Tag Archives: strategy

Medical Device Startups Master Juggling and Balancing with Focus

Medical device startups are faced with numerous challenges and obstacles to get their products to market. Yes, I could discuss the main obstacle for a medical device startup: MONEY. But I'm not going to in this post. Instead, I'd like to share a few thoughts on balancing and juggling and how these apply to medical device startups.

Medical Device Startups Struggle with Balance

Yes, you likely understand the concept of balancing. At least how it applies to walking down the street. I do too, yet admit that achieving and maintaining balance during projects can be a significant challenge. Imagine for a moment you are managing a medical device product development project. It's early in the game still. However, you have to consider all sorts of factors and influence. You're main objective is to get from point A to point B...

Lack Of Planning On Your Part

Should not constitute an emergency on my part. I'm guessing you have heard this saying a time or two as well. But based on the actions of a couple of our clients, I'm guessing this saying has little meaning. Let me share a brief example. A medical device company has several products on the market in the U.S. and many other parts of the world. They are actively pursuing getting their products cleared all across the world. The company relies on distributors in the specific countries to take care of getting products registered. The company has no in-house regulatory or quality resources and has relied on us to serve in this capacity as a very part-time basis. And when I say very part-time basis, I mean that we help with regulatory issues somewhat after the fact. Let...

Should I Be Pushing My Client’s Buttons?

Let me set the stage a little bit first. The medical device client relies on a third party vendor to manufacture their device. The product is a reusable electronic device. If the device has issues at the end customer, the customer might contact the medical device company to troubleshoot and possibly send the product in for repairs. In recent months, the medical device company has been receiving about 5 devices per week in for repairs. The contract manufacturer went through some internal process changes and quickly got behind on the repairs. The medical device company began experiencing a great deal of frustration and angst while the backlog of repairs got bigger. Eventually, the contract manufacturer began to get back on top of the situation, reducing the backlog of repairs to almost zero. Now, there is...

Medical Device CEOs Should Stay Out of Limbo

A medical device CEO should establish a sound business strategy and communicate the vision for their organization (yes, this is true of any CEO). Being strategic, establishing a clear vision, and communicating throughout the organization is tough. And from my experience, very few medical device CEOs have this ability. Most medical device CEOs operate in a state of limbo. We have experienced this first hand with a couple of clients. In one particular case, the CEO was highly critical of third party vendors on meeting timeline, deliverables, and expectations. However, he did not provide the same sort of vigor with internal resources and employees. The CEO was being very wishy washy. Saying one thing, yet often doing another. This sent mixed messages. The employees seemed to have a free ride and were seldom held...