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You just signed a Help Desk Service Level Agreement (SLA) and now think things will get

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

easier. However, you may soon be falling into one of these traps:

1) COVERING THE TRU

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

Examples of combination products may in

TH WITH METRICS

In some companies, those under the radar of SLA compliance may resort

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

to doing the minimum instead of really solving the problem. This includes closing or re

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

assigning customer tickets just to meet the ticket queue deadline. While a review of SL

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

Combination pro

A monthly metrics may look like the help desk is meeting or exceeding metrics, in reali

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

ty the quality of support had started a downward death spiral.

2) DOING ACTIVITIES JUS

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

T BECAUSE THEY ARE IN THE SLA

When creating the SLA, the customer/management may ask f

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

or services and reports because "they are nice to have" and they perceive them as free.

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

However, once the SLA is in force, the help desk staff discover that the customer/mana

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

ement rarely read the reports or utilize these services. But the staff is forced to kee

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

Following aspects would a

p doing them because they are in the SLA.

3) IGNORING ACTIVITIES NOT IN THE SLA

Chang

dd to the challenges in developing combination products:

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

es in current products, organizations, management, vendors, and users may require curre

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

ntly unsupported services to receive some level of support. Helpdesk staff are now face

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

d trying to make both the SLA and non-SLA users happy. But picking the wrong choice may

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

mean that you may be trading a happy today for a thousand unhappy tomorrows.

In concl

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

Professional from academic institutions, pharmaceutical industries, health care indust

usion, take the time to create a realistic SLA that both and your management/customer c

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

an live with -- today and tomorrow. Schedule monthly reviews to see if the real needs a

.

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

re being met.

Periodically sanity check the SLA and see which activities/reports shoul

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

Companies that provide selfless information through particip

d be dropped and which should in the short-term and mid-term. Good luck in your efforts

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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