Main Subject - Business

Is staff turnover driving you bonkers? Do you feel you are losing money and market share? Do you contribute this to the absence of loyalty and dedication among your staff? Would you rather have a "team" and not ever worry about absences or staff turnove

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

r again?

If you have asked yourself these questions over and over again, I have very comforting news for you. You can have a dream team. Like all relationships, it takes time to build a team but it can be done and much easier than you think.

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

Examples of combination products may in

You must brace yourself for what is about to be shared with you. Remember, you are being given help and not raked over the coals. What is common knowledge about most highly educated professionals is, they have academic know-how and special gifts and tal

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

ents as it relates to their training. What is lacking are leadership and management skills. The flow of leadership and management is vertical. It begins at the top and flows to a receptive team. The team is receptive because they are intimately aware of

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

several things in the decision-making process: The best interest of the company, the customers/clients or patient’s and their best interest have all being considered.

Your staffing woes are due vastly in part to lack of strong management. From here fo

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

Combination pro

ward, I’ll use management and leadership, interchangeably. Management is not entirely relegated to a person. This comes as a surprise to you, does it not? Do not think this means you can layoff your Office Manager or Department Managers in the near futu

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

re. You will need them, along with your team, to turn things around. How will this be done? You are wondering. It is accomplished through “systems."Well, what are systems? You ask. American Heritage Dictionary cited nine definitions of which three were

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

more closely related for our purpose. System is defined as:

An organized set of interrelated ideas or principles.
A condition of harmonious, orderly interaction.
An organized and coordinated method; a procedure.

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

especially like definition #2. One would expect organization and coordination but in building a dream team, there must be harmonious, orderly interaction. The organized set of interrelated ideas begins with the company’s mission, vision, and goals. What

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

follows are job descriptions and functions. Systems are written to cover procedural day-to-day tasks and are in place to take care of hypothetical events not expected to occur, or emergencies. We know Murphy’s Law and what it states.

Systems also incl

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

de scripting. There is no fear of having a team of robots but uniformity and an organized set of interrelated ideas. Everyone on the team must say the same things to help establish the company as one of excellence. As a consumer or patient, there is lit

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

Following aspects would a

tle less frustrating than being told several different answers to the same question; and finally being told the truth: “I’m sorry Ma’am, I don’t know." Systems that include scripting put everyone at the same skill-level. No one knows any more than the o

dd to the challenges in developing combination products:

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

ther because everyone knows everything pertaining to the operation of his or her company. In Dentistry, this would differ between the business staff and clinical staff but if you implement cross training of the team in the system, the same applies to y

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

ou.

Can you see how your frustrations and staffing woes become practically nonexistent? One staff member is no more valuable than the other. The “show doesn’t stop" because one person is threatening to leave. When a new team member comes aboard, teach

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

the systems. This eliminates bad habits; actually it corrects them because the systems are a guide. The system can be at fault instead of a manager. The system promotes self-motivation because the procedures are in place against which each team member c

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

n measure their performance. Performance evaluations are no longer about tardiness, absenteeism or negative attitudes but about ways to improve. Why? The systems will not work indefinitely. They improve as growth takes place. Yes, growth! Have I just go

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

Professional from academic institutions, pharmaceutical industries, health care indust

tten your attention? Systems provide yet another tremendous benefit for you. Your misery factor and stress levels decrease. You have a dream team and now you can actually look forward to coming to work. Your practice/business is profitable! Your team is

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

happy! Your patients/customers are happy! You own the practice of your dreams!

Owning the practice of your dreams takes time. There are practice management consultants and marketing consultants who are knowledgeable about systems. Why waste another da

.

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

y wishing when you can be working towards having your wishes fulfilled? Trying to fix a system that is no longer working is not the solution. It never is. Doing the same thing over and over expecting different results is insane. Sometimes we have to go

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

Companies that provide selfless information through particip

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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