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It's important to understand when to add individuals to your business model. Adding a new team member should be an easy transition - that’s where organization comes in. Clearly de

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

fined processes such as workflow, workspace, filing system, and other key functions in the business should be identified. Structure is one of the most overlooked aspects of business succe

; 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 – especially time management and documentation structures.

As the business owner, you have to be disciplined in order to allocate and delegate work to someone else. If you’re not disc

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

plined, focused, and organized - how can you expect for your new team member to function efficiently?

Don't forget the most crucial ingredient; you must have something for them to do and

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

it must not interfere with your workflow. If you don’t know what tasks you want your new team member to handle, how is he or she going to know how to help you?

So how do you get prepared

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

Combination pro

for adding new team members? Here are some quick tips to get you started:

1. Begin by planning time to work on your business each week.

This time should be focused exclusively

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

n your business without interruption from the phones, the Internet and e-mail, or appointments. You have to be disciplined in order to allocate and delegate work to someone else. This fo

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

cused time will keep your business in line with your vision.

2. Identify what you need in the form of a bulleted task list.

Detail this task list for each business function, i.e.

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

marketing, accounting, administrative, operations, management, production, distribution, sales, web site maintenance, etc.

3. Define the skill sets and personality types that best f

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

t your needs.

Don't try to clone yourself; it doesn't work.

As part of the outlined tasks, have specific, measurable goals within each business function. Side Bar: I remember when

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

I was interviewing for a corporate job years ago, I had to interview with six people in sequence. Each gave me a different description of the job. Although I figured that the manager had

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

Following aspects would a

he correct job description, I realized that the company had some challenges and I decided not to work there. Detailing your goals for each business function will ensure you get the righ

dd to the challenges in developing combination products:

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

people on your team.

4. Do your homework to determine what it will cost you to add new team members.

You may only need a virtual assistant to get started - just do your resear

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

h to make the best decision. Start by reviewing your budget for the year. You could hire someone to work just 30 hours a month at $12 per hour to provide support. Be creative with your

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

budget and enlist the help of contractors or collaborating with other businesses as an alternative to hiring employees.

5. Be sure your communication tools (email, phone, mobile, pa

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

m) are in place before you incorporate new team members.

You want your new team members to use your company's communication tools as they communicate on your behalf to ensure a consi

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

Professional from academic institutions, pharmaceutical industries, health care indust

tent image.

6. Once you have team members in place:

Communicate – Be sure your team members understand your expectations and understands the steps he or she needs to take to meet

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

these expectations.

Be patient and expect to hit some bumps in the road. It takes time to figure out what works and what doesn’t work. Flexibility is key during the learning process. I r

.

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

commend being up front in the interview in order to set the expectations on the front end vs.. waiting until a mistake happens..

Appreciate – As Bill Catlette and Richard Hadden write, “

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

Companies that provide selfless information through particip

ontented Cows Give Better Milk.” Your team members will be more motivated if you regularly demonstrate your appreciation of his or her hard work.

© 2003-2006 Effici?, Inc. Sherese Johnso

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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