The Life Cycle of a Medical device. Does device development differ from drug development?
If so, what is the difference?
Answer to Question: MJDMEDSC Medical Sciences
A medical instrument is an instrument, implement or machine, apparatus, machine. An appliance, device. software. material. A reagent of in vitro use is a product that the manufacturer company intends to be used for humans for medical purposes.
Medical devices include simple thermometers, bedpans, and complex programmable pacemakers.
Also, medical devices can include diagnostic products such as equipment’s for laboratory purposes, test kit and reagents.
The drug development process is the process of developing new drugs that target specific weaknesses in cells.
To ensure that a drug is effective, drug development can include pre-clinical and clinical trials.
This report will examine the development process for medical devices.
The development of a medical instrument will be compared to drug development, which includes the life cycle of medical devices.
The Lifecycle of a Medical Device
The life cycle of a medical device is generally described as
Research: It encompasses good clinical practices and clinical trial control, good laboratory practice, and exemptions from investigational device.
Design and development requires good lab practices, design control, document control, as well electronic records.
FDA review and approval: This requires FDA clearance, PMA(produce Marketing Association) and document control
Manufacture & services: This covers Quality system requirements, labeling control, designing controls and recall.
Obsolescence is the absence of records and retention.
Development of a medical device
Five steps are required to develop a medical gadget1. Discovery
It is the first phase of developing a device for medical use.
This is followed by classification soon. It regulates many aspects of the development of medical devices.
The device type and the risk assessed determine the classification. This is different between the United States of America and the United Kingdom.2.
The prototyping stage is where a device goes through its final stages.
The device cannot be used until this stage.
After this, the prototypes were tested in the laboratory with in-vitro- and in-vivo procedures.
These tests provide data on the safety and efficacy the device.
The tests can screen for potential impacts of carcinogenicity to a person’s reproductive health.3.
The preclinical phase is over and human trials start.
These trials can be divided into phases that are distinct from drug-related trials
Phase A. pilot, or explanatory phase
Studies with ten to 30 patients, designed to evaluate preliminary safety and performance
Phase B. Pivotal:
Researches involving 150-300 participants are done to determine if there is any adverse situation and assess the clinical efficacy.Phase C. Post-approval studies:
Even after the medical devices are released to the general public, research continues on the device.
In this phase, data regarding the long-term safety of efficacy has been collected.
The results of these studies, which can take some time, are very valuable for device like permanent prosthetic implant.
It is vital to check that adverse events occurring during clinical trials are not due to a device currently being tested.
These are called SAEs, or Serious Adverse Events. If a device defect is discovered, it should be reported immediately to the regulator.4.
This phase includes the presentation to the appropriate authority of data collected during clinical phases.
This phase is the most important because it determines if the device is to be released on the market.
If the device does not get approved, the manufacturer will likely return to the prior step to create a stronger submission for resubmission.5. After marketing surveillance
Development of a device can never be completed if it isn’t in use.
The post-marketing surveillance stage could be considered a prolonged extension of clinical research.
This stage is where the device manufacturer continues to monitor and collect data related to the device, even after it has been placed on the marketplace for public use.
The long-term data collected could be useful in clinical decisions as well as for the future development and maintenance of medical devices 8.
Process for Drug Development1.
Development and discovery
The researchers use their new insight into a disorder to discover a novel drug.
Researchers conduct experiments once the compound has been identified to obtain information on the drug’s absorption and distribution.
Information on the side effects, benefits and best routes of administration of the drug.2.
Before the drug can be tested on humans, it is necessary to analyze the possible serious side effects.
Here, there are two types preclinical researches that can be performed: one is done in vitro and the other is in-vivo.
It is important to follow good lab practices during this step.3.
Clinical research involves studies that relate to trials done by humans.
This phase also includes sub-stages like the clinical research phase. It involves the study of new drugs, FDA assistance and FDA IND reviews, as well as approval.
Clinical research phases include:a.
The new drug is given to approximately 10 to 100 people with various health conditions.
After the study with a small number of people,b.
This stage involves testing hundreds of patients with the disorder.
This process can take from months to years.
This step is necessary to evaluate the efficacy as well as side effects of the dr9ug.
This step failed to pass for as many as 70% of the drugs.
c. Studying 300 to 3000 people with the disorder or healthy.
This step may take between 1 and 4 years.
This step results in approximately 65-70 percent of drug failures.
This study is designed to evaluate the safety and effectiveness of any adverse reactions that may occur with the drug.
This step can be used to treat thousands of people with diseases.
This step is necessary to ensure safety and efficacy.4.
Investigational process for new drugs
Before starting clinical research, developers should submit an IND request to FDA.
FDA members can request FDA assistance for help in the development of the drug.5.
After the clinical stage, the developers must file another NDA (new drug applicant) application. This is required to allow the drug to be sold.
The FDA team reviews all data submitted by the developers and determines whether the drug should or shouldn’t be approved.
The NDA applications tell the full story of a drug.
The NDA Application is designed to show that the product can be safely and effectively used in a given population.6.
FDA regulates the safety of postmarket drugs
FDA can take a look at the reports and decide whether to add the precautionary measure to the drug.
FDA member inspects drug development plants routinely.
This is possible due to problems that can occur after the use a specific drug.
This is to verify that manufacturers are following GMP (good manufacturer processes).
FDA can stop drug production if they find that the minimum requirements are not being met.
Manufacturers are not allowed to market the drug before it is approved.
FDA created several programs to enable consumers and developers alike to report concerns about the drug.
MedWatch, MedSun and MedWatch are just two examples.
Differences and similarities between the Drug Development and Device Development
Differently, device development can look similar to drug development. However it is deferent in many ways. For example, while drugs are always therapeutic, the drugs may be used for supporting, diagnosing, and therapeutic purposes.
The body quickly processes the drugs and they have long-term effects.
Some dynamic changes may occur in the body of patients who have had devices implanted.
The lifecycle of a medical product begins at research and ends in obsolescence.
The entire life cycle also includes design and development as well as FDA review and manufacturing.
Reviewing the entire process of drug and device design, it is clear that although they are similar in many ways, the process of drug and drug development is very different.
Device development is a similar process to drug development. It includes preclinical study, clinical studies, regulatory reviews, surveillance after marketing, and discovery.
World Health Organisation. 2018. [cited 2018 Juni 23]. Available from: https://www.who.int/medical_devices/full_deffinition/en/
Is the product considered a medical device.
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