JK Medirise sees opportunities in Latin America and Africa

Brückenkopf GmbH recently interviewed with Mr. Ketan Munjani, Marketing and Sales Manager at JK Medirise.

(Q: Question from Brückenkopf GmbH / A: Answer from Mr. Ketan Munjani by JK Medirise)

Q: Mr. Munjani, what is your current portfolio? We understand that your company is a reputable medical device manufacturer, which categories do you focus on?

A: Our company was incorporated in the year 2012, we manufacture Single Use Medical Devices for transfusion & infusion, urology and cardiology purposes. We also deliver anesthesia, surgery, gastro-enterology, and surgery dressing products, and our product lines are expanding.

Q: What are the major markets of your company? The domestic one or international market?

A: We identify the precise need of the client related to the product and delivers products following international quality standards. We serve the international market in the worldwide healthcare sector, and we have obtained and maintained very strong international reputation.

Q: Do you have R&D capabilities of your company, or do you co-operate with third parties?

A: Our company has highly qualified and skilled team members who work in professional environment in the work place. R&D is important to the company. We have our own R&D capabilities but at same time we also work with third parties in terms of R&D to offer the most accurate and reliable products to our customers.

Q: How do you manage product quality control of your products? Do you hold any quality certifications to your products?

A: Yes. We have ISO 13485 Certificate & CE Certificate. In our company quality holds the top priority. Every item passes through strict quality checks at various stages before they are finally approved for delivery.

Q: What do you see as challenges and opportunities in the market in 2017?

A: We foresee new innovative Product as challenges, and we think there are vast opportunities in Latin American and African countries for our range of product. As an international oriented company, we evaluate our success by keeping the aspects of our customers, physicians or healthcare professionals together, as they are the ones whom we are working for.

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Building a Case for Medical Device Interoperability: FDA’s Call to Action

By: Bakul Patel, M.S., M.B.A.

As Yoda might say: build a case for interoperability, we must. While we may not have yet realized the technological accomplishments of Yoda’s advanced world, today connectivity shows great promise for the future.

Bakul PatelFrom blood pressure to brain scans, today’s health care allows for the rapid transfer and use of information between and among different medical devices. This concept—called interoperability—is less about basic communication and more about the smart and safe interaction among medical devices and information systems.

Seamless interoperability among medical devices can improve patient care, reduce errors and adverse events, and lower costs. In fact, interoperability is one of the key factors for safety that can drive innovation in care delivery.

Think of a scenario in which devices collect a patient’s vitals during surgery. Then think about staff having to manually enter those vitals into a health care record because the format of the data generated by operating room devices isn’t compatible with the format necessary for the health care record, which by the way, only operates in one format. In this situation, the lack of interoperability can lead to errors during the manual entry process, and possible inefficiencies in patient care.

Now think about another scenario in which a patient is connected to a ventilator that can alert a caregiver—or automatically adjust its function—by monitoring an oximeter that measures blood’s oxygen saturation levels. In this situation, the interoperability between the ventilator and oximeter better coordinates their interaction and may reduce nuisance alarms, allowing clinicians to focus on true clinically significant alarms.

FDA has been collaborating with hospitals, health care providers, manufacturers, standards-development organizations, and other interested parties to promote medical device interoperability because it helps patients.

Some key activities in pursuit of this goal include the following:

In addition, we recently released draft guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, which outlines our ideas on design considerations for manufacturers developing interoperable devices. It contains our recommendations for information manufacturers should include in their pre-market submissions and ultimate product labeling. It also encourages manufacturers to make all necessary and relevant functional, performance, and interface characteristics openly available, enabling users to safely use medical devices with other devices or systems.

This draft guidance is intended to promote and facilitate development of safe and effective interoperable devices, thereby strengthening the much needed “case” for interoperable medical devices. We intend to work with stakeholders toward a future where interoperable devices increase care efficiency and reduce care costs, while keeping patient safety in the forefront.

We’re encouraging all stakeholders to share comments on this draft guidance with us.

We believe now is the time for all stakeholders—including medical device manufacturers, health care organizations, researchers, and information systems firms—to come together and continue to build this case to accelerate the development and availability of safe interoperable medical devices.

In Yoda’s words…may the force of interoperability be with us!

Bakul Patel, M.S., M.B.A., is associate director for digital health in FDA’s Center for Devices and Radiological Health


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FDA labels pelvic mesh as “high-risk” medical device

Mesh surgical implants used to repair pelvic organ prolapse in women, a condition that frequently develops after childbirth, will face tougher federal scrutiny following thousands of injuries reported with the problem-prone devices.

The Food and Drug Administration said Monday that pelvic mesh will now be considered a class III, or high-risk, medical device, and manufacturers will be required to submit premarket approval applications demonstrating the safety and effectiveness of their products.

The change follows years of reports of pain, bleeding and infection among women who had the devices implanted to correct pelvic organ prolapse (POP). The condition occurs when when the bladder or other reproductive organs slip out of place, causing pain, constipation and urinary issues. The new FDA requirements do not apply to mesh products used to treat other conditions such as hernias or urinary incontinence.

