Digg It - Business

Time is the sparsest of all resources. Use it wisely. It’s not so much about time management as it is about strategic management.

Management tends to focus

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

on the issues of the day more often than on strategic application. Each person in an executive team has areas that they are accountable for and these demand

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

Examples of combination products may in

ttention. Operational issues rise to the top and need attention. The squeaky wheel gets the oil. Strategic issues develop no fires, no embarrassments, and no

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

sudden breakdowns so it’s never an attention grabber. Many companies don’t get to see that they are missing strategic targets until the first quarter; even t

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

en they may dismiss the results as a blip in the economy and wait for the second quarter. It takes half the year to realize there is a problem. It will proba

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

Combination pro

ly take longer to get back on track. Which means another year of underperformance? Can you afford it?

So how does your team schedule strategic meetings. Do

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

you even schedule strategic meetings? If you analyze where your top management teams time is spent, you may be surprised to see what they spend it on. Execut

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

ve and management teams don’t need more than a few hours per month focusing on strategic direction but it needs to be quality time and it needs to be focused

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

As with dialogue and discussion, strategic action needs more decision making than discussion. Discussion leads to no further understanding but rather a del

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

y in decision making. Discussions around areas that have already been strategically determined are counterproductive and waste time. It was determined to be

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

f strategic importance when it was developed so let’s not refocus efforts in the wrong areas. Focus rather on making decisions.

Make sure your strategy meet

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

Following aspects would a

ings are not hijacked by the most current fire that’s being fought. Have another forum for operational meetings.

To ensure that you achieve the objectives o

dd to the challenges in developing combination products:

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

your strategy meeting:

1. Decide before the meeting which activities are valuable. This may be the team leader’s job or can be done in a quick whip around

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

-mail each manager assigning a point to each item.

2. Add a financial value to the ramifications of not doing anything. This will keep you focused on the im

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

ortant things.

3. Rapidly move items through the process of decision making. There is no point in having older items take valuable strategic time from the g

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

oup. Avoid analysis paralysis and keep things moving forward.

4. Ensure there are alternatives available for the team to make. Just as in a sales presentati

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

Professional from academic institutions, pharmaceutical industries, health care indust

on give the members a choice of three things to choose and let them understand the reasons behind their choices.

5. Develop a process for making strategic d

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

cisions. Let it be known and used to monitor and track outcomes.

6. Make sure that a decision once made is not reneged on by managers.

Ensuring that your s

.

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

rategic direction remains on track is important to an Organization. Following the above guidelines can be achieved by following the 'Best Year Yet' program.

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

Companies that provide selfless information through particip

For more information on time management read Stop Wasting Valuable Time by Michael C. Mankins, HBR September 2004 pp27 – 35. Read it to gain further insights

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/23746/diggit-Are-You-Wasting-Valuable-Time.html">Are You Wasting Valuable Time?</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/23746/diggit-Are-You-Wasting-Valuable-Time.html]Are You Wasting Valuable Time?[/url]

Thinking about future careers in Ireland? This article will help you choose the right CAO course and avoid last minute panic.

Great Human Resource professionals add value to any organization. But what can an organization do if they don’t have an HR professional on staff? They still must recruit, retain, pay, and develop their employees. So how can businesses successfully manage without a formal HR group? Here are 5 tips:

Tags

Links

Digg It - Are You Wasting Valuable Time?

Related Articles: