Joharimedtech

Johari Digital is the leading electronic medical device manufacturer catering to global clients. We design, develop, engineer, and manufacture medical devices for global markets. We are the first MDSAP, US FDA, and GMP audited medical manufacturing company in India.

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What is Biocompatibility testing for Medical Device?

Biocompatibility of Medical Device refers to the synergy of the device with the skin surface. Based on the level of interaction between the Medical Device and Skin Surface the tests are divided into several categories. Generally, based on the level of invasiveness Medical devices are classified as Class I, Class II, and Class III. Medical Devices interact with intact skin or broken & damaged skin. Based on the interaction tendency and invasiveness ISO 10993-1 outlines guidelines to evaluate medical devices to ensure patient safety.

Testing for a Class II (Devices coming in contact with Intact Skin) Medical Device

Cytotoxicity

The test ensures that there is no leachable toxicity released from the device. The tests are conducted under controlled conditions on mice or similar small lab organisms to check the device's cytotoxicity.

Sensitivity

Every device is developed ignoring moderate risks. With the biocompatibility tests for sensitivity, we ensure that there are risks that pose an issue of sensitivity for the patients. To evaluate sensitivity an extract is taken from the device and tested on human skin for 24-48 hours.

Irritation

Everybody reacts in a different manner to a specific effect of a Medical Device. It's important to evaluate that the device does not cause any major irritation or pain effects on the skin surface. The device is clinically evaluated under the careful guidance of authorized doctors to ensure the device is safe and specific instructions can be formulated for use in specific conditions.

Why is biocompatibility testing important?

Biocompatibility testing ensures that the device is completely safe to use. In the case of devices that are highly invasive, it's completely prohibited to sell a device that is not biocompatible.

To understand this better, consider the case of Allergan breast implants

Natrelle BIO CELL textured breast implants were recalled as they presented a significant risk of anaplastic large cell lymphoma (BIA-ALCL). The biocompatibility issues and seriousness of the impact these caused lead to havoc. FDA prohibited the distribution and sales of these devices and ordered a recall of around 246,381 devices.

Not performing a Biocompatibility test or cutting corners around the safety of the medical device can lead to fatal consequences for the patient and long legal repercussions for the manufacturers and sellers.

It is important for manufacturers to comply with international guidelines on safety and biocompatibility to limit recalls and maximize safety for the end-users.

Schedule a consultation with Johari Digital Healthcare Ltd to explore regulatory compliant Medical Device Manufacturing with Johari Digital Healthcare Ltd.

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Smart Healthcare Devices: Relevance with changing Healthcare landscape

Are you a start-up, Looking for Medical Device Manufacturing services for fast go-to-market? Accelerate your idea to market with flexible & dependable product development

Johari Digital Healthcare Limited Design and Development and Manufacturing Medical Devices. During the COVID-19 Home Healthcare Device industry gained significant momentum. Devices offering healthcare solutions at home have become ubiquitous. Smart ECG Devices, Healthcare bands, BP trackers, and Blood sugar monitors are a few common examples of this domain. The global wearable medical devices…

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Medical Device Manufacturing: 5 Rules to abide by

Medical Device Manufacturers Need to develop strategies to showcase better outputs. There are 5 strict rules that every Medical Device Developer must follow to ensure quality manufacturing with realistic deadlines and safety.

T - Technology

Technology is the backbone of Medical Device Development. The Manufacturers and developers must keep themselves updated with the latest developments in the domain to come up with the latest innovations. Often companies enter a state of redundancy as they live in silos ignoring where the world is going. Updating the technology portfolio as per the market demand is the key to remaining relevant in the long run.

T- Turnaround Time

Turnaround time is another important factor that plays a crucial role in determining the growth of a Med-Tech firm. A long delay is one of the biggest hurdles in the client-manufacture journey. Every Med-Tech who signs up for Contract Manufacturing sees turn-around-time as the most important aspect to check out while choosing their Medical Device Manufacturing Partner.

T-Transparent Communication

Communication is the key to winning your client's trust. Maintaining transparency in sensitive issues like vendor management, documentation, and supply chain is another key area to keep in mind while choosing your contract manufacturer.

T- Trained & Skilled Workforce

A successful organization or company is nothing but a group of individuals sharing and willing to work towards a common vision. Training your team and making the workers at every level skilled is another major aspect that manufacturers must keep in mind while planning for exponential growth soon.

