زمان مطالعه: 5 دقیقه

Building medical factories and creating a new medical device with it includes many steps from the initial idea to the final product. Every year, billions of dollars are invested in research and development in this industry worldwide. The success (or failure) of a new technology will have a major impact on a company’s bottom line.

Also, product launch represents a major investment in revenue and profit for a company. A successful polymer medical product manufacturing plant can create new markets, reach new customers and increase business with existing customers.

The four main challenges that a new medical device product launch team faces are planning, communication, implementation, and follow-up.

The parties involved in setting up this industry (engineering, technical documentation, marketing and sales, distribution partners and customer support) must work together. Successful medical product manufacturing is typically measured by return on investment, adoption, market share, and customer satisfaction.

  1. Pre-construction stage:

    Innovation and entrepreneurship are widely celebrated in many fields and bring generous dividends to those who succeed. Building medical factories is no different from others seeking financial gain. Several universities around the world have developed entrepreneurship education programs to guide this process. One of the oldest bioscience programs is Stanford Biodesign, which focuses on training young innovators in biomedical technologies. The main approach that drives this industry process is an initial focus on identifying and characterizing a clinical need, rather than starting with a promising technology. Also during the fellowship period, graduate student mentors assess and solve needs in specific clinical areas. These three stages are:

  2. Identification, invention and implementation

  3. Determine the timetable:

    Medical manufacturing manufacturing timelines are determined by several factors, including: A product with new technology can mean a lead time of 3-6 months, up to 18 months or more. The more expensive the price point, the more time potential customers may need to plan the purchase within their budget or, in some cases, seek financing. Program novelty, pilot implementation of new technology to build credibility with potential customers.

  4. Create a product plan:

    During this critical step, make sure you include input from all disciplines involved in the project. Also be sure to consider the unexpected. Consultation with a team of experienced product supply specialists is recommended. They can help you create a comprehensive product launch plan, which includes a communications plan. This provides all members of the project initiation team a clear understanding of the scope, schedule, and execution of the process.

    1. Every task should be delegated appropriately
    2. It is possible to use resources optimally
    3. Share customer documentation implementation strategy with engineering, marketing and implementation teams
    4. Follow up on the progress of product development and modify the documentation plan if needed
  5. Create a customer-centric training program:

    Develop a program to train sales, customer service, and support personnel on the new product so they are prepared to assist customers in installing, using, evaluating, troubleshooting, and maintaining equipment. In addition, you should also:

        • Create a training kit for sales, customer service and distribution partners
        • Provide instruments of sale and collateral
        • Schedule training sessions for product sellers
        • Make sure service personnel are trained and ready to help with parts and service.
        •  
  6. Create and follow a documentation program:

A documentation plan that is customer-centric is the most efficient way for technical documentation managers to control costs that lead to a successful launch. The goals of this plan are:

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راه اندازی کارخانجات پزشکی پلیمری

What determines success or failure?

Accurate assessment of customer needs leads to more successful product innovation with better results. Some suggest that mispricing and failure to fix the problem play a role. Many companies follow a Stage-Gate process, where each activity and stage of a project is reviewed and requires senior management approval to proceed.

Others believe that inaccuracy in sales and marketing planning and its implementation plays an important role in the success or failure of building medical factories and new products. They point to four areas of rigor that must be considered by sales and marketing teams: planning, customer definition, value proposition refinement, and development.

What is the trend in the medical equipment industry?

Here’s a short list of popular medical devices, disorders, and treatments.

  • Focused monitoring of hospital patients
  • Targeted breast cancer treatments
  • Next generation vaccine platforms
  • Telehealth care
  • Neuromodulation for the treatment of obstructive sleep apnea
  • Hybrid closed-loop insulin delivery system
  • Scalp cooling for chemotherapy-related hair loss

As new technology and devices continue to change the medical landscape, success or failure may depend on well-established principles for understanding key stakeholders and customers. Then provide your sales force with targeting guidelines that reflect segmentation by customer needs to give them specific, individualized goals to help them perform and align with your strategy.

    1. Silicones:

Silicones are of interest in medical science due to their high resistance and stability against heat. Their resistance is remarkable even against ozone and hot oils in the construction of medical factories and they have a long lifespan. They are also good dielectrics. Gastric wound adhesive, artificial heart, finger joints, gastric endoscopic tube, valences are made of silicone.

    1. Polyurethanes:

Polyurethanes have more anticoagulation ability than other polymers and are blood compatible. For this reason, they are one of the best choices for making medical instruments.

They can also be sterilized with radiation and oxyethylene gas. They have high fat resistance and good clarity. It is used in cases such as internal injection tube, artificial heart ventricles, surgical dressing, knitted adhesive, etc. And they are the first option for making tools to solve heart problems.

    1. Polycarbonates:

These polymers are the preferred substitute for glass. They are flexible and light in weight and resistant to shocks. In the setting up of polymer medical factories, the transparency of glass and its resistance to heat and high temperature have been taken into consideration in useful packaging industries. The high strength and hardness of polycarbonate has made it equal to metals. and be a good substitute for metals in the medical industry.

    1. Polystyrene:

Basically, they are hard, transparent, brittle and have a low melting temperature. Uses: blood storage tube, serum storage containers, test tube…

    1. Polyolefins:

very economical, flexible, impermeable to water, resistant to grease,

They are chemicals and electrical insulators. They have good tensile and compressive strength.

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Used for: hip joints, medicine bottles, blood bags, packaging, films, etc.

    1. Polyvinyl chloride:

In the construction of medical factories, it has properties similar to polyolefin. But among polymers, the share is less than 10%, and they are used for medical purposes, food packaging, and non-edible uses as well. They are used in cases such as blood bags, artificial hearts, and making artificial organs.

    1. Acrylonitrile-butadiene-styrene copolymer:

This polymer is hard and resistant against chemicals and radiation. It is used as a blood vessel blocking syringe and surgical forceps, etc.

    1. Polysulfones:

They are bright and transparent materials that are resistant to high heat and environmental stresses. And they are not hydrolyzable.

But one of its disadvantages is its high price compared to other polymers.

Uses: surgical instruments, filter membrane, dialysis membrane, etc.

    1. Polyester:

In the construction of medical factories, it is a type of hard and strong polymer that is used in the manufacture of milk and some components of asthma pumps.

    1. Acrylics:

One of the important features of this polymer in the medical industry is its cheap price.

Uses: intraocular grafts, dental polymers, making connecting tubes, etc.

    1. Cellulosic polymers:

Among the applications of medical factories, we can mention the manufacture of dialysis membranes, intravascular ducts, and hemoperfusion. Due to transparency and clarity, the surface polish is also important in these parts.

    1. Poliamid

They are used in making sutures and catheters. They have characteristics such as resistance to torque, twisting, and are sensitive to pressure. Also, they are crystalline materials with high strength and are strong moisture absorbers.

    1. Polymethyl methacrylate:

High clarity and transparency, hard hardness, good mechanical properties, suitable biocompatibility and…

Uses: artificial teeth, artificial cornea, artificial paste, contact lens, etc.

    1. Polytetrafluoroethylene:

The construction of medical factories resistant to erosion and high temperatures, also has a low friction coefficient, and this polymerase has high electrical properties and wear resistance.

Uses: vein grafting, covering orthopedic screws and plates, surface coverings and…

 
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