Main Subject - Business

You may be thinking that your business is just too small for BIG Project Management techniques, but that is simply not the case. Don’t let all of the fancy terms like Network diagram, Gantt chart, and

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

Work Breakdown Structure scare you. And don’t worry if you don’t know how to use Microsoft Project or Primavera or any other PM software application out there…you don’t need it.

Project Management i

; 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 about organizing your data for a specific project and updating it as the project progresses. You can use a Word document or an Excel spreadsheet if you like, as long as you have something documented

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

for your project, you are contributing to the success of that project.

Let’s review the definition of a project…a project has a beginning and an end date with defined resources. So if you have a pro

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

ject that must start tomorrow and end by next Friday with a set budget of $1000 and 2 contractors working on it…You have a project! And you can manage it effectively by starting with a pen and paper.

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

Combination pro

Not convinced yet? Okay, let’s review how we can accomplish this...

First you have to determine how many working days you have to complete the project, minus Holidays, Weekends (unless you are a work

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

aholic like me), and scheduled Vacations. So get your calendars out and start counting. Next, jot that number down for future use.

Now to breakdown the tasks. You can easily create a Work Breakdown S

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

tructure because it is nothing more than a highly glorified detailed outline. Level 0 is the main project goal, Level 1 is the first task, then you can add sub-tasks underneath it and move onto adding

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

your next level(s). For example, here would be a sample WBS for making French toast. *my personal favorite* 

Level 0 Make French toast
Level 1 Gather ingredients (or materials)
(it

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

is okay to list ingredients underneath level) ie spatula, pan, eggs, bread, cinnamon, etc…
Level 2 Preparations

Preheat pan

Add butter to pan

Beat egg into bowl with cinnamon

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

Level 3 Cook

Dip bread in egg mixture on both sides

Add bread to pan

Flip when one side is brown

Remove when other side is brown
Level 4 Clean Up

Wash pan and spatula<

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

Following aspects would a

br>

Rinse dishes and put in dishwasher

Put away ingredients

Clean table

I opted to not include the task of Eating, although it was tempting. ;-)

So now you have your tasks broken down in

dd to the challenges in developing combination products:

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

levels with sub-tasks, now you simply assign them. Next to each task put a person’s name, one of your resources. Then have them estimate how many hours, days or even minutes it will take to complete e

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

ach task. Always involve your staff in this process.

Now you are ready to do some basic calculations. Add up the hours (or whatever unit of measure you used) for each resource and multiple that by th

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

eir pay rate and Voila! You have a great beginning cost analysis for your project.

The next step would be to add in the cost of materials, expenses and such and add that to the beginning cost analysi

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

s figures and subtract from your total budget. Are you under or over budget? If under, Good for YOU! If over, you have to go back to your outline and see where you can cut down on the time for some of

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

Professional from academic institutions, pharmaceutical industries, health care indust

the tasks, or perhaps skimp a little on cheaper materials. Of better yet, what tasks can be done simultaneously! Your absolute last resort is to cut pay rates. You need your resources happy and produ

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

ctive. :-D

Once you have the numbers you want, take all of this information and plug it into a Word document with a table or bulleted list, or Excel with rows and columns.

Here are some tips:
•

.

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

Use cells in a table or cells in a spreadsheet to plot by day, week or task
• Use excel Sum button for totaling columns and rows with 1 click
• Highlight or Shade in color critical tasks th

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

Companies that provide selfless information through particip

at must be completed on time

Keeping it Simple is the key for Small Businesses such as myself, but believe me you are using the basic concepts of Project Management and you CAN be successful with it.

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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