Life cycle of medical devices

Every product goes through the same stages from idea to utilization. Some products are more complex, some simpler, but in general, the same sequence is followed. Even if we do not have a unique idea to create a new technological medical product and we decide to produce the same syringes as everyone else, but under our own brand. What does this usually look like in production? How do we manage the life cycle of a medical product? Let's try to understand together what the stages of the life cycle of a medical device include.

Design and development medical device

In a production facility subject to the ISO 13485 rules, there is a mandatory algorithm of actions for the realization of new projects. After a decision is made to develop a new type of product, the first step is research. This is handled by the R&D department. Design of MI includes not only a thorough study of similar products on the market and the experience of other manufacturers (if any), but also the creation of a prototype based on the design specification. 

After checking the compliance of the developed design documentation with the design specification, the unit cost is calculated. Absolutely all processes affecting the production of MI are taken into account. From procurement and supply of raw materials to logistics to the end user. After the initial calculation, ways to reduce the cost of production are found, if necessary. 

The prototype and initial testing of the project not only solves certain problems, but also raises new questions as to how much the benefit-risk ratio is cost-effective for the end user, including from an economic point of view. A complete risk analysis is prescribed at the design stage. Risk analysis is necessary to answer such questions, but not limited to them: how much is the finished product with our characteristics and processing methods risky for the patient? And for the doctor? And if it is misused? How do we minimize these risks? MI design verification and testing is also applicable in the design and development process. 

Production and control

When the design documentation has been approved, production of a trial series of products can begin. Production is also considered as part of the life cycle of a medical device. A technical file and specification are developed for the product in advance. The basis is, of course, international, interstate and national standards, as well as applicable Pharmacopoeias. A production flow chart is prescribed for the product. 

The production stage is subject to qualification control, when the manufacturer himself tests his trial batch for compliance with the developed documentation - the standard of the organization. After qualification tests, the sample batch is subjected to technical tests in accredited laboratories to confirm the reliability of the results. Once positive quality results are obtained, the products can be put into mass production. 

Clear, understandable and thorough quality control during the production process and the final product is the key to preventing defective products from reaching the market. The process is set up in such a way that even at the stage of accepting raw materials from the supplier there is a filter to prevent poor quality material from entering the circulation. And this applies to every stage, including labeling and the finished product in the warehouse. 

Registration medical device

Medical devices are subject to a compulsory registration procedure for entry into the general register. This topic has been covered in some detail in previous articles from lcs-kz. But let's focus here on analytical examination. Analytical examination or laboratory testing is one of the final stages of product registration. In some cases, defined by legislation, there is no such stage. This is the case for products whose manufacturers have established themselves on the world market as reliable. For example, ICH countries - Canada, USA, EU countries, Switzerland, Japan, Australia, as well as the UK. 

In cases where this step is present, our product is re-tested qualitatively for compliance with the standards defined by the manufacturer. Samples are provided to the laboratory, in the quantity required for triplicate analysis. This quantity can be easily calculated using the manufacturer's methods. Standard samples and reagents are also provided with the samples, if applicable for your product. 

After all necessary tests have been carried out, including both technical and toxicological indicators, the product from this stage is recommended for approval. However, if questions arise during testing or the MI does not confirm the claimed quality, this stage has the right to refuse the application for further registration procedures. If a refusal is received, the product cannot receive a quality opinion and therefore does not receive a registration certificate. This means that the registration process must be restarted, having previously readjusted the production or quality control process, taking into account the reasons for the refusal. Refusal to issue a registration certificate automatically means that the product cannot be sold on the market. 

Post-marketing period 

The so-called post-sale period - when the product has been sold/retired from production after all the authorization documents have been received. It would seem, gone and gone, what does the manufacturer have to do with it next? Notice how the MI life cycle is inextricably linked to the manufacturer's responsibility. After all, when building the production system, the manufacturer plans how it will control the processes of the life cycle of a medical device, up to its utilization. 

For this purpose, there are procedures for consumer feedback, pharmacovigilance and complaints handling. When products start to circulate on the market, through pharmacies, hospitals or other sources, they end up with the end user together with the instructions for use. If this happens, it means that the product has undergone a multi-level and multi-step review and continues to be under regulatory scrutiny. These products can be complained about, complained about and given feedback on side effects or defects, in case of an incident. The regulator can even force the product to be withdrawn from the market and take appropriate decisions, up to and including terminating the registration certificate for the product, and suspending the manufacturer's license if a complaint about the product is confirmed. 

For a product to be used correctly and safely, the manufacturer must provide clear and correct instructions for use, including information on storage and transportation, temperature and other conditions applicable to the MI. For certain products, the Authorized Body requires the manufacturer to submit clinical pharmacovigilance reports to verify the manufacturer's control of its product on the market and its tracking of incidents or side effects not declared at the time of release and registration. These reports are submitted until the regulator considers the product to be safe, but the minimum period is 3 years. 

Disposal medical devices

Medical devices must be disposed of safely for others. There are several groups of medical waste, which, when classified, are disposed of in one way or another. Hospitals, medical centers and other specialized institutions dispose of products according to certain rules, centrally - under contract with a special company. What should ordinary consumers who purchase products for personal use do? Some products must be disposed of as normal household waste according to the manufacturer's instructions. These are, for example, products made of non-woven material or gloves, plasters, etc. For other products, the instructions specify the method of disposal. 

Thus, disposal is the last stage in the life cycle of a medical device. But the manufacturer will keep all the documentation for each batch of the product that has entered the market for a long time. After all, in the event of any litigation, the manufacturer will bring up the entire history of product creation and will be able to show any information, right down to the number of the operator who manufactured a particular part, and any batch sold on the market.