Nowadays, the need for tackling complex and unpredictable issues within the enterprises renders the fact that employees need to be versatile, enthused and willing to learn new skills and behaviors to effectively enhance the operational performance.

Learning agility is a popular concept which enhances employees’ ability in being flexible and adaptive in uncertain business environments.

Validation engineers continue to improve themselves as validation department is regarded as a continuously changing business environments with high degree of the unpredictability.

Carving out new territory in validation sector

The MedTech industry has ostensibly struggled with validation disparities  due to frameworks barriers. An ample assortment of continuous development of the existing validation frameworks, widening from the agility to overall “lean” concept, can be imputed to Agile methodology. The traditional Waterfall method has been always used in validation of computerized systems in MedTech industry in LSHC industry. The advent of Agile methodology was introduced to tackle these limitations of the Waterfall method. This article aims to discern subtle issues of Agile landscape and proffer stepping stones towards its implementation.

The advent of CSV resuscitated the healthcare industry as software qualification is critical for the product quality and subsequently the patient safety. Agile validation is perpetrated to tackle the limitations in Waterfall and subvert beleaguered development methodologies. The onus is to evolve techniques for continuous improvement  and conduct tests in smaller iterations.

Validation engineers tailor the strategy according to a project base and not related to a process, with main focus to meet the standards for product quality and patient safety. Risk based approach will be connected to each sprint and testing is bounded to the level of risk. The convergence of agile methodology and computer system validation  is intrinsic to deliver continuous development, agility and over all “lean” concept. The compliance deadlocks redound a cross-cutting disquiet for drastic changes in validation. The medtech industry renders a sharp rebuke to Life Sciences organisations to embrace agile methodology while in the middle of a Waterfall implementation. Although the type of  software development lifecycle in the medetch industry is not specified in IEC 623304 (Lifecycle Requirements for Medical Device Software) according to FDA, companies are encouraged to adopt Agile into their CSV activities and develop a hybrid waterfall/agile strategy that harmonises inconsistencies around the validation arena.

The agile concept manifests an evolving development scheme where planning, design, and other phased of software development can occur frequency. Agility instantiates an auspicious denouement to attenuate the defect form the waterfall methodology. A quintessence of agile methodology in healthcare organizations aims to enhance the quality of product and subsequently to guarantee the patient health.  The endeavor for implementation of advanced solutions is more than indispensable for a radical veer to fully complaint and cost-efficient healthcare industry. Against that backdrop, there is room for manoeuvre as industries savvy  the importance of agility in qualification of any and all automation tools, and for Continuous Integration/Continuous Development they attempt  to move to Agile while in the middle of a Waterfall based project. The perpetration of working methodologies (hybrid Waterfall-Agile) is considered crucial impetus for the companies to ponder Agile and invest on agile-centric tools, expediting the transition to a complete change over to an end-to-end agile way of working.

Nowadays, the volatility of healthcare business renders the necessity for changes and specifically the adoption of the agile mindset. Structural hierarchy dominates in traditional organizations where run their business in a static, siloed situations. They lack of flexibility as they  follow linear planning procedures and controlled execution. Agile organizations have different skeletal structure and they characterized by rapid and adaptive changes. Agile business management provides a technology-enabled network of teams with a people-centered culture working in fast-learning and rapid-decision cycles.

Questioning the technological potency

Medical devices manufacturers are struggling with growth challenges and stagnant valuations; however, manoeuvrability of the agile pathways circumvents conventional validation practices. The clustering of agile methodologies is the sine qua non for enhancing the value centricity, thus, accelerating growth in medtech. Looking to a later levy, leveraging agility renders a sparking change to an industrial scheme with business risk averseness. Contentious arguments over the implementation of agile concomitantly jeopardise the operations of the enterprise, thus, comprehension of the agility factors is being the crux of the issue.

Conclusion

Agility appears more important than ever in contemporary organizations and this abridgement grapples with keeping abreast of agile methodology and its repercussion on the medtech industry. Enterprises may implement a cascade strategy towards the agile transformation in order to address the challenges posed by operations throughout the value chain.

 

Authors Bio: 

Spyros Achinas is senior validation engineer at Regenity Biosciences in Groningen, the Netherlands. He worked as research engineer at the University of Groningen. Spyros held roles in production and validation at Thermofisher Scientific in Groningen.  Spyros holds B.S/M.S in Chemical Engineering and M.S in Automation Systems from the National Technical University of Athens.

Dr. Nikolaos Charalampogiannis holds a PhD from  the Faculty of Medicine at University of Heidelberg. From January 2016 worked as Consultant at the Urologic Department in SLK-Kliniken am Gesundbrunnen, in Heilbronn, Germany.