MJDMEDSC Medical Sciences

Question:

Please describe the Life Cycle of a Medical device.

If yes, then how?

Answer:

Introduction

A medical device is any instrument, implement or machine, as well as software, material, material, and hardware intended for in-vitro medical use by the manufacturer company. There are many medical devices, from simple thermometers and bedpans to sophisticated programmable pacemakers. Other diagnostic products that may be used in medical devices include equipment for lab purposes, test kits and reagents.

Drug development is the process of creating a drug that targets a particular weakness within a cell. Drug development involves pre-clinical testing and human trials to verify the effectiveness of a drug. This report will cover the process of developing medical devices.

This report will discuss the development of a medical device in comparison to the drug development process, as well as the lifecycle of medical equipment. The Life Cycle of A Medical Device. A medical device’s general lifecycle includes;

Research: It involves good clinical practices, clinical trials controls, good laboratory practices and exempting investigational devices.

Design and development: This involves design control, good lab practices as well as document control.

FDA review and approval: This requires FDA clearance (510(k), PMA(produce Marketing Association) and document control

Manufacture and Services: It covers Quality system requirements, establishment registrations, labeling control and designing controls, recall, complaints, and reporting of medical devices

Obsolescence: It is a combination of record keeping and retention. Design Of A Medical Device The development of a medical device involves 5 steps This is the first step of developing a medical gadget. Next comes classification, which regulates many aspects of the device development process. The device type and the risk assessed determine the classification. The process is different in the United States as it is in Britain.

Pre-clinical research

A prototype is created for a device. This is the last step before the device can be used by humans. After this, the prototypes are tested in the laboratory using in-vitro or in-vivo techniques. These tests are used to determine the safety and effectiveness of the device. These tests screen for possible effects of carcinogenicity on the reproductive and genetic health of a person.

Research

Human trials will begin after the preclinical stage.

These trials are split into different phases to drug-related ones

Phase A. pilot phase or the explanatory phase

Studies that include 10 to 30 patients and are designed to evaluate the safety and performance in the beginning

Phase B.

Study involving between 150 and 300 participants to determine clinical efficacy.

The device’s studies are ongoing even after it is made available to the public.

In this phase, the safety and efficacy data have been evaluated.

Although these studies can provide valuable information, they may not be available immediately for permanent prosthetic implant devices.

This stage is critical to verify that any adverse events may have occurred during clinical trials.

These are known as SAEs, or Serious Adverse Effects. If a device defect is discovered it should be reported immediately to regulatory authorities.

Recommendations

The appropriate authority is presented with data gathered during the clinical phase.

This phase is the most important because it determines if the device will be approved or released on the market.

The manufacturer could return to the first step to submit a stronger application if the device is denied.

A device’s development is not complete if it is still in use.

Post-marketing surveillance can be described as an extended extension of clinical research.

The device developer continues to regulate and collect data about the device even after the product has been placed on the market.

The long-term data can be used to make clinical decisions or for the development of future medical devices.

Process for Drug Development

Discovery and development

Researchers discover a new drug through new insights into a disorder process to design a drug to reverse specific diseases. This is done by using tests of molecular compounds and existing treatment.

After the compound has been identified, the researchers perform experiments to determine the absorption, distribution, metabolism and excretion.

Information regarding the benefits of the compound and the best way to administer it, side effects and the effects on different groups, such as gender or race.

Preclinical phase

The serious health risks that could be caused by the drug must be assessed before the drug is tested in people.

This step involves two types of preclinical researches: one in vitro and one in-vivo.

This step requires that you use good laboratory practices.

Clinical research

Clinical research includes studies that relate to trials done by humans.

This stage includes sub-stages, such as clinical; and research phases. These are the stages that involve the investigation of a new drug, FDA assistance or FDA IND review.

The clinical research phase includes:

The newly-developed drug is given to between 10 and 100 patients with health problems.

After the study in a small group of participants,

This stage tests hundreds of people who have the disorder.

This can take from months to years.

This is done to assess the efficacy of the drug and its side effects.

This test failed for up to 70% of the drugs.

c. Study on 300 to 3000 healthy people or those with the disorder.

This step can take anywhere from 1 to 4 years.

This stage is failed by approximately 65 to 70% percent of the drugs.

This study aims to assess the effectiveness of the drug and regulate adverse reactions.

This step involves thousands of people suffering from a disease.

This step is intended to ensure the safety and efficacy for the drug.

Investigational new drug process

Developers should submit the IND application to FDA before beginning clinical research.

FDA members may request FDA assistance to assist with drug development.

FDA review

After the clinical phase, developers will need to file a second application called NDA (new drugs application), which is related to permission to market the drug.

The FDA team examines all submitted data and decides whether the drug should or shouldn’t be approved.

The NDA Application tells the whole story of the drug.

The NDA application is used to show that the product is safe for use in a specific population. FDA regulates safety of postmarket drugs. FDA reviews reports related to prescription problems and can add the precaution to the medication.FDA members conduct routine inspections of drug development facilities.It is done to check for potential problems after the use of a drug.

This is done to ensure that the manufacturer follows the GMP (good manufacturer procedure). FDA can stop production if the minimum standard is not achieved. Before the drug is approved, manufacturers cannot advertise the drug. FDA established various programs that allowed consumers and developers to report problems related to the approved drug.

MedWatch and MedSun, for example.12

Differential and similarities between Drug Development and Device Development

Although the process of device development is similar to that of pharmaceutical drug development, it is different in certain ways. The devices include software and hardware. While drugs are always therapeutic, but the device may also be supportive, surgical or diagnostic. The drugs are quickly metabolized by the body and have long-lasting effects. Implanted devices in patients’ bodies can undergo dynamic changes that affect safety and function.

Conclusion

The entire life cycle for a medical device begins with research and ends at the Obsolescence stage. The entire life cycle also includes design and development as well as FDA review, manufacturing, and services. The process of drug and device creation is similar, but in some ways they are different. The steps involved in device development are similar to drug development. They include discovery, preclinical studies, clinical research, regulatory reviews, post-marketing surveillance, and regulatory reviews.

Refer to

World Health Organisation. 2018 [cited 2018 Jun 23].

Is this a medical device?

[Document online]: US Food and Drug Administration. 2018. [cited 2018 June 23].

Document on the Internet about drug development: Nature; 2018. [cited 2018 Jun 23].

et. al.

Integrated sustainable lifecycle design: An overview: Journal of mechanical Design, 2010, 132(9).

Fiedler. David Ba. Chapter 1: Reframing product life cycles for medical devices. New York, US: Managing medical products within a regulatory context.

Understanding the 5 stages of medical device development [document available on the Internet] GreenLightGuru, 2018. [cited 2018 June 22].

5 stages in medical device design [document on the Internet] Premier research, 2017. [cited 2018 Jun 22].

Pontius N. A complete guide to medical device development and design: from discovery and conception to design controls, navigating regulatory requirements, quality assurance and risk management. [document on Internet]: Pannam Imaging. 2017 [cited 2018 Jun 22].

Drug development: raising standards for preclinical research in cancer: Nature: 2012: 428(7391).: 531.

The drug development process [document on Internet]: US Food and Drug Administration. 2018 [cited 2018 Jun 22].

Part 1: Drugs and devices and FDA: An overview on approval processes for drugs: JACC Basic to Translational Science: 2016, 1(3), 170-79.

Carpenter, D. Chattopadhya (J.), Nall, C. The complexities of controlling agency time discrepancy: FDA review deadlines, post-market drug safety. American journal of politics: 2012: 56(1): 89–114