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One of the hardest things for a small business owner to do is to delegate. Giving up control, trusting employees to get things done right or even properly ide

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

ntifying tasks that can be delegated are just a few barriers to proper delegation. Sadly, I've been in some offices where the owner was printing off 100 lette

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

Examples of combination products may in

s and getting mailing labels ready while the receptionist was filing her nails waiting for the phone to ring. Something is wrong with this picture.

The first

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

two hurdles require mental changes but the third can be solved very easily with this three step process.

Start with identifying every single task you perform

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

. Write down everything you do in a notepad for a two to four week period. Everything! If you call prospects write it down, sign checks, stuff envelops, hold

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

Combination pro

ertain meetings, meet with suppliers, clients, employees, community leaders, write it down. Do you write or have input into your web sites content? Write it d

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

wn. Lick stamps, clean the copier, sweep the floor, clean the toilet? Write it down.

Next, identify each and every task as to the impact it has on your busin

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

ess. What is its importance to the success or growth of your operation? You can use a Low, Medium and High coding for this and only consider the importance to

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

the business, not whether you like to do it or not or have to do or not. For example, meeting with suppliers may be of high importance while meeting with comm

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

nity leaders might be a medium. Working periodically on your web's content may be of high or medium importance to your business while licking stamps might be

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

low. Code each task according to its level of importance.

Thirdly, look at each task again and code it based on YOUR level of interest. Do you really like o

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

Following aspects would a

r even love to do this task? Use the same Low, Medium or High and make this a third column as you go down your task list. Don't concern yourself with the last

dd to the challenges in developing combination products:

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

step as you do this. Just answer the question, "Do I like doing this". Maybe you love the taste of stamp glue and will code licking stamps as a high. Maybe yo

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

hate meeting with suppliers but love meeting with community leaders. Whatever the case, just go down the list and make the proper coding.

Spreadsheet geeks

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

can use a three column spreadsheet with Task, Impact and Interest as the columns. This way you can do a final sort after you are done so that everything lines

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

up nice and neat. First look for Low Impact and Low Interest items and delegate them to someone immediately! Make sure the person knows how and what to do and

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

Professional from academic institutions, pharmaceutical industries, health care indust

never do these things again. Avoid them like the plague. After you've delegated all of these you can look at Medium Impact, Low Interest items, followed by Lo

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

w Impact, Medium Interest items and move through your list.

Ideally, only High Impact and High Interest items will eventually remain on your list freeing you

.

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

up to do more of the High impact things you love to do to grow the business. Practically however, you will retain some Medium Impact, High Interest and High I

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

Companies that provide selfless information through particip

pact, Medium Interest items from time to time. Everything else should be eventually delegated either to existing employees or new hires as your business grows

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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