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Maintenance of data integrity at the process and product level are of key importance

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Validation of medical devices and its corresponding engineering and manufacturing processes form an integral part of the complete product development lifecycle informs, Suhas Tamras – Global Head, Medical Devices and Healthcare Practice, Tata Elxsi in conversation with Raelene Kambli

What are the new technologies that you think can change the current healthcare landscape? And what are the policy framework required for them to ensure successful utilisation?

Almost all industries have seen a dramatic shift in the way consumers are adopting new technologies. The new age consumers demand information, goods and services at the place and time of their choosing and as an industry, our job is to enable an ecosystem that fulfils such a demand. It is true that consumer for every industry is different but this trend is horizontal in nature.

Healthcare industry, which consists of a healthcare provider, manufacturers of medical devices and drugs, and medical insurance providers, is witnessing a technology-driven transformation itself. While the healthcare system has always been providing evidence-based care but digital health technologies have opened doors for preventive care, which promises to be more efficient and effective in every way. It is proven through clinical studies that patients who are better informed about their health make better decisions pertaining to their health, which in turn leads to better outcomes. Furthermore, it is not only limited to the patient use case. Healthcare Provider (HCP) and OEMs are increasingly using these technologies to make informed decisions and provide meaningful benefits to the end user.

Some of the key digital health technology trends prevalent in the industry are Artificial Intelligence (AI), Internet of Medical Things (IoMT), Telehealth, Augmented Reality (AR) or Virtual Reality (VR) or Mixed Reality (MR) and Blockchain.

As the industry is embracing these technologies, regulatory bodies are feeling the need to modernise their policies. Although the main objective of the regulatory bodies is to ensure patient safety, they are streamlining their regulatory process to encourage innovation in digital health technologies. For example, the US FDA has been vocal about its intent to improve patient outcomes and hence has taken an inclusive and iterative approach towards digital health technologies. They have rolled out a pilot software pre-certification programme for software as a medical device (SAMD) which would be further refined based on the outcome of the pilot and to also include software in a medical device (SiMD), and other software that could be considered accessories to hardware medical devices in the future.

What role does data integrity and validation play for medical devices?

Maintenance of data integrity at the process and product level are of key importance when OEMs are either transforming internally to adopt digital technologies to optimise their internal processes or providing additional value to their end-customers by leveraging digital health technologies.

From the process point of view, OEMs are increasingly reliant on electronic records to maintain data throughout the product lifecycle. Although handling data in the electronic format provide convenience to the users/stakeholders, it poses a unique set of challenges for the OEM. US FDA through its industry guidance 21 CFR part 11 expects the companies to ensure that the data maintained in their systems is always attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). Companies achieve these by implementing controls such as limiting individual access through authorisation, maintaining a secure audit trail, checks for validating the source of data input and enforcing permitted steps, provision for data backup/disaster recovery and importantly the protection of records. Hence, OEMs are required to formulate strategies at the corporate level, implement control for secure data management and validate the system in their entirety.

In the case of product line expansion, OEMs are leaning towards the integration of digital technologies to provide a complete ecosystem of solutions, which not only addresses critical areas in their operating areas but also creates a seamless experience for the user. For example, IoT is one of the most discussed technology topics in the medical devices industry and so is cybersecurity. Implementing an IoT platform is beneficial for both the end-user, i.e. doctors, clinicians, nurses, etc. as well as the OEM. Users can ensure a better clinical outcome by remotely accessing data for informed clinical decisions while OEMs can access device log data to enable predictive maintenance and ensure minimum device downtime. In all cases, the security of data takes precedence over all other ecosystem development requirements. OEMs are aware that the loss of data integrity can lead to severe consequences in terms of patient safety hence apart from ensuring data security at the device or system level, methodologies are also required to be implemented to ensure secure data transmission.

Validation plays an important role in ensuring compliance with the requirements set forth by the regulatory bodies. The validation of the system is required to establish documented evidence that a process or product will consistently perform accordingly to the predetermined specification and quality attributes. Validation strategies at the companies need to be pragmatic in order to ensure effective and efficient compliance with the objectives of the entire validation programme. One needs to prioritise the systems according to their impact on the quality of the product itself and accordingly carry out the validation activities.

What are the costs that companies have to pay for not maintaining data integrity associated with medical devices?

Regulatory bodies rely on documented proofs of OEMs’ compliance claims. If your objectives, plan, protocols and reports are not documented satisfactorily then the system is inadequately controlled for ensuring product quality, which in turn may affect patient safety. Hence, the implication of not maintaining data integrity can be huge in terms of costs. The cessation of sales and product recall may directly affect the company’s top line and at the same time, resources may need to be diverted to address the problems, which further affects the operational cost. The problem is much more for the public listed companies as the investor sentiments may turn negative.

What does a successful validation programme bring together – engineering, manufacturing, regulatory compliance and quality assurance and/or more?

Validation of medical devices and its corresponding engineering and manufacturing processes form an integral part of the complete product development lifecycle. At times, validation guidelines have a broad definition and lack specificity. This may lead to inadequate validation, especially in the case of smaller companies that have a comparatively small pool of resources undertaking multiple tasks.

Hence, it of utmost importance that the functions in the organisation work together and successfully execute a validation programme. A validation team must have representation from dependent functions, in-depth and common understanding of what validation consists of, for different processes and device types, and how validation programme must be carried out.

Tell us about the impact or value that Tata Elxsi has created for its client/partner’s business?

We at Tata Elxsi house an experienced team of engineers that brings an in-depth understanding of various functions involved in the entire PDLC of medical devices. Its geography-specific regulatory requirements exposure, allows it to work closely with OEMs of all sizes to analyse risks in their various processes and mitigate them to deliver quality products. Our expertise in the validation area covers both the device validation and the process validation including test method validation, computer system validation etc.

One of the key aspects that we help our clients consider or cover is the economics of the validation programme. Since the industry is very competitive and in some cases commoditised, the consideration for cost-benefit plays an important role in planning the entire validation programme. Our turnkey approach and proven methodology have helped customer execute the validation programmes in an optimised, efficient and cost-effective manner.

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