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It's been another 12 hour day. Your other half is upset that you missed dinner - again. Your kids can't remember what you look like. You're exhausted and after the 942nd time your mastermind group has told you to hire some help you are finally r

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

eady. But now what? How do you even begin trying to figure out what someone should do? Don't worry, it's not as hard as you think. Below are 4 steps with specific actions to take to ensure you get find the right person and get the most bang

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

Examples of combination products may in

or your buck.

#1 Create a job description The biggest mistake I see over and over again is business owners simply hiring someone and throwing them at the problem without any rhyme or reason. If you are not clear about what you want this person

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

o do for you, how are they supposed to know? Your great new assistant anxiously wants to help out, but can't because you have no clue what to ask them to do. With a little planning, you can be prepared to answer the magic question, "what should

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

do now?"

Your actions: Start by creating your own job description. Make a list of everything you are currently handling. Things like writing proposals, making phone calls, sending out invoices. Once you have your list, put an "x" next to the t

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

Combination pro

ings you want to keep. The rest are all potential items to add to your assistant's job description.

#2 Show me the skills! Now that you have this great list of tasks and responsibilities, break it down into the skills needed to perform those ta

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

ks. For example, if you need someone who will be making lots of phone calls, you will be looking for someone with a good phone voice. Maybe someone who has telemarketing experience.

Your actions: Define what skill sets you are looking for, not

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

just skills such as typing and budgeting, but ways of thinking, and personality traits such as honesty, integrity and being a self-starter. Write a list of opened ended interview questions and at the end of your interview look to see if the pers

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

n has the skills and traits you are looking for.

#3 Write the perfect ad Turn your wants and needs into an ad. You are more likely to get the kind of candidates you want if you specify what you are really looking for. An ad that reads, "Admin A

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

sistant" is liable to get a range of results from someone looking to work full time for $50K per year to someone looking for $8 an hour part-time gig. If you are looking for someone to work 5 hours a week for $10 an hour, make sure you state tha

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

. If you don't specify these details, I guarantee that the perfect candidate will be in your pile. But, she will want a whole lot more time and money than you can afford.

Your actions: Create a clear ad that includes what the job is, how many h

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

Following aspects would a

urs, the approximate pay, where the position is and what you are looking for. Place the ad on low costs sites such as www.craigslist.com . Or try some local charity and religious organizations. Many have job placement programs. Call to see if th

dd to the challenges in developing combination products:

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

y offer free listings.

#4 Create an atmosphere of success: Now you've got the right person. Set them up for success. Create the behind the scenes processes you want them to follow so that you know they are completing things the way you want it

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

one. And remember, document, document, document, (did I say document?) what they are doing.

You never know when an emergency is going to come up. Save yourself time, energy and frustration by capturing all that they do so that it is easily pass

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

ed on to a replacement. You will have turn over - count on it. But it won't be a big deal if you set yourself up for success by having documented processes and systems. This results in not having to recreate the wheel every time you bring a new

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

erson in.

Your actions: Create systemized, documented processes and procedures that can be followed and passed on should your new person not fit the bill or choose to leave.

Before you actually start paying someone, check with your attorney or

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

Professional from academic institutions, pharmaceutical industries, health care indust

accountant to make sure you are paying the person correctly. There are specific regulations regarding the difference between independent contractors and employees. You don't want to end up with a bunch of fines.

Good luck and happy hiring.

© 2

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

05 Beth Schneider. Want to reprint this article, feel free as long as you include the following: Beth Schneider, Chief Infopreneur of Process Prodigy, is a business process consultant who helps solo-entrepreneurs, small business owners and netwo

.

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

k marketers who want to systemize their business to increase profits, increase productivity and grow their business without having to give up the family oriented, flexible, balanced lifestyle they desire. Beth works one-on-one with her clients,

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

Companies that provide selfless information through particip

ffers home study courses, and teleclass boot camps. For more information visit http://www.processprodigy.com and sign up for your FR*EE 5- Step Process Starter Kit and FR*EE Process Tips

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 can't be that every business owner embarks on a quest to make life unpleasant for their customers. Certainly there are those who despise their clients but most are genuinely shocked when you have had an unpleasant experience. Their complaint is usually that they did not know.

There are always more things to do than you have the time or money to manage. How you are able to cope with this situation determines whether you have a chance of becoming a successful business owner.

There are five critical factors that can measure whether your acquisition is working perfectly or not. This article will outline the critical factors and how you can guage whether you are on the right track or not.

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