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i2india views poor commercial seed-stage
financing key hurdle to growth of medical devices
Lack of commercial seed-stage financing is being viewed as a
major challenge for growth in the area of medical devices research and
development space. This is because the largest fraction of funding is going in
to set up diagnostic services and hospitals in the country.
Besides, most R&D funding is going into academic research
only. There are only a few innovative start-ups in the country focused on
IP-driven innovations. Another hurdle is the lack of clear regulatory guidelines
to test and certify new medical devices.
There is also the major issue of start-up mentors to bring
high-risk and high-reward technologies to market. Limited interaction between
Indian medical research teams and industry has led to development of fewer
innovative medical devices that specifically address Indian requirements, Deepam
Mishra, CEO, i2india told Pharmabiz.
The scene for early stage seed funding is an early evolution
in India, though trends are strongly positive. From the central government to
global companies are bullish on the growth of the healthcare technology segment
in India, and are making significant efforts to increase investments. Only with
the maturity of the ecosystem, we could expect to witness considerable activity
in the years to come, he added.
There is an increasing awareness worldwide that innovation
for Indian healthcare requires a different approach than bringing common western
products to India. “We need specific products for the country and this is where
even if there exists an interest to fund such initiatives, technology innovation
is yet to take off,” he said.
In the coming years, a combination of rapidly increasing
consumer income and insurance coverage are likely to raise quality of healthcare
available to middle-class Indians. This in turn would improve products and
services available at healthcare centres across the country, said Mishra.
Challenges for companies in the early stage funding in the
medical devices space are paucity of seed funding, unless backed by a corporate
parent or deep-pocketed individuals. This makes it tougher for early stage
companies, especially technology driven firms to source seed financing. Added to
this weak industry-academia links also makes access to cutting edge technology
ideas and testing facilities difficult, stated Mishra.
Going hand-in-hand with funding is also the lack of
experienced teams. Many companies face issues to hire the right marketing and
sales personnel despite the presence of proper technology solutions. There are
also hassles in distribution which is fragmented. There is lack of product
distribution infrastructure which increases the cost of product marketing in the
country, pointed out Mishra.
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US FDA provides updated safety data on
silicone gel-filled breast implants
The US Food and Drug Administration (FDA) released a report
updating the clinical and scientific information for silicone gel-filled breast
implants, including preliminary safety data from studies conducted by the
manufacturers as a condition of their November 2006 approval.
While the report confirms that silicone gel-filled breast
implants are safe and effective when used as intended, women should fully
understand the risks prior to considering silicone gel-filled breast implants
for breast augmentation or reconstruction.
Based on the report, women should know: breast implants are
not lifetime devices. The longer a woman has silicone gel-filled breast
implants, the more likely she is to experience complications. One in 5 patients
who received implants for breast augmentation will need them removed within 10
years of implantation. For patients who received implants for breast
reconstruction, as many as 1 in 2 will require removal 10 years after
implantation.
The most frequently observed complications and outcomes are
capsular contracture (hardening of the area around the implant), reoperation
(additional surgeries) and implant removal. Other common complications include
implant rupture, wrinkling, asymmetry, scarring, pain, and infection.
The complications that existed for women receiving breast
implants at the time of approval are similar to the complications observed
today.
Preliminary data do not indicate that silicone gel-filled
breast implants cause breast cancer, reproductive problems or connective tissue
disease, such as rheumatoid arthritis. However, in order to rule out these and
other rare complications, studies would need to enroll more women and be longer
than those conducted thus far.
The report includes preliminary safety data from
post-approval studies conducted by each of the two breast implant manufacturers
(Allergan and Mentor), a summary and analysis of adverse events received over
the years by the FDA, and a comprehensive review and analysis of recent
scientific publications that discuss the safety and effectiveness of silicone
gel-filled breast implants. FDA approved silicone gel-filled breast implants in
November 2006 for breast augmentation in women over age 22 and for breast
reconstruction in all women.
As a condition of approval, the FDA required each of the two
companies to conduct six post-approval studies to characterize the long-term
performance and safety of the devices.
Both manufacturers have communicated to the FDA the
difficulties in following women who have received silicone gel-filled breast
implants. The FDA is working with Allergan and Mentor to address those
challenges and increase patient participation and follow-up.
“The FDA will continue to monitor and collect safety and
performance information on silicone gel-filled breast implants, but it is
important that women with breast implants see their health care providers if
they experience any symptoms,” Jeffrey Shuren, MD, JD, director of FDA’s Centre
for Devices and Radiological Health. “Women who have enrolled in studies should
continue to participate so that we may better understand the long-term
performance of these implants and identify any potential problems.”
The FDA is holding an expert advisory panel in the next few
months to discuss how post-approval studies on breast implants can be more
effective.
At this time, the FDA is recommending that health care
professionals and women who have silicone gel-filled breast implants do the
following: women should continue to routinely follow up with their health care
professionals. This includes getting routine MRIs to detect silent rupture. Be
aware of breast implants and they are not lifetime devices. Breast implants are
associated with significant local complications and outcomes, including capsular
contracture, reoperation, removal, and implant rupture. Some women also
experience breast pain, wrinkling, asymmetry, scarring and infection. Women
should notify their health care professionals if they develop any unusual
symptoms. All serious side effects should be reported to the breast implant
manufacturer and Medwatch, the FDA’s safety information and adverse event
reporting program. Report online1 or by calling 800-332-1088. If a woman has
enrolled in a manufacturer-sponsored post-approval study, she should continue to
participate. These studies are the best way to collect information about the
long-term rates of complications.
The report is part of the FDA’s ongoing effort to ensure that
women who have or who may be considering silicone gel-filled breast implants are
informed of all possible complications and outcomes. As an additional step, the
agency has redesigned its website2 to include comprehensive information on
silicone gel-filled and saline-filled breast implants.
The FDA, an agency within the US 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.
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