ASME Summer Bioengineering conference , Marco Island, Florida
June 25-29, 2008
http://divisions.asme.org/bed/events/sbc2008.html
deadline to submit abstracts: January 31, 2008
Friday, June 29, 2007
Wednesday, June 27, 2007
Engineering world Health Organisation
Engineering world health organisation http://www.ewh.org/ is a not-for-profit charitable organisation which trys to use the capacities of engineering schools and engineers to promote the global health specifically by identifying the needs of hospitals in developing world and by helping them to overcome some of the existing difficulties that they have.
This organisation is involved in the aid for assessment of needs of hospitals in developing world, helping in delivery and maintainance of the devices needed as well as training people in hopitals to use and repair the medical devices.
The organisation, encourages design of new medical devices and equipements suitable for these countries ( since their needs is different from developped countries) and build existing designs to ship in these countries.
The Summer Institute is an opportunity for engineering students to gain hands on repair and design experience while simultaneously helping disadvantaged hospitals and patients in a developing nation. Open to students of engineering, physics and chemistry, the Summer starts from one month of intensive technical training combined by courses on language and culture of disadvantage countries and then sent to help hospitals in the areas most needed. To get more information, take a look at their website: http://www.ewh.org/summer/index.php
Complex Biomedical devices 2
As sue has mentioned in the comments of the previous post, at the first glance, cool.click™may seem a combination product, however it has to be categorized in one group to get through the legislations.
Normally, a device that is just used to DELIVER a drug ( as a syringe) is considered as a pharmaceutical product and should get through pharmaceutical legislations. However, sometimes this is the company who decides what is a main function of the product and how it wants to introduce its product and then gets through negotiations with legislative organisations to reach to an agreement about the nature of the product.
Does the device do something more than the drug delivery? Do mechanical parts or electronical parts have physical roles in the treatment,etc? These questions arise while deciding the category of the product. an example may be a coated stent.
In conclusion , It should be considered that the answer to these questions are not always very clear. Sometimes a product may be accepted as a medical device in Europe while as a pharmaceutical product in US and vice versa. The descision is made after discussions between companies and EMEA in Europe or FDA in the US.
Normally, a device that is just used to DELIVER a drug ( as a syringe) is considered as a pharmaceutical product and should get through pharmaceutical legislations. However, sometimes this is the company who decides what is a main function of the product and how it wants to introduce its product and then gets through negotiations with legislative organisations to reach to an agreement about the nature of the product.
Does the device do something more than the drug delivery? Do mechanical parts or electronical parts have physical roles in the treatment,etc? These questions arise while deciding the category of the product. an example may be a coated stent.
In conclusion , It should be considered that the answer to these questions are not always very clear. Sometimes a product may be accepted as a medical device in Europe while as a pharmaceutical product in US and vice versa. The descision is made after discussions between companies and EMEA in Europe or FDA in the US.
Monday, June 18, 2007
Complex biomedical devices
cool.click
cool.click™ is a needle-free device that delivers Saizen® through the skin The drug is delivered subcutaneously and provides the equivalent biological dose of Saizen® as do needle injections. Because it is needle-free, cool.click™ reduces pain and anxiety for patients that are undergoing daily treatment for Growth Hormone Deficiency. Looking at this product, in which group would you place it: is it a medical device or pharmaceutical product?
cool.click™ is a needle-free device that delivers Saizen® through the skin The drug is delivered subcutaneously and provides the equivalent biological dose of Saizen® as do needle injections. Because it is needle-free, cool.click™ reduces pain and anxiety for patients that are undergoing daily treatment for Growth Hormone Deficiency. Looking at this product, in which group would you place it: is it a medical device or pharmaceutical product?
Monday, June 4, 2007
Modeling of Arterial Cerebral Circulation
Studies of Cerebral aneurysm properties provide a better evaluation of their rupture’s danger, which may be deadly. As these properties change with time, ruptures are difficult to assess. CFD analysis is an efficient tool to provide information on the temporal variation of the mechanical forces acting on the aneurysm wall.
Intracranial arteries flow rate and pressure waveforms have to be provided as a boundary condition for CFD simulation in the vicinity of cerebral aneurysm. As the waveform changes from an artery to another, there’s a need to model main cerebral arteries to get the corresponding waveform. This model should go through a validation process to guatantee the result’s accuracy.
Intracranial arteries flow rate and pressure waveforms have to be provided as a boundary condition for CFD simulation in the vicinity of cerebral aneurysm. As the waveform changes from an artery to another, there’s a need to model main cerebral arteries to get the corresponding waveform. This model should go through a validation process to guatantee the result’s accuracy.
To improve and validate the model, reference results are needed: in vivo measurements to provide flow rate and pressure waveforms for cerebral modelled arteries. Measurements can be collected with MRI (general cerebral vasculature’s geometry), Doppler ultrasound (flow rate waveform) and Tonometry (pressure waveform) ,etc. The age range of study group is important. Young people’s artery properties is different from aged ones.
by: Virginie Chenaux
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