Digg It - Business

Deploying Six Sigma means entering a period of significant change in your organization. Productivity and morale almost always suffers in times of great change. The requirements of change and adaptation

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

and the very human fear of the unknown add to stresses of the work environment. In these times, communication becomes more important than ever.

Communication throughout a Six Sigma project is very im

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

Examples of combination products may in

portant because the power and scope of Six Sigma demands a significant commitment from everyone in the organization. Six Sigma successes require clear and open communication at all levels to transcend

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

departmental barriers that would otherwise cause confusion. In addition, any change in an organization will meet some resistance, either intentional or just because of inertia. When management can effe

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

ctively communicate that it is behind that change and can communicate the positive aspects of the change, resistance can be countered and overcome.

Company leadership must be willing to give Six Sigma

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

Combination pro

teams all of the tools and information necessary to apply Six Sigma concepts to their day-to-day activities. It is crucial in Six Sigma projects to clarify the rationale, expectations, goals, and sequ

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

ence of steps in the process. Six Sigma teams with clear, written goals accomplish far more in a shorter period of time than teams without them could ever imagine. This is true everywhere and under all

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

circumstances. Documentation of the Six Sigma process is the opportunity to resolve any misunderstandings of the deployment. A schedule is developed that outlines the strategy to take the process from

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

its current state to one that is within statistical control and in line with the company's Six Sigma goals. Roles need to be clearly defined in how individuals contribute to the schedule and strategy.

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

Employees assess how they can contribute to the organization through the information they receive. A team's quality goals should be set to tie in with the overall company quality improvement goals. Th

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

s happens only when the team has the knowledge they need.

Lack of clarity in communicating business information is probably more responsible for frustration and underachievement than any other single

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

Following aspects would a

factor. It is unfortunately way too easy to not realize that communication is falling short of your organization's needs. Often senior managers sincerely believe they are adequately communicating with

dd to the challenges in developing combination products:

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

employees. However, managers can easily underestimate the number of issues on which employees need information and how much information they need.

How do you know what is important to employees and wh

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

at to tell them? You need to put yourself in the position of the employees. If you were that person, what would be important for you to know to do your job? What would you be worried about in the curre

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

nt situation? What information would help you deal with change? How would you want to be told? You can't answer those questions yourself. You need input from the very people you are trying to understan

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

d. Communication is a two-way street—listening as well as talking. Asking a few individuals what is being said, what people are worrying and wondering about.

Also be aware that the way a person receiv

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

Professional from academic institutions, pharmaceutical industries, health care indust

es news can dramatically affect how he or she feels about it, so you need to choose the medium very carefully. E-mail can be perceived as cold and unfeeling, although it is useful for routine updates t

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

hat don't have emotional overtones. Many messages are better delivered in person, either to individuals or to the team as a whole.

Communication skills take practice. Always be sure the message remain

.

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

s honest, clear and compassionate. Have integrity and build trust. Don't say what you don't mean. Don't promise anything that you cannot or will not fulfill. Above all, follow through on your commitmen

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

Companies that provide selfless information through particip

ts and promises. Nothing turns employees off more than feeling betrayed. Sincere, caring, and constant communication will form the basis for building employee engagement throughout Six Sigma deployment

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/23298/diggit-Communication-in-Six-Sigma.html">Communication in Six Sigma</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/23298/diggit-Communication-in-Six-Sigma.html]Communication in Six Sigma[/url]

Personal leadership builds on uniqueness, and the ability to differentiate, read how.

If you plan to succeed in today’s marketplace, there are three types of people you must have in your professional life.

For most employees, losing their job is a fearsome and ever-present possibility. As your own CEO, you'll never again feel like you're walking a tightrope without a net.

Tags

Links

Digg It - Communication in Six Sigma

Related Articles: