E-Folder - Business

Strategic planning is the process of reviewing where one is, identifying where one wants to g

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

o, and developing plans to get from the current to the future state. Hopefully most business

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

Examples of combination products may in

professionals and organizations know and do this.

However, there’s another aspect of strateg

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, emergent planning, that needs to be leveraged. Emergent planning is paying attention to w

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

at the market is telling you, regardless of whether it supports or is different from your str

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

Combination pro

ategic plan.

Why is both strategic and emergent planning necessary or useful? Because strat

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

gic planning gives us a vision and roadmap … a way to guide our day-to-day behavior towards 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

he future. However, emergent planning is the process of recognizing that our business world

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

and the society within which we live our personal life) is a complex adaptive system.

Here’s

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

an example. As a consultant I develop an annual strategic plan, identifying which products/

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

ervices I would like to provide to which market niches, and lay out activities to develop, ma

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

Following aspects would a

rket and deliver according to these plans. However, often the marketplace has come to me and

dd to the challenges in developing combination products:

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

asked me for something I hadn’t planned to offer. In nearly every case this new opportunity

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

has turned out to create a dramatic growth in my business.

You might wonder, then, why bothe

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

with strategic planning. Why not just wait till you get one of those emergent gifts? One o

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

bvious reason is that you never know whether or when they’ll come along. For another, becaus

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

Professional from academic institutions, pharmaceutical industries, health care indust

the strategic planning process helps you identify/clarify your core competencies, and when a

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

n emergent opportunity arises, it’s much easier to know whether or not you should consider it

.

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

In effect, it’s all about being clear about what you want, but being flexible for what the

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

Companies that provide selfless information through particip

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/44513/e-folder-A-Dual-Strategy-Doubles-the-Chances-of-Success.html">A Dual Strategy Doubles the Chances of Success</a>

BB link (for phorums):
[url=http://www.e-folder.org.ua/article/44513/e-folder-A-Dual-Strategy-Doubles-the-Chances-of-Success.html]A Dual Strategy Doubles the Chances of Success[/url]

If you want to have more control over your career, consider freelancing. This article gives you the tips you need to get started and avoid the common pitfalls of working for yourself.

Your customers don't know what they want. And to assume otherwise is folly. When you begin relying totally on customers to be your product development department, you are asking for serious trouble. It is behavior that you need to be learning about from your consumers. Ask them questions that will get to the heart of how they use your products and services. This is where their experience is crucial.

Tags

Links

E-Folder - A Dual Strategy Doubles the Chances of Success

Related Articles: