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This guide outlines a proven framework, spanning process, people, and platform, to help healthcare innovators scale AI with compliance, collaboration, and clinical impact in mind.
Artificial intelligence (AI) stands at the vanguard of healthcare’s transformation, holding vast promise for enhancing patient care, driving novel discoveries, and improving the efficiency of clinical operations.
However, this promise is checked by real-world challenges: many organizations fail to move AI from pilot phases to fully deployed, value-generating solutions. A recent Deloitte study reveals that while 70% of MedTech startups possess advanced digital capabilities, over 47% of AI projects stall before production deployment, resulting in missed opportunities and delayed health advancements.
Numerous obstacles underline this gap, including healthcare’s strict regulatory environment, complex data governance demands, and the critical requirement for explainable AI complicate implementation.
Unlike consumer-facing industries, the stakes in healthcare are higher—errors can be life-threatening rather than merely inconvenient. AI deployment is further complicated by fragmented data (from electronic health records, imaging, genomics, etc.), legacy IT infrastructure unequipped for AI workloads, and the shortage of multidisciplinary expertise required to manage the entire lifecycle.
In order to navigate these challenges, the authors introduce a holistic “Three Pillars” framework, validated by its successful use at leading medical device companies: process, people, and platform.
This cross-industry standard process for data mining (CRISP-DM) adaptation ensures that AI projects in life sciences follow a structured, regulatory-compliant, and clinically meaningful path.
Business understanding: Projects begin by clearly specifying the clinical problem, desired patient/end-user outcomes, and precise metrics for success. Alignment among clinical, regulatory, technical, and legal stakeholders is crucial at project initiation to anticipate potential pitfalls and establish shared objectives.
Data understanding: Healthcare data is vast yet heterogeneous, ranging from structured EHRs to complex imaging modalities and genomics data. Teams must account for data gaps, biases within historical records, and compliance with privacy regulations (such as HIPAA). Early comprehensive assessments help identify weaknesses that could later derail efforts.
Data preparation: This phase consumes the majority of project time (estimated at 50–70%), requiring robust data cleaning, standardization, integration, and de-identification, as well as the creation of audit trails essential for regulatory submissions. Attention to data lineage and traceability ensures downstream accountability and compliance.
Modeling: Model construction focuses not only on high performance but also on interpretability and robustness. Clinicians must be able to trust and understand the recommendations generated by AI, necessitating transparent algorithm choices and validation frameworks that are sensitive to the volatility of medical practices and the evolving patient populations.
Evaluation: Healthcare AI must surpass accuracy metrics to establish clinical validity, safety, and suitability for diverse populations. The evaluation process is regulatory-driven, often involving documentation for FDA (or other jurisdictional) approval and coordinated engagement with compliance experts.
Deployment: Unlike other domains, AI must be integrated in a way that fits seamlessly into clinical workflows to avoid operational disruptions. Deployment involves user training, vigilant performance and safety monitoring, and rapid-response capabilities for addressing model drift or failure.
The bridge from concept to production is built by orchestrating diverse competencies. The guide specifies “core” and “extended” team roles:
Multidisciplinary collaboration is not optional—it is a prerequisite for overcoming organizational, legal, and operational hurdles.
Modern AI in healthcare mandates robust, secure infrastructure and cloud-based environments to meet these needs:
The real-world case studies below display how applying this framework can overcome common technical and organizational challenges, while also accelerating innovation and improving outcomes across the healthcare and life sciences sector:
1. Interventional cardiology AI system (Boston Scientific):An AI system using intravascular ultrasound (IVUS) images was developed to optimize stent placement. The clinical payoff was substantial: procedures guided by IVUS had significantly lower target vessel failure rates (4.2%) compared to traditional methods (10.7%).
Challenges include terabyte-scale video data, complex international data sharing, slow data transfer, insufficient computing resources, and isolated teams.
Solution: Cloud-based storage and computing (GPU-enabled instances) unlocked cost-effective resources and rapid data movement (from 100 KB/s to 100 GB/s), while IAM controls, encryption, and SSO protected patient data.
Outcome: Rapid project setup, reduced costs, frictionless collaboration, and swift deployment.
2. Supply chain demand forecasting: A separate project on demand forecasting for surgical clips encountered organizational roadblocks: protracted (eight months) data access, siloed teams, and unclear roles.
Solution: The people-focused framework enabled the mapping out of roles, recruiting for missing skills, process standardization, and improved documentation, all of which were instituted within two weeks.
Key insight: Organizational structure and upfront process investment are essential; technical solutions alone are insufficient.
Key insight: Nearly half of healthcare AI projects stall before deployment due to fragmented data, unclear governance, and lack of multidisciplinary coordination.
Framework: The “Three Pillars” model—process, people, platform—offers a structured path from concept to compliant clinical implementation.
In order to fully realize the potential of AI in healthcare, we believe that organizations must move beyond pilot projects by adopting enterprise-level strategies that balance innovation with governance.
The following strategic recommendations offer a blueprint for health systems, life sciences companies, and digital health innovators to construct sustainable and scalable AI services.
1. Invest early in data infrastructure: Effective AI starts with robust data foundations, modern catalogs, governance, and scalable cloud environments. Organizations should allocate 30–40% of their AI budgets to infrastructure and governance, in addition to modeling.
2. Build internal AI capabilities: Relying solely on vendors/partners is detrimental. Sustainable growth requires internal talent (clinical, technical, and regulatory) supported by ongoing training and clearly articulated career pathways.
3. Cross-functional collaboration: AI crosses departmental boundaries. Formalize interdisciplinary models, set up transparent communication, and share project metrics. Regular reviews strengthen alignment and minimize resource waste.
4. Regulatory integration from day one: Don’t make compliance a late-stage activity. Early and ongoing regulatory engagement (for programs like the FDA Pre-Cert) smooths the path to approval and reduces late-project risks.
5. Comprehensive change management:AI impacts personnel and workflows. Successful deployment requires thoughtfully designed change management, including training, gradual rollout, feedback loops, and active user engagement, to avert resistance and task disruptions.
AI’s full promise in healthcare will be realized only by combining robust data/process infrastructure, skilled multidisciplinary teams, secure and agile platforms, and a culture of continuous learning and compliance. AI must not be treated as a mere technical add-on but as a holistic, organizational transformation. Organizations that align their strategy, people, processes, and technology will not only drive measurable improvements in patient care and operational efficiency but also establish lasting digital leadership.
Note: the views expressed in the article are those of the authors and not of the organizations they represent.
About the Authors
Partha Anbil is a senior advisor to NextGen Invent Corporation, an AI, data analytics, and digital transformation company. He has more than 25 years of experience in the life sciences industry.
Deepak Mittal, MBA, MS, chairs the Healthcare and Life Sciences Think Tank Panel of the CBS Alum Club and is a contributing author to industry thought leadership.
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