Interoperability refers to the ability of different systems, platforms, and data formats to work together seamlessly. Today, as innovation is more data-driven than ever, companies can no longer ignore the need for standardized data formats and data-sharing protocols.
This challenge is particularly acute for biotechnology software and medical technology device companies now working to create solutions that are capable of efficient data capture and sharing across various platforms. In today’s biotech and medtech sectors, interoperability is a necessity to ensure innovation, safety, compliance and efficiency — and it must be done right.
I’ve worked with companies in the biotech and medtech sectors for years. Despite advances to address interoperability shortfalls, real-world challenges remain a pressing concern. A strategic marketing partner can work with your product team to help tackle this issue head-on and ensure prospective customers are aware that your company’s products are interoperable.
Understanding Interoperability in Biotech and Medtech
Interoperability is more than just a technical issue; it’s a requirement for advancing biotech and medtech. The absence of interoperability means that software and device companies will struggle to ensure their products can communicate effectively with other systems across their industries. This lack of standardization will not only complicate the company’s own product development initiatives, but it will also keep researchers and scientists across the globe from working to their full potential.
At the heart of interoperability is data. In biotech and medtech, some of these data are genomes, gene expression, proteins, metabolites, images, and structural information about how the pieces fit together. These data are essential for both discovery and diagnosis as well as for streamlining biomanufacturing.
Consider this from an April 2, 2024, Center for New American Security (CNAS) blog written by Michelle Holko titled Biotech Matters: Great Data Competition and Interoperability with Allies and Partners: “The massive amounts of bio-data that can be collected must be saved, organized, and analyzed to unleash the bioeconomy. A challenge is that data are often spread across different databases and organizations, each with its own way of organizing the data, with few industry-wide standards.”
Lack of interoperability also can hamper buyer perception of a company’s biotech or medtech products. If a company’s products cannot easily share data with other systems, it can make those products seem less useful or attractive to buyers, which directly impacts the company’s brand and market growth potential.
Current Approaches to Addressing Interoperability Issues
Technology has enabled the massive collection of data at scale. This, in turn, allows more rapid scientific research and breakthroughs. A solid interoperability foundation must focus on efficient data integration, a requirement to help create meaningful insights from complex biological datasets. Companies that struggle to integrate their systems may find themselves at a competitive disadvantage, losing out on opportunities to lead in their field with potential buyers.
To tackle the challenges of interoperability, the biotech and medtech industries have made efforts to establish standards and protocols. Organizations are working toward the creation and universal adoption of common data formats that can be universally adopted. This can ease burdens on software and device developers as well as their users.
However, there are some challenges biotech and medtech companies are facing in pursuing interoperability.
“Large tech companies are organizing data for text, image, and audio; the task is more challenging for complex bio-data,” according to Michelle Holko in the CNAS blog from last April. “A lack of coordinated effort to build interoperability tools for bio-data makes it exceedingly hard for researchers to assemble and analyze data, and it costs a significant amount of human time and money to curate data from different sources.”
Moreover, access to biotech and medtech data is not uniform in the United States. “Not all data fit neatly into structured databases, and without permanent infrastructure to handle the complexity, data are siloed or deleted,” Holko writes in the CNAS blog. “There are also issues with who has access to data. In the United States, much of the useful bio-data exist in the private sector and are often withheld for intellectual property, privacy, or other reasons. As a result, there are many fewer examples of cross-sector data sharing in the United States. Finding ways to unlock and scale private company data, while preserving America’s commitment to privacy and civil liberties, is critical for U.S. global leadership in the 21st-century bioeconomy.”
Fortunately, the U.S. federal government is supporting a more uniform approach to biotech and medtech data in the near future. A September 12, 2022, Executive Order from President Joe Biden Administration’s White House states: It is the policy of my Administration to coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.
For biotechnology and biomanufacturing to help us achieve our societal goals, the United States needs to invest in foundational scientific capabilities,” and specifically cites “(unlocking) the power of biological data, including through computing tools and artificial intelligence; and (advancing) the science of scale‑up production while reducing the obstacles for commercialization so that innovative technologies and products can reach markets faster.”
The Order specifically cites the establishment of a Data for the Bioeconomy Initiative that will ensure that high-quality, wide-ranging, easily accessible, and secure biological data sets can drive breakthroughs for the United States bioeconomy.
The National Institutes of Health (NIH), the largest funder of biomedical research in the world and a global leader in open data to support scientific discovery, and its National Center for Biotechnology Information (NCBI) house several publicly funded bio-databases that are regularly funded.
NIH is helping to encourage more sharing of bio-data. According to Holko’s CNAS blog: “One way NIH encourages the research community to move to open access has been to partner with scientific journal publishers to make data sharing a requirement for highly prized publications. Building on its open science leadership, NIH expanded its data-sharing policy, and the White House Office of Science and Technology Policy recently released government-wide data-sharing guidance.”
Interoperability challenges for biotech and medtech companies can be resolved if “the United States actively support(s) interoperability and sustainability of data assets,” Holko writes. “First, it should immediately plan for sustainable infrastructure for bio-data. This must include policy actions to support U.S. government agencies that fund research to maintain and manage data assets holistically and persistently. Second, it must urgently fund and foster the development of open-source tools to improve interoperability—the ability to connect data in different locations and analyze across databases.”
How a Fractional CMO Can Partner with the Product Team to Address The Interoperability Challenge
While serving in executive marketing roles spanning biotech and medtech companies, I’ve successfully helped organizations create and share strategic messaging about their unique approaches to closing interoperability gaps. A fractional CMO, especially one with deep biotech and medtech experience, can help develop and promote interoperability-centric content that resonates with both technical and scientific audiences. This can help position the company and its executives as thought and market leaders, supporting overall goals to attract buyers and drive revenue growth.
As a fractional CMO, I’ve engaged with many chief product officers and product teams, working with those who have hands-on experience using the latest tools and technologies to overcome many of today’s most commonplace interoperability issues in biotech and medtech. I’ve personally seen how product teams can use AI and machine learning to enhance interoperability, for example, by offering new ways to integrate and analyze data across different systems.
As these technologies continue to evolve, the potential for improved data management and collaboration is immense. Biotech and medtech companies that stay ahead of these trends and that effectively communicate a leadership role in doing so will be well-positioned to lead the industry into the next decade.
Once an interoperability strategy has been created, executed, and tightly linked to your company’s products, it’s important for a fractional CMO to incorporate three strategies to market your company’s interoperability capabilities effectively:
- Promote your company’s leadership position in interoperability: Ideally, if you and your product team have beat your competitors in crafting an interoperability strategy, you should strongly promote that as a unique feature of your company’s products
- Encourage your CEO to reach out to other companies in your industry to promote interoperability: While it may initially sound counterintuitive, having your company seen as the facilitator of interoperability adds to your brand’s prestige and perception of innovation
- Engage with cross-industry interoperability initiatives: Get involved with any initiatives across your industry involved in setting interoperability standards, which helps your company be seen as contributing to broader industry goals instead of just your own company’s goals
Let’s Get Connected
Solving the interoperability challenge isn’t something that’s easily done alone. Let’s talk about how you and your team can resolve the issue and get on a growth path that puts your scientific innovations at the forefront.
Learn more about the value of working with a fractional CMO in biotech, medtech, and healthtech like myself.
I’d like to help your team members reach their full potential, so you can focus on the future of biotech and medtech—not the limitations of the technologies holding you back.
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