Market opportunities are endless – product lines, channels, business models, geographies, and each combination has its promise. Limited funds are quickly depleted unless razor sharp focus is implemented. Maybe you go after the low hanging fruit, maybe you go after the highest impact.

Formal decision methods are in the tool kit, but what I have found to be more important is to do the analysis, have the debate, and then commit. Singular focus, uncompromising commitment, relentless optimization are the keys to success.

Of course you start with the customer, but who do you ask? The thought leader? The average customer? Do customers know what they really need? If they do not, why would you?

Ruthless feature prioritization, focus on user interface and usability, and iterative agile customer validation of wireframes and prototypes will take us to great products, often quite different than the original concept.

There are many groups that specialize in regulatory submissions and know how to work with regulatory agencies. A bigger challenge is to streamline development processes to minimize cost and end-to-end timelines, from prototype to regulatory approval. Automated document generation, parallelization of work, and careful review of regulations are some of the tools to use.

My basic philosophy is that industry and regulatory agencies have the same goal in mind – safe and effective products. This helped me, for example, to get the first software-only, class III, machine learning product through FDA in record time.

When do you need that uniquely qualified specialist, and when do you prioritize a team that plays well together? How long can people in a start-up wear many hats, and when do you need functional specialists?

I am a Senior Certified HR Professional of the Society of Human Resource Management, and I have hired hundreds and managed thousands of people – in start-ups and in large corporations.