Advice You - Business

Think about your office environment for a moment. Frantic meeting schedule and looming deadlines aside, how conducive is your workplace to stimulating playful imagination and creative

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

brainstorming?

Innovative organizations have created environments which reinforce the following:

Freedom to Succeed and Fall Flat on Your Face. Remember Babe Ruth s

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ruck out three times more than he hit home runs, but it’s the home runs we remember him for, not to mention the great candy bar! Create a safe place for experimentation. Minimize the f

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ear factor by being a savvy gatekeeper of who gets to experiment and on what. For example, you may not want the new kid on the block doing the actual clinical studies on humans. Perhap

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

you can start them off with stuffed frogs… anyway you get the gist.

Bigly Thinking. How “bigly” is your thinking? Are you reinventing the same old stuff, just color

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ng it differently? If so, how are you going to stay in business? Do you have a disdain for the status quo in your company? Ask better questions, not obvious ones. Obvious question: “Wh

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

at’s the next bell and whistle that we can add to our software?” Better question: “What do we think the customer really wants but doesn’t know they want it yet?”

Motivation.
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
trong> In our research over the past few years, we’ve found that the most important motivators for people working in the life sciences and high technology sectors are recognition and
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
pportunity for growth. The fastest way to see more “bigly thinking” go away is to ignore it. Don’t want people to think beyond the cubicle they’re packed into? No worries, just don’t g
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
ive your staff an opportunity to try anything new. In no time at all, you won’t have to worry about recognizing people or giving them anything else to work on. Of course, you won’t hav
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
any staff either!

Commitment. Words are cheap, but actions speak louder than the most clickable YouTube videos. If you are committed to people and their ideas, how
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
o they know? Do you have the cutsie wall poster that says “I Believe in the Magic of Innovation” only to pull a stick out of the hat when someone comes to you with their idea? Keep you
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
r word and watch what happens.

Mutual Purpose. Shared Passion. People with purpose have passion. How well is your team linked to your organization’s purpose? More im
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ortantly, what about you? Do you have any doubt about your purpose – at work? What about life in general? If you don’t have a strong sense of purpose, there is little chance for passio
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
. Passion gives flight to our dreams.

We’re huge fans of innovation and want you to be as well. Visit use online at www.zeroboundary.com to request a copy of our free Imagin
t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
e. Invent. Innovate. Workbook as used at a recent ZeroBoundary Innovation Workshop. The workshop was recently delivered as the cornerstone of the University of California Irv
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
ne Biotechnology Leadership and Management Program. Labeled as "remarkably successful" by the University, the Orange County Register and the sponsoring companies of those in attendance
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

The highlight of ZeroBoundary’s Innovation Workshop is a hands-on educational experience applying specific corporate processes and initiatives. .

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
/video/_player/index.php?xmlPath=http://media2.ocregister.com/video/disneyland030607/xml.xml" target="_blank">Click here to review this video and article from Colin Stewart at the
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
C Register. He followed a handful of managers from various leading Science and Technology Industries as they participated in ZeroBoundary’s workshop and learned from the mouse

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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