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Benchmarking was introduced as we know it now in 1979 by Xerox. The company had a problem with the product sales because of the Japanese competitors. To solve this problem Xerox

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

decided to compare their product quality and features to Japanese products. Ever since the process of implementing the best practices with the help of comparison is referred to as

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

Examples of combination products may in

benchmarking.

Benchmarking starts with the premise that whatever processes an organisation feels require a level of improvement, there are many organisations already achieving

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

world-class performance. Therefore, rather than attempting to develop processes that are of best practice performance from scratch, benchmarking provides organisations with th

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

opportunity to improve processes based upon something that is already being done elsewhere.

At this point, it is necessary to highlight that benchmarking does always not indic

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

Combination pro

ate the need to search outside the organisation for best practices; benchmarking is generally defined at three different levels; Internal benchmarking, External benchmarking and

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

Best practice benchmarking.

This refers to comparing processes and practices within an organisation or division, who are based at the same or a different location. So, for ex

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

ample, if one branch of a travel agent chain has received particularly positive customer feedback for their customer service, managers from other branches, and the organisation

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

as a whole, could benefit significantly by identifying and implementing customer service processes that are the same, or similar to the highest performing branch.

Whatever type

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

of benchmarking an organisation chooses to implement, it is logical that a sound methodology must be employed for implementation to be successful.

Since benchmarking first bec

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

ame popular in the late eighties, many methodologies have been proposed by various authors and organisations.

Advocates of benchmarking argue that the activity brings about newn

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

Following aspects would a

ess and innovative ways of managing operations, which encourages employee empowerment and teamwork, improves quality and is customer focused. It establishes goals that raise pr

dd to the challenges in developing combination products:

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

ductivity levels within an organisation so that they become equal to or better than competition, thus providing a competitive advantage to improve an organisation's market shar

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

e and position. Unlike other performance improvement methods, benchmarking is special because it often involves comparison with external organisations rather than a stand-alone

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

internal analysis. Other common approaches to performance improvement include Business Process Reengineering (BPR) and, within Europe, adherence to International Quality Stand

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

ards (ISO9000).

Benchmarking operates on a comparative basis to identify improvements; comparing what is currently done in an organisation to what could be done to maximise per

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

Professional from academic institutions, pharmaceutical industries, health care indust

ormance and productivity, to achieve continuous, incremental improvements.

Some argue that the philosophies behind benchmarking and BPR are diametrically opposed positions and

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

therefore cannot be integrated; benchmarking is reflective of Japanese "Kaizen" philosophy. Kaizen philosophy follows the Japanese belief that improvements should be made one st

.

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

ep at a time, incrementally to minimise cost, reduce risk and ensure the performance is continually improving. This is contrary to the argument put forward by advocates of BPR

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

Companies that provide selfless information through particip

who suggest that change should be rapid and "breakthrough" to achieve results, suggesting that the two methods cannot possibly work together harmoniously as an integrated method

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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Many say that business is an evil game and is for evil people. They say you have to be dishonest if you are a CEO. They say that most entrepreneurs are rich because they cheat and screw over the little guy. Some even go so far as to say that the difference between a CEO or Entrepreneur and a criminal is merely luck and family name?

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