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Every business is trying to improve profitability, after all this is why the business exists. To achieve this goal there are only two paths that can be taken – increase revenue or reduce costs. The path of increasing revenue is typically seen as th

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

e most positive step. It is exciting, involves expansion and creates opportunities. Conversely, reducing costs is seen as negative and backward and so this approach often gets much less attention that it deserves.

The problem with continuous impro

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

Examples of combination products may in

vement is that it can be really hard work. But, just like its glamorous sibling, achieving lasting and positive cost reduction requires creativity and imagination. Most continuous improvement initiatives begin as a last minute and unplanned way 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.

‘make budget’. The focus is short term and as a result the approach can be a destructive ‘slash and burn’. Managing costs should be a strategic decision not an ad hoc reaction to short term revenue failure.

The hard work of continuous improvement

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

occurs because it is often seen as boring and internally focused. And it often is! Cost reduction is seen as being ‘tight fisted’ and squeezing more out of the lemon or getting blood from a stone.

Also, whatever cost base exists is a reflection o

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

Combination pro

f the past management, after all somebody set up the system or allowed the development of the current cost base. This poses a problem for many because it can be seen as admitting past failures. This is also the reason why it often takes a change in

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

management to kick start a true continuous improvement initiative.

It is because of these issues that people take short cuts and this leads to mistakes and unsatisfactory outcomes. The book A New Strategy for Continuous Improvement explains all

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

the issues with continuous improvement activity but the eight reasons why continuous improvement efforts fail are:

There is no base to build upon - Most continuous improvement initiatives just start with whatever systems the com

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

pany has in place at that the time. They do not review the suitability of those systems or what can change to provide a ‘good practice’ base for future activity.

They rely on finding breakthroughs – Too often companies spend their

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

time and energy looking for the leading edge breakthrough that will change everything. Unfortunately this approach diverts attention from applying the simple and known solutions that already work.

They try to ‘reinvent the wheel’
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
>– Few companies are in the business of management innovation yet too many want to develop management systems or overly customize something to their business. If you are in the early stages of continuous improvement just copy something that works.
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
Later, as part of your improvement processes you can work on evolving that more specifically.

They ‘cherry pick’ good practice – Often it seems easy to try and identify the single element of good practice that is the key to anothe
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
r company’s success and apply that to your own business. This ignores that the result is likely to be systematic and comes from having established a sound base to build upon (see item 1).

They are too hung up on efficiency – In my
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
view efficiency is over rated. Companies that strive for efficiency need to be sure that they are being effective first. There is no point in doing the wrong thing very well.

They don’t pay attention to the little things – It is
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
also too easy and popular to take the ‘big picture’ view and it is often assumed that things will just work. This is especially the case when human intervention is required to document details. In a recent case a company spent millions of dollars o
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
n new inventory software only to find that their team did not complete the required daily updates. This meant that their data was out of date and their original problem was not resolved. They are now focusing on changing their culture and this will
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
lead to the delivery of their main benefits.

They are locked into a silo approach - Business structure often impacts the way we see the world. If someone is busy trying to optimize their own small part of a company in isolation
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
from the surrounding departments, suppliers and customers with whom they interact, it is likely that the result will be suboptimal.

There is no process of renewal – Finally, having completed the tasks required to achieve their im
.

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
mediate goals many companies then change focus onto some other problem. However, if the cost base is not regularly reviewed in line with changes that occur in product, customers, technology etc. then the problem is not resolved only temporarily add
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
ressed.

Good continuous improvement requires a long-term view, imagination, creativity and innovation. Success can be achieved through doing things differently, being systematic in your process and making continuous improvement a strategic choice.

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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