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No grouping of human beings is without some amount of politics. Managing deployment of Six Sigma in your organization will unavoidably run into some personal issues and conflict. However, with deft handling of the personal and po

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

litical issues that come up, along with patience and perseverance, your Six Sigma deployment will not get derailed.

Political factors that can affect a Six Sigma project include personal resistance to change, inflexible company

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

Examples of combination products may in

policies, and incompatibility with existing organizational methods and goals. Not surprisingly, all of these factors also affect business processes of any kind. They are not unique to Six Sigma. This is one of Six Sigma's strengt

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

hs: realistically acknowledging the way politics work in an organization. Six Sigma is not just number crunching. It understands the importance of and encourages the involvement of people throughout and at all levels of the organ

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

ization working together toward a common goal. Six Sigma encourages planning, communication, and openness about processes, procedures, and information.

Many people see change, any change, as loss—a loss of their power or a loss

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

Combination pro

f the security of the old way of doing things. Thus, people are prone to defend the old way, out of habit and out of unease. They wonder how change will affect them and what exactly happens behind the scenes and if they don't kno

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

w, become apprehensive. This is a problem that can be overcome through communication. Six Sigma successes require clear and open communication at all levels. Any change in an organization will meet some resistance, either intenti

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

onal or just from inertia. When management can effectively communicate that it is behind that change and can communicate the positive aspects of the change, resistance and “turf” politics can be countered and overcome.

Another p

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

roblem is people who disregard the value and power of Six Sigma and consequently, they are reluctant to support Six Sigma projects. To the uninitiated, Six Sigma may appear similar to or simply an evolution of other quality progr

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

ams. There have been so many quality improvement fads over the years. It is not surprising that people are now a little jaded. Others may see Six Sigma as solely another cost-cutting or productivity enhancement fad. This is a sho

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

t-sighted view. Six Sigma is neither a fad nor just another quality initiative. It is a “way of life.” It is a multi-level, cyclical movement toward continual process improvement. The quality improvement fads sell themselves as c

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

Following aspects would a

heap and easy quick fixes. The reality is that there are no quick fixes to significant process improvement. Six Sigma understands that; it is not a simple quick process. However, the right Six Sigma training and information will

dd to the challenges in developing combination products:

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

help people to understand that Six Sigma is significantly different; it is a robust continuous improvement strategy and process.

Once projects are begun, Six Sigma projects can become a battle of wills for control over which st

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

rategy, approach, or tool is used. Team meetings can devolve into arguments over which measurement to use, how it will be calculated, which charts will be generated, whether to use DMAIC or DMADV, etc. Six Sigma is not about maki

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

ng things more difficult. It is about using common sense to make things easier. It is certainly about recognizing that there is more than one road to improvement and more than one right answer to a problem.

In overcoming politic

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

l problems, the leadership of senior management is critical. Successful Six Sigma programs are built on a solid organizational foundation. The organizational structure and system needs to be clearly identified and communicated to

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

Professional from academic institutions, pharmaceutical industries, health care indust

the entire organization to successfully implement Six Sigma Quality. Becoming a Six Sigma organization doesn't just happen. Planning and training goes into setting up a successful Six Sigma organization. Employee roles and respo

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

nsibilities must be established and clearly communicated to all. For many companies successful in Six Sigma, the key factor has been the direct involvement of their top leaders.

Six Sigma is about getting everyone involved. A Si

.

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

x Sigma project forms a team of people who work together to identify problems and develop solutions. Such teams are not isolated teams rearranging the world for everyone else to live in. These teams are serving the organization b

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

Companies that provide selfless information through particip

y employing the skills and tools they have learned to increase quality and reduce defects. Instilling the team concept along with expert training will go a long way toward solving potential political troubles in your organization

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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When you sell your time, you sell your life. Maybe it's time for your personal Independence Day.

We take our medical billing software for granted. What we don't realize is the nightmares that programmers go through to get this software to us. What follows is a true account of one of those nightmares.

Whatever business organization is ventured into, the capital gain is what gets the most attention. Business procedures naturally generate a handsome amount of lucrative revenues. Service management is the term used to refer to the administering of serving producing companies. This is largely in contrast with that of the agricultural and manufacturing companies, because the term service management mostly applies to information and technology sectors and at times to auto repair and housekeeping industries.

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