The original medical project development, filled with a lot of disorder and adventurous, which is mainly because the whole team is basically inexperienced. Now that the entire project has been completed, I look back and see that if the entire project had been given the same conditions and redone, it would have been a lot more organized than the first time I did it. Of course, this experience can not only be used in the development of this project, but can also be applied to a variety of projects in the future.
Here's what I would do if I were to develop this project again, after reviewing my own work.
Develop a medical device product from scratch. The product attributes: there are more mature products on the market can learn from. The main technologies involved: structure, materials.
By observation, the materials vary across the product, and so do the risks. Therefore, the big task can be split, split into a material-by-material and then single-point breakthrough. Specifically how to disassemble, you can take the special standard regulations and product specific way, combined with the analysis of competing products to split. So, through the research, we divided the product into three steps to split the demand.
The first step: according to the function and risk is different, can be roughly split into in vivo and in vitro two parts.
Step 2: It can be further subdivided according to the material material and risk.
Step 3: Different materials have different physical requirements, and then split the requirements into individual materials.
The above split is shown below.
After splitting the items, you can get the initial technical requirements for each material. It is important to note that this technical requirement is not final and will be fine-tuned during the development phase.
When writing technical requirements, you need to differentiate between the requirements, because some are material requirements, and some must be composed of finished products to meet the needs. The most common problem encountered in the process, is that the technical requirements of a requirement in the meaning and method do not understand, or do not know whether to add. This is mainly due to a lack of perceptual awareness of the technical requirement. I learn this technical requirements are generally: 1. first check the information, to understand the definition of each name, if you can find the source of the indicator and the meaning of the better; 2. ask the supplier, the general supplier can know the significance of these indicators; 3. ask people in the industry, you can have done a similar project quality or R & D, it can be a teacher of the training (consulting teachers, you can consult the training coursework on the e-mail); 4. Directly on the hands of the test. Through the steps from 1 to 4, you can basically have a deeper understanding of each technical requirement of the material.
In determining the physical and technical requirements of each material, you need to design the appearance and size of the product. At this point, you can refer to the design rules of the competitors, and combined with our clinical program and sales strategy (very important!!!) , to 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 for each material, you can take the corresponding technical requirements to the corresponding search for suppliers. For more information about suppliers, please refer to Medical Device Development Workshop 1 - Suppliers.
After sampling, testing, and confirming the feasibility of the product, small batch production orders. Need to remind a point, the sampling volume is not too small, because the need to verify the process, especially for the need for special processing technology, such as the need for machines, fixtures or dispensing and so on, try to prepare more, can be 50 ~ 200 sets.
If the project time is too urgent, here is a way to learn: If and suppliers to confirm that the technical requirements can basically meet or suppliers have done similar products, sampling and small batch production can be combined with the order, but agreed with the supplier, out of the problem we bear, but if this batch of no problem, after the volume of output problems, the responsibility borne by them. Here to note that the contract signed, do not have "sampling" of the word, directly into a formal contract for materials. Here to re-emphasize, this is the next best thing, if not an emergency and do not advocate, because this itself is at risk.
In the process of communicating with suppliers, you can synchronize and communicate with them about the feasibility of some production processes. Although not necessarily done by them, but after all, they have some experience to draw on, can tell us what process can be better to achieve the function we want. After listing the preliminary process flow, when the sample product in hand, you can start the test. This is generally in the sampling stage. There are some need to buy the corresponding equipment, but also need to find the corresponding suppliers at this time, such as some cleaning equipment, welding equipment, heat sealing equipment, etc., of course, there is also a way to sterilize.
Looking for equipment suppliers and the above is almost the same, but also sampling, and then test semi-finished products can meet our technical requirements. One note, be sure to carefully understand the difficulty of the equipment and the possible contamination. If the operating difficulty is too high, or may produce too much pollution, you can entrust this part of the process to the production of material suppliers to do , so that the product can be made into an outsourcing rather than outsourcing, and to avoid the internal trouble if the manpower or environmental conditions do not allow.
In principle, each process can be done to verify, do not do to confirm. Because after confirming the parameters, it is possible not to verify each production batch, but confirmation as an indirect proof, there may still be risk factors that have not been taken into account, leading to increased risk.
For products with equipment, the equipment shipped to the company has to go through IQ, OQ and PQ. among them, IQ and OQ can let the manufacturer to send people over to help complete the installation and training, but PQ must be done by yourself. Generally speaking, the supplier can give us the appropriate OQ parameters, or in the sampling time to help us debug the initial appropriate parameters (sample size must be enough). One thing to note: If we want manufacturers to help us do OQ, we must prepare enough products for ourselves first. Otherwise, on our own, because there is no way to fully test the equipment whether there is a problem with the operation of the equipment, their own will be relatively rusty, can only be a variety of late things to all together and then their own fumbling, problems, the need to contact the manufacturer through the communication tools to solve the problem, a lot of inefficiency.
To do the verification process, you need to test production of three batches of products, through the detection of technical indicators to confirm whether the standard, to confirm the stability of the process. This is of course if the production process can be quantified in some processes, but also to find out the optimal value of quantitative indicators and upper and lower limits.
To do to confirm the process, the need to determine the upper limit of the parameters of the equipment, the lower limit, for a lot of composite parameters of the equipment, can be through the orthogonal test to speed up the confirmation process. Probably know the upper limit and lower limit values, you can go down to find the optimal parameters, while test production of three batches of products, to see if we determine the parameters to withstand the test. A large amount of material will be used here, so the number of three batches must be sufficient. Note that the parameters of different materials may be slightly different, so do not try to use a parameter and then meet a variety of different materials, such as different products eo sterilization, because of the different packaging methods, and may be holding time and other parameters will be different.
There are some processes that do not require equipment, but need to do some fixtures to assist production. For this process, the jig needs to be done in advance, through the verification to confirm its feasibility and stability of the small batch production. This can only try to do a good job in the early stage, because there are some problems, only in the back of the mass trial production may be found. One of the lessons learned is to strictly control the pre-production period, and to achieve a success rate of 100%, in order to consider the design of this jig as basically up to standard.
If the material can arrive at the same time is the best, if not, according to the various parts to experiment with semi-finished products to meet the technical requirements. Determine the feasibility of the process, according to the technical requirements of the product, and then design a corresponding testing program for the quality department to test.
After confirming the process, down with three batches of incoming material for trial production. Here is a kind of R & D to production, to verify the mass production, whether the process is still feasible. May be in front of a variety of verification are no problem process, in the small batch production process, there will be new problems, this problem may be efficiency, may be stability. No problem is okay, if once the problem, serious may also need to return to re-engineer. Therefore, the pre-verification as much as possible to do, more to ensure that there is no problem.
Here we need to emphasize, is to do honestly, do not try to cut corners, all the process testing, finished product testing are done to ensure the feasibility of the process.
If three batches of incoming materials made out of the finished product test results are not a problem, then the product can be sent to the type inspection.
In the above process, we are in the first development of mapping, trapped in a lot of pits. This is also brought up again here, and can be focused on in the project.
So the synthesis of the above said, if we say to redo the project, then first of all, in the technical requirements, will be combined with the company's ability to detect, try to meet the premise of the special standard, out of a technical requirements. After the technical requirements into technical needs, and then negotiate with the supplier. After determining the project, the project will be promoted. In terms of specialized technology, such as mold and structure, professional engineers will be asked to be responsible. These processes, in fact, are basically similar to what was done before for the first time. After that, it is each point, there are corresponding filing, and the whole project process, there is also a systematic record, both to facilitate the coordination, but also to facilitate the management.