White Paper
There’s no question that in vitro diagnostics (IVD) offer tremendous value as both a healthcare service, and as a business. In 2022, the global IVD market was valued at $71.43 billion. That number is projected to grow by nearly 50% by 2029, when it’s expected to hit $107.42 billion.1 This is no surprise, as diagnostic testing results impact up to 70% of healthcare decisions.2
Yet the true value of diagnostic testing is not being realized. A great deal of value is left unlocked, as many IVD manufacturers sit on troves of data siloed across multiple devices and disconnected from other stakeholders.
Many patients who would benefit from diagnostics are never tested. Outdated maintenance methods drain value for device manufacturers, and there’s little visibility into how devices are used in the field or data to optimize performance.
Diagnostic labs are facing tremendous pressure to be cost effective, while also expanding their portfolio of services with increasingly complex offerings to stay competitive. This places high demands on IVD manufacturers to be both margin conscious and innovative.
Meanwhile, the entire medtech sector is facing new pressures on the bottom line. As reimbursement pressures are rising, payers and health systems are demanding real-world evidence to justify the cost. Medtech as a whole is not leveraging digital as effectively as it could, and is missing opportunities to add value to their products and solutions.
Further, new digital disruptors are using technology advances to gain market share. As medtech companies scramble to accommodate new regulations on patient data, there are increased security risks to juggle, and many companies are ill equipped to do so without support.
Medtech is clearly moving to digital. A Deloitte survey of 22 medtech companies found that all of them were investing in device connectivity, and 77% considered integrating data from new technologies to be an important challenge.3 But will these investments produce the untapped value in diagnostics?
What the industry desperately needs to achieve that vision is a solid digital foundation: connected diagnostic devices on a top-of-the-line platform that can support new digital products and services.
"I understand the value of digital health solutions [for diagnostics]. The faster you can respond to an issue and implement change and get feedback on if the change is working—that is powerful and is worth its weight in gold."
– Strategic Digital Portfolio Executive at a leading medtech company
1 Fortune Business Insights. Medical Device; In vitro Diagnostics (IVD) Market. Market Research Report. June 2022.
2 Rohr UP, Binder C, Dieterle T, et al. The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report. PLoS One. March 2016.
3 Hakim L, Shah S. The next wave of innovation: Technology and value-based care are transforming medtech R&D. Deloitte Insights. Nov. 30, 2018.
The key challenges in the IVD space impact everyone from the labs that run diagnostic testing to the doctors who use the results to create treatment plans and the patients who need lab results.
The most important challenges for IVD companies can be broken down into four categories:
Devices are expensive relative to other types of interventions, and they are never uniquely uniform for everyone... There is so much opportunity."
– COO at a remote patient monitoring company, former Senior Marketing Director at a top 10 medical device company
Digital solutions are critical for value capture for in vitro diagnostics. There is a need to access and aggregate data that comes from different silos in the healthcare IT ecosystem. Capturing actionable data from a diagnostic test requires pulling data from both the laboratory information system (LIS) and the testing instrument itself.
Linking that test result data to clinical impact or patient outcomes requires accessing patient data that typically resides in the EHR. Identifying solutions that can aggregate this myriad data in a meaningful, accurate, secure and actionable way is a challenge not just for our industry, but for our customers and healthcare providers alike. That’s why data and digital solutions are critical for a true realization of diagnostic test value."
– Meghan Thelen, Senior Director, Value-Based Healthcare, bioMérieux
Many companies tackle device management with a reactive mindset. They wait until a problem arises, and address it only when it is throwing a wrench in day-to-day operations. An end-to-end digital IVD solution empowers companies to assume a proactive mindset, anticipating issues before they arise and taking preventive measures to head off problems before they get out of control.
Digital health offerings can address challenges for diagnostic companies. In a connected digital ecosystem, we'd see seamless integration and transition of IVD data across devices in a lab, and clinical decision support applications would be built on top of it to extract crucial insights and help elevate the role of labs in the healthcare ecosystem.
"There is a huge opportunity for digital solution innovation in the field of infectious disease diagnostics. Of course there are clear opportunities for digital in terms of instrument connectivity. There’s considerable potential in leveraging cloud technology to capture instrument level data and aggregate that data at a massive, even global scale. There is a continued opportunity for investment in automation capabilities in diagnostic medicine. And, there remains considerable opportunity and need for clinical decision support tools to facilitate better clinical decision-making and more consistent patient management."
– Meghan Thelen, Senior Director, Value-Based Healthcare at bioMérieux
Intelligent lab workflow
Labs will benefit from an intuitive digital workflow that drives faster results.
Device lifecycle and maintenance tools
Diagnostics companies can cut costs significantly on field service and downtime for devices with remote capabilities, like over-the-air updates. And device management tools can help optimize device use and management.
Clinician and patient solutions
Clinical decision support tools that provide results and important information for interpretation and ongoing testing management can help drive clinical impact.
Device and consumer data insights
Actionable insights from device data can change lagging indicators into proactive assessments that drive sales and upsells, and identify new revenue streams.
Clinical real-world data engine
Real-world data can be leveraged to expand claims and market access, enable value-based contracting or strengthen clinical marketing.
An IVD platform should include:
BrightInsight's connected diagnostic platform can help IVD companies accelerate digital initiatives. This platform was built on our industry-leading compliant digital health platform. It's a one-stop shop for IVD manufacturers, enabling them to streamline workflows, accelerate revenue growth and drive innovation.
WORKFLOW PORTALS
Maximize workflow and visibility, manage devices and reduce costs with portals for labs and manufacturers. Host algorithms to improve clinical decision support.
ANALYTICS DASHBOARDS
Grow revenue with unique real-world data captured by our platform that powers actionable insights about users, devices, workflows and clinical decision-making.
A PROXY AGENT
Facilitate the communication pathway between the device and the cloud with a proxy agent installed on your devices.
INTEGRATION MIDDLEWARE
Improve your data exchange with standard interoperability (HL7 and FHIR) with best-in-class privacy and cybersecurity.
Optional modules include:
CLINICAL DECISION SUPPORT TOOLS
Improve clinical workflows, contextualize diagnostic results and enable a better understanding of the whole patient to support clinicians in making informed decisions.
MOBILE APP
Provide timely test results combined with important contextual information for interpretations to both patients and clinicians. Clinical decision support tools enabled on the app can also drive the impact of testing.
"This is a place to come for a snapshot of what is happening in the lab… a go-to of which analyzers are running and where there are problems. It's your new best friend."
– Hospital lab technician, US
"Who wouldn't love this solution? It's all about control—everyone wants to control their destiny."
– VP and General Manager at a top medtech company
A leading diagnostics company needed an end-to-end solution to connect distributed testing equipment in 90+ countries with operators, EHR and lab information system (LIS).
BrightInsight provided a connected diagnostics platform that:
[We chose BrightInsight because] they are clearly willing to partner with us to make sure that we're successful. Working with someone that truly valued our relationship more as a partnership was important."
– Senior director for a top IVD company
BrightInsight is the platform diagnostic companies trust to optimize workflows with transformational device management tools. Our compliant technology and proven team accelerate time to market and reduce set up and maintenance costs. Our best-in-class cybersecurity and privacy teams reduce risk and facilitate global compliance and scalability.
We have found in BrightInsight a partner who shares our commitment to advancing public health with innovative, customer-centric solutions. Our engagement with BrightInsight will enable us to bring our digital health solutions to market faster with the goal of improving patient outcomes."
– Brian Armstrong, Senior Vice President, Clinical Operations – North America, bioMérieux
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