Advice Pool - Business

Six months ago, Nucor Corp. looked like it might be in big trouble. The North Carolina-based minimill steelmaker, which recycles steel from cars, dishwashers and other items to make new steel, had lost power at its Hickman, Arkansas plant. Management anticipated it would be a ful

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

l week before operations there would be back online.

Yet, within hours of hearing about the electrical grid’s failure three Nucor electricians performed the business equivalent of climbing Mount Everest: they drove from their plant locations in Alabama and North Carolina to the

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

Examples of combination products may in

ickman plant and worked 20-hour shifts until the plant was up and running again, only three days later. The unusual thing about this story is that these front line workers rose to the challenge of their own accord – no supervisor had asked them to make the trip. The really unusua

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

thing is that this scenario is not viewed as all that spectacular among the folks at Nucor.

As Business Week noted recently, “Nucor’s flattened hierarchy and emphasis on pushing power to the front line led its employees to adopt the mindset of owner-operators.” This approach st

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

mmed from the leadership model of former Nucor President F. Kenneth Iverson, who maintained that employees will continually go above and beyond for the organization if they’re duly rewarded, treated with respect and granted real authority.

Building an organizational culture that

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

Combination pro

fosters progress through performance-based rewards and empowering employees at all levels allows companies to be more nimble and adaptable to change. In his recent book The Four Pillars of High Performance: How Robust Organizations Achieve Extraordinary Results, Paul C. Light bri

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

gs this theory to the forefront in describing two of his pillars: Agility – giving employees the authority to make routine decisions, and Adaptability – changing with circumstances and taking advantage of new opportunities as they arise.

The government has also researched the be

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

efits of empowering employees. In a 2005 review of 100 workplace studies, the U.S. Department of Labor examined the link between progressive employment practices and improved bottom line results. The Department found that a positive correlation exists between motivating and empow

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

ring employees and significant improvements in productivity, employee satisfaction and financial performance.

Roanoke, Virginia-based Advance Auto Parts, a leading provider of vehicle-related products and knowledge, has made good use of this correlation. Recently, after surveyin

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

the leadership team about the company’s workplace culture, the employee-centered values already in place were codified. The first value is now “We care about our team members/family/community”; the second value is “We have a strong focus on the customer.” In practice, these valu

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

s are reflected in the basis for manager bonuses: employee engagement.

U.S. companies aren’t the only ones making use of employee engagement to reinforce organizational adaptability. Champion Compressors, an industrial air compressor designer and manufacturer with nine branches

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

Following aspects would a

in Australia, uses the key concern of safety as a unifier for its 200 employees – and a conduit to grant them real authority. After all, their front line workers are the ones assembling components for Champion’s compressors, pistons, vacuum systems, filters and water chillers eve

dd to the challenges in developing combination products:

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

y day.

Champion’s environmental health and safety coordinator, Simon Meyrick, says the company aims to foster a workplace culture in which the prevention of unsafe practices becomes automatic. The organization achieves this by empowering its staff through regular training, reinf

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

rcement and equality. Staff are encouraged to provide their input at “tool box” meetings, which occur outside of designated training times. As a result of this attention to staff’s needs and talents, Champion earned the highest marks in the 2005 Australian Achiever Awards, which

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

ate Australian businesses in criteria such as care and attention, value, attitude and communication.

While some organizations have looked inward and involved their employees in aspects of the business as much as possible to maximize its effectiveness, there is still room for imp

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

ovement. In its 2005 Customer Experience Management Global Survey, The Strativity Group – a firm that helps companies create lasting, profitable relationships with their customers and employees – found that only 33 percent of employee respondents affirmed that they have the tools

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

Professional from academic institutions, pharmaceutical industries, health care indust

and authority necessary to serve their customers. This represents a decrease from 37 percent in 2003.

Still, the dialogue among leadership and HR staffs is slowly but surely moving toward adaptability via employee empowerment. In an April 2006 article in Roanoke County, Virginia

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

s Blue Ridge Business Journal, the county’s Director of HR, Joe Sgroi, says he has seen “an expectation, especially among management, of cooperation, adaptability and flexibility. The reward is not pay, but having someone say, ‘We appreciate your idea and we’re going to put it in

.

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

place.’”

Organizations should take notice of the model used by companies like Nucor. Although it’s a Fortune 500 company with more than 11,000 employees, its employee-centric practices can apply to any business – even not-for-profits. All it takes is a willingness on leadership’

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

Companies that provide selfless information through particip

part to give employees the mechanisms and ability, along with its blessing of trust, to provide excellent service. If more organizations took this leap of faith, they, too, could have what Joseph A. Rutkowski, a Nucor engineer who came up through the mills, calls a “magic” place

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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