T-Tough Calls

Often your client and team might not agree on a decision. It might look flawed initially or you may not effectively communicate the implications of the decisions at the initial stage to your client. But, if you decide out of your client's agreement you should be ready with positive implications to justify the steps taken.

At Johari Digital Healthcare we abide by various nuances of Medical Device Manufacturing to offer regulatory compliant and seamless Medical Device Manufacturing.

Schedule your consultation today!

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Why are we reliable Medical Device Manufacturers?

We know you’ve been looking for someone who can guide you through all the steps of Medical Device Manufacturing. But, the market is full of

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Medical wearable devices: what are they?

Medical Device wearable devices are new-age tools to keep track, diagnose and treat different health conditions. Initially, the function of a smartwatch was limited to several modes of basic tracking. With technology development, sensor-based devices are gaining extreme popularity. More and more developers across Health & Med-Tech domain are entering the wearable segment. The wearable medical device market is estimated to grow from $27.91 billion, in 2019 to $74.03 billion by 2025 at a CAGR of 17.65%, according to a report by Mordor Intelligence. There are numerous reasons for the exponential growth in the wearable medical device domain.

Why are Wearable Medical Devices gaining popularity?

The popularity of Wearable Medical Devices is due to the following reasons:

Personalized User Experience

Wearables based on the sensor technology or some other similar technology offer customized treatment. Unlike clinical devices, wearable medical devices offer more personalized treatment.

Cost-savings

To get an ECG done in a clinical setup, you have to spend more amount as compared to when you're using a watch or a health band with a continual ECG monitor.

Privacy Secured

Often, people are highly conscious of their health information. The confidentiality clause is intact in wearable medical devices.

Portable

The entire ECG setup cannot be taken from one location to another. The watches or other sensor-based devices can be moved from one location to another.

Continual Tracking

The Wearable Medical Devices offer an in-house continual tracking facility of different health patterns. Some functionalities that developers have incorporated to date are:

1. Heart rate Monitoring

2. Sleep Pattern Monitoring

3. BP Monitoring

4. Oxygen Concentration Measurement

5. Distance covered (Physical Activity Trackers)

Offering so many different applications the wearable segment has gained a significant explosion. With the population becoming more aware of health tracking, Medical Device Manufacturers are developing strategies to cope-up with the growing demands of the wearable healthcare industry.

To get quality Wearable Medical Devices Manufactured across multiple domains of the healthcare segment schedule your consultation with Johari Digital Healthcare Ltd.

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The gamut of Technologies we've worked on!

Ultrasound

Ultrasound is a diagnostic, pain-relieving as well as aesthetic technology. The deep-invasive heating of tendons, joints, muscles, and ligaments causes restoration of the movement and pain relief. The Non-Thermal ultrasound produces a cavitation effect for expansion and contraction of the cellular fat. The thermal heating effect of the ultrasound is effective in pain relief and non-thermal is highly effective in fat reduction.

Homogenizer

The technology is widely used in the industrial arena, lab research, universities, and pathology applications. At Johari Digital Healthcare Ltd we've delivered world-class homogenization technology for an error-free and spillage & contamination-proof sampling of biological samples.

AI, ML, Cloud-Based Technology

Making devices accessible is the need of the hour. To improve accessibility, boost revenue, and enable connected healthcare, developers are now focusing on utilizing AI, ML, and cloud-based technologies in their devices. SAMD is also another major trend amongst developers in healthcare. Numerous concepts are being built to solve problems that weren't identified before. For instance, with increasing cases of sleep disorders, the market now has numerous apps and devices to track sleep or aid in developing a healthy sleep.

Electrostimulation Technology

Electrical stimulation technology is also referred to as alternative medicine. The non-invasive, non-pharmacological pain-relieving solution caters to an array of pain conditions. Different modalities of the electric current from TENS, Russian, galvanic, faradic, and so on can be used for different indications. Some of the common indications of Electrostimulation Technology are:

1. Spine & Neuro

2. Orthopedic

3. Physical Medicine & Rehab

4. Gynecology

5. Sports Medicine

6. Oncology

Cranial Electrical Stimulation Technology

Cranial Electrical Stimulation Technology is a neurostimulation technology indicated for use in insomnia and anxiety. The application of Cranial Electrical Stimulation causes the release of neurotransmitters like serotonin, epinephrine, and nor-epinephrine that impart relief. The mild waves calm the sub-cortical region of the brain.

