Just Answers - Business

Recognizing that the time had come to replace our hot water heater, my wife called our plumber to schedule an appointment. She placed the call at about 11 a.m. When the agent asked, “Would you

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

be available between one and three?” Lori asked, “Which day?” The agent replied “Today of course.”

Hearing a strange noise coming from our furnace, another call was placed. Again, the appoint

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

Examples of combination products may in

ment was made and the problem was solved the same day. (Are you surprised that the furnace and the plumbing company have the same ownership?)

Earlier this week my wife had a problem with her kn

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

ee and after seeing our family doctor she was referred to a knee specialist - a specialist considered one of the best in Indianapolis. When she called for an appointment, I feared the worst. I

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

nstead, she had an appointment within 24 hours.

My guess is that as you read each of these short stories. You are surprised at the service we received. The fact is, this level of service shou

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

Combination pro

ld be the norm, but sadly isn't. Our experience has lowered the expectations of most of us.

The Good News

The good news in these examples is that it is easier than ever to stand out.

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

When you are good, people will notice. When you are excellent, they will rave.

This goes for us personally, professionally, or as an organization.

Below are six steps that you can take to con

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

inue to raise your own standards of excellence. These steps will make it easier than ever to stand out, be noticed, and have greater levels of success and satisfaction.

What You Can Do

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

1. Get a current check on performance. Talk to those you served, whether your family, coworkers or Customers. Find out from them, how well you are doing in meeting their expectations.

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

Listen to their feedback. Don't justify your current performance or blame others. Simply listen.

2. Determine the standard they want. Again, ask your Customers or those you serve for

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

their input. Listen to their needs, wants and hopes.

3. Determine the standard you want. Remember that their expectations may not be very high based on their experience. Take their f

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

Following aspects would a

eedback and ideas into account, but remember that it is your responsibility to set the level of excellence you want to reach. Set the bar is high as you wish.

4. Under promise and over deli

dd to the challenges in developing combination products:

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

ver. Taking the first three steps will heighten awareness and likely raise expectations immediately. As you work to grow your standards remember that you can reach your goal is small steps

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

. Make promises based on your current capacity, not your fondest wish. Make the promise, then deliver more, then raise the level of your promise a bit the next time. Steady and slow wins the

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

ace – and remember it won’t take long to leave those you are racing with far behind. This approach will help you raise your standards, and the trust others have I you too.

5. Ask “what's no

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

t excellent?” This question will help you continue to find ways to improve your standards and delivery. Ask this question of yourself, of your teammates, and of other interested parties.

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

Professional from academic institutions, pharmaceutical industries, health care indust

6. Measure performance. You've set new standards for yourself. The only way to reach them and maintain them is to measure your performance against those standards. Depending on the sta

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

ndards you are setting this may be very simple or quite complex. Don't make the measurement more difficult than necessary, but remember to measure.

It is clear that these steps have obvious ap

.

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

plication for serving Customers better. While I encourage you to consider their applications to customer service, I also hope you will consider using them in other areas on your life.

It's tim

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

Companies that provide selfless information through particip

e to raise the bar. It's time to set new standards. Standards won’t raise themselves; we must raise them consciously and consistently. The steps above will help you take that conscious action

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.justanswers.org.ua/article/15373/justanswers-Creating-a-New-Standard-of-Excellence--Six-Things-You-Can-Do.html">Creating a New Standard of Excellence – Six Things You Can Do</a>

BB link (for phorums):
[url=http://www.justanswers.org.ua/article/15373/justanswers-Creating-a-New-Standard-of-Excellence--Six-Things-You-Can-Do.html]Creating a New Standard of Excellence – Six Things You Can Do[/url]

In Italy there are a lot of small and medium enterprises (SME) that often act as subcontractors to bigger firms. For example, most of the Italian shoes come from industrial districts, where the orga...

Everybody has heard the horror stories about bosses that don't care, bosses that take advantage of their employees, bosses who don't do their jobs, etc...

Is your name the one that will come to mind when counselors or professors need help or are asked for a student or recent grad to interview for a story? Don't overlook networking opportunities through your alma mater.

Tags

Links

Just Answers - Creating a New Standard of Excellence – Six Things You Can Do

Related Articles: