White Paper
Biopharma and medtech executives are faced with a number of complex considerations when developing digital health platforms to differentiate therapies and brands.
Building a platform that can support your most important and high-visibility digital initiatives is no small task, and the stakes are high—especially as the digital health space gets more competitive by the day.
Internal tensions among stakeholders can run high, as some think the best path is to handle the entire build and launch internally, while others believe that bringing in an outside partner is the most efficient way to get a solution to market.
But here’s the truth: It’s rarely a clear-cut buy vs. build choice. It’s more useful to think of it as build vs. build, with companies developing some digital capabilities in-house and partnering on others.
So, the real choice for biopharma and medtech companies is not buy vs. build, but rather determining how you want to build. Biopharma and medtech companies need to decide which teams or team members should spend their time and energy on a platform build, and then identify when and where an outside partner can add value.
For most companies, picking a platform partner that has industry expertise and a strong track record of bringing solutions to market makes the most sense. That partner can act as an extension of your team, freeing up your internal resources to focus on their core competencies.
This white paper raises the key considerations for both build approaches and offers helpful criteria for deciding when it makes sense to bring in a partner to augment your in-house capabilities.
Today’s biopharma and medtech companies face two options when setting out to build a digital health platform. Option A is to build a custom underlying platform and digital health solution in-house, leveraging internal talent and resources, in addition to third-party resources on an as-needed basis.
Alternatively, in Option B, you can choose to bring in a platform partner who leverages their expertise to configure their pre-built platform for your digital solutions, while allowing you to scale for future product launches, freeing your team to focus on differentiating your product offerings.
In this white paper, we’ll outline both options.
Whether you decide to take Option A or Option B depends on a few key considerations:
We’ll explore the answers to these questions for both Option A and Option B below, although after understanding the significant investment and resources needed to build and maintain a custom platform in-house, readers will come to understand Option B as the only viable option.
OPTION A:
There are many reasons why stakeholders may want to build their platform in-house. In this competitive space, senior leadership may have concerns about intellectual property as well as the reliability of external partners. Often, leaders have been burned in the past by vendors with poor communication, lack of effort or unexpected cost overruns.
It’s also important to note that building in-house does not eliminate the need for external partners—you’re still likely to use the services of task-specific vendors, like consultants, system integrators or cloud partners. But these vendors are not experts in the full depth and breadth of digital health solutions. Rather, they have niche expertise that can alleviate specific blind spots among team skills, so they’re not likely to add much value to the final product, or help it scale.
Have you ever heard the phrase, “the two best days of a boat owner’s life are the day they buy it, and the day they sell it”? The same adage can be applied to biopharma or medtech companies who build their own custom platform. After years of maintaining a platform that increasingly falls short of meeting the needs of internal stakeholders and trying to retain digital health engineers who are relentlessly recruited by tech startups, companies will wish they had partnered from the start.
If you decide to build internally, another consideration that helps illustrate the high cost and major workload associated with choosing Option A is system integrators.
Major consultancies—or system integrators—can be very helpful in building out strategies or thinking through new digital health business models, but at their core they are not experts in developing regulated software.
From a scalability perspective, a custom platform will limit a company’s ability to add additional products or brands onto the platform, integrate with third party medical devices or Health IT systems or expand into new regions. Having an open, managed service platform that isn’t custom built for one product or company eliminates these scalability issues.
Building a platform from the ground up can delay time to market for a biopharma or medtech company as there are no pre-built functionalities or systems to leverage. It can take years to build a new platform, which also can lead to product delays or allow competition to leapfrog you.
There are also significant costs involved any time a biopharma or medtech company wants to make any of these types of updates, in addition to high upfront costs for the custom build. Our biopharma and medtech customers have validated that the total cost of building a custom platform can be ~$10 to $20 million, and the resources required to maintain a custom platform cost ~$10 million annually per product.
Beyond simply selecting a system integrator, a company then needs to identify, onboard and maintain ~25 technology vendors and ~20 software tools to support the development, security, privacy and analytics capabilities. In both of these scenarios, it’s clear that building a custom platform is expensive, requires a lot of upfront work and ongoing maintenance, and often ends up not being able to scale to meet an organization’s evolving needs.
