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There are many management areas. Infrastructure is such a field that is normally not too popular as a discipline. It is not directly visible, at least not in the sense that you can measure the output – in terms of number of products or serv

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

ices related to the investments that are done. Yet, if the topic of infrastructure is not properly set on the management agenda, it will put itself there, on the moment you least expect it. All over the world we have seen what incidents lik

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

Examples of combination products may in

e Katrina can bring about. It is not said that the infrastructure of Louisiana was insufficient, but issues like security and safety are infrastructural. And these are difficult to manage, not only the public services that are managed by po

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

liticians and governmental organization, but also within private companies. Infrastructure is always the last point on the management agenda.

There are a number of reasons why it is so hard to manage infrastructure. Before we broach the su

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

bject, we let’s define the topic of infrastructure. We use a rather broad definition. It is all that is to do with the needed support to get the business running. It is about giving support, facilitate, serve or in different words, providin

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

Combination pro

g the glue to run the operation smoothly. The real fundamentals are the normal utilities like water, gas and electricity. These are the basic needs supporting the rest. Information and Communication Technology is another category meant to s

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

upport the communication throughout the entire organization. As long as the functionality is not specifically dedicated to a main business function, it falls also in this support category. For all kind of maintenance applies the same. Human

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

Resource Services like periodic trainings and general educational services are also supportive and could be categorized as such.

All the above elements of infrastructure share a common aspect which is that they all serve a general goal<

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

/b>. They are not specifically offering one solution but they serve a broad area. In fact (infrastructural) support serves others (both humans and systems) in achieving their tasks. If you remove the infrastructural plug out of the wall, e

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

verything else stops functioning. In terms of requirements you are dealing with abstract issues. The requirements are non-functional and are addressing abstract aspects like: security and safety (internet and buildings), integrity (informa

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

tion), reliability (communication, electricity), accessibility (website), etc. The problem with these abstracts is that you can not measure it easily. You are talking about levels of safety and about incidents that lower such levels. Basic

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

Following aspects would a

ally it is about past statistical information that is needed to address future management energy. And then the question is what level is acceptable? This can only be determined by past incidents. Like the one in Louisiana.

Most managers ha

dd to the challenges in developing combination products:

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

ve a short attention-span. We care for day-to-day problems and infrastructural issues occur only incidentally. Once the ‘storm’ is literally over, the attention is moved to something else and general support is left aside; ‘Everything’ is w

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

orking again. So managing infrastructure leaves you dis-satisfied; once the problem is over, people go back to what really matters, what is satisfying current needs.

Related to the first aspects is the fact that infrastructure is not gl

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

morous. We all want to perform and the individual success is what counts most and for all. As in tennis, it is the singles final that is valued more than the doubles. It is the fact of live. And this truth is found in each organization.

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

Personal achievements are higher valued. We stress output and performance. We have only one dollar to spend, so we rather spend it on individual bonus when a sales-target is met, rather than a bonus for a supporting team that has dealt wit

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

Professional from academic institutions, pharmaceutical industries, health care indust

h 2000 upset customers because of product being less than expected, damaged, mal functioning or what ever.

Another point that makes the management difficult is that issues related to support are not easily identified as such. Just check in

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

your company the problems that occur and which are never solved. They keep on coming back. These are the symptoms. Then you know that you have deficiencies in your infrastructure. Al these problems do not have an owner, so they are

.

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

wandering around as orphans in your organization. If their amount is growing, you can be sure that a calamity will be near.

To prevent this you should set infrastructure on the management agenda. You could use the balanced score card for t

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

Companies that provide selfless information through particip

his. And you should reserve a pool (budget) which you feed with a fixed percentage from projects and new businesses. If the symptoms are not decreasing you should raise this percentage. Better safe than sorry.

© 2005 Hans Bool / Astor Whit

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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