Main Subject - Business

Outsourcing = Global Momentum

The global business landscape has changed dramatically in the last couple of years thanks to growth of outsourcing. Outsourcing has gained strength as a management strategy for sustaining global growth as well competitive adv

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

antage to overcome the challenges of ever growing business complexities. So whether it’s a Fortune 100 transnationals or even a small enterprise, everyone is looking at outsourcing as a key growth engine thanks to the increased levels of process specialization an

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

Examples of combination products may in

d sophistication. Domain specialization and not just economies of scale are key to the success of any outsourcing relationship. Outsourcing has been recognized to save companies and not just costs.

Evolving Outsourcing Relationships

Organisations now re

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

ard outsourcing as a key initiative for overall growth and not just as mere cost saving exercise. Hence organizations are increasingly seeking best-in-class outsourcing specialists and not just large best of breed outsourcing service providers. This is especial

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

ly true in the IT & engineering verticals as organizations even outsource new product development tasks to specialized offshore vendors. Research intensive, customer focused outsourcing relationships now have to include the following to remain competitive:

•

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

Combination pro

nnovation Update. Quarterly, bi-annual, or annual innovation reviews (also known as innovation boards) focus typically on state of the market, industry trends and relevant information, technology updates, solution demonstrations, site visits, etc. Leverage ot

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

her industry peer groups to understand what is happening in your industry, the outsourcing industry, and other sectors.

• Benchmarking. Clients should always activate their benchmarking clauses and focus on best practice as comparators of innovation—not

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

just cost comparisons. Benchmark both functional excellence and outsourced environments.

• Stakeholder Satisfaction Surveys. Perform monthly, quarterly, and annual customer satisfaction surveys. They should be “360 degrees”—covering multiple dimensions

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

and all internal and external stakeholders.

• Deliver on Partnering Promise. Hold regular collaborative planning sessions. Where people are briefed on the strategic and business objectives. Service providers need to come up with implantable strategies o

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

n how best they can meet their clients’ business challenges. This makes the outsourcing vendors to think and act above simple tactical delivery.

• Value sharing framework. A transparent value-from-outsourcing sharing mechanism on a case-by-case basis shou

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

d be harnessed to pay for business services delivered. Inclusion of regular mutual rewards for both your organization and that of the service provider boosts people motivation at all levels.

• Service Excellence. All SLAs must be tied to process excel

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

Following aspects would a

lence or customer delight will not happen. Project milestones, “go-live” events, and pilots are tangible means of tracking process maturity & excellence. Other measures include customer satisfaction, productivity, Six Sigma (defects), work elimination, etc.

•

dd to the challenges in developing combination products:

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

>Outsourcing Management. The internal governance team should have a transformation or innovation owner, sufficient staff & budget to help drive innovation and must hold the provider accountable for innovation. Reassure and demonstrate to the provider that the

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

relationship is long-term; otherwise they will be inclined to disinvest in innovation and the relationship. Your organization must retain process management expertise at a level at which you can clearly articulate future state requirements, evaluate proposals b

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

rought forward by the service provider, and work with your organization to get the business case for change.

• Executive Visibility / Support. Senior executives from the service provider side must have high visibility and access. This includes steering

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

committees, reciprocal headquarter visits, joint speaking engagements, regularly scheduled calls, quarterly and annual briefings.

• Behaviour/Communication/Culture. Be prepared to invest in and encourage business process transformations that are aligned

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

Professional from academic institutions, pharmaceutical industries, health care indust

to business goals - rather early in any outsourcing relationship. Transformation requires a partnership mindset, not a transactional orientation. Innovation is often not brought to bear because clients do not ask for it, define what they mean by it, and motivate

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

the provider to deliver it, or put restrictions around it. Clients rarely help the provider to understand what is important to them.

Consultative BPO

Outsourcing has now scaled the maturity milestone globally and hence is increasingly consultative in nat

.

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 rather than being mere business vendors. Outsourcing relationships now proactively meet business challenges as specialist BPO vendors invest to stay ahead of the learning curve. Outsourcing is often regarded as a change catalyst and hence clients are increasin

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

Companies that provide selfless information through particip

g using outsourcing initiatives in their growth strategies/ employee career planning initiatives.

Joint client-service provider partnering is key to this new consultative approach where both invest in transformations and not just fund reactive process management

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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Main Subject - Consultative Business Process Outsourcing (BPO)

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