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There are many different settings where physical therapist practice their craft. These settings may include schools, hospitals, private outpatient clinics, nurs

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

ing homes, and in private homes. Home care physical therapy is typically thought of for patients that are homebound, thus unable to commute to an outpatient cli

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

Examples of combination products may in

nic. There has been a new trend in physical therapy in which the clinic is brought to the patient. A few different models are currently being used. Some thera

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

ists have a mobile clinic in the form of an RV. These RV's are equipted with treatment tables, exercise equipment & all the typical modalities you would find in

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

an outpatient clinic. A second model that is less expensive would be a therapist coming to the home with a portable treatment table, and other hand held modali

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

Combination pro

y equipment.

Benefits to treating patients in their home include:
- Improved compliance by not missing treatment sessions
- Therapists c

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

an evaluate a patient in their REAL natural environment.
- Patient's don't have to travel to a clinic thus making it more time efficient
- Privacy for

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

he patient and their family
- Eliminate disruptions from other clients, phone calls etc.
- Typical in home sessions are one hour, one on one with a the

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

rapist.

This allows for effective treatment sessions and reduces the possibility of injury.
- Following surgery, having a therapist come to the home may el

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

minate complications of driving a car or having to negotiate dangerous obstacles on your way to an outpatient clinic.

Is in-home physical therapy right

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

for you?

There are a few questions you must ask yourself before considering in home physical therapy. The first is, how do you feel about initially having

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

Following aspects would a

a stranger in your home. After the first few minutes with a therapist, you are divulging personal information regarding your medical history. The therapist wil

dd to the challenges in developing combination products:

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

be a stranger for only the first few minutes. Secondly, are you capable of concentrating without distractions in your home.

Minimal space is required for

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

the therapist. They need to set up a table and may require an outlet for modalities. Therapists are typically creative with space and can take advange of a sm

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

ll area to achieve the required room for exercise. Most equipment required for therapy is light and portable.

In my experience, patients love the convenien

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

ce of in home therapy because it is one less trip they need to take. Typically, patients can have therapy sessions very early in the morning before going to wor

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

Professional from academic institutions, pharmaceutical industries, health care indust

, or late in the evening following work. The whole concept is to promote convenience and patient compliance.

Insurance coverage is dependent on the

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

therapist. Some therapists participate in network with medicare and other comercial plans while others are out of network. It is important to communicate with

.

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

the therapist prior to the first visit to find out how your treatment sessions will be covered.

In-home physical therapy is not right for everyone.

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

Companies that provide selfless information through particip

If you enjoy staying close to home, have a tight time schedule to keep, and enjoy exercising out of your home, then you should consider in home physical therapy

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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