Harnessing the Value of Data & Digital for MedTech: Webinar

Randy Horton

Published on: January 8th, 2025

As we welcome 2025—more than three decades since the launch of the first web browser—many MedTech conversations still focus on how “data and digital” will shape the future. But what about delivering meaningful impact right now? How are forward-thinking medical device manufacturers using advanced digital capabilities to boost profitability, strengthen competitiveness, and improve patient outcomes today?

Orthogonal and a panel of industry experts joined for a candid discussion on the practical steps MedTech leaders could take to accelerate their data and digital transformations. Attendees discovered how successful organizations leveraged AI/ML, generative AI, cloud, mobile computing, and product analytics to meet (and exceed) their KPIs and OKRs. The panel also examined common pitfalls—well-intentioned strategies that missed the mark—and how to avoid similar setbacks.

Webinar Recording

Executive Summary

As the MedTech industry continues its digital transformation, leveraging data effectively has become strategically imperative. This webinar, hosted by Orthogonal, featured insights from two industry leaders on best practices for harnessing data to drive efficiency, innovation, and regulatory compliance.

Top 3 Takeaways for MedTech Leaders

Digital Transformation is a Competitive Advantage. MedTech firms must transition from hardware-first mindsets to software-driven strategies.
Data Monetization is Key. Treating data as a strategic asset enables new business models and operational efficiencies.
Regulatory Alignment Enhances Speed-to-Market. Early collaboration with regulators ensures compliance without slowing innovation.

The Digital Evolution in MedTech

The conversation opened with an acknowledgment that while, broadly speaking, MedTech manufacturers today recognize the importance of digital transformation, the progress towards actual adoption varies significantly between companies. Some domains of MedTech such as diabetes care have been at the forefront of integrating software into medical devices, while others, such as orthopedics, remain in earlier stages of digital integration.

A key point that was stressed in the discussion was the need for companies to move beyond traditional hardware-focused mindsets and embrace digital-first approaches. Software cannot be treated as an auxiliary component of a MedTech manufacturer’s strategy. Rather companies need to treat it as a core aspect of every business and product strategy.

Key Challenges and Considerations

1. Digital Infrastructure Gaps

As a broader industry, healthcare has lagged in the adoption of technology and digital-first mindsets. This then flows down (and generally not in a good way!) to MedTech manufacturers: MedTech companies must navigate outdated, siloed healthcare infrastructures.
A lack of across-the-board interoperability across all parts of healthcare including MedTech coupled with a pervasive usage of closed-source systems slows down innovation.
This is a problem that will require industry to advocate and actively partner with the government and others in the ecosystem to improve industry-wide digital standards.

2. Data as a Strategic Asset

Companies often undervalue their own data, treating it as a byproduct of their core work, rather than a key asset in and of itself.
Effective data structuring and analysis can drive new business models, such as MedTech-as-a-Service and real-world evidence generation.
Successful digital transformation often entails an ability to monetize data assets while navigating a range of compliance challenges.

3. Regulatory Considerations

The FDA is adapting to the rapid evolution of AI and software-based medical devices.
Companies must balance innovation with compliance, ensuring digital health products meet regulatory standards without sacrificing speed-to-market, safety or effectiveness.
Early engagement with regulatory bodies can streamline approvals and mitigate compliance risks.

Case Study: Nanowear’s Digital Transformation Journey

Venk Varadan, Nanowear’s CEO and Founder, shared his experience in building a data-driven healthcare platform. Nanowear pivoted from hardware-centric model to a data-driven platform, emphasizing full-stack software expertise to optimize data pipelines.

Key Lessons for MedTech Executives

The importance of full-stack software leadership within MedTech organizations.
Challenges in integrating AI-driven insights while maintaining regulatory compliance.
The potential benefits of structuring data for multiple stakeholders, including payers, providers, and the researchers supporting those organizations.

Innovative Business Models Enabled by Data

The panelists discussed how many of the emerging trends in MedTech business models are being enabled by data transformation, including:

Warranties and Outcome-Based Pricing: Leveraging device data to offer risk-adjusted warranties or reimbursement based on healthcare outcomes generated by usage of devices .
MedTech as a Service: Subscription-based business models such as software platforms that integrate with medical devices or pay-for-usage medical devices.
Provider Wrap-Around Services: MedTech moving beyond device manufacturing to also offer direct patient management services.

Strategies for Digital Transformation

As MedTech companies navigate the complex landscape of digital transformation, several key strategies are essential for success in harnessing the full potential of data and digital technologies:

1. Prioritize Data Structuring & Analytics

Implement systems to capture and analyze all device-generated data.
Identify key metrics that drive business and clinical decision-making.
Treat data as a long-term strategic asset, and not an operational byproduct.

2. Build In-House Digital Capabilities

Invest in full-stack software engineers who understand (to some extent) both firmware and cloud-based solutions.
Replace siloed software and hardware teams with cross-functional groups.
Consider training internal teams instead of fully outsourcing software development.

3. Engage Regulators Proactively

Work with the FDA early in development to align with evolving digital health regulations.
Foster collaboration between MedTech firms and regulatory agencies to drive industry-wide improvements in digital adoption.

Future Directions & Actionable Next Steps

The webinar concluded with something of a call to action for the industry:

Advance Industry-Wide Interoperability: Push for standardized, open-source digital platforms.
Leverage AI & Real-World Evidence: AI-driven insights enhance clinical decision-making.
Expand Digital-First Mindsets: Prioritize digital strategies from the earliest phases of development

The Bottom Line: By systematically integrating software, data, and digital capabilities, MedTech companies can accelerate innovation, enhance regulatory compliance, and improve patient outcomes. So let’s get to work!

Watch Webinar Recording

Speakers

Venk Varandan, CEO and Co-Founder, Nanowear

Venk Varadan is the co-founder and CEO of Nanowear, a New York-based healthcare technology company pioneering remote diagnostics through cloth-based nanosensors and AI algorithms. With a unique background spanning healthcare and finance, Venk previously worked in investment banking, advising on transactions worth over $3 billion. He also held roles in product marketing and sales at pharmaceutical companies Eli Lilly and Sanofi. Venk holds an MBA from Columbia University and a BS in Biochemistry from Duke University. Under his leadership, Nanowear has achieved FDA clearance for their innovative SimplECG technology, an undergarment that continuously captures and transmits vital health data.

Bernhard Kappe, CEO and Founder, Orthogonal

Bernhard Kappe is the Founder and CEO of Orthogonal. For over a decade, Bernhard has provided thought leadership and innovation in the fields of Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems. As a leader in the MedTech industry, Bernhard has a passion for launching successful medical device software that makes a difference for providers and patients, as well as helping companies deliver more from their innovation pipelines. He’s the author of the eBook Agile in an FDA Regulated Environment and a co-author of the AAMI Consensus Report on cloud computing for medical devices. Bernhard was the founder of the Chicago Product Management Association (ChiPMA) and the Chicago Lean Startup Challenge. He earned a Bachelor’s and Masters in Mathematics from the University of Pennsylvania, and a Bachelor’s of Science and Economics from the Wharton School of Business.

Moderator

Randy Horton, Chief Solutions Officer, Orthogonal

Randy Horton is Chief Solutions Officer at Orthogonal, a software consulting firm that improves patient outcomes faster by helping MedTech firms accelerate their development pipelines for Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems. Orthogonal makes that acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., Agile, Lean Startup, User-Centered Design and Systems Thinking) with the regulated focus on device safety and effectiveness that is at the heart of MedTech.

Horton serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS and the Human Factors and Ergonomics Society (HFES).