As a Medical Device Manufacturer with 40+ years of expertise, Johari Digital Healthcare Ltd. has worked on all the mentioned technologies. We craft Medical Devices to deliver better healthcare with higher accessibility, quality, and affordability. Our diverse portfolio has products across multiple categories of life sciences, laboratory, industry, and so on.

Schedule a consultation today to avail quality, cost-optimized and fast manufacturing services.

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Expansion to Medical Device Park

It's an extreme pleasure to announce our expansion to 1,30,000 sq. ft. of the area in Medical Devices Park, Jodhpur, Rajasthan. To foster better healthcare, we are continually expanding our capabilities in terms of area, automation, and workforce.

Why is the expansion so special?

The expansion is special due to the following reasons:

Increase in innovation in healthcare

The expansion will increase the pace of innovation across multiple segments. The area will be utilized for nurturing projects across life sciences, diagnostics, pain relief, and wellness.

Increment in work opportunities

Increment in the area, capacities, and business also brings immense opportunities for young engineers and other talented individuals to work for their nation. The establishment of such spaces caters to the mission of inhibiting brain drain from India.

Promotion of make in India

Johari Digital Healthcare Ltd. works to accomplish the mission of "Make in India". With the expansion, we would be catering to global Med-Tech giants all over the globe for their manufacturing needs.

Commercialization of ideas from academia

The research and developments in universities can be utilized to develop products that can be commercialized. The scaling will open avenues for academia and the industrial sector to collaborate.

Johari Digital Healthcare Ltd. invites healthcare units from all over the globe to partner with us to deliver quality healthcare devices to their end-consumers.

Johari Digital is the leading MDSAP, US FDA, and GMP certified electronic medical device manufacturing company headquartered in Jodhpur, India. Our advanced physiotherapy & wellness devices have been successfully catering to the Indian and Global markets for the past 4 decades and continually evolving in relevance to consumer needs. With an extensive distribution/service network, we consistently support our clients to nurture strong partnerships. Our diverse product portfolios across multiple healthcare segments like Therapeutics, Aesthetics, Life sciences, and Diagnostics.

Schedule your consultation today

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Difference between Health Canada and US FDA

Health Canada has flexible regulatory procedures as compared to US FDA. The differences lie in multiple segments from classification to final approvals of medical devices.

The US FDA classifies the devices into 4 key segments. The classification includes Class I Medical Devices for low-risk devices, Class II Medical Devices for mildly risky devices, and Class III and Class IV for critical or high-risk devices.

US FDA classifies the device into three classes for medical devices. Class I, Class II, and Class III Medical Devices, each of these is divided into Class I for mildly risky devices, Class II for slightly riskier devices, and Class III for high-risk devices.

Other than this cost of medical devices regulatory is another major concern between the Health Canada and US FDA. The Health Canada regulatory procedure is comparatively flexible and costs less than US FDA.

Vanessa's law

Recently, there has been an update that says more of the clinical information will be made available to the general public to improve the decision-making. This will also help manufacturers to gain insights on what works well and what doesn't work well.

The opening of data gives ample opportunities to Medical Device Developers to pitch their product to national and international markets with relevant changes. The market feedback will catalyze innovation and boost the decision-making process.

Which of the one is superior?

In general, US FDA is the more acceptable and popular regulatory authorization accepted worldwide. The market size and technological advancement in the US is far ahead of Canada which is the reason for US FDA being more popular and acceptable certification for medical devices.

· To sell medical devices in Canada the manufacturers must have MDSAP certification.

· Other than MDSAP the manufacturer must comply with ISO guidelines of Medical Device Manufacturing

· MDEL and MDL are two respective licenses for selling Medical Devices in Canada.

Johari Digital Healthcare Ltd. has 40+ year of Medical Device Manufacturing expertise along with GMP, MDSAP and ISO:13485 certifications. Companies looking for Medical Device Manufacturing in life sciences, Healthcare, wellness, Biotechnology, Microbiology, Diagnostics and so on can get in touch with us for cost optimized, regulatory compliant and time bound seamless manufacturing experience.

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Ensuring quality at all levels of Medical Device Manufacturing

What ensures the quality of the medical devices?

It’s Testing and Quality Control.

