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Answer: Starting one.

Most of us realize that there is probably a better way to perform certain functions or tasks, but improvement programs

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

seem to take second seat to getting the product out the door. But wait a minute. Wouldn't streamlined ways of doing the work help to get the

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

Examples of combination products may in

product out the door faster? Of course, but it is just so hard to set aside time to "think" about improvement programs, let alone initiate th

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

em. Most process improvement activities today are part of a technology initiative, but they do not need to be limited to these activities. F

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

urther, most Business Process Improvement (BPI) efforts conducted with the installation of a new system, just scratch the surface.

Downside o

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

Combination pro

technology initiated BPI efforts:

* The BPI efforts are secondary to the technology initiative. Technology BPI efforts tend to be shortsight

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

ed, directing attention on the processes that need to change in order for the technology to be used -- rather than how the technology may enab

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

le the business process. Concentrating on the process BEFORE starting a technology project allows you to focus on the work itself - rather tha

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

n the technology.

* The purpose of implementing the new system tends to get lost in the shuffle, hindering optimization of the business proc

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

esses.

* Efforts are restricted due to project timelines and limited resources

* Once the process has been reviewed and revised so it compl

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

ments the new system, efforts stop. Business processes are larger than the technology that serves them.

* Although users and process owners

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

Following aspects would a

are involved in creating a better method, the activity is managed from a technical perspective, rather than a business perspective. Taking t

dd to the challenges in developing combination products:

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

ime now is essential for achieving, maintaining or enhancing your competitive edge. Do not wait for the next IT project to start thinking abou

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

t your business processes. Here are a few ideas to help you get energized to take action.

How to become more proactive:

* Start collecting

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

data to help identify and measure potential areas of improvement.

* Set up a mechanism for getting information and ideas from those perform

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

ng the tasks.

* When a problem surfaces, take the time to get to the root cause. The tendency is to immediately move to "fix" mode, which

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

Professional from academic institutions, pharmaceutical industries, health care indust

may result in short term improvements.

* When implementing the above, keep it simple - do not overcomplicate this effort and do not make a

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

big deal about the shift. It is simply a matter of thinking in a slightly different way, not changing the entire culture.

* Make process 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

provement a way of life - a continuous effort. Once you have shifted to a more proactive operation, it is time to start stimulating innovati

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

Companies that provide selfless information through particip

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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