“Global Best Practices For Safety, Quality & Performance Of Medical Devices To Patients’ Perspective”

While medicines and Medical Devices are always expected to be a safe remedy for human ailments, unfortunately, there is also the phenomenon of ‘unsafe medicines and sub-standard medical devices’ due to unscrupulous elements in society manufacturing and marketing fake, spurious, mislabelled medicines and medical devices, as well as medicines and devices with sub-standard ingredients and components. As more and more consumers are adversely affected by these drugs, and global health concerns grow, efforts were needed to bring stakeholders together to address this public health problem. This was the genesis of the Partnership for Safe Medicines-India. Strategic efforts were required, and lessons may be useful for other emerging markets.

We must define and bring clarity on the definition of medical devices and harmonise it to the global standards. Medical Device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article.

The word “Effectiveness” needs to be replaced by the word “Performance” in when we refer to Medical Devices. Unlike Drugs where their effectiveness is measured, for Medical Devices it is performance that is evaluated and compared. Drug Efficacy is dosage dependent, whereas performance of Medical Devices depends also on usage and user skills.

The “Manufacture” of Medical Devices has been defined on the same lines as for Drugs in India, whereas manufacture of Medical Devices is quite different from Drugs. Operations like altering, ornamenting, finishing are mostly carried out as after sales service and needs to get defined so that patients are not made to pay for brand new devices whereas they are sold old used devices, which needs regular maintenance and checks.

We must address the top eight expectations of a consumer from the medical devices manufacturers and traders: Standards, Quality of Service, Choice, Accountability, Information, Non-discriminatory, complaint redressal and accessibility.

“Indian Medical Device Contract Manufacturing - Trends and Opportunities”

The global medical device industry is highly fragmented and competitive but will grow to about US $302 bn in 2017.

The global medical device contract manufacturing industry has become more attractive due to need of OEMs to reduce costs, accelerate time to market and allow OEMs to focus on their core competencies.

The Indian medical device market is growing well but relies on imports. There are significant import substitution opportunities for medical device OEMs. However, OEMs face competition and contract manufacturing partner related challenges.

India’s strengths, which include one of the largest pools of scientists, doctors and engineers in the world, one of the world’s youngest work forces, and English speaking professionals, are allowing medical device OEMs to successfully partner with Indian contract manufacturers for device designing, device design rationalization/ localization, device development and full device manufacturing.

“Packaging Testing For Medical Devices”

Packaging industry is continuously evolving as medical device company’s change in the design, development, and manufacture of packaging systems. Packaging must comply with ISO 11607 in order to satisfy European regulations and obtain a CE Mark. Fulfilling the requirements within ISO 11607 ensures that a medical device packaging system allows sterilization, provides physical protection and maintains sterility up to the point of use. The key areas to be focused in the packaging areas are stability, package integrity, performance and strength testing. The challenge to the medical packaging supply community is to truly understand what is needed. With all these new and improved materials available to packagers, how many have been implemented?