHASE 1:

Initial evaluation

At the beginning of your RFP, many potential partners may have thrown their hat in the ring. During phase one, you’ll work to objectively evaluate who “checks the boxes” in terms of the most important core competencies and experience.

Focus on:

  • Completed project launches
  • Operational maturity
  • Necessary certifications
  • Service offerings
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PHASE 2:

Capabilities and expertise

This phase is a deep dive into the key areas where your potential partners need to demonstrate both a deep understanding of the digital health landscape and the expertise to execute on your roadmap.

Examine:

  • Team member experience
  • Company stability
  • Technical capabilities
  • Data analytics
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PHASE 3:

Pricing and references

Finally, phase three includes a final assessment of the potential partners’ reputations and a conversation around pricing. You'll need to ask the right questions and weigh differences in scope to make a true value comparison.

Consider:

  • Pricing details
  • Industry reputation

LET'S DIVE DEEPER INTO EACH PHASE

 

 

PHASE 1:

Initial evaluation and qualifications

Because the digital health space is still relatively young, there’s no guarantee that every company that responds to your RFP has the experience and expertise needed to successfully bring your digital health solutions to market. By asking the right questions in this phase, you’ll easily be able to weed out respondents without the real-world experience required to operate in this complex industry.

Key areas of focus:

Completed project launches

Potential partners should be able to speak about their experience with leading biopharma and/or medtech companies. This should include more than just proof of concept work; full-scale releases demonstrate competence in taking projects from concept to launch, and beyond.

Questions to ask:

  • 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

The ideal digital health partner has achieved success across multiple areas, including products, regions, therapeutic areas and numbers of patients on their platform. Newer startups lack the experience gained from live projects and may be using you to "learn on the job."

Questions to ask:

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

In the healthcare space, security, privacy and regulatory compliance and controls are paramount. According to IBM's latest "Cost of a data breach" report, the average cost of a data breach globally reached a high of $164 per record in 2022. Healthcare breaches are the most expensive of any industry—and the financial, legal and reputational risks are higher than ever. Mega breaches of 50 to 60 million records cost $387 million in 2022. Potential partners should be able to show proof of certification in the most stringent controls.

Questions to ask:

Please list the ISO standards and other relevant certifications for which your development model is certified, 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, 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?

Service offerings

In this preliminary phase, it’s important to ensure that each partner you’re considering has core competencies that align with your project roadmap, regardless of phase.

Questions to ask:

  • Can you provide strategy, concept evaluation and market research?
  • What do you provide in terms of go-to-market and end user adoption strategy?
  • Are you equipped to serve as our legal manufacturer of record (LMR)?
  • Tell me about what you offer for post-launch maintenance and support.
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PHASE 2:

Capabilities and expertise

Now that you’ve identified the potential partners that have the core capabilities and experience you need, you can spend phase two comparing the strengths and weaknesses of your remaining candidates. Every potential partner will have standout strengths and a few weaknesses. 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

It’s important that both the partner’s leadership and the project team assigned to you have deep experience in digital health and a robust understanding of the challenges specific to this highly regulated industry.

Questions to ask:

  • 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

The launch of a single digital health solution is just the beginning. Whether you’re simply concerned about maintenance and updates, or you’re planning on leveraging your partner platform to continue your digital transformation, it’s important to work with a company that’s in it for the long haul.

Questions to ask:

  • 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

Many platforms are antiquated, hold siloed data and don’t integrate with other products, let alone with offerings from disparate vendors. Ensure your partner’s platform can easily scale beyond individual products or regions and integrate with the broader healthcare ecosystem.

Questions to ask:

  • 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

Digital health exponentially increases the amount of data that biopharma and medtech companies generate, potentially growing to include data from tens of millions of patients daily. As the velocity, variety and volume of data increases, transforming data sets into actionable insights becomes critical to informing market strategies and driving product development.

Questions to ask:

  • 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?
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PHASE 3:

Pricing and references

In this phase, you should have narrowed down your list of potential partners to a few top candidates. This will allow you to fully explore pricing considerations while also doing your due diligence with a final reputation check.

Pricing details

Phase three is the right time to evaluate overall pricing competitiveness. This isn’t always a simple, apples-to-apples comparison, as different partners structure their products and their contracts differently. If two proposals include offerings that are substantially different in scope, you’ll need to price out the incremental work not covered by proposal A to cover the work detailed in proposal B. Likewise, if the two proposals require different amounts of internal support, scope the cost of the internal resourcing needed to do that work. These questions can help you do the right math.

Questions to ask:

  • 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?
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Industry reputation

It’s important to take the time to double check your finalists’ reputations in the industry. This can be done both by asking questions and doing your own research.

Questions to ask:

  • 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).

Ready to learn more about the RFP process and find out if BrightInsight is the right partner for you?

Visit BrightInsight.com
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