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Quality improvement should be a system-wide initiative. Many healthcare facilities think of quality only as it applies to the clinical side. They concentrate on outcomes defined by accrediting bodies such a

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

s JHACO. Many businesses are like this too. However, the best organizations use quality tools throughout their organization. I want to show you the benefits of doing so.

As a healthcare professional would

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

Examples of combination products may in

you even think of just treating one part of the body to keep a patient healthy? For instance, do you think that just by concentrating on the heart that you can keep the rest of the body healthy? Certainly

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

not! Healthcare professionals know that to keep a body and mind healthy they must concentrate on the whole body. That’s why we give patients regular physicals.

A healthcare facility or site is much like a hu

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

man body. All parts much function well to insure positive outcomes—patient health, a good bottom line, and time and staff to get things done. A hospital is more than just the doctors and nurses. The admin

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

Combination pro

istrative staff and all other supporting staff are important too. For instance, in a recent issue of Quality Progress an article highlighted a change in food delivery which greatly impacted profit and patie

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

t satisfaction. The hospital decided to let patients order food from a menu much like any commercial restaurant at any time convenient to the patient and not too unreasonable for the hospital. They respon

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

ded to patient needs and wants and saved money doing so.

If your site is a family doctors office, do you think that the only important functions are those provided by the doctors and nurses? What do you thin

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

k a patient would do if he or she got excellent delivery of primary health treatment and prevention but had a horrible experience with billing? That patient might very well end the relationship with your

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

acility.

Research has shown that the key to profits is customer loyalty. One of the key ingredients of customer loyalty is quality of service and product delivered by satisfied employees. That means that e

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

very facet of an organization is important in delivering a service or product.

So how do you get started?

--Leadership is a key ingredient. Leaders at all levels must support system-wide quality.

--Gathe

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

Following aspects would a

r information on quality improvement ideas from all areas and staff. No one’s ideas are unimportant.

--Form cross-sectional teams to solve the important problems that you have identified.

--Gather baselin

dd to the challenges in developing combination products:

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

data about the process as it exits now so you know when you are improving and by how much. Monetary measures are important.

--Make a detailed plan that all team members can agree upon and educate the staff

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

about the tools needed to implement the changes.

--Implement the changes and measure your success.

--Make the new, improved methods standard operating procedures.

Many of the ideas above come from Lean Hea

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

lthcare ideas and other quality improvement initiatives, such as Baldrige and Six Sigma. The CFO of one local hospital with whom I spoke—Metro Hospital of Grand Rapids, MI—stated that Lean was one their p

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

imary tools and that it had made an enormous impact at their sites. Metro was even recognized recently in a national publication of The Institute for Healthcare Improvement as a leader in quality.

Impleme

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

Professional from academic institutions, pharmaceutical industries, health care indust

nting quality improvement throughout an organization is a difficult task. For many, this approach is a radical cultural change. Such changes fail without commitment from leadership and steady and firm hand

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

guiding the changes. I suggest that you start small and spread the initiatives methodically throughout your organization. At each step demonstrate to all the benefits for the organization and to the indiv

.

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

duals. Doing so will ensure that many will buy into the changes and commit to continuing quality improvement. I know of some organizations, which have gone through several Lean training initiatives but have

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

Companies that provide selfless information through particip

failed to maintain it system-wide for a variety of reasons. They end up losing many opportunities to improve the bottom line, increase client loyalty, and improve employee satisfaction in a job well done

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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And so, over scrambled eggs and bacon, I was gently fired. After seventeen years, in three cities, and across two divisions of the company, it was over. These are some of the things I've learned since that Terrible Breakfast.

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