A key part of a formal Strategic Business Plan for an investor-driven, Class II medical device startup is the Opportunities and Threats section. Traditionally, I like to identify not only the Opportunities, but the initiatives that we'll take in order to maximize our targeted opportunities. The converse is true; for every Threat or Risk, I like to identify Contingencies that can be at our fingertips to mitigate the risk at hand. Here's a quick overview on how both Generative

As a 37 year veteran of the medical device and life science market, I've been through some upheavals over the years. My first experience as a medical products manager goes back to the failed attempt to revamp the U.S. healthcare system in the early to mid-1990s. It unleashed a lot of price pressures on our industry that have never really receded. We're about to experience downward pressures once again. Going forward, small to mid-sized medtech companies should assume a st

Agentic AI is transforming the design and development of Class II medical devices by acting as a co-engineer that orchestrates complex tasks with minimal human intervention, accelerating product timelines while maintaining rigorous regulatory compliance. Its autonomy enables faster concept development, structured design controls, improved documentation, and real-time regulatory readiness.[1][2][3] Integrated Design Acceleration By automating and sequencing multi-step workflow

The intersection of strategic business planning, regulatory compliance, and artificial intelligence (AI) will in great part define the next decade of medical device innovation in the United States. As advances in machine learning, predictive analytics, and connected health technologies accelerate, medical device firms face a dual imperative: To harness AI-driven efficiency while maintaining rigorous adherence to the regulatory expectations of the Food and Drug Administration

Industrial, trucking and financial markets are already showing signs of stress or outright recession. The pending shock to the nation's healthcare delivery system will only add to the woes. A quick Google search reveals economic storm clouds are gathering, "Recent tariffs are a contributing factor to the current difficulties in the industrial and trucking sectors, intensifying an existing freight recession and contributing to job losses and reduced demand. While other factor

In today’s fast moving medtech landscape, traditional business planning and regulatory compliance are no longer enough to secure profitable growth. The game-changer is the intelligent integration of these disciplines with artificial intelligence (AI), a shift that promises to compress development timelines, reduce costs, and sharpen portfolio focus. Strategic business planning has always set the course—identifying market needs, competitive positioning, and reimbursement pathw

A lifetime ago, when I was serving as a Naval Intelligence Specialist in the U.S. Navy, I was taught how to (manually, mind you) take an enormous amount of data, distill it down to what was cogent to the mission at hand, provide context, and communicate it on an executive level.  IPOS/Mission Planning in the Intel Center aboard the U.S.S. Ranger, CV-61 (I told you it was a lifetime ago!) received three separate deliveries of approximately twelve hundred paper pages of data fr

A Performance Transformation White Paper and Five Year Forecast Introduction & Market Trends Over the course of 2025, I had the privilege of attending MD&M West and BIO in Boston.  While in attendance, I took the opportunity to do some direct market research with business owners, senior executives and business development professionals.  I was able to speak with more than 120 industry professionals from outsourcing firms in the medical device and life science/therapeutic deve

How Small to Mid-Size Biotechnology and Drug Development Companies Can Benefit from Agentic AI. A TPP defines the intended attributes of...

Strategies for Life Science & Medical Device & Development Companies Over the course of 2025 I had the opportunity to meet with dozens of...

Well, as the humidity of summer begrudgingly gives way to the crisp, kaleidoscope of fall, we once again find our way into the Strategic...

I was conducting market research this morning in support of Performance Transformation’s 2026 Strategic Business Plan.  Specifically, I...

I had the privilege of attending the recent MD&M West conference and had the opportunity to speak with more than 60 attendees.  It was...

When I published my book, The Transformational Entrepreneur , back in 2011, one of the fundamental premises I put forth was that...

Well, ready or not, it’s here.  The AI revolution is upon us, and we can either act accordingly and adapt, or turn our course towards the...

Recently surveyed executives anticipate a 20% to 30% improvement in their company’s productivity with the application of Artificial...

I was going through my archives the other day and came across an interview I did with the Investor’s Business Daily from April 13, 2012. ...

Not too long ago, I was a part of a leadership team that successfully sold our company to a multinational corporation.  Our company was...

Back in the early part of this century, I began toying with alternatives to the traditional, hierarchical, organizational structure. ...

I was watching one of the Saturday morning pregame shows, College GameDay, this past weekend when the subject turned to culture. This...