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Four Kinds of Consciousness and Abilities for Medical Device Research and Development

Views: 465     Author: Site Editor     Publish Time: 2020-08-07      Origin: Site

The medical device industry is an accelerating developing industry. More and more companies are participating in the device industry in the form of research and development, production, or operation. Especially in recent years, companies that originally focused on pharmaceuticals have also stepped into or even transformed into the medical device industry, providing devices such as tying forceps, corneal scissors, adjustable speculum, irrigating cannula, etc.


The development of medical devices includes independent research and development, introduction and iteration. Basically, the investment in the development process is huge. In order to ensure the successful development of the project in the process of R&D, design, review and registration, market operation, and sales and profitability, there are four kinds of consciousness and abilities that medical device manufactures should have.


EN-9201 Stainless Steel Tissue Scissors


1. The Consciousness of Medicine and Device Products.

Preventive health care, clinical medical care, nursing rehabilitation and other medical procedures are highly professional and life-critical. The value of a medical device to patients and medical staff should be viewed objectively in the development or introduction. What is the function of the product, what are similar products, the classification and attribution, registration strategy, existing resources of the company, the judgment of this series of important nodes should be based on medical science, on the basis of specialist clinical practice, and on the basis of China's national conditions.



2. The Consciousness of Administrative Regulations.

Administrative regulations include "Regulations on the Supervision and Management of Medical Devices" and special regulations. For example, to ensure the safety and effectiveness of medical devices, we have "Medical Device Registration Management Measures" and "Medical Device Clinical Trial Quality Management Regulations". To guarantee the the production quality of medical devices, we have the "Safety Production Law", "Product Quality Law", and national standards for medical device inspection. Administrative regulations are the basis for testing and reviewing whether a medical device can be allowed to appear in China during the process of product research and development. Therefore, you should be familiar with the regulations and judge in advance.


Stainless Steel Castroviejo Suturing Forceps


3. The Consciousness of of Legal Risks.

It is mainly reflected in the clinical application, whether there are problems that have not been discovered in clinical trials, and if not, the company will recall the devices and make compensation. Such examples are not uncommon. The strictness of clinical trials will directly affect the probability of such events. The law at this level is the Tort Liability Law. If the medical damage is caused by product design issues, the company will encounter very serious consequences. Therefore, the various possibilities and probabilities in the later stage should be studied and judged in time, and the risk of medical damages must be strictly avoided in the product development and design in advance. After the product goes into the market, the supervision, tracking and management of medical damage risks need to be normalized, even for small products such as sharp medical scissors, synthesis reduction forceps, etc., we must pay attention to the possible medical risks.




4. The Consciousness of Business Efficiency.

It is concentrated in market calculations, pricing techniques and profit forecasts. All companies were very optimistic in the PPT during the project roadshow. In the past two years, the more famous ones are "100 million mental patients in China" and "200 million infertility", etc., and the market estimates appear to be too optimistic. It comes from the needs of investment and financing.


The actual consideration should be objective or even slightly conservative in estimating the market size. The projects selected in this way may meet expectations or even exceed expectations. There is also a strict consciousness of time nodes. If the time node of a project cannot be guaranteed, real-time variables in the market such as competing products and technical updates will increase uncertainty. On-time delivery is a rare ability. After all, it is to keep pace.


Therefore, when developing a medical device project, possessing the ability of clinical consciousness and medical product process management, the ability to understand administrative regulations and judge trends, the ability to avoid medical damage and product quality risks, the ability of rapid and reliable business planning and execution are a comprehensive guarantee for creating value for doctors and patients, medical institutions, society, and the companies themselves.


Belle Healthcare has strictly complied with safety rules and laws and regulations for 11 years, and produces qualified high-quality products, including needle holders, medical suture scissors, disposable needle holders, high flow nasal prongs, etc. If you are interested in medical device products, please contact us.