Main Subject - Business

The surety and effectiveness of a Six Sigma project relies heavily on leveraging the enterprise-wide knowledge of the project implementation team. Hoping for t

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

he best could hardly have any meaning, provided the team lacks overall knowledge of the goals, customs, and the treasury of knowledge and practices of the over

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

Examples of combination products may in

ll organization in specific and cross-sector knowledge in general. It is crucial for the project implementation team to know alternative practices and strategi

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

es available within the organization, and current status of the project.

Leveraging the Existing Knowledge Base In Six Sigma

The knowledge levels expand as p

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

r the following in an enterprise:

1. The HOW and WHY of process flow, the implementation goals and the change management strategies

2. Knowledge about the en

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

Combination pro

erprise including the goals and the current juxtaposition, alternatives, etc.

But it is easily noticeable that the availability of ready information on both i

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

s chronically lacking. The way to move ahead in situations such as this can be with the trusted tools of knowledge sharing such as brainstorming, innovation an

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

organizing ideas which help get ideas out of the box.

At the core, Six Sigma isn't self-sufficient and it somehow inexplicably still remains in a rut that it

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

is enough to be experienced about problem solving whenever one is encountered. So, as a logical consequence, it cultivates habits which draw lines between too

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

-specific knowledge and overall knowledge which leads to lost opportunities due to lack of initiatives for innovations and broader perspectives.

Valuable Area

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

For Knowledge Beyond The Project

Enterprise-wide knowledge is quite capable of an all around contribution to the overall cause of the Six Sigma implementatio

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

Following aspects would a

n. Tackling a multi-faceted problem with problem-specific specialization is futile and will blunt the effectiveness of the project team.

Take a look at DMAIC

dd to the challenges in developing combination products:

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

gain; in the measurement stage, selecting the right metric is only half the job. But knowledge that tells you how to simplify and foolproof it; and in the cont

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

rol stage questioning things rationally: how could anything be sound? Why couldn't there be mistakes, how can measurement and control processes be automated fo

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

best of implementation, etc.

Opportunities for Leveraging Enterprise Wide Knowledge

Take the 2 instances that are extremely effective ways of bringing knowl

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

dge to surface.

1. Retrospect- Looking back to review as to the gains of pilot project or an actual project and the reports of a review committee. Retrospect

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

Professional from academic institutions, pharmaceutical industries, health care indust

helps to gain insight into the reasons of success or failures.

2. Action Reviews- This is a fact-finding exercise which focuses on the slippage between two pa

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

ameters, such as what has happened and what was planned.

Accessing enterprise knowledge can't be possible just by forceful ownership. Use of congenial and fac

.

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

ilitation techniques must be resorted to, to bring out cross-departmental knowledge. Some other techniques to bring such knowledge to the surface are below:

1

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

Companies that provide selfless information through particip

Peer Assist programs by face to face interactions

2. Evaluating contextual relations between projects

3. Final, stage-specific, project documentatio

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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