Answers - Finance

Like any other product that is out there, you should consider the benefits of owni

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

ng versus equipment leasing. The difference is that in leasing you do not out rig

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

Examples of combination products may in

t own the equipment but use it and pay for it on a daily, weekly, monthly or yearl

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

y basis. The fact that you do not own the equipment means that you do not have to

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

fork over a large sum of money to make the purchase. Yet, is this is the right ch

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

Combination pro

ice for you and your business? It is important to weigh the pros and cons of equi

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

pment leasing in your individual situation to determine this.

To help you, here a

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

e some things that you should consider.

• What is the overall cost of the equipme

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

t if you purchased it? If you lease it, how long will it take you to pay this sum

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

? If equipment will cost you a good deal more in the long run, you may not want t

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

work with this. Yet, there are many instances where it can save you money as wel

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

Following aspects would a

.

• Determine your equipment need. What is the value of the investment and is th

dd to the challenges in developing combination products:

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

is something that your company can even afford at this point?

• Who will maintain

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

the equipment in the long run? If this is the owner’s responsibility, it may be w

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

se to lease from them because they will cover those costs.

• Is there an option t

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

o lease the equipment for a certain period of time and then to purchase it at a lo

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

Professional from academic institutions, pharmaceutical industries, health care indust

er price later? Because the equipment will be worth far less in just a few years,

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

you may be able to get a better, more affordable price at that point.

Equipment l

.

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

easing has many advantages especially for those who only need it for a short perio

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

Companies that provide selfless information through particip

of time. Yet, making the right decision of your company should be done carefully

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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Answers - Equipment Leasing: Should You?

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