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When planning your home remodeling or renovation project one of the main decisions you need to make is who will manage the project. You may have engaged a Designer, and add managing the project to their contract. Alternatively, as is common practice, the main builder may act as the Contracting Manager. Or you may decide to take on the project management role

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

yourself.

Designing a building or renovation is not just about how it will look and function but also what materials are used, when they are needed, ensuring payments are made to suppliers and subcontractors, and quality assurance. If you feel you have the experience to deal with this, great. But be warned, its not as easy as it may sound. Contracting your o

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

Examples of combination products may in

wn home result in savings of up to 20 percent but can end up costing you more than if you contracted out, if delays, poor engagement and low quality results.

The 10 most common mistakes made by homeowners acting as remodeling and renovation project managers are:

Insufficient Planning - the success of your project is probably 80% bas

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

ed upon good planning. This means dealing with as much detail as possible up front; always planning for contingencies and checking the progress of work against the plan every day. Small things can mount together to be big outcomes, and not always favourable. A plan keeps you focused when there seems to be multiple activates going on at any one time. Project m

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

nagement can be a full time job so part of your planning is ensuring that you have sufficient time to dedicate to the project management role. If you don't know what a Critical Path is - find out. This structure of dependencies will be the defining thread of your project plan.

Poor Materials Management - Time and Materials planning is

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

Combination pro

a big task but it can be very costly not having the right materials in the correct quantity at the right time. In large projects you will engage a quantity surveyor to estimate the material requirements. Some may add a time element to your material requirements plan, otherwise you need to work closely with your builder and supplier to ensure that lead times

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

are built into the delivery scheduling of materials to avoid delays.

Not Planning Sufficiently For Contingencies - materials can become unavailable due to warehouses burning down, transport strikes, import problems and even short supply being given to a more valued customer. Labour can become unavailable due to illness, injury or over

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

un on previous jobs. You need to have contingency plans to manage this and understand the impact of an alternative choice of materials in terms of the support structure required and finishing. Remember - What is possible in six weeks, on average takes ten weeks and in a worst-case scenario could be twelve to fifteen weeks. You need to be able to reschedule to

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

meet these types of delays.

Poor Record Keeping - keep and file everything, and keep records well organised. Your finance provider will most likely require proof of completion at each stage and a summary of expenditure to date, before releasing the next progress payment. If not using finance, good record keeping is just good manageme

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

nt. You need to know exactly where you are in terms of time and dollars against the plan specification. This should be the final task you do each night.

Not Managing The Work Site - there are a number of regulations and workplace safety items that need to be covered during any building project. When trying to keep costs down it is tem

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

ting to throw caution to the wind and avoid the cost of indemnity insurance for destruction or property and for injury to those working on and visiting the site. If you do, you are a fool - and any builder or subcontractor who works on a site without ensuring these things are in place, are also foolish. Ensure that your subcontractor agreements make them resp

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

Following aspects would a

onsible for safety and insurance of their area of work.

Slack Quality Assurance - use a work-check-approve-work cycle on every stage of the project. The three most critical parts of the project from a QA perspective are the foundations, framing and services. The foundations are the base upon which every other part of the design specif

dd to the challenges in developing combination products:

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

ication relies. Get this wrong and the problems start snowballing. QA is one task that should NEVER be rushed through or passed over when under time pressure. The downline impacts are too great.

Poor Subcontractor Management - one benefit of using a builder as the project manager is that they have a network of trusted subcontractors.

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

In a full home renovation, there can be 20-30 subcontractors. You need to use a well planned system for engaging, qualifying, contracting and managing your subcontractors. And remember to check and sign off their work BEFORE they leave the site and certainly before you pay them. You may like to engage an independent building consultant to manage these inspect

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

ons.

Poor Communication - Act professionally, it gives subcontractors more confidence that the project will be well managed. Let everyone involved with the project know what you are expecting from them in terms of deliverables and quality. Even with the most detailed plan, inevitably things will crop up that need discussion and adjust

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

ment. If all parties are not using the same lingo, it is easy for messages to get miscommunicated and misunderstood. Invest the time to learn the standard building trade terms, and if ever you are in doubt - ask for clarification. With the intensity of managing a home renovation or remodeling project, especially if its your first attempt can mean you forget t

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

Professional from academic institutions, pharmaceutical industries, health care indust

o communicate to contractors and suppliers as humans. A word of thanks goes a long way; a round of cold drinks on a hot day goes even further.

Poor Change Management Control - this ties in with the item above. All changes should be documented and signed off, however insignificant it may seem. Builders and subcontractors are human, th

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

y make mistakes. You need to ensure that any remedy or changes resulting from those errors is agreed, documented and charged to the appropriate party. I have been in the position where a builder made a major error which could not be undone, and meant the design had to be changed to 'accommodate' the error. He then tried to charge ME an additional $8000 based

.

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

on the change in design.

Not Keeping Check Of The Budget - although this is part of record keeping and contingency planning, it is worth a mention as the final item on our top 10 list. All project will overrun the initial estimate. It is normal practice to add 15% contingency to allow for alternative materials, increased costs, higher

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

Companies that provide selfless information through particip

cost for replacement labor etc. It is so easy for $40 here and $25 there to become $3000 over a two or three week project. This is why it is so imperative to update your expenditure every single day so you know exactly where you are. There is nothing that will stop a building project in its tracks faster than subcontractors fear of not getting paid.

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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Within any reporting structure/hierarchy, there will typically be challenges in even the best reporting relationships. Clearly realize that your particular situation may not be that unique. Learn how to address this issue by managing your manager effectively. Manage Up!

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