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The COVID-19 outbreak has suddenly brought an upsurge in the IVD manufacturing segment. Based on the Allied Market research, the global market of in-vitro diagnostics devices is estimated to reach $91.09 Billion at an impressive CAGR of 4.8% by 2027. The demand for rapid and on-point care/diagnostic systems is rising significantly. As the demand is rising, Johari is re-inventing capabilities to satisfy the growing demands of the industry.
Syrma Johari MedTech- Preferred choice as
In-Vitro Diagnostic Device Manufacturer
We are a leading In-vitro Diagnostic Device Manufacturer creating products in sync with the latest trends and requirements with a deep understanding of the intricacy’s peculiar to IVD. Our advanced manufacturing capabilities, innovative approach, a strong vendor network stringent compliance with regulatory makes us your perfect In-Vitro Diagnostic Device Manufacturing partner.
Our Technology Landscape
Some of the key In Vitro Medical Devices on which we have been working on:
- AI based Blood Sampling Device for Malaria & Sickle cell detection
- Spectrometry and colorimetry based Clinical Chemistry Devices
- Glucometer Devices
- Cancer Diagnostic Devices
- Infectious Disease Diagnostic Devices
- Immunodiagnostic Devices
- OTC IVD Devices
We are Expert in
[icon name=”arrow-circle-right” class=”” unprefixed_class=””] Industrial Design
The diagnostic devices require precision and specific understanding of IVD design. Keep user’s ease at priority. The operating ease, handling ease, and instruction language must be easy to understand for all kinds of users. At Johari, market feedback and research are crucial parameters for successful conceptualization and designing of an IVD product.
[icon name=”arrow-circle-right” class=”” unprefixed_class=””] Simulation Modeling
Simulation Modeling involves testing the design in a computer-aided program for its processes. Simulation prevents surprises and provides clarity on how the device will work as well as presents possibilities to make the functionality smoother. It’s virtual prototyping to ensure design efficiency, reliability, and safety. As an experienced OEM/Contract Manufacturer, we know the criticality of simulation modeling for IVD manufacturing.
[icon name=”arrow-circle-right” class=”” unprefixed_class=””] Accuracy and Quality
IVDs are used by end-users, on-point care personnel, and at various risky avenues. It’s important to evaluate functionality of the device for accurate results as any error means a wrong diagnosis followed by irrelevant treatment. At Johari, we perform a proper clinical evaluation of the prototype before sending the device for mass manufacturing. This ensures the device is perfectly safe and delivers accurate results.
[icon name=”arrow-circle-right” class=”” unprefixed_class=””] Cost optimization
Cost optimization is the main goal of outsourcing manufacturing. At Johari, we have strong vendor network, design optimization techniques, material analysis experts and various other innovative ways to optimize the overall manufacturing cost.
[icon name=”arrow-circle-right” class=”” unprefixed_class=””] Quality & Safety assurance
Many IVD devices (Class II) are over-the-counter products. It’s important to analyze quality and manufacturing in compliance with US FDA and other regulatory standards to develop safe Class I, Class II, and Class III-Vitro Diagnostic tools for use. At Johari, we maintain stringent compliance with regulatory guidelines to manufacture safe In-vitro Medical Devices. Our processes involve efficient quality control (Initial Quality Control, in quality control and Final quality control) to keep quality intact.
[icon name=”arrow-circle-right” class=”” unprefixed_class=””] Off-the-shelf Software in IVD
This kind of utility helps reduce cost and time to market. A set of pre-defined programs can be directly used in the device without any major re-work. The major elements (positioning/motion control/robots/ drive and control electronics, control/data processing/GUI software, liquid handling, precision fluidic control and dispense) come in handy with OTS. As far as the modules are flexible and scalable these are good and efficient to enhance longevity and reduce time to market. As IVD manufacturer Johari has an enriched experience in Off-the-shelf software management to reduce time to market and extra effort.
