Cases - Business

Somebody asked me recently: how come you don’t have a ‘big’ name to project your business and attract people with the grandeur? As it usually goes together, present

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 oneself big implies that there will great results. My ego was attacked (I thought) and I felt the usual twist in my stomach while bravely defending the name of

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

Examples of combination products may in

mall Steps. I talked about having a logo that ‘looks big’, about a Chinese name that ‘sounds big’ and then I came to the philosophy of small steps and what it reall

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

y means. I thought of Lao Tze’s wisdom: “If you want to be fast, go slow” and it all fell into place as Chinese philosophy once again supplied a solid explanation 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

just one line.

Why Small Steps?

It is understandable that people perceive their own problems as huge obstacles that can’t be overcome easily, oth

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

Combination pro

rwise they wouldn’t contact a coach for assistance. Clients often come to me and ask for some great miracle that will take away the great burden that they have. And

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

it is only natural that a coach may sway with the clients’ perspective and indeed suggest great changes when listening and asking questions. However, a sudden big

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

hange can induce an avalanche of stress and confusion, emotional reactions start exploding like a newly awakened volcano, while the person is trying to pick up on t

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

he new challenges that these changes bring. To put it simply I’ll quote the famous proverb: “Be careful what you wish for – you may get it!”

Recently I wo

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

ked with a client interested in changing their career, which would be a big change that they had been striving towards for a long time. Understandably, there was a

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

ose of fear preventing them from moving forward. I generally believe that people can follow their dreams and money will come effortlessly, but suggesting such a jum

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

Following aspects would a

p to this client would mean working with a large fear factor and crossing many boundaries heading straight for the risk zone. Instead, the client created a financia

dd to the challenges in developing combination products:

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

plan and visualized their desired future in which they were ready to leave their current work and start with a new profession. The client is ready for the change w

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

hen their confidence increases, in the meantime you ask yourself (and them) what is the smallest step that they could make to demonstrate that they are moving towar

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

the desired future. Keep adding steps like polishing a sculpture before you are ready to show it to the world.

With changes taken in small steps we create a rippl

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

effect: one after the other more changes follow and initiate the creation of lasting positive change. These changes may include changes of attitude, adjustment of

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

Professional from academic institutions, pharmaceutical industries, health care indust

beliefs, even something as simple as clearing your working space to create more clarity in how to manage your time and work efficiently.

As Insoo Kim Berg and Pete

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

Szabo in “Brief Coaching for Lasting Solutions” say:

Just having a map of where we want to go is the first step of a thousand-mile journey. Since the nex

.

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 step of carrying out the plan depends on the client, and not on the coach, the next phase of discussion must center on what the client needs to do to carry out wh

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

Companies that provide selfless information through particip

ch step first and what comes second, third, and so on.

Enjoy the art of taking the small steps to inspiring change!

Copyright 2006 Dalida Turkovic

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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When a product is first launched into a market a firm will have to decide what price to charge.

In this final installment of medical billing and the electronic transmission of claims, we will be covering the last record in a claim file, the ZA0 claim trailer record.

Resumes by nature are meant to inform, impress, and inspire a potential employer and get the employer to want to talk to you. Most employers only spend about twenty seconds looking at each resume they receive, and worse, most employers view the information contained on resumes as a way to weed out applicants . Putting your best foot forward to present a concise, compelling case for why you should be hired is crucial to getting you invited to the party.

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