Main Subject - Business

Project heroes. We’ve all heard of them. Some of us have even seen them. A project is in jeopardy.

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

This guy (or gal) comes out of nowhere, analyzes the situation, tells you exactly what the problem is

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

Examples of combination products may in

, and then goes on to fix it before you can even update your project plan!

Some project managers plac

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

e a high level of trust in project heroes. As a result, their superman (or superwoman) is assigned to

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

the most fascinating projects and their technical decisions and sizings are never challenged. In the

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

Combination pro

meanwhile, the rest of the development team implements banal functionality or fixes defects.

What

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

’s Wrong With This Picture?

Well, for one thing, too many project managers pick heroes based on t

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

eir can-do attitudes instead of their ability to consistently deliver software on time and according t

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

o specs. As a result, developers who are fed up with boring tasks and want to be treated as heroes sud

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

denly become overly optimistic when asked to size features.

Additionally, I’ve seen many so-called he

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

roes hold up entire companies because they wouldn’t admit that they were having trouble meeting their

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

Following aspects would a

schedule. By blindly trusting everything your champion tells you, you undercut your ability to take

dd to the challenges in developing combination products:

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

corrective action in a timely manner.

Finally, an emphasis on project heroes discourages cooperation

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

among the many stakeholders in the software development process since many champs tend to undermine th

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

ir peers.

Asking a developer to justify his estimate doesn’t mean you don’t trust him. Asking for a

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

second opinion doesn’t suggests she is incompetent. It simply proves that you understand risk is part

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

Professional from academic institutions, pharmaceutical industries, health care indust

of any project and that you do your best to assess and minimize it.

Giving carte blanche to project

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

heroes sometimes – but rarely – leads to high-quality software developed in record time. More often t

.

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

han not, the result is a pattern of schedule slips that are not acknowledged or reported until it’s to

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

Companies that provide selfless information through particip

o late, built up frustration amongst team members, and a lot of I told you so when your champion fails

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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It is great to be young and to have that entrepreneurial spirit. Many businesses have been made successful with this concept of youthful enthusiasm and mature approach.

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Leaders in businesses set the standards and the pace for their people. And sometimes it is surprising how much their people look to them to show the way. So if you are the boss, take it for granted that your behaviours are being seen, and you can use this emphatically to be a model for the character of your business. Read on to find out how...

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