'We Can Cure Cancer' [MD Manufacturer]
Zener Engineering Services Ltd • 3 June 2021
Medical Device Regulatory Compliance
Zener Engineering Services Ltd were asked by a Blue Chip Manufacturer, (who had no, or very little, experience of Medical Device Manufacturing), to help bring, in their words, a 'Cancer Cure' to market.
How the Medical Device cured cancer was explained in basic principle to the ZES representative, which sounded logical. The Medical Device was not approved and only had been tested on around 25 patients, who had signed disclaimers, supervised by a doctor in Europe.
The Blue Chip Manufacturer wanted to mass produce the Medical Device in 6 months.
The Blue Chip Manufacturer had also decided that formal Clinical Trials were not required.
The main objective for ZES was to manage the implementation of a new Manufacturing Facility and ensure that the Manufacturing Process and Medical Device were validated.
The Blue Chip Manufacturer had employed other Consultants, not via ZES, who had little experience of Medical Device Manufacturing, or even the life science industry.
Upon realisation by ZES of the intended approach to be adopted by the Blue Chip Manufacturer, ZES attempted to educate and mentor the Blue Chip Manufacturer's staff and other project consultants with less experience.
Consultants claiming to have significant experience were working on Qualification Protocols (IQ/OQ/PQ) without a URS or Validation Plan being in existence in any form whatsoever, for either the Manufacturing Facility or Medical Device.
After a relatively short period of time trying to educate a number of people, ZES left the project as the Blue Chip Manufacturer wished to listen to those who advocated not performing formal clinical trials and achieving full production of an approved Medical Device within 6 months, to cure cancer.
At the time of writing, (and 5 years after ZES being involved) the Medical Device in question is yet to come to market and ZES has been informed that the Blue Chip Manufacturer has in fact now abandoned the project after 4 years, after spending an enormous amount of money.
This is yet another example where companies large and small are simply taken in by so-called expert Suppliers and Consultants who tell their clients what they want to hear.
ZES always operate with the utmost integrity and provide straight and honest answers,
even if it does not sit well with the Client.
ZES regularly act on behalf of Clients to ensure project requirements are satisfied
in a compliant way by their Suppliers.
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