Plastic mesh is often used to strengthen the pelvic wall and support internal organs in cases of prolapse. The mesh is often inserted through the vagina, using a small surgical incision. The Washington Post recently reported that as many as half of women may experience pelvic floor symptoms in their lifetime, and 200,000 undergo such operations each year.




The FDA action comes more than four years after the agency concluded that women getting vaginal mesh have more complications than women who undergo traditional surgery with stitches. Mesh products were introduced for pelvic repairin the 1990s and promoted as a way to speed patients’ recovery time. But the FDA said in 2011 that about ten percent of women experienced complications from mesh, sometimes requiring multiple surgeries to reposition or remove it.

Patients have filed tens of thousands of lawsuits against mesh manufacturers, including Johnson & Johnson, Boston Scientific and Endo International. In 2014, Ireland-based Endo said it would pay $830 million to settle more than 20,000 personal injury lawsuits.

In a second rule, the FDA said vaginal mesh will now be classified as a “high-risk” medical device with a class III warning. Previously the implants were considered “moderate-risk” devices and carried a class II warning.

FDA recommends that women be aware of the risks associated with surgical mesh. On an advice page on the FDA website, the agency writes: “Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options.”

Non-surgical options include pelvic floor exercises known as Kegels. There are also non-invasive devices such as the PeriCoach, a smartphone-connected pelvic floor muscle training device for incontinence.

The FDA first proposed the changes announced Monday in 2014 draft orders.

Like 90 percent of medical devices sold in the U.S., pelvic mesh was originally cleared under a streamlined FDA review process for devices deemed similar to older products.


FDA permits marketing of fecal continence restoration system

The U.S. Food and Drug Administration today approved the Fenix Continence Restoration System to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.

Fecal incontinence is the inability to control bowel movements. It is a common problem that is frequently underreported, especially among older adults. The most common cause of fecal incontinence is damage to the muscles around the anus (anal sphincter) from vaginal childbirth or functional disorders such as diabetes.

“Non-invasive treatment options for fecal incontinence, such as drugs, dietary changes and other medical measures, sometimes don’t adequately address a patient’s symptoms,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “The Fenix System affords a viable surgical option to address this condition when other methods have failed to improve a patient’s quality of life.”

The Fenix System has three components: an implant, an anal sphincter sizing tool and an introducer tool. The implant is a series of titanium beads with magnetic cores that are connected by titanium wires to form a ring shape. The attractive force of the magnetic beads augments the anal sphincter to minimize involuntary opening of the anal canal, reducing the likelihood of severe fecal incontinence. The implant device is offered in multiple sizes to accommodate variation in sphincter size. The sizing tool is used to associate the anal sphincter size to an appropriate implant.  The introducer tool is used to guide the sizing tool and the implant into position.

The FDA reviewed data for the Fenix System through the humanitarian device exemption (HDE) process. A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the U.S. per year. Since a device manufacturer`s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations, the HUD provision of FDA regulations provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations.

The Fenix System was studied in 35 adults who failed conventional medical therapy for treating fecal incontinence. Study evaluations were performed before and after the procedure and at six weeks, three months, six months and 12 months post-implant. The 15 participants studied at U.S. sites will have annual evaluations until five years after the device was implanted.

Probable benefits were evaluated using a bowel diary to track fecal incontinence events and by a validated, disease-specific questionnaire called the Fecal Incontinence Quality of Life Scales to quantify changes in quality of life before and after implantation of the Fenix System. After 12 months, 62.9 percent of participants experienced a reduction of fecal incontinence episodes by half or more; 54.3 percent experienced a reduction in fecal incontinence days by half or more; and 37.1 percent experienced a reduction in urgent episodes by half or more. Study participants also showed improvements in quality of life measures including improvements in depression, self-perception, and feelings of embarrassment. These results suggest that patients with fecal incontinence could benefit from the device when they have failed other fecal incontinence therapies.

The Fenix System should not be implanted in patients with suspected or known allergies to titanium. The sizing tool and introducer tool should not be used in patients with suspected or known allergies to titanium, stainless steel, nickel or ferrous materials.

The implant is considered magnetic resonance unsafe. After implantation, patients should not be exposed to a magnetic resonance imaging (MRI) environment as it could interfere with the magnetic strength and the function of the device.

A recommendation should be made to patients receiving the Fenix System to register their implant with the MedicAlert Foundation or an equivalent organization. In the event alternative diagnostic procedures cannot be used and MRI is required, the implant can be safely removed.

Adverse events identified in the clinical trial for the Fenix System include pain, infection, impaction or defecatory disorder, device erosion, device removal/re-operation, and bleeding.

