Advice You - Business

We all realize that the speed of change in organizations and in our lives is increasing dramatically. In order to succeed, employees must help one another survive this rapid change.

Let me relate a story that happened to me to illustrate this point. Some years ago in July a weather front came through Marietta,

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

Ohio dumping about six inches of rain on the surrounding area. The next day, the rain continued until 11:00 am when it suddenly stopped and the hot summer sun came out, just like God had turned off the faucet. I thought about the change that had probably taken place along a little creek where I liked to hike. I

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

Examples of combination products may in

had plenty of vacation time so I took off the rest of the day to visit my favorite ravine. I went home, put on some cut off shorts and an old pair of tennis shoes, and headed down the path.

I reached the mouth of the creek and to my surprise I saw several tons of gravel that had been raked from the bottom of the

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

stream and deposited at its mouth. A new terrace landform had been created that night. I looked at the stream bed and saw the grass matted on the ground. The water had receded but it must have been three or four feet high in the height of the flood. I tiptoed across the water and started up an old logging road

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

presently being used as a four-wheeler and bicycle trail.

Everything was in various shades of green as far as the eye could see. The July smells permeated my nostrils and made me smile. I could feel the weight of stress slipping off my shoulders with each step. Suddenly, among all the green, a blur of yellow c

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

Combination pro

ught my attention in the distance. I became fixated on it as I walked toward it. Once I got closer, I realized that the yellow was from the undersell of a box turtle. He was stuck straight up in the mud - a vertical turtle! Needless to say, I was surprised by the turtle’s predicament. I walked around him a co

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

uple of times in search of an explanation to this unusual situation. While pondering his turmoil, I suddenly noticed that a large landslide had occurred on a nearby 70-foot embankment. I instantly knew what had happened. As the rain pounded the hillside the previous night, the turtle found himself a nice safe p

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

ace to dig a burrow in which to wait out the storm, just like he had done for decades. As the ground became saturated, it all gave way, ripping the turtle from his safe hiding place and depositing him vertically in a four-wheeler rut.

I shook my head and thought to myself, this turtle is a lot like some of my cl

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ents. The catastrophic change had unexpectedly snatched the turtle out of its comfort zone and thrust him into a new, dangerous experience. Similarly, for years, many of my clients had performed their work a certain way and were rewarded for their success. Then someone said, we’re going to teams or we are imple

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

enting new software and everything changed. Now they weren’t seen as competent and were being pushed into early retirement. Realizing the nature of this event, I stuck my walking stick behind the turtle’s shell, popped him out, washed him off in the stream, set him on the grass, and said, “Fare thee well, my Ver

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ical Turtle.” My role in the turtle’s life was as a Change Enabler; I helped him survive a catastrophic event that had impacted him through no fault of his own.

We can’t stop change nor should we if we could. The trick is how to survive change and help others survive it. I believe that we should look for oppor

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

tunities to be Change Enablers with subordinates, peers, and other organizational members. Help others by teaching them what you know and learning from them. Help them put events in perspective when stress is building. Help them by communicating the whys behind organizational initiatives. By these actions empl

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

yees create lasting and productive work relationships. Who knows; next time you may be in need of some help. Effective leaders are those who take on the responsibility of enabling all employees to survive the change in today’s organizational life.

The week following my encounter with the vertical turtle, I used

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

him as an illustration of the need to help our fellow employees survive change. As I repeatedly told the story, I wondered what had happened to this unfortunate turtle. Finally, I ventured back to the location where I had found the vertical turtle. Just before I reached the now dry patch of mud that had encased

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

the turtle, I started to step over a small tributary when I looked down to my left. There was a plunge pool 18 inches wide and 2 feet deep cut out into the bedrock by torrents of water over millions of years. It was half full of water. What do you think I saw? To my surprise, my buddy, the vertical turtle, was

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

in another serious mess. This time he was desperately trying to extricate himself from the sheer, slippery slopes of the plunge pool. He would get half way up and fall back into the water. I watched him struggle several times to no avail. It was soon apparent that the turtle was not going to be able to get out

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

on his own. He was dead to be. When his energy ran out, his fate was to eventually drown.

At first, I thought, “What, are you stupid! If I save you, am I going to create a stupid turtle species?” Soon, I thought better of the event. The fact is I have made more than one stupid mistake in my life. Everyday

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ife can be confusing. Two mistakes are entirely possible even for people with the highest competence and the most excellent intentions. Once again, I came to the turtle’s rescue by plucking it out from the water, setting him on the bank and saying, “Fare thee well, my Vertical Turtle.”

The facilitative leader m

.

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

st have patience and persistence when leading organizational members. Be clear with directions and focus most of your communication on how to succeed in the future, rather than on what went wrong in the past. Learn from your failures and allow others to do the same. Risk taking is seldom demonstrated in those o

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ganizations where the rule is one strike and you’re out.

Facilitative leaders must view risk taking as a positive learning event. Taking risks enables others to invent ways of successfully surviving change. Learning from failures increases our worth as employees because we are less likely to repeat that mistake

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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Advice You - The Vertical Turtle - Two Lessons About Enabling Change

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