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Do you think the truth has anything to do with change? Really? It does and I’ll show you what I mean. Several years ago I was working a project for a company doing around $8 billion dollars a year at the time when the CEO d

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

ecided to improve every process ten times … thus the project was dubbed 10X.

It was colossal in its size and scope. They put two hundred people on the project and ninety consultants and planned a mere two years, at the beh

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

Examples of combination products may in

st of the consultants, to complete the end-to-end redesign of every process in the organization. The advice was that they could do this in one year design and one year implementation. Foolhardy but we all embarked on the jo

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

rney.

The redesign included accounts payable, receivable, a new handheld computer for the retail side of things, inventory system and you name it. The size and scope made it impossible to complete but what made it worse wa

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

the complete absence of truth. Not only did anyone not want to tell the Emperor he had no clothes, telling the truth was punished severely.

Well as you can tell this was a train wreck waiting to happen. The change train w

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

Combination pro

s barreling down the track and it was just a matter of time. The operations group headed by my boss was given the project to ‘implement’ at the two year and three month mark. The only problem was there was nothing to implem

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

nt that actually worked.

One example was the handheld computer. At six weeks before test launch when my partner and I took over the project for implementation we were presented with a balsa wood model. That is not a mispri

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

nt; we were presented a balsa wood model. At the four week mark the actual unit showed up and was eight pounds instead of the design of four and wouldn’t pass the four foot drop test, only two. Yet, the rollout was destined

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

to be so the new unit passed through the field integration test lab with flying colors.

What do you think happened? In the field it bombed in three days and my partner and I had the train wreck sitting right before our eye

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

. When we got the design crew together we said, “We have to know what happened. No one gets shot here, there’s a new Sheriff in town so relax and tell us the truth”. It was a classic and silence ruled the room.

After some

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

ime a coder who was sitting on the floor of the conference room with his head down raised his hand. I said go and he said, “Pain avoidance!” It threw me a bit and I asked for an explanation. He said simply, “It was easier t

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

Following aspects would a

tell them what they wanted to hear than to tell them the truth, it was just too painful”. Herein lies the lesson of truth and change.

Leaders must make it safe to tell the truth. They must create what I call an Umbrella o

dd to the challenges in developing combination products:

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

Safety where it is okay to tell the truth. Why did Enron happen? One reason was that it was not okay to tell the truth. It is always important but during times of change in an organization it is more important than at any

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

ther time. In the example above the handheld computer left the field integration testing lab with 187 known defects. That happened because to the leaders the timeline was much more important than the truth. It is a leadersh

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

ip responsibility.

Imagine a continuum running from left to right. Now divide that continuum into a block on the left representing ten percent of the line, and a block on the right representing another ten percent. That wi

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

l leave you with eighty percent in the middle. The left ten percent represents people like me who will tell the leader the truth, as I or you see it anyway, regardless of the consequences. Now the ten percent on the right r

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

Professional from academic institutions, pharmaceutical industries, health care indust

presents people who will lie to you no matter what. They lie because they are liars so don’t spend any time on that since liars lie.

Now the eighty percent in the middle represents most people in today’s organization who t

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

ll situational truth, they do what I call ‘abuse the truth’. They do that because of the leaders in today’s organization and their need for political correctness and inclusion at all costs. The leader’s job is to move the b

.

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

ock on the left, truth, as far right as they can. This means on your continuum you will have thirty, forty, maybe fifty percent who will come in and tell you the truth. You do this by creating a safe environment and seeking

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

Companies that provide selfless information through particip

the truth rather than the answer you want.

If you don’t create an Umbrella of Safety in your change work you will fail. It will not be a question of whether you will fail; it will be a question of when. The choice is yours

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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Have you ever felt confused when it comes to your career? Maybe you’ve felt unsatisfied in your work, longed for some challenges, or knew you wanted to enter a certain profession or start a business, but just felt unsure about what to do. Whenever this topic comes up with my clients (as it has also come up for me), I’ve learned to notice that it isn’t really about confusion, it’s more about fear of success.

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