Useful Advices - Business

The short answer is, “Yes!”

The longer answer is, “Yes, and here’s why.”

Have you ever had the unfortunate experience of working where management does not fully realize or understand the value of invest

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

ing the extra time and effort required for quality improvement? Such an experience is certainly not uncommon. You really know the value of upper management support if you are in a corporate climate that d

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

Examples of combination products may in

esn’t support process improvement from the top on down.

Upper management support for Six Sigma is critical in two areas. First, the power and scope of Six Sigma demands a significant commitment from the

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

organization. This requires support from management to transcend departmental barriers. Second, any type of change in an organization will meet some resistance, either intentional or just by virtue of ine

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

tia. When upper management is behind that change, resistance can be countered and overcome.

You can't take on Six Sigma with a lackadaisical attitude. You can't implement it piecemeal. Six Sigma is not f

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

Combination pro

r dilettantes. If you’re in, you’re in deep, and you’re in for the long haul. Of course, for real and lasting process improvement, that is how it should be. Without a 100% management commitment to the Six

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

Sigma program, Six Sigma turns into just another "management program."

There will always be resistance to changes brought into an organization, and change requires continuous support, encouragement, 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

monitoring from top management to overcome that resistance. There are plenty of ways for projects to fail, and it is always convenient to blame the new tool. If you look hard enough though, if Six Sigma f

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

ils, the failure is clearly the fault of management. If management truly has their eye on the customer and is intent on providing quality products and services, then Six Sigma has a good choice for keepin

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

g everyone focused.

Everyone can agree that continuous process improvement is worthwhile, but obtaining the dedication of time and money to do it is often difficult. The support of upper management is an

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

absolute requirement for quality. The organization’s leaders set the agenda, make the rules, and authorize the resources. Without management's genuine commitment, your company's Six Sigma effort will find

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

Following aspects would a

it difficult, if not impossible, to achieve lasting improvement. Management buy-in is necessary but not sufficient. Leaders must literally lead the way and inspire people to engage and play their role.

W

dd to the challenges in developing combination products:

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

hen your senior management leaders are onboard, they can oversee the implementation of the Six Sigma effort. They can respond appropriately both to successes and to roadblocks. Six Sigma cannot be the sil

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

er bullet alone; it has to have complete support and commitment from all levels of the organization. There are many other quality improvement methodologies that have the capability to help organizations.

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

ne of the crucial differences between them and Six Sigma is that Six Sigma recognizes the requirement for complete organizational support and dedication.

Thus, Six Sigma is ideal for projects that requir

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

e cross-functional groups, and the solution is not apparent up front. Upper management needs to understand that implementation of Six Sigma needs to be more widespread in an organization than isolated pro

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

Professional from academic institutions, pharmaceutical industries, health care indust

ects. Management also plays a crucial role in focusing Six Sigma toward broad application. Management trained in the essentials of the Six Sigma methodology select the projects that are aligned with busin

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

ss goals. Then, these managers must select and mentor Six Sigma project leaders called “Belts.” Belts in turn are mentors to others who share their skills and seek to continually improve themselves, those

.

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

around them, and the organization as a whole. The Six Sigma mentoring concept and the insistence on senior management buy-in are excellent ways of focusing issues related to the implementation of Six Sig

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

Companies that provide selfless information through particip

a throughout the organization. When upper management holds up Six Sigma as the method by which an organization defines and implements change throughout its structure, significant and lasting change ensues

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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Over the years you will be asked by both prospects and customers to have your company create, build or supply a product, service or capability that is not part of your standard line. You need to get some answers to determine the significance your prospect places on this opportunity. You need information too.

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