E-Folder - Business

"If you go to work on your goals, your goals will go to work on you. Whatever good things we build end up building us.” (Jim Rohn)

How is your first quarter of this year going so far? M

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

any organisations and the people in them start 2007 with boundless energy, hope and eagerness to reach new goals, to succeed even more than last year, to change for the better. Some cele

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

Examples of combination products may in

rate their achievements with champagne while others who weren’t so lucky hide in shame. What exactly turns a goal into gold?

A simple threesome does: Give Tools - Go Test - Gain Trust.

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

1. Give tools

Nothing is more frustrating than to start working towards your goal and not having the tools. This insight is often discovered while the project is already on its way inst

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

ad of being analysed beforehand.

Solution: check with your colleagues, management, clients, suppliers, business partners what is needed first. Make a list of the what, where, when, why

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

Combination pro

nd who and communicate that to all. Decide what budget is available and what can (not) be done. Create alternative scenarios.

2. Go test

To avoid disappointment it is wise to test your

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

new strategy. Do a test run with some customers. Ask a business partner to test the service or product among colleagues or ask someone outside the industry. Check if the new development

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

is in line with your company’s core values. Test half way through the project and adjust if necessary. Know that there is no end to testing: decide when you feel it is right, don’t let i

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

formation overwhelm you, trust yourself.

3. Gain trust

A goal means change. People don’t like change. Changing people is harder than setting a goal. People are wise to know what can an

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

can not be done. Ask your team and business partners to create the goal with you. Hold brainstorm sessions, do a survey to get feedback, organise a goal setting event. Most of all: be

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

lear on the why of the project. Keep people informed on every step and allow time for feedback and adjustments. Make sure you present the ideas that were implemented. Nothing is more fru

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

Following aspects would a

strating than realising that the proposed suggestions or the complete project itself were never put into practise. It kills trust.

Focus on Feelings

Goalsetting is easy. The steps that

dd to the challenges in developing combination products:

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

lead to your success are more important. Spell them out. Then celebrate each step that brought you forward and don’t wait for the champagne after the complete goal has been reached. Keep

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

up the spirit by having a ‘failure feast’ and acknowledge that most temporary obstacles are lessons prior to success. Dare to leave your rational mind at home and have a ‘focus on feelin

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

s’ debrief of the project. Ask your colleagues how they feel about the journey so far. What is hard, what is fun, what is annoying, what is going against your feelings? Most problems are

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

hidden behind a rational list of solutions while underneath fear, anger, disappointment, frustration are sabotaging the outcomes. It will solve many obstacles by addressing emotions open

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

Professional from academic institutions, pharmaceutical industries, health care indust

ly. More important: it will release lots of energy that can be poured into the new project.

Move from your mind to your heart. Check what your gut feeling or intuition is saying about t

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

e logical steps towards a goal. Express yourself and say “what about the pressure this will put on our small team?”, “what will happen with the waste we produce?”, “why increase the prof

.

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

t when we are doing great already? Isn’t it time to share our abundance?”.

The heart of goal setting is in the human heart: how do I, you, our client and our environment feel about this

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

Companies that provide selfless information through particip

goal? Achieving goals with positive bottom line figures is just a by-product. Find a balance outside your balance sheet and turn your human capital into gold and don’t forget: dream bold

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.e-folder.org.ua/article/44444/e-folder-Into-The-Goal-Mine--The-Heart-Of-Goal-Setting.html">Into The Goal Mine - The Heart Of Goal Setting</a>

BB link (for phorums):
[url=http://www.e-folder.org.ua/article/44444/e-folder-Into-The-Goal-Mine--The-Heart-Of-Goal-Setting.html]Into The Goal Mine - The Heart Of Goal Setting[/url]

Liquor Control Systems are a revolutionary technology that may just change the way bar sales are handled. It is a spout that goes on top the bottle of liquor that measures the amount of liquid poured. As the liquid is poured a wireless transmitter measures liquor and sends that information to a computer which then totals the price. Pretty amazing huh!

Cutting fluids in machine tool environments can cause serious health problems for workers. Using a Mist Eliminator greatly reduces the risk.

Follow along with Jane and Bob, fearless management heroes, as they traverse the depths of work environments and pull together a team, while taking into consideration work styles of leaders and team members alike!

Tags

Links

E-Folder - Into The Goal Mine - The Heart Of Goal Setting

Related Articles: