Medical Device Development and QSR - Article Example

Students Name Professor Course name Date Product development strategy The C-FAST device a new, faster and effortless way of diagnosing the Hepatitis C virus, that delivers the promise of creating a revolution in the medical field. It is a hand operated device, which has hand held grip on one side and on the other end is a thin metal rod, which in actual sense looks like a radio antennae and the handheld grip has a trigger like design. It is designed as a non-invasive device to be used in the diagnosis of Hepatitis C virus and possibly provide a cure too. The Hepatitis C Virus affects the liver and is since known to be a major cause of chronic liver disease. Its genome is a single –stranded RNA positive polarity molecule. According to (Shiha, 4) all living and non-living objects generate electromagnetic fields. Living things have systems which are complex and they are formed by a series of smaller components such as atoms, cells and organs. Energy is transferred within these components causing them to generate the electromagnetic fields mentioned earlier. The C-FAST device being a non-invasive device is developed on the idea that all viruses do emit electromagnetic signals, and given the unique structure of every virus, the electromagnetic signals are unique the virus. With this in mind the C-FAST device is designed in a way that the resonant electromagnetic energy of the Hepatitis C RNA is recognized as a molecule signature frequency. This way the device is able to identify and match the virus, and an identical match is translated as positive. This non-invasive device effectively identifies the Hepatitis C virus with unprecedented speed since no specimen is drawn from the patient and it only takes about one minute. The metal like rod once pointed at a subject will follow the subject if he/she has the Hepatitis C Virus to whatever direction he/she moves, but will remain in a neutral position if the subject does not have the virus. In a nutshell the C-Fast uses electromagnetic frequencies like those that have been used in bomb detector devices. It is a very effective device since it is reusable and can be used to diagnose many clients. No blood samples, chemical kits and complex laboratory requirements are required. It is portable, easy to use and will be developed for multiple uses but, has to be used only by qualified personnel. The C-Fast device is simple and effective because it does not require any form of sterilization since no contact whatsoever is made with the subjects body during the testing process. Product classification The C-FAST can best be classified in Class 3 (General Controls and Premarket Approval) according to the product classification guidelines by the Food and Drug Authority (FDA). This is because it is a novel product, utilizing the electromagnetic signals for identifying the Hepatitis C virus. Being in class 3 it is further identified as a medical device due to its nature of design and it does not enjoy any exemptions. According to the FDA classifications it is best viewed as a combination product whose main aim is to diagnose whether a subject has the Hepatitis C virus or not, and it does not affect the structure or function of the subject’s body. Furthermore the C-Fast device does not involve any chemical reactions in its application. It is novel and does not match any other device because those in existence require chemical reactions in their application. The existing Hepatitis C virus diagnosing methods apply the PCR method where they deal with the DNA of the cells in their tests and chemical reactions are involved. The C-Fast device is unique in that it diagnoses by identifying the RNA of the virus in a subject, without any chemical reactions involved as well as without physical contact. In addition to the information highlighted above, the C-Fast falls under Class 3 because it is very new and it has received major criticism. Despite having ascertained its validity, reliability and specificity in testing and providing accurate results, this device is still undergoing further investigation to prove its applicability. Given this knowledge the device will best be classified in class 3 under the investigational device exemption such that other clinical settings are allowed to test it applicability and forward their recommendations. Product verification and validation In order to penetrate the U.S market, a verification and validation plan is necessary. The device verification of the C-Fast device is a simple one since the research on its application has been concluded. Weighing 300 grams, the device is simple and it identifies a molecular signature in a subject by the help of electromagnetic signals. The device is designed in a way that a molecular signature of the Hepatitis C Virus RNA is stored in a memory card that is located in the device. Therefore, an electromagnetic signal emitted by a subject is quickly captured by the signal stored in the device and his quickly forms a match. Once there is interaction of the two signals, kinetic energy is generated and it is enough to move the C-Fast devices’ pointer towards the source of the electromagnetic signal. According to the FDA requirements, validation of the C-Fast device calls for testing and retesting the devices’ ability to withstand environmental conditions, defining the handling protocol of the device in order to classify who is allowed to operate it and also we will include proper labels, provide user instructions and finally