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Every change leader at one time or another is faced with selling training to the big guys. And what happens? The training budget, if you have one at all, is the first to be cut. Why? Because the leaders just don’t know what they don’t know. They don’t know wha

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

t happens to their troops when new systems are installed or new processes.

Let me tell you what that means. Imagine the proverbial four box quadrant with all four boxes of equal sides. There are two boxes on the bottom with two boxes sitting on top, one on ea

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

Examples of combination products may in

h. We’ve all seen it. One popular quadrant is the time management matrix. So imagine you’re looking straight at the four boxes. The bottom left box we’ll call number one, the bottom right number two, the top left number three and the top right number four.

Al

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

ong the bottom two boxes runs a continuum from one to ten that represents a person’s skill on the job. That is their basic competence. Running vertically on the left side bottom to top is another continuum from one to ten, starting at the bottom representing a

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

person’s experience, meaning years in the business. So if you are with me, the bottom represents a person’s skill or proficiency, zero being no skill and ten being highly skilled. Up the left side the other continuum is a person’s experience, zero being new to

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

Combination pro

the job and ten being a person with years on the job.

If you take an organization that has been relatively stable, systems in place for some time and people in place even longer it is easy to demonstrate the value of training when making large scale systems

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

r process changes. Let’s look at two different people that are impacted by the coming changes.

Fred, we’ll call him, has been with you forever. He has many years experience with what he is doing and has been using your system since you implemented it five yea

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

rs ago. If we give Fred a score for experience, let’s say it’s a nine. Fred’s skill with the systems we’ll say is an eight. His score would then place him on an axis that is in quadrant four, top right. He is an asset to your organization in this area.

Now le

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

’s look at Freda. She is new to the company but has experience in the business, yet the systems are somewhat new to her. We give her a seven for experience and a five on your systems. That places her in quadrant four like Fred, just not as high. When you do th

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

e rest of your team you find most in quadrant four, top right. That’s not surprising since your organization is stable.

Then in comes a new CEO like many that I have seen and you’ve been going crazy getting ready for the past year and a few months to implemen

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

SAP. When you flip the switch on SAP, and let’s assume just for giggles that it actually works, haven’t seen that yet but let’s just say it does, what happens to Fred and Freda?

With a new system everything is new. So Fred’s experience in the industry remain

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

Following aspects would a

s the same but is impacted by a new way of doing business so instead of being a nine, he drops a couple places to maybe a six. Now when it comes to skill he is certainly no longer an eight but a two or three dependent totally on how much training he is given.

dd to the challenges in developing combination products:

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

sually training is cut, is unrealistic and everyone in the joint is now a two or three. So which quadrant is Fred in? He is now in quadrant one on the bottom left … some experience that helps but no skill.

Freda is in the same boat only worse. Everyone in the

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

place drops into quadrant one because they are instantly stripped of both their experience and skill. Draw this out on a piece of paper for your outfit and you’ll see the people drop from the right top quadrant to the bottom left and that means you have probl

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

ms running your organization in the meantime.

In the consulting world, working on ERP project implementations and large scale process change, it happens all the time. How long does it take for people to get back up to quadrant one where they are comfortable a

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

nd capable … the true answer is, it depends. But for super users, those who spend their day with the systems, we’ve seen it take up to a year with the best cases being six months to full proficiency.

You can’t eliminate the problem entirely but you can mitiga

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

Professional from academic institutions, pharmaceutical industries, health care indust

e the damages. First, make sure that the new system is adequately tested and not thrown on to the street in an act of anticipated heroism. Since we know in eighty percent of the implementations we see that this isn’t going to happen, the only other thing you c

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

an do outside of group prayer, is to make sure that you have real, detailed training, well in advance and with time for key users to become believers in the system and drive it through. If you do, you’ll cut the learning curve in half.

Understand that you can

.

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

t fight this; it is just the way it is. We’ve found that by drawing this four box diagram and plotting your people on one slide and then showing them all in quadrant one on the other, it helps the big folks get their minds around the problem. Now I said it hel

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

Companies that provide selfless information through particip

ps, it isn’t an end all. You have to fight for training or pay the terrible price of enduring the pain of the learning curve as everyone travels back up from the bottom left box, quadrant one, to the top right box, quadrant four. The choice is yours.

Ed Kugle

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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Brands are what separate you from your business. Although businesses deal with people, people within an organization often change.

Although you should take control of your own career progression, you're probably not alone in the effort. Your current manager, for one, should be helpful in giving you information, feedback, and support you need to grow and build your marketable skills.

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