Advice You - Business

You may have read the book Good to Great, by Jim Collins. In his book he explains how many companies thought being good is… well, “good enough.” In these times of constant change and global competition, it is important to always

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

look for improvement --especially when it comes to safety.

Who wants to settle for “good enough” safety? In most cases, good means the company is willing to settle for an injury. “Good enough” safety means setting safety goals

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

Examples of combination products may in

based on lagging indicators. (An example is to reduce lost time injuries by 10%.) Great safety means setting a rigorous goal of zero injuries. According to Collins, you want to be rigorous and not ruthless when growing your com

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

any. This same concept should also apply to safety in the workplace.

Is Your Safety Process Rigorous or Just Plain Ruthless?

Ruthless safety could be characterized as a company that tends to punish employees by verbally

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

beating them over the head with the safety manual for getting hurt on the job. Don’t read this wrong…every company must have a disciplinary policy to get the attention of employees who don’t understand the consequences of unsaf

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

Combination pro

behavior. But to truly change behavior frontline leaders must always clearly identify the behavior required to prevent injuries. After all, the goal is “Nobody Gets Hurt.”

Rigorous safety could be characterized as clearly defi

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

ned behaviors that workers are held accountable for that prevent known hazards from injuring them. If a worker continually proves that he or she has no intention of behaving safely, then disciplinary action must be taken. Rigoro

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

us safety means that leadership has the best interest of the employee at heart.

5 Factors for Rigorous Safety Leadership

Leading employees to behave safely on the job is not an easy task. During our 15 years of experien

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

e of consulting with top executives on workplace safety, we have had many leaders tell us that if they had known leading employees to behave safely on the job was so hard to do, they might have turned down the position of superv

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

isor, foreman or lead. Yet, there is hope.

Leaders from the frontline can be effective by learning about dealing with these five human factors:

1. Expectations:

Unspoken, unrecognized expectations in the workplace can

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

lead to job frustration, substandard safety performance, decreased job safety commitment and even high turnover. Understand that most employees expect to have a workplace free of hazards. Workers have varying expectations when i

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

Following aspects would a

t comes to factors such as autonomy, work/life balance, career opportunities, stability, structure, and teamwork. The key is to learn what expectations the individuals in your organization have and then work with them to meet or

dd to the challenges in developing combination products:

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

, in some cases, adjust those expectations.

2. Communication:

Being a superb safety communicator is difficult to accomplish. Think about the people to whom you communicate safety requirements on a daily basis. You will

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

notice some are strong in certain communication skills, but weak in other skills. Learn everything you can about your communications style and how it affects others – what impact do you have? If you don’t usually get a positive

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

reaction from those around you, take a course in interpersonal skills.

3. Innovation:

Change, whether anticipated or unanticipated, can be difficult. To innovate, grow and improve a safety culture requires individuals

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

ho are able to see the big picture. Accept that change is a part of life and learn let go of the past and embrace and apply new techniques, technologies, and tools when appropriate.

4. Organization:

Safety innovation c

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

Professional from academic institutions, pharmaceutical industries, health care indust

annot be done without teams of people dedicated to hitting the goal: A Zero-Injury Workplace. Leaders must be able to organize a team and motivate it towards the goal. Imagine everyone leading each other to the goal of a zero-in

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

jury workplace.

5. Appreciation:

Great leaders accomplish great things. Great leaders appreciate the people who make things happen. Understanding how one reacts to certain situations as a leader is vital to being a suc

.

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

essful leader.

Get Rigorous for a Bright Future

Becoming rigorous about safety is hard work, but it is rewarding. When a company and its leaders commit to improving their effectiveness with rigorous safety programs, emp

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

Companies that provide selfless information through particip

loyees are more motivated to behave safely so they can home to their families every day without injury. After all, no matter what level you are in the company, the goal is “Nobody Gets Hurt.” That’s a goal everyone can live with

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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