Applying Strategic Planning to the Adoption and Integration of AI in Medical Device Design, Development & Manufacturing

I was conducting market research this morning in support of Performance Transformation’s 2026 Strategic Business Plan.  Specifically, I was conducting a deep dive into how to mitigate the risk associated with the adoption and integration of AI technology in medical device design, development and manufacturing.  Over the course of 2025 while conducting conversations with companies exhibiting at both MD&M West in Anaheim and the Boston meeting of BIO, the ambiguity around how best to move forward was palatable.  Let’s try to shed some light on this mission critical issue…

At these conferences, to a company, everyone acknowledged the need to move into the AI space, but most were at a loss as to where to begin.  They also expressed the awareness they needed to do so sooner rather than later…but without a jumping off point, they were faced with substantial ambiguity.

They’re right to feel this way.  While the research varies widely (AI doesn’t have a lot of historical data to base projections upon), even the most conservative projects illustrate multi-billion growth running anywhere between the high 20% CAGR to well into the 40% CAGR rage.  Truly unprecedented.

I’ve had the privilege of being engaged in projects spanning early Big Data initiatives (Bell Labs & UPMC, 2009), Machine Learning engagements (e.g., Talent Sprocket, 2012), home care for Alzheimer's patients (CareGenesis, 2015), as well as Remote Patient Monitoring projects/IoT over the past several years, to custom Agentic AI product development for medical device since the beginning of 2025.  It’s provided some perspective.

When it comes to medical device design, development & manufacturing, AI technologies can be applied to several areas:

• Large Language Models ~ These are what most people think of when it comes to AI.  An accelerating resource for initial market research, marketing and communications.

• Agentic AI ~ Lesser know, but coming on fast are agentic models that can optimize, accelerate and support iterative processes, such as design iterations (digital twins), dynamic QA, line transfers (in manufacturing), dynamic regulatory compliance, virtual bench testing, continuous competitive/market/regulatory assessments, and other controlled processes that support the development and manufacturing processes.

  
  

• Agentic AI in IoT ~ This is the embedding of AI products within medical device IoT systems.  

In addition, barriers to adoption and integration include:

• Regulatory and Compliance Challenges ~ Most of these challenges are well within the reach of most developers.  However, more implantable technologies embracing AI means more Class III technologies moving through the process.  Also, the regulating bodies are coming up to speed with how to apply regulations to these products.

• Data Privacy, Security and Interoperability ~ Again, most developers are up to speed with HIPAA and cybersecurity, but interoperability will continue to be a challenge for several years.

• Clinical Validation & Trust ~ Will a lack of significantly equivalent predicates significantly lengthen approval/clearance times?  This also touches on third party payer strategies and seeking ways to add value to their data sets. This can also be the jumping off point for value-based care models.

• Infrastructure & Integration Constraints ~ While within reach, planning will be required to initiate momentum and sustainability.

• Organizational and Cultural Resistance ~ This is perhaps one of the greatest barriers.  The best way to gain buy-in in is through engaging the rank and file and key, internal influencers to help build out the adoption strategy. Once they see AI as a tool and not a threat, these barriers will lower.

• Ethical and Legal Uncertainties ~ It will be critical for senior management to be at the helm of any adoption strategy.  Maintaining a “human-in-the-loop” design paradigm will also help hedge risk and align with regulating bodies.

At first blush, it can be overwhelming.  This is where incorporating formal, Strategic Planning can help.  If you’d like to discuss what this process may look like for your organization, please feel free to reach out!  We’d be delighted to have a complementary conversation!

All The Best,

Terry Murray

© 2025, Performance Transformation, Inc.