The Fenix System is manufactured by Torax Medical Inc., based in Shoreview, Minnesota.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

2015 in Review : Milestones in the medical device revolution

2015 will be remembered as the year that took the medical device revolution in the country to the next level. Here are the most significant ‘medical device’ highlights that ensured that it remained at the top of the agenda from policy to parks.
Medical Devices Park
States like Andhra Pradesh, Maharashtra and Gujarat are set for a fierce battle to establish a medical device park. However Andhra Pradesh has already taken a lead by finalizing its site in Vishakhapatnam in consultation with the industry partners. The allotted land is about 226 acres and is said to be in an ideal position to have an industrial park dedicated for medical devices. Focus will be on creating an Eco System for High End Medical Device Manufacturing and Import Substitution with an eye for Export Market.
Delinking of medical devices from schedule M III of pharmaceuticals

This year the Government took a vow to delink the medical device industry from the pharmaceutical sector, giving a major push for ‘Make in India’ in the medical device sector, according to people privy to the development. The health ministry has agreed to delink schedule M III of the Drug Rules, which deals with medical devices, from schedule M, which deals with drugs and pharmaceuticals.
Issue of Draft Medical Device Policy

The Department of Pharmaceuticals (DoP) this year issued the draft National Medical Device Policy-2015, for strengthening the ‘Make in India’ drive in medical device sector. As per the draft policy, an autonomous body ‘National Medical Device Authority’ (NMDA) will be created which will provide a single window mechanism to the industry with an objective of promotion of the medical device industry to make the country not only self-reliant but also a global hub of production and innovation in medical devices.
Removal of duty anomalies in medical devices sector
This year the Government agreed in principle to rectify the inverted duty structure for the growing medical devices sector. An inverted duty structure impacts domestic industry adversely as manufacturers have to pay a higher price for raw material in terms of duty, while imported finished products land at lower duty and cost lesser.
Materovigilance Program of India
After several horrific cases of malfunctioning medical devices, like babies being burnt to death due to short circuits in incubators or hip implants causing blood poisoning, the health ministry has approved a materio vigilance programme in an effort to ensure safety of medical devices. The plan is to be coordinated by the Indian Pharmacopoeia Commission, the biotechnology wing of the Sree Chitra Thirunal Institute of Medical Sciences and Technology, Central Drug Standard Control Organization (CDSCO) and National Health Systems Resources Centre.
Designation of WHO Collaborating center
The union health ministry’s apex body for technical assistance, the National Health System Resource Centre’s health Technology Division this year has been designated as the first World Health Organization (WHO) Collaborating Centre for priority medical device and health technology policy in South Asia. This is the fourth such center established globally.
Biomedical Equipment Maintenance Model
This year India joined the club with those few countries who have a budget line for maintenance of medical devices. The program is based on outsourcing of medical equipment maintenance to a single third party service provider which would be monitored on the basis of uptime.
Govt approves 100% FDI in medical devices sector
The Central government this year allowed 100 per cent FDI under automatic route in medical devices sector to encourage manufacturing of equipments, including diagnostic kits and other devices. The 100 per cent FDI, will be permitted under the automatic route, meaning a foreign investor will not have to seek the permission of Foreign Investment Promotion Board (FIPB) to acquire an existing company or set up a new manufacturing unit in the medical devices sector.

FDI in Medical Device in India

RBI formalizes automatic 100% FDI in medical devices sector

he government on Wednesday allowed 100 per cent FDI under automatic route in medical devices sector to encourage manufacturing of equipments, including diagnostic kits and other devices.

“Easing of norms for medical devices industry by creating special carve out in the extant FDI policy on pharma sector will encourage FDI inflows in this area,” said an official statement issued after the Union Cabinet meeting here.

The 100 per cent FDI, it added, will be permitted under the automatic route, meaning a foreign investor will not have to seek the permission of Foreign Investment Promotion Board (FIPB) to acquire an existing company or set up a new manufacturing unit in the medical devices sector.

The condition of ‘non-compete clause’ would also not be applicable to greenfield (new project) as well as brownfield projects (existing units) of this industry.

Earlier FDI up to 100 per cent was permitted, subject to certain conditions.

While FDI in new projects is under automatic route, brownfield projects are placed under the government approval route.

The policy on pharmaceutical sector covers medical devices since this area is not separately covered.

Now, the Union Cabinet has given its approval to amend the existing policy to carve out medical devices segment.

“So far both in greenfield and brownfield projects, 100 per cent FDI is allowed. Within the same category, a distinct new sub-category has been carved out with regard to medical devices,” finance minister Arun Jaitley said.

 Medical devices include any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specially for human beings or animals for one or more of the specific purposes.

It also includes a device which is a reagent, calibrator, control material, kit, equipment or system whether used alone or in combination thereof intended to be used for examination and providing information for medical or diagnostic purposes.

 India has achieved an eminent global position in pharma sector. However, the same has not been replicated in the medical devices industry, it added.

“In this age of super specialisation, if medicines and pharma are one aspect, in which India has attained a certain amount of core competence, we still haven’t achieved that in medical devices, particularly which are to be installed in human body for the purpose of treatment,” Jaitley said.

 “The country has a huge pool of scientists and engineers who have potential to take medical device industry to a very high level. Domestic capital market is not able to provide much needed investment in the sector,” it said.