Advice You - Business

What?

In college, we evaluated a case study called The Parable of the Spindle. One of the mai

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

n points of the case was that in many restaurants, cooks and chefs were considered higher status employees than waiter

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

Examples of combination products may in

s. Whether this was right or wrong is not the point. The point is that waiters were “giving orders” to the cooks and t

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

his caused considerable tension. Someone came up with the idea of using a spindle, like you still see in many restaura

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

nt kitchens.

The spindle solves several problems. The waiters no longer give the cooks verbal orders. The written ord

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

Combination pro

ers are attached to the spindle and submitted in a much more organized fashion. It is easier for the cooks to decide w

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

hat to do next; the spindle rotates and the orders come up in priority order. Everybody feels more comfortable and the

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

new process helps get things done in a more organized and appropriate fashion.

So What?

If this si

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

mple process works for cooks and waiters…it will work for you and your projects.

Now What?

All the

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

popular word processing software programs have a “table” function. You can easily create tables to serve as your “elec

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

ronic spindle” for projects you work on or manage. Although sophisticated project management software is available, a

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

Following aspects would a

word processing table document is a simple solution that’s easy to learn. Simply create a table with the following col

dd to the challenges in developing combination products:

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

umns:

Category of the item (for example, People, Products, Processes, Resources or any categories that make s

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

ense for your particular project)

What is to be done

Who will do it

When they will do it

A column

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

for general comments, if needed

A column to keep up with the status of the item (in-process, completed, etc.)

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

ul>

Then, sort the table by date and you are ready to get started on your project. This is also a great way to

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

Professional from academic institutions, pharmaceutical industries, health care indust

monitor the progress of projects you manage. You simply glance at the table each day and see what is scheduled for co

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

mpletion and what is still pending. You can revise the document and re-sort it if unexpected items need to be added to

.

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

the project plan. It’s a great way to stay on top of anything that is important to you.

There are three pote

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

Companies that provide selfless information through particip

ntial problems with planning…no planning, not enough planning and overplanning. Keep it as simple as possible.

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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