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Every county has difference types of engineering practice. Our Malaysia has our own “format” of engineering practice. As we are in civil engineering field, we have certain types of standard fees in private sector. Where we have to survive b

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

ased on these fees. If we not follow these, we will be slowly remove out from market. Therefore, it is an important factor in control capital expenditure in operating an engineering consultant company.

As for the present market, engineering fees are getting very c

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

Examples of combination products may in

ompetitive. In order to getting project, we have to go into business. It basically just like doing a business, we have to make profit in order to survive. Only the difference is we are professional. We can not sacrifice engineering. Since engineering fees are so co

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

mpetitive, we have go into control business overhead. Basically, it will divide into two phases. First is office operation and then is field operation cost.Before we going into these. We have to do some basic analysis on the project to be taken. Such as time frame

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

of project, location of project, what will be if project has abandoned? Can we reimburse when project has extended? Is it worth to do it? For example; do a unit of bungalow in Sabah where your office based in KL.

Office operation cost mainly on the design team and

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

Combination pro

some management cost. Company must have a proper organization structure. Such as said one director, two senior engineers, four junior engineers, eight-draftperson etc. The design team. First of all, we have to control in design. Then will be the drafting and final

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

is printing. Just like computer software giant, Bill Gate said this decade is speed. We have to speeding in design by using more computer software to cut down time frame being use for a project. Every project must proper plan by allocates suitable time frame. This

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

time frame is based on our experiences on previous project. The time frame is very important in our servicing industries. If time frame cannot be met, then we will lose our client. We cannot simply speed up our design without any qualities, i.e. design is not prope

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

r done. This will cause more overheads on the rework and mistakes. It is not recommended to do so. No doubt we speed up in beginning of project, we lose more time in operation. As a result, design can be prepare by junior engineer and have to check by at least one

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

senior engineer. Then come into drafting. If drafting not proper monitor, it also causes a lot of wasting in time. We have to get senior draftperson to monitor junior draftperson. Senior draftperson is important in receiving instruction from engineer. He has to ful

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

y understanding message given and converts into drafting. Without him, engineer has to do this works. This also creates overhead of wrong assignment of duty. Engineer cannot concentrate on main engineering field. Printing can cause high expenses if not proper monit

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

Following aspects would a

or. Papers and plot ink cartridges are expensive. We have to control on it. If a lot of printing then we have to print into tracing and send to printing shop to print. What ever paper can recycle, use it.

In office, project management is important. Every project d

dd to the challenges in developing combination products:

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

ocuments such as design calculation, drawings, authorities letter, computer file must be proper managed. When we look for an old project or on going project, project information must able to retrieve in a few minutes. We can not spend time on searching project say

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

a half day. One of the option is going into paperless office. It doesn’t mean not to use any paper at all. Paperless is to certain extent. Important document such as appointment letters, contract documents and authorities letters must keep hardcopies. Where else, i

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

ncoming fax can be saved into computer and filter it before permanent save. These can cut down paper usage and office space used for storage. Project assignments are important, never assign two or more engineers to do a similar job. It is wastage of resource.

When

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

come to field operation, if possible request a site representative to handle project at site from developer. So we can cut down time spend on site. Otherwise, we have to allocate people to it or send people more frequent to site. Any site inspection, if possible to

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

Professional from academic institutions, pharmaceutical industries, health care indust

carry out after site meeting. We can request contractor to send us to site. This will save on transportation cost. Site operation cost is really high. Therefore we must proper manage in order to save cost. No doubt one of our duty is carry out site inspection. We

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

have to judge ourselves in order to carry necessary site visits. Project far away from office, such as office in KL and job site at Kelantan. Normally site visits will take you at least one or more days. So you have to proper manage it before you leave office. Do n

.

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

ot leave out anything that required to bring to site.

No matter how we manage business, we must not sacrifice professional ethics. We can do any thing for client to a certain extent. Beyond it, we have to say NO. Such as design a structure that not complying to co

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

Companies that provide selfless information through particip

de of practice. Balancing expenditure versus optimum design for efficient operations and maintenance is important in engineering service industries. We have to always monitor on going project and do a judgment of new project assignment in order to survive in market

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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