You might have a revolutionary Medical Device idea but it's futile when you cannot take it to the market. The regulatory landscape and fast-evolving dynamics of the medical industry have kept innovators on their toes. The testing processes are divided into three broad segments of IQC, IPQC, and FQC.

·    IQC (Initial Quality Control)

·    IPQC (In-Process Quality Control)

·    FQC (Final Quality Control)

The broad categorization is done by the level of risk associated with each segment of the manufacturing process.

IQC (Initial Quality Control)

Initial Quality Control is the process where the raw materials including components, parts, and sourcing are evaluated for quality and compliance. An electronic medical device is all about the parts used. Hence at this stage, the parts are evaluated for quality. Then passed on to the next stage for production and assembly.

IPQC (In-process quality inspection)

In-process quality control is all about taking care of the quality and components at the processing level. During the handling, there might be incidences where the component might become unfit. Or, maybe the processes involved or technicians are not working as per the SOP. The steps followed to ensure that none of this happens and everything is properly at its place are considered under In-process quality inspection.

FQC (Final quality control)

Once everything is done its time to verify the product as per the given specifications. In the Electronic Medical Device Industry, the tests include Burn tests, Leakage tests, Failure tests, Safety Tests, and so on to ensure the product has been manufactured as per the SOP guidelines.

When the testing is done point to point according to the Medical Device Manufacturing SOP the process is fast and delivery is ensured. An efficient quality manufacturing system ensures minimal loopholes and financial deficits. A MedTech organization with maximum emphasis on Quality is bound to grow 4 times faster than others.

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Key Differences between IVD (In Vitro Diagnostic Devices) and LDT (Laboratory Developed Tests)

The diagnostic industry is growing at a fast pace and, regulations are being made to validate the efficiency of the process. The purpose of IVDs is to satisfy the end-user requirement. The IVDs reduce dependency on conventional long testing procedures and healthcare professionals. The lengthy testing procedures involve excessive patience, effort, time, and cost. It becomes utterly important to come up with solutions that make healthcare easier and accessible. IVDs are emerging as a popular trendsetter for the younger generation looking for easier alternatives to keep a regular check on their health status.  

On the other hand, Laboratory Developed Tests are validated and used by a single laboratory. Generally, these tests are designed for a rare health condition. Unlike conventional IVDs, these are not specific devices that need regulatory approval or PMA from FDA. These are formulated with specific combinations to deliver customized testing. Over time LDTs are growing at a fast pace and there have been significant issues around whether these must be regulated like IVD devices or not. 

Both these segments are growing tremendously.  

Let’s outline some key differences between IVD and LDT:  

IVD (In Vitro Diagnostics)  

1. These are manufactured for the mass population.  

2. The concept is basically to provide an efficient alternative for long procedures.  

3. IVDs are formulated to reduce the complexity and provide a point-of-care diagnosis. For instance, consider a pregnancy test kit or a diabetes testing equipment, or an oximeter. These are simple devices meant for making primary care.  

4. An IVD needs a robust regulatory for approval by FDA.  

5. There is a proper clinical evaluation involved in the manufacturing of In-Vitro Diagnostic Medical Devices. IVDs need to be safe in terms of electrical design, mechanical design, intended use and, so on.  

6.The test kits under the IVDs are one fit for all.  

Some common examples of IVDs  

Pregnancy Test Kits  

Temperature Monitoring devices 

Glucometers 

Rotavirus detection test 

IVD for syphilis  

Laboratory Developed Tests 

The LDTs cannot be distributed or sold to any other laboratories, hospitals, or patient care centers. The testing is performed by the clinical staff and managed by M.D/PhD staff with expertise in testing methodology. The staff is readily available to assist with testing issues and potential impact on patient care.  

Some common examples of LDTs  

A common test for rare genetic disease called Huntington disease.  

 Chemical test for glucose, protein and various other body fluid detection (Pleural fluid or Joint Fluid) 

Flu test for lower respiratory tract infection  

Drug tests for mass spectrometry 

IVDs and LDTs separately have been working well to date. Both of these segments are equally important to cater to the mass population and specific rare populations.  

