New ways of thinking encourage new ideas and ultimately new products!

The Real Secret to New Product Development

by Michael Drues, Ph.D., President, Vascular Sciences

Accepted for Publication in the Regulatory Affairs Professional Society (RAPS) Newsletter, May 2001

Anyone who stops learning is old, whether they are 20 or 80.

Anyone who keeps learning stays young. — Henry Ford

Education. What does that word conjure up? Memories of sitting endlessly in uncomfortable chairs, attending faceless lectures while professors drone on and on about esoteric theories as you daydream about what the real world would be like? Or what’s worse: thinking about where you will go on your next vacation! That’s what education means to many people—but it doesn’t have to be that way!

Think of your brain as a muscle (ok, it’s not a muscle, but bear with me a moment to make the analogy work). What happens when you don’t exercise a muscle for a while? It atrophies. The same thing happens to your brain. We lose our mental agility—often times without even realizing it! We may be able to get through our normal day-to-day activities, but our creativity, our imagination, our ability to “think outside the box” certainly suffers.

So how do we exercise our brains? How do we keep the creative juices flowing? One way is education. Unfortunately, so many of us have such unpleasant memories of our educational experience, that the mere thought of going back and taking a class makes us break out in a cold sweat. But medical technology is advancing so fast that we must force ourselves to keep up or we may be out of a job! Not only should your company offer liberal tuition reimbursement, you should actively encourage your employees to take advantage of it. And despite recent changes in the tax law, tuition reimbursement is still a good deal. But attending classes at your local university is only one possibility—there are many others.

Send your employees out into the clinic to see how your products (and those of your competitors) are used first hand. Medical products are interesting in that the people who design the products rarely get a chance to use them the way they were intended to be used (i.e., according to the label claims).

To use another analogy, it’s like trying to design a new car without being able to drive the car yourself. You have to rely on others (for medical products it’s usually the physician) to tell you how they felt while driving the car. And to make matters worse, some companies add a middleman, often a marketing person, to get the feedback from the physician. Then, the marketing person comes back to the company and tries to explain to the scientist or the engineer what they thought the physician was telling them. Have you ever played the telephone game when you were a child? What happens to the message after it goes through a few people? The same thing happens here only the stakes are much higher. And so are the consequences!

Another suggestion: bring in outside professionals to lead discussions, conduct seminars and even aid brainstorming sessions. Often when you bring someone in, the content can be customized to meet your specific needs. But, be careful not to focus too narrowly! Often, discussing a product from a seemingly unrelated area can spark an idea on how to solve one of your existing problems. You can even ask if your facilitator will sign a confidentiality agreement so that you can use your products as case studies (something usually not possible when attending a seminar open to the public). Many times, having a new set of eyes look at an old problem is enough to spark a new idea. To use an old cliché, you must actively and continuously encourage your employees to “think outside the box.” How? One way is to ask simple questions. Here are two of my favorites from cardiology, though there are numerous similar examples in every field of medicine:

Question: “If the heart is always full of blood, why does it need coronary arteries?” Sounds like a reasonable question. Think about how many companies are developing products to treat coronary artery disease (CAD), clearly one of the largest medical problems we face today. Suffice it to say, there are too many to count! And yet it’s amazing how many people responsible for designing products to fix CAD cannot answer this simple question!

Do you see this as problematic? If someone is trying to design a new car, but they don’t understand what the car is supposed to do, they probably won’t be able to do a very good job. And they certainly won’t be able to come up with a new, innovative solution like designing a motorcycle or a sport utility vehicle.

Here’s another example: If you were to look at how coronary artery disease forms, you might notice that the lesions (called stenoses) are not round—they are, in fact, very eccentric. So “why is the shape of nearly all medical devices used to treat CAD round?” Does this sound similar to the old “round peg in a square hole” problem? Could there be an advantage in making an angioplasty balloon catheter that has a triangular cross-section? Perhaps. But the point is, you need to step “outside the box” in order to even consider the possibility.

OK, so exercising your brain is important. But it also can be expensive. How can you justify the cost? Just like anything else, accountability is key. If you send an employee out to attend a seminar, for example, have them come back and lead a discussion on what they learned. Don’t just have them write a trip report that other employees may or may not read. Remember, you want to stimulate creativity and imagination—this often happens best in small groups. Perhaps they can even lead a brainstorming session to consider how to incorporate what they learned into a new or an existing product. Of course, some ideas might be more immediately incorporated than others. But don’t lose track of the point—new ways of thinking encourage new ideas and ultimately new products!

Last, and certainly not least, involve FDA. Not only is it a challenge for us in industry to keep up with new technologies, it is an equal if not greater challenge for FDA since they have so many different technologies to keep up with. Partner with FDA early on. Invite them to visit your company or go out and visit them. Involve them in your educational activities, perhaps even in your brainstorming sessions. They may be able to provide you insights early on that in the long run may save you significant time and money. As we are all very aware, medicine is a business today. It is no longer sufficient to simply show the safety and efficacy of a new product—we often have to show a cost benefit as well!

Bottom line: use these tools, and others, to actively and continuously stimulate creative thinking—“think outside the box” is an overly used cliché—but it is also very apropos. Perhaps Albert Einstein said it best:

Imagination is more important than knowledge, for while knowledge points to all there is, imagination points to all that can be. — Albert Einstein

These tools don’t simply make the new product development process more efficient. They allow you to use knowledge coupled with imagination to inspire revolutionary product ideas that can benefit ourselves, our companies and our society.

 Michael Drues, PhD, is President of Vascular Sciences (www.vascularsci.com) in North Grafton, MA. Dr. Drues is also an Adjunct Professor of Medicine at Northeastern University in Boston, MA, where he teaches courses in pathophysiology, biotechnology and regulatory affairs. Dr. Drues conducts a variety of medical device design seminars. Dr. Drues can be reached at mdrues@vascularsci.com or 508-887-9486.

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