Venudhar Rao Hajari: The Pioneer In Medical Devices' Quality Assurance & Devices Engineering

Over the last 20 years, Venudhar Rao Hajari has built a successful career in the areas of Medical Device Development Quality Assurance, Software Testing, and High Speed Digital Design with the expertise to support the healthcare and embedded systems fields He evolved into a true industry engineer leader. In this unique interview, Venudhar shares some of the memorable moments in his life, challenges he encountered on his way to becoming a medical device engineer and his future work.

Q1: Why did you choose the field of ‘Quality Systems and Software Testing’ as your field of specialization?

A: I would say it was instinct and drive. As a youngster, I was in awe of how things operated and the detailed processes involved in the development of dependable systems. The knowledge of electronics that I gained at Nagpur University was eons ahead of me, but imagining and having the product look up to its reliability ensured that I elaborated studies on Medical Device Quality Systems and Software Testing. It is gratifying to know that one has precisely tackled a problem and is not available to an end user or patient.

Q2: What is your position at Smith & Nephew and what does it entail?

A: In my current position as a Staff Quality Assurance Engineer, I am involved in the planning and evaluation of system and software and electrical requirements within cross-functional teams. I am also responsible for failure mode analysis and the automation of the radio frequency surgical device's new product development. There are also regulatory requirements such as the completion of FDA 510k and CE marking. This position calls for a combination of hands-on experience, management, and regulatory understanding. 

Q3: How do you manage the issue of compliance with medical device related requirements during the development of medical devices?

A: Compliance is a complex issue that begins with the standards of IEC-60601, ISO-13485 and FDA 21 part 820 - FOR THE TIME BEING. I engage with R&D and manufacturing engineers to facilitate the application of these standards throughout the entire product development cycle. This includes submission of VO&E documents, submission of verification and validation plans and reports, and retraining on standardization and controlling changes in industry climate and quality systems. It’s about integrating systems of quality and compliance into the organization and its people.

Q4: For which contract companies did you primarily work for in your overseas employment? Can you trace the impact these projects made in detail through these contracts?

A: One project that many clients and even independent experts mention in their reviews is the implementation if the so-called “head PET”. There were significant improvements in the devices that I developed, particularly for ENT and orthopedic surgery, during my tenure at Smith & Nephew. For imaging CAD systems, I supervised the integration of software into the subsystems of PET Consol, which was also in the active phase of development when I worked at the company. My focus in each of these contracts was how to innovate or how to make design customs that resolve the challenges facing most medical practitioners needing these devices. 

Q5: It’s essential to be proactive. Quite a variety of efforts should be required to keep advancing one’s knowledge and practice. How much responsibility do you have in this regard? 

A: This question is actually very good for any engineer or IT professional. In addition to day-to-day work, such additional tasks include working with the existing code, writing articles, and creating new machines or models. Improvement in these directions can also be achieved through any standards or certification, such as the one Cambridge Institute offers in systems engineering. Professional bodies such as Working Groups assist members in their efforts and inform them regarding innovations or any effective practices being used in the industry.

Q6: Please, tell us more about your involvement in digital design, especially high-speed digital design in the context of design in your work. 

A: High-speed digital design is very important for developing medical devices that are dependable and efficient. In my work history, I have designed and validated systems based on Intel and AMD cores and developed a 10 Gbps backplane for blade server designs. Such knowledge is crucial when working with complex devices where the aspects of integrity of data and real time processing of information are most important.

Q7: Why do you think it is important for engineering teams to have leadership qualities to manage the team effectively?

A: In engineering, leadership is all about effective communication, empathy and inspiring and motivating the team. It is necessary to communicate technical restrictions while stimulating creativity and welcoming new techniques to improve existing ones. I put an emphasis on creating collaborative atmosphere in the team so that leaders shoulder the responsibility for delivering satisfactory work. Also, performance appraisal and technical training sessions are essential in this respect.

Q8: Can you share the most difficult period in your career, where your hard work faced a real challenge? 

A: Aside from the common issues associated with change and organizational growth, one major challenge was the introduction of Agile and iterative models. It was an entirely new process and perspective that had to be integrated. However, with sufficient training and clear communication of the advantages of these methods, I was able to assist my teams in going through this transition. Yet, one more challenge is responding to the pace of regulatory developments and I have reported this issue by means of continuing education and working directly with the regulatory authorities. 

Q9: So, that made you believe more in the possibilities of using and implementing your patent in Low-Cost Digital PET Design in reality but surely it did have a stronger influence. 

A: The patent was a turning point for my career and it strengthened my belief in the importance of creativity and r&d in everything that I do in the future. It enabled me to pursue new partnerships and therefore new collaborations, which enabled me to be more active in developing medical imaging innovations. This accomplishment has also encouraged me to pursue new conceptions and strive for new possibilities in medical device design.

Q10: What advice would you give to aspiring engineers looking to compete in the medical device industry?

A: My recommendation is to develop a comprehensive understanding of both the technological and the regulatory components of the industry. Always have an open mind and be willing to learn as technology is not static and neither are standards. Make an effort to develop a sound knowledge of the entire product cycle from conception through to post-marketing. Last, but not least, do not ignore the importance of teamwork and communication. Most of the time work in this area goes beyond the individual and one has to be able to appreciate the contribution of others.

Venudhar Rao Hajari has created and shaped this new version of himself working for many years in systems engineering, software engineering and medical device development. He has spent the better part of the last twenty years advancing the performance and reliability of complex medical technologies. For this, apart from Venudhar’s proven comprehensive understanding of the market and its technical demands, there is ample development activity as well. Because of such strength and willfulness, most of the people around him were able for many great things.

Published on: Wednesday, December 11, 2024, 09:38 AM IST