Advice You - Business

The first thing that comes to mind when thinking about why a large organization would outsource is "cost savings". However cost savings s

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

hould be only one piece of their motivation. Organizations are looking for ways to streamline and provide opportunities to refocus on cor

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

Examples of combination products may in

e competencies. In order for outsourcing to make sense, an organization should identify those services that must be done to manage the bu

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

siness but are not "what they do best". For instance, a Health Plan is in the businesses of providing stellar services to customers (memb

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

ers & providers). Core competencies definitely include developing state of the art products with flexible benefits and contracting compre

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

Combination pro

hensive provider networks. However, core competencies may not include handling mail, imaging, and claim data entry.

Outsourcing must sup

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

port an organization's business model and deliver at least the same if not better quality than what was produced in-house. Savings is an

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

expectation, however, easily lost if the outsourcing engagement is not carefully structured to deliver the turn-around and quality require

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

d to meet internal business expectations. So, savings? Yes definitely a target goal! But ... the selected BPO must deliver more than "w

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

e will do cheaper". They must deliver the highest level of quality within a specified turn-around time. Imagine the frustration if an ou

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

sourcing engagement is built strictly around savings, without the proper attention placed on quality for instance. Let's use our Health P

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

Following aspects would a

lan as an example again. There certainly are opportunities for significant savings to have an offshore team key from image for claims and

dd to the challenges in developing combination products:

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

enrollment. However, it is important to remember that health plan customers care about turn-around and quality. Customer abrasion due t

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

o less than stellar quality or delayed turn-around is significantly more costly than any savings the vendor may have provided both financi

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

ally and in reputation.

Keep your eye on the ball! Organizations should carefully evaluate their processes prior to planning an outsourc

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

ing engagement and if the decision is made to move forward, careful attention should be given to developing comprehensive requirements. A

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

Professional from academic institutions, pharmaceutical industries, health care indust

ppropriate Service Level Agreements (SLA's) must be negotiated to ensure expected performance. And, once the engagement is underway, rigo

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

rous monitoring of the vendor's performance must take place. Contract governance is an expense worth investing in to ensure outcomes meet

.

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

or exceed expectations and should definitely be a line item in the outsourcing budget.

Email your questions or comments to:

Kimberly Jo

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

Companies that provide selfless information through particip

nes Principal Consultant email: kimberly.jones@analyzeitconsulting.com web: www.analyzeitconsulting.com phone: 502-558-9466 (mobile

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.adviceyou.org.ua/article/32528/adviceyou-Outsourcing--Keep-Your-Eye-On-The-Ball.html">Outsourcing - Keep Your Eye On The Ball!</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/32528/adviceyou-Outsourcing--Keep-Your-Eye-On-The-Ball.html]Outsourcing - Keep Your Eye On The Ball![/url]

Is your office cluttered and unorganized? Our tips will help you to transform your workplace into a efficient, productive office.

As a freelancer, you're not only responsible for your creative-works, but you're responsible for your marketing, briefing, presentation, accounting and filling system matters as well. You are also responsible for all incoming calls, make appointment and take any complain (if any). Being a freelance graphic designer is not only about creativity and design, but it needs strong commitment and takes a big responsibility.

The Portfolio, Programme and Project Management Maturity Model (P3M3) is a reference guide for structured best practice. It breaks down the broad disciplines of portfolio, programme and project management into a hierarchy of Key Process Areas (KPAs). The hierarchical approach enables organisations to assess their current capability and then plot a roadmap for improvement prioritised by those KPAs which will make the biggest impact on performance. Research demonstrates that ROI from process improvement using a maturity model approach ranges from 2:1 to 27:1. Most articles on portfolio, programme and project management maturity models focus on the 'accreditation' aspects of the model. This article focuses on how to use the model as a framework for process improvement by applying change management techniques from Six Sigma.

Tags

Links

Advice You - Outsourcing - Keep Your Eye On The Ball!

Related Articles: