Cases - Business

During my many years of professional experience I was constantly researching the roots for success or failure. I was poised to find out what it was in the end what made a difference. I

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

am sure that is something every entrepreneur would like to know and there are lots of books out there dealing with different issues.

When reading through many of those books and compar

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

Examples of combination products may in

ing it with my experience on a daily basis I felt that there was something important missing. Sure, probably all the more than obvious reasons are listed and even advice is given how to

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

control that. Processes are recommended with step-by-step instructions on how to follow it and yet very often it’s just not working. So together with my partner we developed a system.

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

Think about what you have already tried out and done, but are you satisfied with what you got? Or do you also feel that there must be something more to it?

Here is a case study for you

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

Combination pro

of a client of mine to illustrate what I mean:

This entrepreneur was successfully running a midsize business in a rural environment outperforming competitors even during tougher econo

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

mic times. He was presented with the opportunity to acquire a poor performing competitor three times the size of his business in a nearby city.

First big mistake made:

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

Being successful for so many years my client made the decision to just implement all his processes in place for the acquired business. He was absolutely sure that what worked in his bu

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

siness would work there as well. It didn’t!

Second big mistake made:

In order to be in control what was going on he hired a General Manager who was pre-screened by 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 usual process. Since he knew him personally he was sure that it would work out. It didn’t!

Third big mistake made:

Since he was too busy to be personally there and

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

upervise the new business he decided that weekly meetings with the General Manager would do it! It didn’t!

Fourth big mistake made:

Since he had already a proven syst

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

Following aspects would a

em at his place on how to organize things and work with people, he didn’t talk to the employees there asking for their input. His system failed.

Result:

Within three

dd to the challenges in developing combination products:

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

months he found the new business deep in the red numbers and he couldn’t figure out what to do. So finally he asked for help, because he recognized that there was something, he just did

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

n’t know.

When I presented my program to him and his leaders I asked them, if they had an idea how many different points I would observe at this place. The guesses were between 30 – 80

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

different points. Much to their surprise I told them that for business like this I would at least observe about 750 – 800 different points!

These points are based on our personal findi

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

ngs during 26 years of professional experience based on a lot of research and interviewing people. It is something you will not find in the books.

After having performed this “state-of

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

Professional from academic institutions, pharmaceutical industries, health care indust

-the-company-review” I could come up with a program for him on how to turn around quickly the business and he was able to do it within about four months!

To make a long story short:

I

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

is not the one big point you might look for to change. It is rather the many little things often overlooked which make the difference. And it is not enough to find these many little di

.

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

sturbances; you must know and understand the meaning behind it!

In the end it comes down to the Human Dimension and Caring Leadership which makes all the difference of the world. It re

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

Companies that provide selfless information through particip

quires entrepreneurs who are willing and eager to explore new ways of doing business admitting that they don’t know it all.

Walter H. Groth
Institute for Life and Career Transitio

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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