April 14, 2022
April 14, 2022
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
Meet the Expert: Jeff Block, Senior Consultant, Compliance (Medical Device and Diagnostics)
As a Quality consultant, I am in a supporting position for our clients: my expertise lies not within the actual design and manufacturing of the product, but rather the compliance to the various standards and regulations that govern a particular type of medical device. If the manufacturer does not keep to the mandated regulations, they will not be able to remain in that market; by assisting our clients with their Quality System and compliance needs, my efforts indirectly support the on-market availability of much-needed medical devices and equipment.
Another focus of my work is to try and make the maintenance of such compliance as efficient as possible, so that the proposed solutions can actually be implemented and maintained throughout the lifecycle of the device. Therefore, by providing support in shoring up the Quality aspect of the design and manufacturing process, ProPharma Group allows our clients to focus on the design and marketing activities of the business, enabling the user and patient to enjoy the benefits of a successful medical device implementation.
As a new ProPharma Group colleague, my primary goal is to become familiar with our operations and let people know that I am available to start assisting our clients with their risk management and design control concerns.
What I’ve noticed over the years is that regulations continue to tighten and become stricter, in the never-ending search for reduced product risk and greater customer satisfaction. Therefore, there is less room for creativity when designing products and quality systems to meet the requirements of the various regulations worldwide.
For product safety and patient satisfaction with their medical devices, this outcome is welcome; for the manufacturers and distributors, this means increased design costs, overhead, and post-market issue responses required in order to market their products. Industry (and its consultants!) can take this as a challenge to find ever-more efficient ways to execute product design to save costs, but a side effect may well be more and more outsourcing of the quality systems to try and gain some savings on payroll and expenses.
Be precise in your language and wording. So many times, different standards and regulations use the same terminology to mean completely different things, so when you are discussing an issue, make sure that your meaning is absolutely clear to your audience and that there is no way for your words to be misinterpreted. Lack of effective communication, I believe, delays progress more than any other single factor.
I enable expedited market access by providing top-notch compliance expertise. My role supports ProPharma Group’s higher purpose by enabling our clients and manufacturers to bring their products to market quickly and keep them there as long as patient and user demand exists for the products.
My free time, if you can call it that, is spent with my family and their various extracurricular activities. I enjoy coaching and refereeing youth soccer, auto racing, and the occasional music concert. My family enjoys traveling to visit extended family and friends whenever we can.
I never wished to work at a desk and push papers around for no good purpose; I always wanted my career to have a positive impact on people’s lives and society in general. In Medical Devices, I was fortunate to find that career, and I’m proud of my contributions in Quality Risk Management thus far. ProPharma Group embraces the same desire to improve the lives of patients via their efforts in supporting our clients and allowing them to effectively promote and market their products to the public that needs them, and I’m happy to be a part of this team.