Cases - Business

It should go without saying that there is no better way to maintain a carefully created People Place than to hang on to your existing loyal producers. Unfortunately, not nearly enough emphasis is applied in this area. Begin by taking note

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

of who these employees are.

Retain Proven Performers

Utilize your existing personnel resources – be aware of the experience, skills and ambitions of current employees. Get out and be visible among your staff – they are your most valuabl

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

Examples of combination products may in

resource.

One of the leading causes of discontent is poor placement, the consequences of which are felt at all levels. Unfortunately, all too often these days, any available body is thrown at a position or a set of responsibilities and i

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

’s called a done deal. There’s no better way for an employer to shoot himself in the foot, taking down an otherwise productive staff member with him.

If there are no openings available to rectify an existing misplacement, consider expandi

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

g the current responsibilities of valued staff members to maximize their valuable experience. Make the most of their know-how in other ways in your organization, such as implementing a mentoring program and offering the challenge to your t

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

Combination pro

usted employees who have “topped out.”

Perhaps these staff members would be interested in forming a team of administrative interviewers, or in developing and executing an administrative orientation program. The possibilities are endless.

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

Perhaps there is a lateral move to a position that would better fit expanding skills, experience and changing interests. Go to great lengths to utilize your existing resources. It is always the less expensive, more efficient route.

Don’t

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

underestimate the power of simple recognition in retaining valuable staff. You may not have the wherewithal or the mechanism in place to reward staff members in a tangible way, but that should not keep you from establishing a program to si

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

gle them out with a “pat on the back.” A small gift at the next company function, a monthly recognition luncheon, a name in the employee news or on the bulletin board are simple and cost effective, but nonetheless expressions of appreciati

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

n.

Know Your Leaders From your Managers

There is perhaps no concept more important than this. Loyal employees can be forgiving of much, but misapplication in this area is often the straw that breaks the proverbial camel’s back. Much of

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

he rest will be naturally addressed by one who knows the fundamental difference between these two concepts.

The rule of thumb here is:

Manage processes and procedures - lead, guide & teach people.

If you are experiencing problems, determ

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

Following aspects would a

ine whether you and your leadership staff are confusing these two areas. While an effective management team will often need to be engaged in both, they are not interchangeable, and like oil and water, they don’t mix.

It really is that sim

dd to the challenges in developing combination products:

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

le, not necessarily easy, but definitely simple. It’s no surprise that people respond to the human approach and there’s little in management of humanity. By nature of the definition, leaders are out in front, rarely expecting of their fol

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

owers what they have not first paved the way for. Occasionally leaders are bringing up the rear, but then only to protect the rear flank.

The mature leader possesses leadership sophistication, a ripeness of attitude, in relating to any gi

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

en situation, that each member of the leadership team has gained as a result of experience. There is openness and a willingness to continue the personal growth process.

Interpersonal skills are of paramount importance. Leadership must be

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

non-discriminatory, developing solid working relationships across all levels. This may appear to be blatantly obvious, but sadly is all too often overlooked in the name of accelerated organizational progress. Both leaders and managers mus

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

Professional from academic institutions, pharmaceutical industries, health care indust

be willing to facilitate conflict resolution, as well as to confront issues surrounding relations between teams, departments and organizational levels.

An effective leader has a sincere concern for the success of those he leads, treating

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

taff members as individuals, giving credit, taking pleasure in making people look good. A great leader keeps the objective as simple as possible, always promoting understanding, always acting as a role model, and standing out of the way, n

.

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

t interfacing unnecessarily, so staff can get on with their work.

An effective leader will make the difference between a successful administration and a failure. The most brilliant processes, designed and directed by the most able manager

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

Companies that provide selfless information through particip

will fall flat at some point if the leadership is not right. It is not necessary to prioritize purpose over people, or vice versa. If leadership has done its homework, everyone in the organization will arrive at the vision simultaneously

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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