What is your professional background, and how did you get into the medical device and IVD industries?

My training is in the clinical lab, I used to manage a hospital lab for a ~300 bed hospital with active emergency room. From there, I was recruited to industry and spent 14 years at Bayer in technical and marketing roles, eventually managing Bayer’s US POC glucose business. I worked with a NASDAQ traded product development firm for a few years, then managed a rapid diagnostic product line for Flu A/B, RSV and others. I’ve been in product development now for about 20 years.

What types of products or technologies have you helped bring to market?

In my experience bag, I launched a new hospital product for diabetes care during my tenure at Bayer, launched a new automated hematology product for an animal health company, and introduced a new rapid diagnostic for C. diff. I’ve been involved with many other new product development and market introduction activities. This included all things related to needs and feature identification, value creation, message development, market strategy, distribution strategy, and execution on strategy.

What roles have you had that uniquely prepare you to support NPI and pilot-scale projects?

I believe my experience in launching multiple products gave me significant experience in how to prepare for initial product transition from design, then to understand market dynamics and go to market strategy for preparing for scale up and meeting demand. I’m the first to caution to ensure that a new product introduction doesn’t go on backorder immediately due to underestimating demand. It’s all about planning!

How do you work with clients to customize solutions that meet their regulatory and commercialization needs?

One benefit of working with Tensentric is that we don’t have a ‘one size fits all’ approach to new product commercialization because we work with diverse clients. A startup may need additional support on the details around materials planning and procurement and supporting recommendations on compliance with ISO13485 and FDA regulated manufacturing. A more mature company will understand these needs and may only be seeking initial production start for market introduction with an eye on DFM and cost reduction as market update ensues. We employ a flexible approach tailored to our client’s needs.

What hobbies and non-work activities are you most passionate about?

I’ve studied martial arts for >20 years and earned black belts in 3 styles. I’m currently studying TaeKwon Do and provide a free monthly self-defense course for members of the community.