Monday, July 20, 2015

Medical device clinical trials

 Vatsal Chhaya: To begin with, I am a biomedical engineer but have explored my vocational career in a different, rather challenging domain - health technology assessment and implementation research! Why so? I would not hesitate to say that so called "technical domain"- the most common fate with Biomedical Engineer- did not attract my mind much. Because to me, it was always more or less similar to what the electronics engineer does!

It would not be overstatement if I would say that Biomedical engineering is considered very superficially in most of undergraduation and graduation programmes. To be specific, I would say from my personal experience that hardly any college would be there which actually focuses on medical device policy related aspects. I would like to bring to discussion this new paradigm with 6 rarely explored aspects on Biomedical Engineering.

 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 !!

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