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What is your staff doing today?

Chances are good that you could probably run down your list of direct reports and provide me with a fairly detailed summary of what each person needs to accomplish by

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

5 o’clock.

However, what if I asked what you wanted your staff to complete by the end of this week, month and year? Even better, what if I asked your staff? Would they have any idea?

This month, 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

am going address the challenge of setting clear and meaningful expectations and ensuring that your staff is consistently focused on your expected outcomes.

When I introduce this topic to business ow

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

ners/managers, I typically get the following response, “CJ, we don’t need to worry about this with my staff, they know exactly what I expect from them.” Unfortunately, after I meet with the staff I u

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

ually find that although they have a good understanding of the tactical duties they need to complete each day, they struggle answering the following questions:

What is the direction of your departmen

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

Combination pro

t and the company?

How do your daily duties affect this direction?

In what areas do you excel and how does this help the company reach its goals?

In what areas do you need to improve and how would

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

this help the company reach its goals?

What is your future within this company?

Many managers look at these questions and think, “Who cares if they understand the direction of the company, just get

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

your work done!” This type of thinking is flawed for two reasons. First, if your staff is unable to answer the questions above they will be less likely to effectively deal with challenges on their o

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

n (Why is it important that I learn how to handle customer complaints? I’ll just let the boss deal with it.). Instead of focusing on how to grow the company, many managers spend too much time addres

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

sing routine problems (micromanaging).

Second, if your team isn’t clear how critical their efforts are to the success of the company, it is a lot more difficult to get them to “put in the extra effor

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

t”. Managers with this problem often times find themselves begging their employees to stay until 5:30pm, skip lunch or come in for a couple of hours on a Saturday. Before you say, “They’ll come in o

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

Following aspects would a

n Saturday or I’ll fire them”, don’t forget how expensive it is to recruit and train new employees.

So, how do you address this challenge? I recommend the following steps:

1. Set clear, meaningful

dd to the challenges in developing combination products:

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

nd simple goals. A powerful set of goals will include input from your entire team and will reflect their own personal and professional aspirations. In addition, these goals must be so clear and simp

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

le that they can be memorized and fit on the back of a business card.

2. Create an individual “positional contract” with each employee. This process (and document) should focus on the following;

Det

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

ailed discussion of their regular duties.

Summary of how their position helps the company achieves its goals.

List of expected skills to develop/improve and why this improvement will help the compan

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

y achieve its goals.

Discussion of the individual rewards for the company reaching its goals (incentive plan).

3. Reinforce, remind and review. The biggest mistake companies make is putting a bunch

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

Professional from academic institutions, pharmaceutical industries, health care indust

of meaningful expectations in a binder and then only referring to them once a year. You have to keep your staff focused and motivated. Zig Ziglar said it best - “People often say that motivation doe

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

sn't last. Well, neither does bathing - that's why we recommend it daily." Here are a few quick tips to keeping everyone focused:

Post your goals everywhere!

Set aside time (at least monthly) with

.

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 individuals on your team to specifically address how their activity is affecting your goals.

Provide your team with a progress update on a regular (at least monthly) basis and post this progress

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

Companies that provide selfless information through particip

near your goals.

There is no doubt that this will require more time and effort, but the benefits of having an inspired team that is crystal clear about their individual and group expectations is huge

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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