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Six Sigma is not just for large multinational corporations. While there are difficulties inherent in implementing Six Sigma in a small company rather than a large business they can be overcome. Six Sigma can work in any size

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

business because the nature of Six Sigma is dependent upon characteristics inherent in any business, not on the size of a business. Smaller organizations frequently are short on resources and expertise in change initiatives.

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

Examples of combination products may in

owever, they also have more flexible process flows, a shorter decision-making chain, and higher visibility of senior management. Smaller organizations can actually effectively establish Six Sigma faster than large businesses

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

if deployment scope is correctly managed.

Scope of Deployment

Six Sigma is designed for all-inclusive deployment across an organization. However, s maller organizations do have constraints that limit their ability to initia

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

e a large scale Six Sigma implementation. If your organization does not have the resources to create an infrastructure for organization-wide Six Sigma deployment then start with a pilot program.

One of the beauties of Six Si

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

Combination pro

ma is that its central methodology is scalable. Six Sigma, emphasizes intensive training and extensive analysis—qualitative characteristics that work regardless of the size of the organization. Likewise, Six Sigma DMAIC (desi

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

gn, measure, analyze, improve, and control) discipline s work no matter the size of the organization or even the size of the Six Sigma project. Even a small Six Sigma project can yield significant results. Breakthrough improv

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

ments in processes and bottom-line profitability come not from quantity of resources, but the quality and the intelligence with which they are employed.

Small and medium-sized organizations may not have the resources of larg

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

r companies; however, in most cases, smaller organizations can be more nimble, flexible, and focused on results. Approaching initial implementation of Six Sigma through a pilot program will yield tangible results without over

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

whelming your resources from a small “quick-hit” project. These results can then be replicated throughout the organization, in many cases even faster than in a large organization.

Issues Critical to Smaller Organizations

Wh

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

n deploying a pilot Six Sigma project there are several important issues to consider inherent to smaller organizations. First, the choice of a project is critical. The pilot project will set the tone for Six Sigma deployment,

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

Following aspects would a

so it should be a good one that can show significant and visible results in a reasonably short period of time. The project must clearly address one or more business goals thereby contributing to one or more core enterprise me

dd to the challenges in developing combination products:

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

asures. Each project must also be completable within three to four months, so careful upfront scoping is essential. Projects must be continually tracked and updated for line management during existing business reviews.

Anoth

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

r issue is training. In smaller organizations, training budgets and especially time available to devote personnel for training is limited. Thus, it is not always practical for personnel to be absent from their day-to-day duti

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

s to attend months of training. Fortunately, there are some Six Sigma consultants who can deliver required Six Sigma training in an accelerated format and even onsite. Thus, smaller organizations can give their people the nee

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

ded training with less disruption to their normal business, improving internal synergy while providing greater organizational flexibility.

Six Sigma implementation teams can encounter critical resource restrictions, often du

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

Professional from academic institutions, pharmaceutical industries, health care indust

to a personnel limitation where people are available for project functions only on a part-time basis. It is essential at project inception that the right people are involved, doing the right things. A small but committed for

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

e of the right people with proper training, given the proper authority will go far in getting things started. Good and fluid communication is also critical.

Upon successful completion of the Six Sigma pilot, the scale of the

.

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

deployment is then expanded to other areas of the organization, incorporating the lessons learned from the pilot project. Just as it is much harder for a large ship to turn than a small ship, smaller organizations can change

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

Companies that provide selfless information through particip

and adapt more quickly than large organizations. That does not mean that small organizations will automatically be successful when deploying Six Sigma, but making change take place and getting buy in to the changes are easier

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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