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Many businesses are missing out on a key source of ideas for improvement: their employees. Most work environments are organized into some form of hierarchy. This type of structure te

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

nds to stifle analysis and questioning from the majority of employees in those organizations—those near the bottom of the org chart. Evaluating processes and operational efficiencies

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

Examples of combination products may in

are typically left to managers. The people who are actually participating in those processes, the cogs in the machinery, are often overlooked for insight. This is a mistake, and it

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

behooves both employees and managers to break this trend.

For employees the key is to be outspoken. Pay attention to your “sphere of influence,” always searching for small refinemen

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

ts. Then approach a supervisor or a manager and suggest that you want to be part of refining the organization. Tell him or her that your “ground-level perspective” might provide uniq

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

Combination pro

ue insight into what is really going on in the organization. Discuss a handful of the refinements you have already discovered, focusing on improvements that would have an effect on p

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

roductivity or cost. Keep your ideas small in the beginning, and provide feedback specifically pertaining to your role in the organization. If you become a reliable source for small

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

ut meaningful refinements your value to the organization increases. For example, a line-worker working at a car manufacturer might find that he or she spends an extra 1-2 minutes per

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

car because of the layout of their work area. Perhaps a toolbox requires a 30-second walk around a large machine, or the source for parts is organized in an inefficient way. These k

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

inds of “rough edges” can only be identified by people who perform this work; by the line-worker. Saving 1-2 minutes per vehicle over time adds up to a significant improvement on a l

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

ine that builds hundreds of cars a day.

For managers and supervisors the key is to seek ideas from your employees. Communicate the fact that you want them to provide feedback about

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

Following aspects would a

their work. Give them guidelines to help them identify those “rough edges.” For example, suggest that workers take a few minutes to think about their day-to-day activities. Tell them

dd to the challenges in developing combination products:

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

to look for points in the day that seem inefficient, activities in which the employee is working-around something. Ask them “where is time wasted in your daily activities?” Provide

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

a mechanism for employees to provide you with feedback, perhaps at the beginning of a weekly meeting, or one-on-one during the course of the day. Seek ways to improve their jobs, and

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

that will lead to ideas on how to improve the business. Don’t just ask for problems. Tell them to bring up problems, but to also provide the solutions. That way the employees are not

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

focusing on complaining, they are solving problems by providing the solutions. Above all, trust your employees. They are closer to the actual work of the organization than you will

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

Professional from academic institutions, pharmaceutical industries, health care indust

ever be. No idea should ever be treated as a bad idea. There may be suggestions made that are impractical for one reason or another, but the idea here is to promote employee particip

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

ation. Nothing stifles participation and creative problem solving like rejection. Be positive and always ask for more.

When employees and managers work together to identify and fix

.

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

inefficiencies the whole organization wins. Employees become empowered because they are part of the solution, and their individual contribution becomes more meaningful. Managers and

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

Companies that provide selfless information through particip

supervisors suddenly have a limitless new source for ideas on how to improve productivity and efficiency. The organization as a whole benefits from happier, more productive employees

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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