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Launching & manufacturing a new medical product in the market entails multiple risks. Medical Device Prototyping is done to identify opportunities and challenges in the initial stages of medical device design development. It is necessary to evaluate end design, function, and material at the prototype level. A minor mistake or ignorance at the prototype level can complicate manufacturing, stretch the production time and, incur a significant financial loss.
Medical Device Prototyping involves analyzing the medical device design on multiple parameters of efficiency in end-user environment. At the idea level the design might look revolutionary but actually holding it in the 3-D format brings actual problems to the front.
Understanding Stages of Medical Device Prototyping
Medical Device Prototyping is a multilevel process to check the design robustness before transferring it to the mass volume production stage. At this stage, prototype engineers can use their knowledge to make multiple iterations of the product design. The hit and trial are effective in choosing the best prototype to transfer.
Medical Device Prototyping involves four stages in general:
- Alpha Prototyping
- Beta Prototyping
- Pilot Prototyping
- Final Product
1. Alpha Prototyping
Alpha prototypes are non-functional and, these test the dimensions of the product design. Design dimensions must match the user intent of the device. This stage evaluates the ease of use the product will offer to the end-user.
2. Beta Prototyping
Beta prototypes are a step ahead of the predecessor prototype. These are slightly more advanced. The beta prototypes test the sturdiness of the parts or components. In case any error is encountered it is immediately brought to the notice of key stakeholders for rectification.
3. Pilot Prototyping
Pilot prototypes are necessary for soft launches and clinical trials. This is similar to the final product and require a final polishing to manufacture a product.
4. Final Product
This is when the design is ready for mass manufacturing. The final product has all the required modifications which address all challenges identified in the previous prototyping stages.
7 Benefits of Medical Device Prototype development
- Room for Modifications
- Time & Cost optimized
- Customization facility
- Communication
- Efficiency in an end-user environment
- Regulatory compliance
- Patent Overlap
1. Room for Modifications
Let’s suppose you are making a competitive product for a better acceptance rate. One way is to theoretically compare the designs and another is to hold the visualized design of your future product in a 3D model and compare it with the competing product. Which of these options do you feel is more effective? The prototype model gives better clarity on changes or enhancements required. The possibility of identifying modifications and scope of improvement is way higher in prototyping than other ways of analyzing the design feasibility.
2. Time & Cost Optimized
Every new product design is susceptible to modifications at a later stage. Rapid prototyping saves time and money involved in modifying the whole lot over a single prototype. As the issues are identified at the primary level the errors can be minimized. The error would have been transferred to the whole batch of production. Thus, the whole lot manufactured would have been useless and a waste of time and resources.
3. Customization Facility
CAD offers a wide range of flexibility. The prototype can be tweaked into various shapes and designs without changing the other components. Thus, an idea can be molded into various forms and checked for economic, industrial, and manufacturable feasibility.
4. Communication
A physical model communicates way better than a virtual design. It’s easy to communicate challenges in design, manufacturing, or concept with a 3D Model in hand.
5. Efficiency in an end-user environment
While crafting an idea in your head it might look like it’s the most useful invention. But when you make a 3D Model you can check the product in the end-user environment. Most importantly, you can evaluate whether the product serves the desired user intent.
6. Regulatory compliance
At the prototyping stage, you can also evaluate if the processes are in line with the regulatory guidelines of ISO 13485: 2016 and US-FDA. In case, the process does not comply with regulatory guidelines you can change the process or part which violates the guideline accordingly.
7. Patent Overlap
This is important when you want to manufacture a product for a competitive market. There may be several instances where you want your product identity to be unique. In the prototype stage, one can easily check and evaluate the design for overlap with similar existing technologies.