After further exploration, Option A becomes simply untenable for most biopharma and medtech companies. Fortunately, Option B is a solid alternative..
OPTION B:
Deciding to partner and purchase a digital health platform can feel uncomfortable at first, especially for biopharma and medtech companies that mostly develop proprietary products internally. But remember, organizations used to be uncomfortable about transitioning to the cloud, feeling it would be better to maintain their own data center. Now it's a competitive disadvantage to not be on the cloud.
By partnering with a digital expert and purchasing a compliant platform, biopharma and medtech companies will experience a number of advantages.
"We leverage off-the-shelf products from a cloud infrastructure perspective, so we can focus internally on developing differentiated data models and algorithms that drive business value. Our IT organization works directly with the businesses to think holistically about the insights we can generate from the data—outcomes can be one objective, but we also think about the new types of insights we can generate from real-world data in the future."
– Scott Sandschafer, former CIO, Novartis
"At Roche, most of our commercial products and clinical trials are multi-national, so our regulatory strategy needs to be contemplated across regions and across varying regulations. This will be the case for most leading biopharma companies. If you leverage a solution like BrightInsight that meets the most stringent requirements and maintains compliance as part of their managed service, you don’t have to worry about your regulated digital solutions in the U.S. versus Europe versus U.K. and so on. You just know they’re compliant."
– Paul Upham, Head of Smart Devices, Roche/Genentech
The BrightInsight Platform has pre-built capabilities to meet most core digital health needs out of the box and can be configured to support specific use cases. The Platform includes robust user onboarding and account management tools, including integration with external identity systems via single sign-on (SSO), as well as healthcare functionality, like medication management, electronic patient-reported outcomes (ePRO), physician alerts and more.
Our device instrumentation capabilities can manage medical devices, in vitro diagnostics and other connected medical instruments. Patient management tools—including care plans and surveys, medication and appointment management, patient education, secure messaging and more—are designed to empower providers and patients alike.
The Platform can be adapted to meet specific needs with full-featured configuration management and administration tools. And analytics dashboards provide actionable insights to optimize digital health solutions.
The BrightInsight Platform is built using a microservices-based architecture 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 global security, privacy and regulatory requirements. With this Platform in place, you’re well positioned for future digital health expansion: new products and features, scaling your user base and expanding into new markets.
BrightInsight replaces the need for lengthy and complex ‘build from scratch’ implementations. Instead, we offer a proven platform and configurable solutions, built to meet the most stringent global security, privacy and regulatory requirements.
Biopharma companies launch digital solutions in as little as six months with the BrightInsight Platform.
Top 20 biopharma companies trust BrightInsight to build and launch their commercial regulated digital health solutions.
We handle global regulatory compliance, so you don’t have to.
"After conducting a rigorous evaluation, we selected BrightInsight because it has the only regulated solution with a robust Quality Management System and comprehensive privacy and security certifications. BrightInsight’s Platform allows us to focus on therapeutic innovation, rather than the underlying digital technology."
- Brian Johnson, Director, Digital Health, CSL Behring
BrightInsight provides the leading global platform for biopharma and medtech regulated digital health solutions. We are the launch partner companies trust to accelerate time to market for regulated digital health products including apps, algorithms, medical devices, connected combination products, companion diagnostics and Software as a Medical Device.
We can also serve as the Legal Manufacturer of Record for your digital health products. When building your digital health solutions on the BrightInsight® Platform, you are future-proofing compliance while ensuring scalability across geographies.
Our vision is to transform patient outcomes globally by bringing the power of digital technology to healthcare, and we work every day to achieve this by accelerating regulated digital health innovation for our customers through our scalable medical-grade platform.
There are a number of variables biopharma and medtech companies need to consider when building a digital health platform. At the end of the day, it’s important to invest in a solution that can support your evolving needs quickly—such as adding new products or entering new markets—in a regulated environment that meets the requirements of regulatory bodies globally.
Additionally, purchasing an open, managed service platform will delight healthcare providers and patients. Investing in the BrightInsight Platform means that clinicians and patients won’t have to deal with another siloed solution, app or system that won’t integrate with their other devices and systems.
When building a digital health solution, partner with our best-in-class team and leverage our regulated BrightInsight Platform to maximize your speed to market, minimize your risk and future-proof your platform.