A Volte-face on Introgressed and Adaptive Validation: CSV Implementation In MedTech Industry

Spyros Achinas1, Efthymios Poulios2, Nikolaos Chralampogiannis3

1 Regenity Biosciences, Blauwborgje 32, 9747AC, Groningen, The Netherlands

2 4th Department of Surgery, Attikon University Hospital, National and Kapodistrian University of Athens, Medical School, Rimini 1, Chaidari 124 62, Athens, Greece

3 Department of Urology, Faculty of Medicine, Heidelberg University, Ludolf-Krehl-Straße 13-17, 68167 Mannheim, Germany

The use of computer systems has been considered a strategically distinctive option for the entire transition to digital data management. The gap between the paper-based and the electronic records calls into question how the MedTech industry can ensure the compliant data management. The computer systems enable granular visibility of the enterprise operations and insights beyond the production floor and efficiently adapts to computing requirement peaks and valleys.

Subtle issues are popped up amid the validation of electronic data generating systems which may underpin the drive for globally modernization and digital transformation in MedTech. The quest for devising a suitable means of smart validation has been a matter of concern of validation engineers (See fig. 1 for pivotal aspects of CSV). Over the last years, MedTech industry has progressively integrated computerized systems to support production. As a consequence, their criticality on GMP level has increased the pressure from regulatory authorities on clarification of the computers’ role on industry. Regulatory audits,  related to computerized systems validation, generate significant observations on the aspects of qualification and data integrity. These observations can lead to serious caveats of the applied manufacturing and quality system with direct consequences on the business and corporate image.

Business leaders envision the implementation of computerized systems in MedTech industry as a significant aspect to create a healthy economic arena; thus, digitised approaches to reduce time is indispensable to re-direct the linear economy into a sustainable trajectory. The leapfrogging to computerized systems and their integration for automated manufacturing processes can have a positive contribution to the overall production savings and may create a roadmap to establish attractive economic activities. In the past, one of the criticisms levied at the implementation of computerized systems has been the lack of a standardized policies and guidelines. EU GMP Annex 11 and US FDA 21 CFR Part 11 are nevertheless pivotal incentives for the manufacturers to accelerate digital transformation providing transparency, productivity and agility across the enterprise.

Building a Solid CSV Foundation Will Improve Execution and Efficiency

Fig 1

Figure 1. Enumeration of essential factors for CSV.

Bridging computational requirements with manufacturing factors assertively tacks tensions and trade-offs at the technological-policy interface and revives competitiveness. Industrial initiatives are recommended by the European Union to enhance the computer systems sovereignty and to add industrial credibility and benefits for the society. Current practices and policies for computer validation  are not coherent, and more synergy and dedication towards a solid CSV foundation would ease the integration of computerized systems. While computer systems are built by the software companies based on the CSV regulations, MedTech manufacturers must revalidate the computerized systems in their facility to maintain the validated status. The regulatory bodies during inspections expect to see documented evidence of technical approach for validation and data management. Strong evidence of validation will lessen the risk to patients and purvey rational safeguards against hurdles in clinical practice.

The generation and manipulation of the vast amount of data is critical for business leaders. A holistic approach to leverage digitalization and engineering facets is essential to interconnect all participants in the product lifecycle – operators, buildings, machines, materials, engineers , designers and automation, products. Adopting digital mindset and enabling smart engineering are intrinsic for the transition towards sustainable business processes. Data integrity is regarded as the sine qua non of successful commercialization and delivery of medical devices, thus, CSV concept is regarded as the centrepiece of departmental consolidation and enterprise realignment. The CSV concept manifests an evolving scheme that is characterized by a patient-centricity, , veritable brainstorm attitude, inaugural global engagement, upfront technological requisite and an apparent economic arena.

Fig 2

Figure 2. Scheme of aspects contiguity in MedTech enterprises. Grey area depicts the potency wherein CSV can be implemented.

This article proffers a brief abridgment on the standpoints of CSV implementation in the MedTech industry. 


Spyros Achinas is validation engineer at Regenity Biosciences in Groningen, the Netherlands. He started his career as bioprocess development engineer at the Bavarian Institute for Agriculture in Munich where he worked in the development of  fermentation pilot units. Later, he worked as research engineer at the University of Groningen where he worked on the design and fabrication of 3D printed bioreactors. Spyros held roles in production and validation at Thermofisher Scientific in Groningen.  Spyros has B.S/M.S in Chemical Engineering and M.S in Automation Systems from the National Technical University of Athens and M.S. in Sustainable Resource Management from Technical University of Munich.

Dr. Euthymios Poulios obtained his medical degree at the Medical School of the University of Athens in 1999. He completed his specialty in General Surgery at the Constantopoulio Hospital of Nea Ionia “Agia Olga” in 2008, participating and performing more than 800 operations. He retrained in advanced laparoscopic surgery and minimally invasive surgery at the University of San Francisco and the University of Strasbourg. He specialized in advanced colon surgery at Cleveland Clinic and Robotic surgery at Yonsei University. In 2009, Mr. Poulios joined the 1st Surgery Clinic of the Hygeia Hospital.

Dr. Charalampogiannis completed the specialty of Urology at the Red Cross Hospital of Athens in 2011. From October 2012 to December 2015 he was appointed as Consultant Urologist at Diakonie Krankenhaus of Schwäbisch Hall, Germany. From January 2016 to September 2019 he worked as Consultant at the Urologic Department in SLK-Kliniken am Gesundbrunnen, in Heilbronn, Germany. He’s been in private practice in Öhringen, Germany since 2019. From April 2019, he is PhD candidate at the Faculty of Medicine at University of Heidelberg focusing on the use of a robot for treatment of complicated nephrolithiasis. He has authored more than 30 full text manuscripts published in peer-reviewed journals.

Medical Device News Magazinehttps://infomeddnews.com
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Experts Views and Opinions

The creation of CAR T cell therapy begins with collection of the patient’s blood and separation of the lymphocytes. These include T cells, B cells, and innate lymphoid cells, all of which are separated through apheresis (leukapheresis). It is this separation process which, if optimized, has the potential to revolutionize immunotherapy treatments for cancer patients.
The latest results from a clinical trial presented today at the VEITHsymposium in New York City demonstrate how new living blood vessels created through restorative medical devices have become reality and can open unthinkable treatment avenues for patients. Xeltis is developing cardiovascular devices, namely artificial vessels and valves, that gradually create living and long-lasting vessels made of patients’ own, new healthy tissue.
In the dynamic realm of entrepreneurship, where seasoned professionals often take center stage, the story of Sai Mattapalli and Rohan Kalahasty — both 17-year-old high school seniors — emerges as a beacon of inspiration. 
Within two years, the U.S. will have a shortage of 98,700 medical and lab technologists and more than 80% of health systems are currently reporting shortages in their radiology departments. More than half of the radiologists in the U.S. are 55 and older, and the flow of residents to fill the gap isn’t nearly big enough. The staffing shortage is even more acute among radiation technologists and in the U.K., 97% of radiology departments cannot meet diagnostic reporting requirements.
Dr. Litwin advises, "Approximately 60 study sites worldwide are participating in RESPONDER-HF, a randomized clinical trial of the Corvia Atrial Shunt." What to know more about this life-saving device? Read what this expert has to say.

By using this website you agree to accept Medical Device News Magazine Privacy Policy