use packaging material that will not affect the functionality. As highlighted previously, an investigational device exemption is required by the FDA in order to ascertain the viability of the C-Fast device. This is important for a product whose technology is unprecedented in the medical field. This is imperative because the FDA will require us to file a Pre-Market Approval (PMA) because the Class 3 products are classified as high risk, and since the C-Fast device does not resemble any other, its operations have to be established. This is so because the FDA aims to establish whether it poses any risks to the target population. Nonetheless this is important because the C-Fast is an electromagnetic signal detector that utilizes electromagnetic interactions of the body’s internal energy composition and this may be seen to pose a threat to the human population. According to (Fish &Richardson, 20), it is important to obtain the Investigational device exemption through the FDA, before we can conduct any clinical trials within the country. The FDA will permit the use of the device for testing within clinical settings and this will be easy to carry out because the C-Fast device can be applied to different clinical settings and populations (Shiha, 5). A report by (Fish &Richardson, 20) further explains that such novel medical devices are often classified in class 3, and manufacturers have to go through a process of having them reclassified to class 1 or 2. Alternatively the FDA will require us to file a 513(g) application in order to request a formal opinion on how the C-Fast device will be regulated. Project plan The entry of a new product such as the C-Fast device may prove difficult since it is a new technology and many players may be skeptical about the viability and applicability of the product. Since the major intention of this project is to have the C-fast device approved by the FDA in order to access the U.S market, it is important to consider the timelines and developmental phases involved. To begin with, establishing whether the device in use is a prototype or it is a fully developed product is an important step towards the right direction. Should the development process of the product begin today, the completion of the first and second phases will take a period of one year, giving s a prototype. The prototype will be put to further examination and experimentation such that in another year we have a completely functional product. The labeling and packaging considerations will be carried out in a period of three months in order to ascertain the proper labels to be included as well as the right packaging material in a bid to protect the functionality of the device. This being a medical device in class 3 of the FDA product classification, we will submit a market application to the FDA in order to be cleared. In our case we will seek to obtain an Investigational Device Exemption under the category of non significant risk device from the Investigational Review Board (IRB). Once the approval is granted, the focus shifts towards obtaining a Pre market Approval (PMA) exemption by the FDA. However due to the nature of our product, we will need a 510(k) submission, seeking guidance as to the proper classification of our product. Approvals by the FDA take on a period of 30 days and we believe that our product will pass the IDE approval, to be in the market for six months, after which we receive an exemption from PMA which is a period of 30 days after the application. Thereafter we shall apply to have our product listed and registered by the FDA. After this process the product will be approved in the last quarter of the year 2017. Post approval phase Once the C-Fast device has been approved for use in the U.S, we will focus on further product development with the aim of expanding the target electromagnetic signals. This means that we intend to focus on the non-invasive diagnosis of other viruses apart from the Hepatitis C virus. On the other hand, we will continue conducting market studies on the reliability and efficiency of the device. Since the product has very little or no maintenance costs associated with it and it is simple to operate, I believe we will successfully contest for reclassification such that it falls in class 1. This is because it is non-invasive, easy to use and little risk to the user. Therefore the only regulatory costs involved are those surrounding registration and product development. However, the other major issue to deal with after approval is how to curb duplication of the product in order to minimize potential harm. Therefore the product will have specific distributors who will be licensed by the regulatory body. The input design will be revised with the aim of introducing a special code for every device manufactured, such that they retain uniqueness and originality. Finally we will incur costs by allowing a third party to inspect, test and retest the product for accuracy, reliability and validity. This way we will ensure the product remains superior and it will carve way for more superior developments. Works cited Fish and Richardson. Wireless Medical Technologies: Navigating Government Regulation in the New Medical Age, Washington DC: Fish’s Regulatory & Government Affairs Group, 2013 Shiha,Gamal et al. A Novel Method for Non-Invasive Diagnosis of Hepatitis C Virus Using Electromagnetic Signal Detection: A Multicenter International Study. International Journal of Medical, Pharmaceutical Science and Engineering. 7 .12 (2013):1-7 Read More