[/et_pb_text][et_pb_code admin_label=”R&D Slider” _builder_version=”3.0.98″ module_class=”rdslider_info” disabled_on=”on|on|on” disabled=”on” parent_locked=”on”]<ul class=”rd_slider”><!– [et_pb_line_break_holder] –> <li><!– [et_pb_line_break_holder] –> <div class=”banner_lt”><!– [et_pb_line_break_holder] –> <div class=”banner_img”><!– [et_pb_line_break_holder] –> <img src=”https://sjmedtech.com/wp-content/themes/johari-child/images/rd_img.jpg” alt=”” /><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> <div class=”banner_rt”><!– [et_pb_line_break_holder] –> <div class=”banner_cont”><!– [et_pb_line_break_holder] –> <h2>R&D</h2><!– [et_pb_line_break_holder] –> <h3>DSIR, GOVT. OF INDIA RECOGNIZED<br/><!– [et_pb_line_break_holder] –>IN-HOUSE RESEARCH AND DEVELOPMENT</h3><!– [et_pb_line_break_holder] –> <p>Johari’s Research and Development teams in India, Serbia and the U.S. include highly qualified and experienced professionals who are focused on applying leading edge innovation and technology to your medical product concepts. We are now one of the most renowned industries having GMP and DSIR recognized R & D from Government of India for performing projects and developing new formations which will be beneficial in healthcare sector.</p><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> </li><!– [et_pb_line_break_holder] –> <li><!– [et_pb_line_break_holder] –> <div class=”banner_lt”><!– [et_pb_line_break_holder] –> <div class=”banner_img”><!– [et_pb_line_break_holder] –> <img src=”https://sjmedtech.com/wp-content/themes/johari-child/images/expertise_slide1.jpg” alt=”” /><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> <div class=”banner_rt”><!– [et_pb_line_break_holder] –> <div class=”banner_cont”><!– [et_pb_line_break_holder] –> <h2>R&D</h2><!– [et_pb_line_break_holder] –> <h3>DSIR, GOVT. OF INDIA RECOGNIZED<br/> <!– [et_pb_line_break_holder] –>IN-HOUSE RESEARCH AND DEVELOPMENT</h3><!– [et_pb_line_break_holder] –> <p>Johari’s Research and Development teams in India, Serbia and the U.S. include highly qualified and experienced professionals who are focused on applying leading edge innovation and technology to your medical product concepts. We are now one of the most renowned industries having GMP and DSIR recognized R & D from Government of India for performing projects and developing new formations which will be beneficial in healthcare sector.</p><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> </li><!– [et_pb_line_break_holder] –> <li><!– [et_pb_line_break_holder] –> <div class=”banner_lt”><!– [et_pb_line_break_holder] –> <div class=”banner_img”><!– [et_pb_line_break_holder] –> <img src=”https://sjmedtech.com/wp-content/themes/johari-child/images/rd_img.jpg” alt=”” /><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> <div class=”banner_rt”><!– [et_pb_line_break_holder] –> <div class=”banner_cont”><!– [et_pb_line_break_holder] –> <h2>R&D</h2><!– [et_pb_line_break_holder] –> <h3>DSIR, GOVT. OF INDIA RECOGNIZED<br/> <!– [et_pb_line_break_holder] –>IN-HOUSE RESEARCH AND DEVELOPMENT</h3><!– [et_pb_line_break_holder] –> <p>Johari’s Research and Development teams in India, Serbia and the U.S. include highly qualified and experienced professionals who are focused on applying leading edge innovation and technology to your medical product concepts. We are now one of the most renowned industries having GMP and DSIR recognized R & D from Government of India for performing projects and developing new formations which will be beneficial in healthcare sector.</p><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> </li><!– [et_pb_line_break_holder] –> <li><!– [et_pb_line_break_holder] –> <div class=”banner_lt”><!– [et_pb_line_break_holder] –> <div class=”banner_img”><!– [et_pb_line_break_holder] –> <img src=”https://sjmedtech.com/wp-content/themes/johari-child/images/expertise_slide1.jpg” alt=”” /><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> <div class=”banner_rt”><!– [et_pb_line_break_holder] –> <div class=”banner_cont”><!– [et_pb_line_break_holder] –> <h2>R&D</h2><!