“Medical Devices (Implants) and Computational Modelling : From Design Optimisation and Quality to Next Gen Regulatory Compliance Support Tool”

As a nation, we are content with using technology from the west and hardly invest in research. As such, we are almost non-existent on the global innovation stage. Moreover, we are also very slow in the introduction of new technology. Mini drafters in engineering colleges are a classic example of outdated technology still in use whereas the world has moved on to software products for their drawing needs. Application of numerical techniques such as finite element (FE) modeling in biomedical engineering is another example. Though FE has been around since 1950s, its use in biomedical engineering took another couple of decades. Countries like USA and UK are already thinking beyond its traditional use in design and quality. Using these methods in parametric and clinical studies and its use in device approval process are being investigated by FDA and other such agencies. Here is a chance for us to explore the incorporation of these methods in Indian medical device regulatory process that will not only help our industry to design quality products but also save time and money.

“Development of Plastics Injection Molded Medical Devices: Analytical Approach”

The Indian health care industry is taking great strides. In the last few decades, the industry has grown to the status of a leading sector in the country with a sizable base.

India is doing extremely good in plastic disposables and low-end plastic injection moulded medical devices. Unfortunately, 80% of our high-end medical devices are imported from other countries; on other hand there is 60% of export of or indigenously produced medical devices, especially disposables medical.

This is due to lack of innovation, lack of systematic approach to the development, Absence of good product design capability, Limited Knowledge of Manufacturing and Quality Assurance, limited world class manufacturing facility to open market and unclear regulatory support.

There is clear need of applying systematic approach to the device development, what developed countries in US and Europe are following from design brief to validations to mass manufacturing of medical devices.

Following structured development practices will definitely change the scenario of India- at present not being good at development of high-end plastics medical devices.

“Clinical Research in Medical Device”

Over the course of the past several years, regulatory authorities in both the India and abroad have begun to implement restrictions on the approval and clearance of medical technologies, resulting in a need for additional clinical evidence and long term efficacy information in order to support approval. At the same time, a period of economic uncertainty has also resulted in many healthcare professionals re-examining the products and technologies being used, in an effort to stem rising costs and the rate of medical interventions. These two pressures have changed the way in which manufacturers view, plan for, and execute clinical research on their devices and technologies, resulting in new challenges for clinical executives, as well as different priorities for clinical studies.

There is a clear need for safety and performance to be established before new medical devices are approved but there is a fundamental tension between providing highlevel clinical evidence and promoting innovation. Rational practice with minimal inappropriate use is in the interests of patients and providers, and clinical safety must come first. It is very important to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance (PMS).

A premature conclusion that a device is effective can result in more harm than good, whereas a premature decision that a device is ineffective may deprive patients of useful treatment. If there is any ‘residual safety concern’ then further clinical evaluation should always be the priority.

“Development Of Radioprotective Pathogen Films”

Protective barriers, now commonly referred to as personal protective equipment (PPE), have been used for many years to protect patients from microorganisms / radioactivity present on staff working in the healthcare setting. More recently, with the emergence of AIDS and HIV and the resurgence of tuberculosis in many countries, use of PPE now has become important for protecting staff as well. While some PPE, such as clean examination gloves, are extremely important in reducing the risk of transmission, others (e.g., cloth caps and shoe covers) continue to be used without convincing evidence of their effectiveness (Larson et al 1995). In fact, some common practices, such as having all staff in the operating room, not just the surgical team, wear masks, may increase costs while providing minimal, if any, protection to patients (Mitchell 1991). In addition, to be effective, PPE must be used correctly. For example, surgical gowns and drapes have been shown to prevent wound infection only when dry. When wet, cloth acts as a wick or sponge to draw bacteria from skin or equipment up through the fabric that can then contaminate a surgical wound. Healthcare workers are confronted each day with the difficult task of working safely within a hazardous environment. Today, the most common occupational risk faced by healthcare personnel is contact with blood / radioactivity and body fluids during routine patient care. This exposure to pathogens/radioactivity increases their risk for serious infection and possible death. Health workers in some occupational settings, such as surgery and delivery rooms, have a higher risk of exposure to these pathogens i.e. H.I.V. than in all other departments combined (Gershon and Vlahov 1992; Gershon and Zirkin1995). Because of this increasing risk, better infection prevention guidelines and practices are needed to protect staff working in these areas. Also staff members who know how to protect themselves from blood and body fluid exposures and consistently use these measures will also help protect their patients.

While there is a growing awareness of the seriousness of AIDS, as well as hepatitis C, and how they are acquired in the workplace, many healthcare staff does not perceive themselves to be at risk. Moreover, even those that do perceive the risk do not regularly use protective equipment such as gloves, or other practices (e.g., handwashing) available to them. Although this may have been true several years ago, in 2002 WHO estimated that more than 40 million people were infected with HIV around the world and that the virus is increasingly affecting the heterosexual population and spreading to nonurban areas. Different radionuclides have been tested for the trans-permeation of fluids (DTPA, Na2Tco4-, and MDP). Commercially available Anti HIV protection suit was used as control. Gamma counting of 0.5 ml liquid was done using dose calibrator as initial count. Calibrated liquid were transfer on the film before that a tissue paper were fixed at the lower side of film. Tissue paper will show the absorption of radioactivity which has been transmitted/permeate through film/cloth. At the time of interval (1Hr, 2Hr, 4Hr, 6Hr) counts of tissue paper were taken using gamma counter. Gamma count of tissue paper explained the permeation ratio from the film. Both surface of developed film were tested for the purpose of permeation percentage. Based on the above studies it can be concluded that film developed has property to check radioactivity permeation across the film. The film has also been
tested in comparison to commercially available biological suit film and is more protective.