Main Subject - Business

Have you ever thought that your unconventional way of viewing the workplace tends to create cold sweat down the back of your boss? That is if he is a bureaucrat - a custodian of the status quo! It’s not really old fashioned shoes or light green krimpilene trousers that make your boss’s management style so outdated. It is his closed mindse

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

t, which passionately resists change and obsessively treasures policies and procedures. This is fertile breeding ground for complacency and killing creativity in a team!

Achieving results are not at the top of the list for your boss. Whipping up a whirlwind of rules and regulations is. He embraces the company’s policy at the expense of e

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

Examples of combination products may in

verything else. Getting things done with speed and a high sense of urgency doesn’t even make it onto his list. He will rather unleash report-writing mediocrity. Knowingly or unknowingly, he is an expert in causing obstruction. Your boss is a proper and self-respected ambassador for “rules” and “red tape”. Today’s accomplishments are not t

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

hat important, but years and decades with the organisation are incredibly admirable from his point of view.

Your thirst for performance and drive towards excellence is quite frankly a major irritation to the boss. He has already concluded a long time ago that there is absolutely no reason to get overly excited or passionate about the com

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

any. Not then, not now and not in the future! The ultimate goal for him is to retire and until then, bask in the glory of all his titles. Someone still has to break the news to him that times have changed and these days, you buy your own gold watch at retirement. The valuable contribution that you can make towards the organisation doesn’t

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

Combination pro

even feature on his radar screen. Through years and years of service, he has “arrived”. Your boss is acutely aware of his positional authority and power. Everyone obeys him, because they are forced to. He is oblivious to the unproductive effect of his lack of influence on the team. Culbert & Ullmen caution that we recognize the hierarchy

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

trap: “…one must also recognize that hierarchy is a cancer that causes human systems to close down. It almost always limits truth telling, authenticity, openness, and give-and-take exchanges.”

So why does your boss hail from the stone-age?

Your boss doesn’t need to drive around in a Fred Flintstone car, wearing a leopard skin and carry

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

a club to have a primitive way of thinking. It has also nothing to do with age. William Blake once wisely remarked that “the man who never alters his opinion is like standing water and breeds reptiles of the mind.” Years and years with the organisation without any competition in the industry forged your boss into a bureaucrat. Quantity i

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

the absence of quality has become his measurement of success. Charles Foley describes these types of bosses as: “bureaucratic adversaries, with their single-minded devotion to preserving the order of things and their place within that order.”

Bureaucratic bosses form part of a global clan that spans around countries, cultures and contin

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

ents. Their “well-deserved” justification is always the same: “been there, done that, got the tie”. The walls in their offices announce in stereo surround sound their self-perceived value through framed diplomas, degrees and certificates. Their views and behaviours in the workplace reveal it all. It can only be described as self-justified

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

entitlement. The organisation “owes” it to them. They have given years of loyalty towards the company in exchange for job security. But guess what? There waits a rude awakening! The workplace has changed. No company or organisation can afford to give you permanent job security anymore. You have to make yourself invaluable by producing re

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

Following aspects would a

sults, mentoring those around you and contributing towards the bottom-line.

How do you manage a boss that is a bureaucrat?

Maybe you are bored out of your skull in a sleepy business setting or stifled beyond comprehension in a stuck-up bureaucracy. You need to do something! A word of caution: be prepared to fight an uphill battle agains

dd to the challenges in developing combination products:

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

your boss’s self-justified complacency and inward focus.

In modern times, there is no way that any one of us can afford to get stuck in the rut of rigid tradition. It is easy to understand that innovation adds vitality to any organisation. Unfortunately for most of us, working under a bureaucratic boss, there will always be a nagging fe

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

ar of being criticized, looking stupid or failing with our new ideas. This is why you need an abundance of courage. You should never be scared to deal with this type of boss. The future of the organisation is depending on it. If you are not going to stand up, who will? This is leadership in action! Don’t bargain on your boss to sponsor an

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

y change. Your influence and enthusiasm will have to create the necessary momentum for transformation. Build your business case slowly and back it up with solid data. Continue to lobby your boss tactfully.

There is the danger that you can be negatively perceived as a non-conforming rebel, because you are threatening that which is familia

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

r to your boss. Remember that bureaucrats become stuck in the strait jackets of their own comfort zones and tradition. The time will come where you have to sit down with your boss for a discussion. You might be anxious. Let your boss know that it is difficult for you to speak up, but you do it out of respect for the company and him as an

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

Professional from academic institutions, pharmaceutical industries, health care indust

ndividual. Don’t forget to express your appreciation for his “attendance”. Use non-judgemental words and describe the result of his management style on everyone. Give specific examples. Listen respectfully to your boss’s version of events. Provide non-threatening, but practical suggestions on how to potentially remedy the situation. Make

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

sure to thank your boss for lending his ear to you. Remember, you had the vision, so now you have a job to do!

So what is the ultimate solution?

Some managerial minds in the workplace are like cement … permanently set! They need to understand that persistent innovation is a lasting competitive advantage. Innovation and change is a sure

.

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

way to open the doors of accomplishment for any organisation.

Everyone needs to grasp the hard-hitting business reasons that demand innovation. No strategy, procedure or course of action has a permanent lifetime. We live in an age of killer competition and the key to a company’s survival in the ever-changing workplace is innovation. Lead

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

Companies that provide selfless information through particip

ers need to nurture innovative organizations. They have to tap into the trust and collective guts of all employees to stomach uncertainty and risk new and creative ideas. True innovation is exactly the opposite of a bureaucracy. It requires a new way of thinking and viewing business. Traditional assumptions must be challenged at all times

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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