Medical Device Development Process Compared To Drug Development Process

Describe the Life Cycle of a Medical Device. Does device development differ from drug development? If yes, how?

A general Lifecycle of a medical device includes

A medical device is an instrument, implement, machine, apparatus, appliance, implant, software, material, and reagent of in-vitro use intended by the manufacturer company to be used for human beings for medical purposes such as diagnosis, modification, prevention, treatment of disease or injury ¹. The medical devices are ranges from simple thermometer and bedpans to the complex programmable pacemakers. Medical devices may also include diagnostic products like equipment's for lab purposes, the test kits and reagents ². A drug development process the defined as the process of developing a new drug that has efficacy to target a particular weakness in a cell. The process of drug development includes pre-clinical development and trails in humans to ensure the efficacy of a drug. The process or development steps of medical devices will be discussed in this report. The process of developing a medical device will be compared with the drug development method including the life cycle of medical equipment’s ³.

A general Lifecycle of a medical device includes

• Research: It includes good clinical practices, clinical trial controls, Good laboratory practices and investigational device exemptions.
• Design and development: It requires design control, good lab practices, document control, electronic records ⁴.
• FDA review or approval: It requires 510(k) clearance, PMA(produce marketing association and document control
• Manufacture and services: It includes Quality systems requirements, establishment registration, labeling control, designing controls, recall, complaints and reporting of medical device
• Obsolescence: It includes record and retention ⁵.

There are 5 steps of developing a medical device

1. Discovery

It is the first stage of developing a medical device. This process is followed by classification soon, which regulates most aspects of the process of device development. The classification is made on the basis of device type and the risk assessed, this is different in the United States and the United Kingdom.

2. Pre-clinical research

In this step a device undergoes prototyping. Until this step, the device is not yet ready for the human use. After that, the prototypes tested in the laboratory by using in-vitro and in-vivo techniques. These tests provide a data related to the safety and efficacy of the device. For example, genetic and reproductive toxicology screen assays that screened for possible impacts of carcinogenicity on the reproductive health of a person ⁶.

3. Research

After the preclinical stage humans trials begin. These trials are divided into some phases that are different from drug-related trials

Phase A. pilot or explanatory phase

Studies that include ten to thirty patients and are designed in a way to evaluate the preliminary safety and performance

Phase B. Pivotal:

Studies where 150 to 300 participants take place to d3termeince that clinical efficacy and search for the adverse situations.

Phase C. Post-approval studies:

Studies related to the device continue even after the medical device has been released for the public. The evaluation for the long-term safety and efficacy data has been done in this phase. For the device such as permanent prosthetic implants, the results of these studies are very useful however it may take time to gather. During this stage, it is important to ensure whether any unfavorable events that may occur during the clinical trial might be attributed to a device that is being tested. For the regulatory process, these are called SAEs (Serious Adverse Effects) if there is any device deficiency occurs it should be reported to concern regulatory body ⁷.

Discovery

4. Regulatory reviews

In this phase, the data which is collected during clinical phase is presented to the appropriate authority. This is the most important phase because it is decided in this phase only that the device will be released in the market or is not approved. If the device is not approved then the manufacturer may return to the previous step to build a more strong application for resubmission.

5. After marketing surveillance

The development of a device is never completed as long as it remains in use. The post-marketing surveillance stage can be determined as a long extension of a clinical research. During this stage, the device developer continues to regulating and data collection related to the device after a product is released into the market for public use. The long-term data collected may be helpful for clinical decisions and for future development of a medical device ⁸.

1. Discovery and development

In this step the researchers discover a new drug by new insights into a process of a disorder to design a drug to reverse the effects of a specific disease, by using some tests of a molecular compound, by existing treatment,
once the compound is identified the researchers conduct experiment to gather information of absorption, distribution, metabolism, and excretion of the drug. Information related to the benefits of the compound, favorable dosage, best route of administration, side effects, and its effects on the different groups of people like by gender and raced ⁹.

2. Preclinical phase

Before testing the drug in people the serious harm that may occur due to the drug should be analyzed. In this step, two types of preclinical researches are done one is in vitro and another one is in-vivo. In this step, good lab practices should be followed. 

3. Clinical research

Clinical research is the studies related to the trails done by people. This phase includes sub-stages such as clinical; research phase, the process of investigating a new drug, FDA assistance, FDA IND review, and approval.

Clinical research phase includes:

a. 10 to 100 health or diseased participant are administered with the newly developed drug. after the study on a small group,
b. Hundreds of people with the disorder are tested in this stage. This process takes months to years. Purpose of this state is to find out the efficacy and side effects of the dr9ug. Up to 70 % of the drugs failed to pass this step.
c. Study of 300 to 3000 healthy or people with the disorder. This step takes 1 to 4 years to complete. Around 65 to 70% of the drugs are failed in this step. The main purpose of this study is to examine the efficacy and regulation of the adverse reaction if the drug.
d. Thousands of people with diseased condition take place in this step. The aim of this step is to ensure safety and efficacy of the drug ¹⁰.

Pre-clinical research

4. Investigational new drug process

The IND application should be submitted to FDA by the developers before starting the clinical research.

FDA assistance can be asked from FDA members to take help related to the development process of the drug.

5. FDA review

After the clinical phase, the developers need to file another application that is NDA (new drug application) which is related to the permission for marketing of the drug. during this stage, the FDA team reviews or examine all the data submitted by the developer and makes the decision whether the drug should be approved or not. The NDA application states the full story of the drug. The purpose of the NDA application is to demonstrate that the product is safe and effective in a population.¹¹

6. Postmarket drug safety regulation by FDA

FDA reviews report related to the problems with the prescription of the drug and can decide to add the precaution to the drug. The FDA member conducts routine inspections of the drug development facilities. Is can be done due to the problems occurs after the use of a particular drug. The purpose of this step is to ensure that that the manufacturers are following the GMP (good manufacturer process). FDA can shut down the production of the drug of it is found that the minimum standard is not met. The manufacturers are prohibited to advertise the drug before the approval of the drug. FDA initiated various programs that allow the developers and consumers to report issues related to the approved drug. For example MedWatch and MedSun.¹²

In different ways the device development is similar as the pharmaceutical drug development however it is deferent in some ways such as the device include software and hardware’s, the drugs are always therapeutic but the device may be therapeutic, supporting, surgical and diagnostic. The drugs have long-term effects on the body and are metabolized quickly by the body. The devices implanted in patient’s body may undergo some dynamic changes associated with function and safety.⁷

Conclusion

The life cycle of a medical device is started from research and ends at Obsolescence stage. The whole life cycle includes other stages such as design and development, FDA review and manufacturing and services. The After reviewing the process of both drug and device development it can be concluded that the process of the drug development and device devilment is almost similar but different in some ways. The process of the device development includes discovery, preclinical study, clinical research, regulatory reviews and post-marketing surveillance that are quite similar to the steps involved in the process of drug development.

References

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