– [et_pb_line_break_holder] –> <h3>DSIR, GOVT. OF INDIA RECOGNIZED<br/> <!– [et_pb_line_break_holder] –>IN-HOUSE RESEARCH AND DEVELOPMENT</h3><!– [et_pb_line_break_holder] –> <p>Johari’s Research and Development teams in India, Serbia and the U.S. include highly qualified and experienced professionals who are focused on applying leading edge innovation and technology to your medical product concepts. We are now one of the most renowned industries having GMP and DSIR recognized R & D from Government of India for performing projects and developing new formations which will be beneficial in healthcare sector.</p><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –> </li><!– [et_pb_line_break_holder] –></ul><!– [et_pb_line_break_holder] –><div id=”bx-pager” class=”bx-pager”><!– [et_pb_line_break_holder] –> <div class=”bx-pager_cont”><!– [et_pb_line_break_holder] –> <a data-slide-index=”0″ href=””>TECHNOLOGY DEVELOPMENT</a><!– [et_pb_line_break_holder] –> <a data-slide-index=”1″ href=””>PRODUCT DESIGN </a><!– [et_pb_line_break_holder] –> <a data-slide-index=”2″ href=””>EMBEDDED DESIGN</a><!– [et_pb_line_break_holder] –> <a data-slide-index=”3″ href=””>USER EXPERIENCE DESIGN</a><!– [et_pb_line_break_holder] –> </div><!– [et_pb_line_break_holder] –></div>[/et_pb_code][et_pb_text _builder_version=”3.0.98″ background_color=”#ededed” background_layout=”light” custom_padding=”20px|20px|20px|20px” header_3_text_color=”#991010″ header_2_text_color=”#072f9e” custom_margin=”50px|||” parent_locked=”on”]
Johari’s Capabilities as World Class
Medical Device Prototype Development
As a manufacturer of health technology equipment, products and systems, medical device prototyping is fundamental to your medical product design and development process. Creating early samples of your health technology products gives you the opportunity to test and evaluate the concept and work on further improvement.
We provide the following services for medical device prototyping:
CNC Machining
We employ CNC Machining of complex parts for rapid prototyping. We work with complex geometries, offering precise and accurate parts building. Our team has in-house experts, one-to-one collaboration, pro-active DFM, Competitive pricing, and fast turnaround time.
[icon name=”arrow-circle-o-right” class=”” unprefixed_class=””] CNC Milling
[icon name=”arrow-circle-o-right” class=”” unprefixed_class=””] CNC Turning
[icon name=”arrow-circle-o-right” class=”” unprefixed_class=””] 5-Axis CNC Machining
[icon name=”arrow-circle-o-right” class=”” unprefixed_class=””] Precision CNC Machining
Vacuum Casting
[icon name=”arrow-circle-o-right” class=”” unprefixed_class=””] Low cost for silicone molds
[icon name=”arrow-circle-o-right” class=”” unprefixed_class=””] Fast process for parts building
[icon name=”arrow-circle-o-right” class=”” unprefixed_class=””] Wide selection of materials
[icon name=”arrow-circle-o-right” class=”” unprefixed_class=””] High precision and fine details
[icon name=”arrow-circle-o-right” class=”” unprefixed_class=””] Excellent Surface Finish
Parts Finishing Capabilities
Final finishing involves making the product market-ready for matching the aesthetic requirements. For gaining the accurate appearance of the final product, the product must go under a post-finishing procedure. The post finishing services at Johari involve ensuring proper color, texture, gloss, and surface finish of the intricate parts. The post-finishing procedures include hand-finishing, sanding, blasting, polishing, painting, and printing. For surface finishing, we offer a wide array of procedures, including laser etching, anodizing, powder coating, metal plating, vacuum metalizing, chromate, chemical finishing, passivation, heat treatments, etc.
We hope this article helped you gain knowledge about Rapid Prototyping and its importance in medical device mass manufacturing. Let us know your feedback or explore Rapid prototyping with Syrma Johari MedTech Healthcare. Drop in your message in comment section.
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