Next, what would you do if you redeveloped the project after working on your own?
Develop a set of medical device products from zero to one. Attribute of this product: There are mature products on the market that can be used for reference. Mainly involved in technology: structure, materials.
Through observation, the material of the whole product is different and the risk is different. So, you can break down the big tasks into materials one by one, and then break them down one by one. How to disassemble can be separated by special standards and product specific methods, combined with the analysis of competing products. Therefore, through research, we divide the product into three steps to split the requirements.
The first step: according to the different functions and risks, it can be roughly divided into two parts: in vivo and in vitro.
Step 2: subdivide according to materials and risks.
Step 3: Different materials have different physical requirements, and then split the requirements into individual materials.
The above split is shown in the figure below.
After splitting the project, the preliminary technical requirements of each material can be obtained. It can be noted that this technical requirement is not the final version, and it will be fine-tuned in the development stage.
When writing technical requirements, we should distinguish the requirements, because some are material requirements, and some are composed of finished products to meet the needs. The most common problem encountered in the process is not understanding the meaning and method of a requirement in the technical requirements, or whether it should be added. This is mainly due to the unclear perceptual understanding of technical requirements. My general requirements for learning this technology are: 1. First of all, check the information to understand the definitions of various names. It would be better if we can find the source and significance of this indicator; 2. Ask suppliers, and general suppliers can know the meaning of these indicators; 3. Ask people in the industry, you can do research and development of quality or similar projects, and you can be a training teacher (if you consult a teacher, you can consult by email on the training courseware); 4. Start the experiment directly. Through the steps of 1 to 4, we can basically have a deeper understanding of the technical requirements of materials.
When determining the physical and technical requirements of each material, it is necessary to design the appearance and size of the product. At this time, you can refer to the design rules of competing products and combine your own clinical plan and sales strategy (very important! ! ), work out what kind of product model we need, so as to initially design the prototype appearance and size of the product.
With the preliminary technical requirements of each material, suppliers with corresponding technical requirements can be found. For detailed information about suppliers, please refer to Medical Device Development 1- Supplier Harvest Summary. In the early stage, we can find several different suppliers for horizontal comparison. At the same time, we must first confirm the relevant qualifications that suppliers need to provide, and don't pay the communication fee, and then find that their family has no qualifications.
After proofing and testing, the product is confirmed to be feasible, and the order is produced in small batches. Need to be reminded that the amount of proofing should not be too small, because the process needs to be verified, especially for those that need special processing technology, such as machines, fixtures or dispensing, as many as possible, 50~200 sets can be prepared.
If the project time is too short, here is a reference: if you and the supplier confirm that the technical requirements can basically be met or the supplier has made similar products, you can place an order by combining proofing and small batch production, but we have an agreement with the supplier that we will bear the problems ourselves, but if there is no problem in this batch, they will bear the responsibility. It should be noted here that the signed contract should not contain the word "proofing", but should be directly made into a formal supply contract. Here, I want to emphasize again that this is the best policy, and it is not recommended unless there is an emergency, because it is risky.
In the process of communicating with suppliers, we can also communicate with them the feasibility of some production processes. Although they may not have done it, after all, they have some experience to learn from and can tell us what technology can better realize the functions we want. After the preliminary process flow is listed, the test can be started when the sample product is available. This is usually in the proofing stage. Some need to buy corresponding equipment. At this time, we need to find corresponding suppliers, such as some cleaning equipment, welding equipment and heat sealing equipment. Of course, there are sterilization methods.
Finding an equipment supplier is similar to the above, and it is also proofing, and then testing whether the semi-finished products can meet our technical requirements. One thing to note is that we must carefully understand the operation difficulty and possible pollution of the equipment. If the operation is too difficult or the pollution may be too great, you can entrust this part of the process to the supplier who produces the materials, so that you can purchase the products instead of outsourcing, and you can avoid internal troubles and external troubles when human or environmental conditions do not allow.
In principle, every process can be verified, so don't confirm it. Because after determining the parameters, it is not necessary to verify every production batch, but as an indirect proof, there may still be risk factors that are not considered, which will lead to an increase in risk.
For products with equipment, the equipment must pass IQ, OQ and PQ when it is delivered to the company. Among them, IQ and OQ can be done when the manufacturer sends someone to install the training, but PQ must be done by itself. Generally speaking, suppliers can give us suitable OQ parameters, or help us debug the initial suitable parameters (enough samples) when proofing. It should be noted that in order for manufacturers to help us do OQ, we must first prepare enough products ourselves. Otherwise, for ourselves, because we can't completely test whether there is a problem with the equipment, the operation of the equipment will be relatively unfamiliar, and we can only explore it ourselves when various things come later. If there is a problem, you need to contact the manufacturer through communication tools to solve it, which is much less efficient.
To verify the process, three batches of products need to be trial-produced, and the stability of the process is confirmed by testing whether the technical indicators meet the standards. Of course, if some processes in the production process are energetic, it is necessary to find out the optimal value and upper and lower limits of quantitative indicators.
In order to carry out the confirmation process, it is necessary to determine the upper and lower limits of equipment parameters. For many equipments with compound parameters, the confirmation process can be accelerated by orthogonal test. After knowing the upper and lower limits, we can find the optimal parameters and try to produce three batches of products at the same time to see if the parameters we have determined can stand the test. A lot of materials will be used here, so the quantity produced in three batches is enough. Note that the parameters of different materials may be slightly different. Do not try to use one parameter to satisfy eo sterilization of different materials, such as different products, because different packaging methods may lead to different parameters such as heat preservation time.
Some processes do not need equipment, but some fixtures are needed to assist production. For such a process, it is necessary to make the fixture in advance and confirm its feasibility and stability in small batch production through verification. This can only be done as well as possible in the early stage, because some problems can only be found in the later batch trial production. One experience is strict control in the early stage, and the success rate must basically reach 100%, so that the fixture design can basically meet the standard.
If the materials can arrive at the same time, so much the better. If not, we will test whether the semi-finished products meet the technical requirements according to each part. After determining the feasible process, according to the technical requirements of the product, design the corresponding test scheme for the quality department to test.
After the process is determined, three batches of incoming materials are used for trial production. This is the conversion from R&D to production, which verifies whether the process is feasible in mass production. In the process of small batch production, new problems may appear in the processes that have been verified in the previous stage. This problem may be an efficiency problem or a stability problem. No problem. Fortunately, if something goes wrong, you may need to go back and redesign it. Therefore, the preliminary verification should be done as well as possible to ensure that there is no problem.
What needs to be emphasized here is to do it honestly, don't try to cut corners, and do all the process inspection and finished product inspection well to ensure the feasibility of the process.
If the inspection results of the finished products made of three batches of materials are all right, then the products can be sent for type inspection.
In the above process, we fell into many pits during the first exploration. It is also mentioned here, which can be focused on in the project.
So in general, if we want to redo the project, first of all, in terms of technical requirements, we will try our best to make a technical requirement based on the company's testing ability and on the premise of meeting the special objectives. Then convert the technical requirements into technical requirements, and then negotiate with suppliers. After the project is determined, the project promotion will be carried out. Professional engineers will be invited to take charge of professional technology such as molds and structures. These processes are basically the same as those done for the first time before. After that, every point has a corresponding archive, and the whole project process has a systematic record, which is convenient for overall management.