A). Abiomed got an approval for their fully implantable artificial heart through and HDE approval. The purpose of the HDE is that it helps small numbers of patients who have no alternatives. However, the company is unable to sell more than 4,000 devices per year and must be able to monitor every patient who receives their device. First, Abiomed was able to convince the Office of Orphan Products Development (OOPD) that their device can be designated as a HUD. Next, they were able to submit their application (for a fee of $0). This application is very similar to that of PMA, but doesn’t require to contain results that the device is effective for its intended purpose (fda.gov). However, the application does need to show that the device does not pose a risk and that the health benefits outweigh the risk or injury after use. Additionally, no other devices are available for treatment and that they could not otherwise bring it to market. Approximately after 75 days of review time, CDRH approved AbioCor. Next, Abiomed had to obtain an IRB approval before they would be able to use Abiocor at any facility. B). Abiomed chose HDE path instead of the more conventional paths because Abiocor is essentially considered an orphan device with no others like it on the marketplace. Unlike PMA and 510k that require a submission and review …show more content…
fee to FDA, the HDE path has a waived fee and the application review time is only 75 days, which is short than even a 510K. This is an ideal situation for small companies who want to be able to get their device in the market and be able to gather data early on without having to pay the amount a PMA would cost. C).
The reason why Abiomed most likely chose the HDE regulatory pathway compared to PMA is because PMA’s clinical studies and trials are very costly and requires large, multicenter trials to demonstrate safety and effectiveness. However, by choosing the HDE path, companies (mostly start-up companies) are under pressure to obtain clinical evidence and generate revenue. Although HDE prevents to make profits off of the device, companies are able to get their device to market by allowing a company to obtain initial performance data and estimate their revenues in the long run. Additionally, the HDE pathway time of approval is much shorter than of a
PMA. D). With the classification of a device as HDE, there are several downsides that a company must be able to accept. First, US sales are limited and a company can only treat up to 4,000 patients per year. If sales exceed the Annual Distribution number, the company cannot keep those profits. Next, a company must have a label on their device stating that it is a humanitarian use device, and that it is authorized by FDA, it has not been proven that it is effective. Lastly, a company must follow essentially the same steps a PMA would require and must comply with GMPs/QSRs. I believe these are genuine limitations because you are essentially doing a PMA application but at a reduced fee and in a short period of time. These benefits outweigh that the company cannot make profits off of their device. Essentially, they are not losing any money, but getting a better deal to have their device enter the marketplace faster and at a much lower cost, as compared to a PMA.
They say that “EHRs’ financial costs and benefits can affect the rate at which providers adopt them, while quality improvement (QI)
regulations - what's next? Health Matrix: Journal of Law and Medicine 2, no. 1 (Spring): 49- (22 p).
Stage 1: This stage is primarily for meaningful use of an EHR in a clinical setting. The EHR technology the physician uses must meet at least 15 requirements and 5 “menu” criteria that are listed in the HITECH Act. The EHR used must be able to store patient demographic information, an e-prescribing with drug interaction alert content, and contain patient’s insurance information.
At first the LTP was mainly financially driven. After the initial success of some of its products, Amgen’s LTP devote more attention to qualitative targets.
trials of investigation medical products. The FDA also has to review and approve in a
strict or they can take too long to approve a drug. But I think for the most part, the FDA is really
In the early 1980’s, Denver experienced significant economic growth due to the booming oil, real estate, and tourism industries. The major airport that operated within Denver during that time was the Stapleton Airport. Up to 1970, the Stapleton Airport was able to accommodate the demands of Denver but in subsequent years it was unable to meet the ever growing needs of the city. The Stapleton Airport was seen as a liability and limited the attractiveness of businesses that were swarming to it. Issues with handling high traffic volume, disruptions in connection schedules, and an overall poor airport layout led the city of Denver to decide whether they wanted to expand or replace the Stapleton Airport. A study performed in 1983 determined that an expansion of Stapleton’s capacity was needed.
... system, Sam Nolan should approach Century Medical’s finance department and propose the same system to them. The finance department will then forward the proposal for the higher management’s approval.
Months ago we saw the disclosure of vulnerabilities surrounding St. Jude pacemakers, and Muddy Waters Capital. For those who don’t know what transpired, a security research firm discovered alleged vulnerabilities in St. Jude’s product line. The financial firm had hoped the disclosure would cause the price of the stock to fall [1], enabling them (Muddy Waters) to capitalize on a short sell. [2] Subsequently, St. Jude sued both the security firm, and Muddy Water. [3]
This is why the pricing strategy that newcomer, Jason Jowers is working on is so important for the promotion of this new package that is being offered. Atlantic Computer is looking to compete against one of its competitors; Ontario Computer, Inc., who has claimed about 50% of the low-end basic server market. The business consumers will be attracted to the Tronn and PESA because they will need a server that will allow them to keep their employees on the network, while improving operating costs at the same time.
The XenoMouse: The Case of Where the Business Should Go 1) What are the pros and cons of Abgenix collaborating with a partner on ABX-EGF in comparison to going solo? A partner to the business brings an advantage of providing additional capital, resources, and other material to develop the ABX-EGF drug program, all the while limiting the amount of risk that Abgenix takes on. For example, the drug may not develop correctly and fail in trail(s), or possibly the turns out to be unsuccessful, this after Abgenix provides a large amount of their limited resources. It’s also a benefit that the partner will have complementary knowledge, assets, and resources to market, sale, test, and develop the drug for market and/or testing.
Also DMC's perceived late discovery of the study. (Other manufacturers don't seem to know so DMC may still be ahead of the others in information, but their machine is 3rd choice so timely information is more critical to DMC)
FDA set up the offices of Orphan Product Development in 1982 to focus on drugs, medical devices, foods for medical purposes, and biologics such as immune globulin for rare disorders. President Reagan signed the Orphan Drug Act into law on JAN. 3 1983. It guarantees the developer of an orphan drug seven years of market exclusivity and 50 percent tax credit for certain clinical research expenses. Imagine Pepsi or Coke having a monopoly on each other's soft drink, that would be the equivalent on that. Initially, the act app...
Investigators are responsible for determining the initial device risk and presenting it to the institutional review board (IRB). The IRB is then responsible for reviewing the risk determination and modifying it if the board disagrees. If the FDA has already made the risk determination for the study, that determination is final. The FDA is also available to help the sponsor, clinical investigator, and IRB in making the risk determination. FDA regulations 21 CFR 812.2 also states that for studies involving use of an investigational device, the investigator must obtain either a "significant risk" Investigational Device Exemption (IDE) from the FDA, or a determination of "non-significant risk" from the institutional review board (IRB). The FDA’s “Guidance for Institutional Review Boards and Clinical Investigators” provides such criteria for the investigator and IRB to use in making these decisions.
Law is a set of enforced rules and regulations that society must follow. It controls and governs our activities and if broken may result in some form of punishment.