The COVID -19 pandemic situation created a major stir in the medical device manufacturing services globally. The current dynamics are pretty volatile and data reveals that the coming years will see a major shift in trends.
Telemedicine, digital data boom, Mobile app integration, and home-based medical devices shall continue to grow with enormous modifications and advancements.
The automation technologies ML, IoT, AI, and contemporary trends will continue to shape the future of medical device industry.
The boost in healthcare as a whole requires everyone from biomedical engineers to healthcare marketers to get on their toes to scale up the game and upgrade their facility in terms of technology and market trends.
Johari, walking with the global shift in medical device manufacturing!
The way we think is the way we grow!
The global market demand for medical devices in 2017 was $413 billion, in coming times the market for such devices will continue to grow 5% annually. The approximate sales data shall reach closer to $530 billion in 2022.
Being an ISO 13485: 2016, cGMP compliant and MDSAP approved medical device manufacturing company, we are inclined in transforming the technology into medical assets that serve the purpose.
This facility consists more than 45,000 square feet of manufacturing space. The manufacturing facility involves a wholehearted approach to every step of the process. A Class 10,000 clean room, as well as model and prototype assembly labs.
We have Research & Development, QA/RA, Product engineering, and Data security systems. The adaptability of our systems makes us flexible to take up projects at any stage of development.
Supply chains is carefully managed for cost optimization, and the highest safeguards in documentation ensure lot control of raw materials. We have the talent and the resources to take your medical device manufacturing project from pilot to full-scale manufacturing with comprehensive and stringent project management oversight every step of the way.
Ideation & Design
An idea is a key parameter for rolling the device on a larger front. It requires analysis on several segments including financial, feasibility, production, and market viability. At our design lab, we assure effectiveness in design by keeping the following checkpoints in mind.
- Design Feasibility
- Design’s economic gravity
- Market potential
- Customization feasibility
- Input cost
- Profit margin
- Patent Landscaping
From Value to Volume
We don’t just create volume but we ensure quality at all points of time. Focusing on device performance while controlling costs and maintaining compliance with ISO:13485 and MDSAP guidelines.
How are we evolving our production capabilities?
Medical device manufacturing has two major phases involving design & manufacturing. Many times, we are approached for either of them and sometimes for both. At our facility, we are engaged with medical device manufacturing, testing, validation, and packaging. A single umbrella caters to all the aspects involved at any stage.
Automated PCB Soldering Technology
- Automatic 3D printing PCB to multiply production to four-folds. The accuracy is up to 12 microns and the time involved is halved.
- The rejection rate from the automatic printing machine is 0. Our facility has experts printing up to 6 layers of PCB.
- The reduction in the calibration time makes PCB production effective. To comply with ROHS guidelines we ensure lead-free soldering.
- Open for customization and modification according to project requirements.
- 5D inspection facility (STI – Solder testing inspection).
Pick & Place Technology
- To optimize the speed of component placing on the PCB, an automated process.
- The capacity of the device is 32000 CPH/ hour.
- The precise placing ensures a durable PCB. (0.6 -0.3 mm small components).
Reflow Oven Machine
- The reflow soldering of the PCB components with 8 reflow zones. 4 heating zones and 4 cooling zones to meet industry standard.
Automatic temperature optimizing soldering station
The Smart Heat technology for boosting the soldering process up to highest level of precision & accuracy. Automatic calibration reduces the manual labor and cost. Improves overall efficiency by reducing time and effort required to solder components. Ensure protection from power supply from non-conforming cartridges. The device has been designed to speed up the process with zero error for durable component soldering on PCB’s.
Our Medical Device Manufacturing Process
Pilot Device Medical Manufacturing
Pilot manufacturing is a task to completely get assured about the idea and design before it gets into full-fledged manufacturing. Engineers work on the process to continuously upgrade and improve the process. The pilot device manufacturing controls costs and helps in the identification of the issues before they capture the entire market.
Cell Manufacturing
The medical device manufacturing process begins with the procurement of raw materials to assure quality and raw material for medical device manufacturing. In a manufacturing cell, all the components of assembly and sub-assembly are used to create device components. All the operations in the assembly or sub-assembly are performed in U- shaped configuration. Cell manufacturing is an important part of maintaining agility in the system.
Medical Device component manufacturing
The material used for component creation determines the process which can be used to build the components. Some parts are injection molded from plastic while others are processed by extrusion. The technique is determined by the viscosity of the material to be used. The materials with higher viscosity are molded by the extrusion technique while the materials with lower viscosity are molded by injection plastic molding.
3D Printing
3D printing is involved in the rapid prototyping of the devices; the technology has a huge potential. The medical device manufacturers and device builders are already creating implants, models, and different medical device layouts to make the campaigns much more alive and genuine. Prosthetic limbs, artificial organs, and bone replacements may become a reality in the days to come. The FDA is already on the path to set guidelines and regulations for 3D printed devices in medicals and implants, so it can be predicted that we’ll have a tsunami of products and developments with 3D printing.
Welding
Welding is a process of making physical connections, while small, must still provide the appropriate level of mechanical strength. Ultrasonic welding, resistance welding, laser welding, and Tungsten gas inert atmosphere are important for the welding process.
Medical Device Software Development process
The new generation of electronic medical devices is nowhere less than a walking doctor in your pocket. All the devices are gaining a smarter edge that makes programming and software development a challenging part. The interactive GUI, smart functionality, customized operation, and data integrity are key parameters to be kept on the checklist while developing medical devices for the current times. Since COVID-19 many alarming changes have been done in the way healthcare was being delivered and medical devices were manufactured. Data has become an integral property as digital is gaining pace. Sensitive information requires a strong software backbone and we are continuously building it.
Opening to AI, ML, and IoT
Currently, we are rigorously researching to enhance our services and product with current technologies of AI, ML, IoT, and big data. The power of the new generation technology is revolutionizing healthcare globally by making it compact, economical, and accessible. We as global healthcare contributors are on our mission to become a global leader in delivering futuristic medical device manufacturing services and products.
Quality Control
For meeting the highest levels of compliance it’s mandatory to keep quality assured from procurement to packaging. To comply with ISO13485:2016 and MDSAP guidelines we stick to SOP at every level. The rigorous testing protocols ensure the highest standards in the material, manufacturing, and performance of our devices. Also, we believe in taking a step ahead to maintain 100% efficiency and zero error in our processes.
Packaging
Every device has a specific requirement for packaging, the type working for one might not work for another as well. Several factors need to be considered depending on the sensitivity and fragility of the device. Delicate instruments require careful handling to protect them from any damage and vibrations during transport. Sterilization of the devices is yet another important factor to consider while developing a medical device, from beginning up to transportation. We ensure a safe and non-hazardous environment for our medical devices.