Advice You - Business

The history of the downfall in companies has consistently shown a common weakness: Not letting go of what they are not great at executing.

Core competencies are the identified areas of expertise a company has leveraged in the marketplace. What these companies rarely are capable of is creating val

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

ue in non-core functions like human resources, technology, sales & marketing and transportation.

Third party outsource management companies are flourishing as more businesses come to grips with the reality of higher efficiencies and value that can be leveraged in their non-core competencies for a b

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

Examples of combination products may in

etter focus on what they do best to create real profitable growth.

The drivers of this clear trend are new scalable technologies otherwise not affordable by an individual business, increasing pressure to compete on price in a commoditized world and recognizing differentiated customer needs that req

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

uire support teams companies have a hard time resourcing. Third party outsource firms have created industry leading technologies by sector, attracted clients for critical mass to leverage greater spend savings with critical providers and understand the need for sourcing dedicated account support te

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

ams. This outsource business model is highly efficient and a tremendous value for businesses who understand the need to focus on their core competencies for real profitable growth.

Often we hear business executives complain about the number of outsource companies knocking on their door. They wond

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

Combination pro

er how can so many of these entities exist? The answers are the need/demand is so great, greater scale translates to more savings potential and scalable technology with dedicated teams can be leveraged for the benefit of all concerned. Outsource providers see the need and can deliver real value f

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

or all engaged. As the trend business outsourcing increases, more providers are entering the market and this is great for competition and deliverable values. Instead of being aggravated about this new trend in business management, leaders should embrace the opportunities that are being presented.

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

Rather than a loss of control, businesses actually gain more control of their processes, increase measurable results due to enhanced visibility through technology and develop greater operating efficiencies.

The process of reviewing potential outsource vendors can be daunting but none the less wort

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

h the effort. No doubt there will be many internal parties resistant to change as a real threat to their employment. Often the CEO is reluctant as department heads are loyal and usually able to create reasons why they performing well enough and share concerns over a perceived loss of control. The

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

selection of an outsource firm should be by the executive team and not by those potentially impacted by change. Since outsourcing should displace at least some current workers, employees with transferable skills should be integrated into new challenging positions to demonstrate their value or give

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

n a severance package if possible. The reality is they currently part of the problem, not the solution, so action is best for all.

We have clearly moved out of the industrial age, are well into the technology age and entering the knowledge age, where traditional experiences and past job positions

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

Following aspects would a

are ill equipped to create value in the transforming workplace. Companies are compelled to be on the leading edge of technology support, leveraging spend for savings and customizing customer support if they want to grow profitably. Why settle for mediocrity when you can leverage for the best?

Tra

dd to the challenges in developing combination products:

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

nsportation is an excellent case study. In the last decade the last vestiges of a regulated transportation network have dissipated. The grid of mode options and complexities of service options are so complex, no one asset company is large enough or nimble enough to handle all a given business supp

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

ly chain needs. Technology has only recently been scaled by third party transportation management companies to create real time supply chain visibility and therefore efficient, reliable and best cost provider selections for each movement of goods. The spend savings, real time inventory visibility

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

and support that third parties can provide are miles ahead of what any individual company can economically accomplish on their own. Smart outsource firms work on a no cost contingency basis with results guaranteed in contract. Internal department heads will raise past war stories and shortcomings

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

with previous attempts to change but the reality is those who do not adapt to more favorable service/cost structures are doomed to lose market share and profits to those of their competitors who do.

Recognize what competencies you are great at as well as where functions in your business are not a c

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

Professional from academic institutions, pharmaceutical industries, health care indust

ore competency. Avoid the temptation to just turn to big providers in the service you looking for as a new wave of boutique providers are often more creative with technology and leveraging shared spend savings. Avoid a bid approach as not the best way to determine who truly best for your business.

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

Much like an independent insurance agent, there are players in the field who will study your needs and research for the highest value that meets your customized needs at no cost to you. There are providers more suited to your unique needs, seeking help in discovering the right fit from the many c

.

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

hoices only makes sense.

Letting go of a perceived need for control, past allegiances internal and external, as well as past experiences can open up resources that will be focused on growing profitable new business. This is leadership versus management with actually more control over your true bus

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

Companies that provide selfless information through particip

iness and deliverables that will ensue.

Change requires courage. Change will be great when it translates to faster growth and real bottom line gains for your business. Outsourcing is changing the way business is done for those who truly value excellence and shareholder value. Let go and be great

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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Why are we so foolish to wrap ourselves in the deception of ‘corporate rationalism’ While it is true that we need finance to live, how much is enough?

With some many groups to join and others to attend, how do you know which one is best for you. This article gives you some suggestions on how to define what is quality for you.

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Advice You - Outsourcing - Letting Go of What You Not Great At

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