By Adam Freeman, Senior Consultant with confinis ag

I started my journey in MedTech in an IVD blood lab. From there, I spent eight years as an Investigator with the United States Food and Drug Administration (FDA). Over those years, I evolved into an expert in medical device design, manufacture, quality, and compliance. During the interesting years as inspector the wish grew to directly use my expertise to support the companies in fulfilling the necessary quality regulations. To do so I left the FDA in December 2017, and began a new chapter as a Senior Consultant with confinis ag. That sent my life from San Francisco California, the capital of the Bay Area and the home of the Silicon Valley to Bern the Swiss capital in the heart of the European Alps. There is definitely a learning curve to operating in French, German, and a mix between the two. I’ve chosen the challenge of immersing myself in all I can in this parallel world which is that of Swiss and European ways. With this journey, I’ve found myself in conference rooms of regulatory experts whom are discussing and defining their way for the interpretation and implementation of the new EU regulatory publication of the Medical Device Regulations 2017/745.

From my perception, the new European MDR is the promising attempt to harmonize the European and American regulations. Both entities intents are to establish the same framework which has been defined within EN ISO 13485 and EN ISO 14971. In summary a risk-based quality management system which ensures risk are defined, controlled, and appropriately managed within the regulatory compliance frameworks of the jurisdictions within each operating country. The degrees of separation between the two regulatory sets, that is FDA’s Title 21 Code of Federal Regulations and the European Union’s 2017/745 Medical Devices Regulations, are summarized as different market clearance processes, different regulatory reporting architectures, and subtle differences in the risk- based classification schemes for Class I, II, and III versus Class I, IIa, IIb, and III. All in all, however, the main intent to note for the quality management system is to protect the public health by ensuring the safety and efficacy of the products being produced.

In my new role as consultant, I have the pleasure to partner with big and small companies as a coach for assisting with new design plans, internal audits, and to assists in starting up new sites. I’ve contributed to determinations on using specific contract manufacturing sites, and helped others with purchasing controls to ensure their suppliers meet product specifications. For most start-ups it is a real challenge turning on a quality management system. Supporting them in creating a lean system as well as tailoring design-control processes considering company specific operational requirements are activities where I can bring in my FDA experience and pave the way for a regulatory compliant and workable set-up.
The inherent basis for the quality management system is to control and manage many running processes while ensuring each effectively meets its intended use. The quality system consists of different components: Management Controls, Design Controls, Corrective and Preventive Action Controls, and Production and Process Controls. Together they form a quality engine. To move your company successfully, safe and efficiently it is important to design each of the components specifically for your company’s needs.
A good engine design will facilitate smooth running and avoid getting stuck and unpleasant repair. Translated I believe this: Without implementing for example Design Controls a decisive component of your engine from the beginning, your company cannot run smoothly.
The engine of a bigger company needs more power, is more complex and relies on more parts. Everybody in the organization is a part of the quality engine and needs to contribute to keep the engine running smoothly. Not each and every individual is able to still know all the details. In practice, the challenge is to capture all the knowledge in the different operational sections and combine it to a risk-based management integration for process optimization and for ensuring the flow throughout the company. Highlighting what your hazards and critical control points in e.g. your production process are, will prevent your engine to get stuck in the downstream due to deviations or worst-case recall based on unrecognized process drift situations.
Taking the engine analogy further: we generally don’t trust our car to run for years without taking care of it, right? Looking at your company engine, I believe that internal audits and management reviews, checking on the set specifications and KPIs you know to be required to run smoothly, are basically servicing the company engine. Appointing a management representative by the executive management and allocation of adequate resources is key to ensuring the findings of the servicing is put in practice and the quality management system engine is operational within the organization.
To close the loop, continuous improvement of the engine depends on your knowledge about the performance of your products in the hands of the users. IE Vigilance reporting, recall reporting, and reporting of key performance indicators are valuable sources for input to reaching the next level of performance.
Do you want to discuss the development or maintenance of your engine?
I am ready to share my experience with you.
My contact:, +41 79 832 8550