Advice You - Business

More than 500 managers and executives in the electronics hardware and design sector, many from elec

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

tronics contract manufacturers and technology original design manufacturers (ODM), were recently po

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

Examples of combination products may in

lled in an online survey which presented numerous questions and various business perspectives and s

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

enarios for commentary and ranking.

Part of the survey, which was presented online by www.VentureO

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

utsource.com, asked electronics original equipment manufacturing (OEM) survey respondents currently

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

Combination pro

outsourcing contract manufacturing and product design to about ranking specific objectives related

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

to their company’s business strategic priorities.

The top three business strategic objectives rank

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

ed in the order of importance are:

1. Reduce order-to-delivery time
2. Manage inventory more

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

ffectively
3. Reduce manufacturing costs

Meanwhile, the same business strategic priorities we

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

re also presented to electronics industry contract manufacturers and original design manufacturers.

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

The top three business strategic objectives these respondents ranked in the order of importance ar

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

Following aspects would a

e:

1. Manage inventory more effectively
2. Improve effectiveness of sales and marketing effor

dd to the challenges in developing combination products:

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

ts and activities
3. Improve demand forecasting

Interestingly, nowhere to be found in their r

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

sponses was the number one business priority for OEMs – reduce order-to-delivery time.

Additionall

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

y, the survey also identified some of the criteria electronics managers and executives in OEMs curr

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

ntly outsourcing either their product manufacturing or product design to rate the importance of cer

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

Professional from academic institutions, pharmaceutical industries, health care indust

tain criteria presented when selecting a contract manufacturing or product design company for a bus

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

iness engagement. The top five, with the criteria most important listed first, are:

1. Accountabil

.

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

ty - does what it says, when it says
2. Quality certifications and facility approvals
3.

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

Companies that provide selfless information through particip

Relative business experience
4. Financial stability
5. Product design capabilities

* *

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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