Main Subject - Business

We all know the importance of training and developing our staff. It keeps team members motivated, generating increased producti

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

vity. They eagerly use their skills to the benefit of the business. So why is it that we continue to take short-cuts with train

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

Examples of combination products may in

ng?

There are a couple of reasons. First, some fear training their employees. They don’t want to spend big money to train work

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

ers, only to see them quit and use their new skills to benefit a competitor.

In Stephen R. Covey book, The Speed of Trust
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
>, there is a quote from an unidentified CEO. Someone asked him, “What if you train everyone and they all leave?” He responded
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
, “What if we don’t train them and they all stay?” Enough said.

Another reason companies don’t train people is the cost. Let’
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
face it, when times are tough and budget cuts loom, it’s very easy to drop employee training. Unfortunately, this short-term m
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
oney saving tactic is extremely costly in the long run. It does a disservice to the people, lowering morale, and most important
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
y, it negatively impacts the company. Of course these negative impacts are not easily measured. They are not individual line i
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
tems on an income statement like the training budget. Typically the manager that cuts training gets a bonus for making his/her
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
umbers, and future dips in profit are rarely tied back to a lack of training. The cycle continues.

Training does not have to c
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
ost a fortune. Using the train-the-trainer method where a select few people attend a class and then train the rest of the team
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
an be cheap and very effective. Peter Drucker stated, “Knowledge workers and services workers learn most when they teach.” Enc
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ouraging team members to teach others is a very effective training method and according to Covey it “accelerates the rate of le
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
rning, both individually and organizationally.”

Ironically, the same managers that put little to no effort into training are o
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
ften the same that complain that there is a shortage of qualified labor. They will sound off about the importance of constantly
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
changing, and the need for companies to continuously re-invent themselves in the global economy, but will put very little effor
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t into what is required to do so.

Don’t let fear or budget constraints keep you from developing your team. Obtain formal train
.

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
ng as appropriate. Encourage your team members to teach each other, and do some teaching yourself. A skilled team that retools
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
frequently is more productive, and has a much better chance of keeping your company vibrant and profitable well into the future

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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Main Subject - Training and Development - Employee Retooling is Critical to Long-Term Success

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