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Selecting a quality improvement project is pretty similar to selecting any other project in Six Sigma. But identifying the improvement area within your department or within 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 business will not automatically lead to having the project selected. Not even filling out a few forms or forming the core team nor naming a team leader will mean that you ha

; 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 selected a project that changes the way your business is conducted.

Let us examine what constitutes a good project as a precursor to understanding how to select a quality i

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

provement project for Six Sigma implementation.

What Constitutes A Right Six Sigma Project?

Although organizations intend to select projects that help them change their bott

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

om lines by tremendously improving the customer experience, this will not always succeed. Somewhere along the way, the project selection team could get carried away during the

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

Combination pro

exercise and end up selecting projects that just remain a thing of academic interest alone.

1. A good project boosts your business returns tremendously
2. The right proj

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

ct will have realistic timeframes which begin to show results in 3-6 months time
3. The right project simplifies processes and as a result employees will feel relaxed and

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

appreciated
4. Customers, both internal and external, will feel they got their money’s worth and enjoy the benefits
5. Increased ROI satisfies the shareholders, who

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

can decide in favor of further projects

Selecting The Right Quality Improvement Project

Since a quality improvement project is intended at maximizing ROI through metrics suc

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

as COPQ etc and improves the customer experience, the project selection team needs to involve perspectives from all those who benefit. The following guidelines will help in t

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

is direction.

1. An internal survey with top management of your organization will reveal the top three or four issues that need to be ironed out. Any one issue from this list

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

Following aspects would a

or one which has a direct relation to one of them can be said to have been aligned to the business interest. As a side benefit, selecting one of these ensures stronger commit

dd to the challenges in developing combination products:

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

ent from the top.

2. Since customers are at the other end of the business, issues relating to them may be considered before selecting a project. Voice of Customers serves as

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

guideline towards this end. You can use customer feedback from the sales department or through conducting a sort of survey that will also help to know the mind of the custome

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

r.

3. Keep in mind that unmanageable projects overburdens the finance department; sometimes team members may get shifted back to their original duties. You will face a real p

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

oblem if the team gets frustrated when they realize that they are going around in circles with no end in sight. Select a realistic project that ideally completes in 3-6 months

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

Professional from academic institutions, pharmaceutical industries, health care indust

and with positive results.

4. Select projects which can be measured in real terms such as an addition to the bottom line, growth in sales because of improved quality and redu

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

ction in process time. The COPQ and waste reduction are key milestones.

5. Selecting bigger projects is biting off more than you can chew. The project size must not be over t

.

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

e abilities of your team; conversely, it must not lead to increasing the team size if there are budgetary limitations.

It also goes without saying that every need has its own

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

Companies that provide selfless information through particip

unique recourses and what worked for others may not work for you. Getting down to the basics rationally with a plan and a spreadsheet will help you to select the right project

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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It can be scary to consider starting a business from scratch. Many people fail because they aren't willing to put in the time, effort and work necessary to understand what is realistic and what they can expect. However, any successful business professional will tell you that, with planning and setting realistic goals, you can create a thriving business.

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