Medical device clinical trials

Unlike Pharmaceutical technologies, there are no dedicated established centers- MEDICAL DEVICE CROs in ample amount which could satisfactorily facilitate a medical device product evaluation and commercialization nor clinical evaluation guidelines in medical devices sector i.e. ISO-14155, ICH-GCP in adaptation oriented towards medical devices are taught in institutions so as to enable the students take such projects and come up with an excellent guideline document for producing local, national or global impact.

Medical device related health economics: The education could be imparted with Intended Learning Objective (ILO) of providing insight to economic evaluation of clinical effectiveness or diagnostic accuracy of medical devices with respective cost dimensions. This may comprise projects like preparation of costs database, estimation of budget for reimbursement schemes on medical device failure and so on.

Medical Technology Surveillance: There is little guidance available in field of post-marketing surveillance of medical devices especially in India. Unlike PvPI and hemovigilance, no such programme is available for medical devices. A model or strategy for the same could be invoked for purpose of brainstorming in students.

Regulatory Affairs and Standardization: Understanding how to put boundaries to innovations while their diffusion is something highly expected to be taught. It is fact that MATLAB,LABVIEW related digital image processing projects are promoted always but no project is seen which might have explored ethical issues related pros and cons associated with image processing i.e. violation of PNDT act, misdiagnosis of any abnormality or disorder. Moreover, there is less education provided on CE marking, Medical device standards, Medical device testing.

Intellectual Property Rights: No course I came across so far incorporates this aspect from project perspective i.e. project on assessing IPR issues faced by device manufacturers, comparison of device patentization framework of different countries, petty patents.

Bridging translational gap: It is hard fact that even after outstanding project model, there is no support in terms of how to accelerate it for professional growth with commercialisation purposes. Most of projects are just for sake of completion and not with realization and/or continuation of further journey. Such lacking in system is also proposes threat of plagiarised projects (ready-made models/circuits in markets) or “frog-in-well” approach during project.

I believe if this type of thinking could be done "apriori", then biomedical engineering’s value could be realised like never before. And also I believe that these aspects, when ingrained in curriculums, it would be “pride” rather than “speechlessness” or “cluelessness” when somebody would ask the reason for choosing this branch.

I would be happy to see as many as comments and suggestions for this post.

Let's start our journey for evidence-based-medical device research and development !!

Genelife Clinical Research: 5th Anniversary

As Genelife Clinical Research is growing 5 year old on February 26, 2015, with the steadfast confidence of Clients, Consultants and employees have shown to Genelife Clinical Research by entrusting to her services. When our company was founded in 2010 with a very small team, we could hardly foresee our growth to an international company with a staff of 32 within this short span of time. Many people predicted we will not last a year in the industry because we were too idealistic and simple to cope with business environment. Fortunately, we survived not only the initial phase but also the most difficult phase of Indian Clinical Research industry. When I started this organization I had a clear vision for success. I wished to create an amazing environment and hire the smartest people. Together we will build a beautiful system to delight the customers and makes the world just a little bit better. I started working night and day to make my vision “to be most respected CRO” reality, but the things did not go as planned due to some external and financial issues. Fortunately, we came out of that with some unexpected luck and trust of our clients. Every member of Genelife team have worked hard to make sure Genelife’s success and celebrate 5th anniversary.

Five year is long time as well as short time, compared to a big companies like Quintiles, we are still adolescent. On the other hand, five years in a sector that is constantly and rapidly advancing is an achievement, we can be proud of. It means we have managed to establish ourselves in this sector. We have claimed our rightful place here. This reflects with the kind of work we are doing. Currently we are having maximum approved studies in India with one of the best operations tools to run these projects. Deliverability has been our strength for retaining all business we have.

Since inception Genelife Clinical Research capitalized on the company's vision “to become the most respected CRO”. In these 5 years we have translated our knowledge into a full portfolio of drug development which empowers clients to close the gap between their requirement and regulatory needs. In near future, we aim to expand our horizons into the field of BA/BE, Pharmacovigilance as well as studies conducted in other Regulated market in and outside India. Keeping past experiences as well as future dreams in our mind, Genelife Clinical Research shall strive hard to reach the highest peaks with positivity, quality and excellence and make a noteworthy contribution in the field of Clinical Research.