Some Major Concerns with respect to In-Vitro Diagnostics 

In-Vitro Diagnostics are associated come with some major concerns including cybersecurity, high cost, and accessibility. Each of these concern is discussed below:  

1. Cybersecurity: With AI and Data being shared over networks, cybersecurity has emerged as one of the major concerns. FDA has recently come up with several strict guidelines to make connected wearable devices secure. The interoperable and interconnected devices like diagnostic tools, medical implants and so on are on a continuous radar of being hacked and accessed. For instance, a pacemaker was once hacked and lead to a fatal consequence. Thus, it’s utterly important to ensure cybersecurity in the Medical Diagnostic and implantable devices.  

2. High Cost: The cost of such IVDs used in clinical setups is high and manufacturers need to devise ways to make IVDs and wearable Diagnostic Devices more accessible to a wider population. Currently, the effort and high valued components used in the IVDs make them slightly less affordable.  

3.Accessibility: Initially, the IVDs were technically difficult to operate and therefore required a lot of training. With privacy becoming a major priority manufacturer must focus on making devices accessible in terms of handling and operation.  

Conclusively, IVD and LDT development shall continue to grow in near future with significant regulatory reforms in place. IVDs are gaining significant popularity in the medical device space and manufacturers to gear up towards developing capabilities and manpower relevant to manufacture In-Vitro Diagnostic Devices.  

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Importance of Medical Device Manufacturing

Over the last few years, there has been a dynamic change in the medical device manufacturing domain. The core objective of outsourcing manufacturing is cost savings, operational efficiency, and access to new capabilities that provide a competitive advantage in their area of specialization.

As per reports, the medical device manufacturing outsourcing market has the potential to grow by USD 27.12 billion during 2021-2025, the market's growth momentum will accelerate at a CAGR of 7.81%. Contract manufacturing is one of the primarily focused areas based on reports.

There is massive competition in the industry & companies must check strategies to explore new efficiencies in research, development, product design, and manufacturing. The key focus must be on manufacturing Medical Devices to reduce costs and accelerate time to market.

Medical device outsourcing services help OEMs to shorten development, accelerate Real-time production, expand market share, and cost advantages. Considering the risks involved in the process is important for medical device manufacturing.

The demand for R&D and Designing services for medical devices is expected to benefit the market. In the last few years, there has been a significant inclination towards outsourcing critical processes, such as concept, design, prototype, validation, feasibility testing, regulatory compliance, and post-market engineering activities like product maintenance and upgrade.

OEMs are now focused on leveraging services that can help reduce product recalls, Regulatory validation time, and stretched time-to-market. As we are progressing towards embedded Class II and III medical devices microelectronic chips, meticulous device testing has become vital to ensure user safety and product performance.

Regulatory compliance is the challenging part, in outsourcing, a good medical device contract manufacturer will already have experienced personnel ready to handle regulatory compliances for your product.

Apart from cost savings, outsourcing provides you access to a professionally qualified, experienced product and services that can help you accomplish various responsibilities and other related tasks accurately and efficiently. To be ahead of your competitors and meet the growing demands of the healthcare industry, we should consider outsourcing to meet medical industry standards.

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Entering a new dimension in Medical Device Manufacturing

Johari Digital Healthcare is on an exponential growth curve. The company is devoted to maintain high-quality products & services that will benefit and support its valued partners. Observing a steady growing demand of global business in MedTech, Johari Digital announces the expansion of its facility, adding a sprawling 20,000 sq ft Design & Engineering center.

Johari Digital is at a crucial juncture of leaping towards the future of medical manufacturing. The versatile product development and manufacturing portfolio comprise innovative life science products, diagnostic devices, and therapeutic devices. With the expansion, we are well-positioned to handle the increasing projects in multiple domains of healthcare technology. Johari’s experience in Mechanical Engineering, Electrical/Electronic Engineering, Software Design & Development, Quality Testing, Packaging, and global supply chain management make it a preferred Medical Device Manufacturing organization. By adding to the existing facility, we aim to optimize manufacturing cost and increase overall efficiency.

India as a potential Medical manufacturing hub

Skilled human resources including qualified engineers and scientists have strengthened India’s position as a medical device manufacturing destination.

Strict policies for Intellectual property rights & data security, low operation cost, PLI (Production linked incentive) scheme, Robust ecosystem to scale production, and Equipped Medical device parks are key factors driving global Medtech corporations towards India for outsourcing their medical manufacturing. The government initiative of “Make in India” is also a catalyst for Global corporations to consider India as their manufacturing destination.