Medical Device Project Management Is Our Sweet Spot

I’ve been working with a medical device client for the past 10 months. The company develops and manufactures single-use disposable medical devices. For most of the engagement, I have assisted the client with quality and regulatory (you know, FDA related stuff) services and support. Since being there, I have observed the performance of the marque product. This product has been in the U.S. market for the past several years and has steadily grown. There are a few competitive products in this space, one from a large medical device company which has a significant majority of the market. However, year after year, my client’s product chips away gaining a few percent of the overall market. This is the upside.

This particular product, though, also represents the majority of the business risk for the client. While the product is an extensive of the other products in their portfolio, it is not a simple device. There are numerous parts and pieces that connect, disconnect, etc. Plus, as the company chips away at the market share owned by the large medical device company and their product, the two competing products are slightly different in their functions and operations. And there have been some issues.

The client has typically played “fire fighter”. When an issue is identified, they respond with trying to fix it. However, I’m not sure the root cause and solution is always understood. I mean no disrespect, but the approach has kind of been throwing stuff against the wall to see what sticks.

Meanwhile, there are numerous other initiatives underway hogging valuable resources at the client. Continuous process improvements. Day to day manufacturing and related issues. The company has also had a desire to launch a brand new product too. All of these activities have sucked virtually all the time away from product portfolio management opportunities. I’ve been observing this for a few months.

The other day, I shared my observations with the executive management team. I shared with them that this current product represents the future growth potential of this company. I shared my concerns that if they do not take the time to evaluate the product’s performance during the past few years and identify ways to improve this product, it’s my opinion that their growth will stall while increasing the overall business risk and exposure. I suggested it is time for them to open a project to review all the data and brainstorm ways to strengthen this product’s position in the marketplace.

The president loved this suggestion. He agreed that it is time to take this on. But he had some concerns about who would be the right resource to manage this project. I was a little confused by this comment. Had I not clearly shown that Creo Quality and my expertise were perfect for this endeavor? As I listened, I realized that this client knows the CQ brand as quality and regulatory–not project management. I realized that while providing invaluable services and support that the client desperately needed, I had failed to convey to them that medical device project management IS the sweet spot for Creo Quality. When I shared this with the company president, he was a little surprised. It was in this moment that I realized a few important things about my business. It was in this moment that I realized I have been managing medical device projects for this client for several months, yet had failed to help them connect these dots.

The CQ brand is all about medical device project management. While it will might be difficult to convey this message to this client, I have to do a better job of demonstrating this core competency and value proposition to future clients.

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