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A major problem that all small to medium sized growing businesses face lies in handling expansion and staffing. To get the most out of your staff, you want to hire at the ideal time – that exact time when you start ramping up and exceed normal ca

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

pacity. Here, there is no wasted time or money on unnecessary staff. But how do you know when the right time is? There is no way to predict the future. This article describes the few necessary steps that precede a staffing decision and details ho

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

Examples of combination products may in

to create the best possible timeline for your hiring.

So You Think You Can Staff?

Assess the situation – To go from Point A to Point B, you have to know where Point A really is. Without assessing your

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

current situation, you will have no idea as to how you should proceed. Sit down and look at your current business model. Crunch some numbers to find out how your staff is being utilized. Are you nearing capacity in your normal day-to-day operati

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

ns? Has there been an increase in the number of your customers? These are good signs that you need to hire more help. But these are also the most obvious tip-offs.

If you plan on expanding your business into other markets by taking on new produc

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

Combination pro

ts or services or by bringing outsourced jobs in-house, then you really need a clear view of how your future business will operate.

Develop a business model – The next step plans the trip you will take from Point A to Point B. S

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

t down with someone who has an accounting, strategic management, or consulting background and outline the next few quarters or even the next few years of your business under the new model. You can hire someone on an hourly basis or work with some

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

one already in your company. Just make sure this person can help you develop the best possible model possible. Plan everything out to the finest detail. What new tasks will there be? How long will they take? How do these tasks interact with each

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

ther? How many people will be needed for each task? How much will you pay each person? Will the pricing in your expanded business be able to cover new salaries and fixed costs associated with ramping up? What are the critical points in the timeli

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

ne where equipment and staff must be added? And, most importantly, where is the break even?

Keep asking questions even after you’re done with the model. Revisit it as often as you can to get a fresh look at it.

Filling the jobs

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

– Now that you’ve planned out all the new tasks associated with your expansion, you need to think of the jobs that go along with them. Even more questions arise. Do you need multiple people to do one job? Can one person handle multiple jobs? Can

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

Following aspects would a

he current staff take over some operations for a few months to save money? What kind of strain would this place on the current staff?

Start assessing your business environment and the social aspects of how your business currently runs. Is it ver

dd to the challenges in developing combination products:

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

y businesslike or is it a more casual environment? Think about the type of person that would have the best fit with your business. Look at the tradeoffs between skills and personality. Is the job this person would be doing so hard that you need t

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

focus more on skills? Or is there some leeway in the position where you could focus on a person who fits your business environment more?

Plan, Prepare, Analyze, Wait, and THEN Hire:

Plan in the long term. This is wher

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

e developing a business model comes in. Find the most likely outcome of your future growth and plan staff accordingly. Mark critical points in your timeline where you know you will have to take on extra help. But be sure to plan in terms of capac

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

ty, not time.

If you are hiring a person to work on a certain task and your business is growing, you’ll want to think about how this person will get along with other people. You may eventually have to hire two people to work side-by-side on the

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

Professional from academic institutions, pharmaceutical industries, health care indust

same task. And have contingency plans if people want to go on vacation or suddenly quit on you. It’s best if you plan coverage where certain people can temporarily fulfill two tasks at the same quality when others are unable to work.

Look at the

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

tradeoffs between their current experience and their ability to learn. Is this person overqualified or under qualified? You can always hire someone who is lacking in skills but has proven his or her ability to learn and adapt quickly. Remember, y

.

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

ou’re planning on growing your company and an adaptable person like this can be very beneficial.

Take the time and find the right person. If this employee is going to grow with your company, you need to make the correct choice. NEVER get hasty a

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

Companies that provide selfless information through particip

d offer someone a position right after an interview. Interview all applicants at least once. Meet informally over lunch. Know their history, goals, and deepest desires. This person has to mesh well with your company. Just remember to take it slow

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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