Arthrex

Tomoko Chantelle Kondo

No one doubts the importance of compliance, especially in this highly regulated industry you belong to, MedTech.

 After spending more than 20 years as a Legal& Compliance professional out of the MedTech industry, I joined this industry and realized its uniqueness – detailed and complex.

Thus, let me talk about MedTech's compliance features and reasons for being highly regulated from my perspective.

Firstly, while our products, medical devices, are designed and manufactured with innovation and sensitivity, we are expected to be engaged with its users, HCPs, and almost in every aspect of our commercial activities such as product development, clinical trial, place on the market, post-marketing surveillance etc. Although the final beneficiaries are patients, HCPs are responsible for their effective and safe use. The products touch the patient’s body, not only the surface but also deeply situated organs. Moreover, some products stay inside the body and must function stably for a long time.

Manufacturers have started our business with a passion for saving and helping patients and creating better lives for human beings directly and by supporting HCPs. Therefore, innovation is one of our drives to push us forward. We want “Better“products and treatment to be provided to patients.

“I believe that one of the meanings of compliance in this industry is to manage and balance that passion may not be across the border.”

I believe that one of the meanings of compliance in this industry is to manage and balance that passion may not be across the border.

Secondly, I would like to point out another uniqueness: the activities related to the role of this industry, which is highly public. For example, we are expected to provide our products as part of disaster relief. To design better products, we must collaborate with public institutions using public funds, which means taxes. Providing educational grants shall also contribute to human resources development for the medical device industry.

Moreover, since our products are innovative and sensitive, prior training for specific products will be required. Unfortunately, high-value products are mostly expensive, especially publicly funded HCOs, and cannot decide to use/purchase without trial use/samples.

While the former is very public, the latter category sounds more commercial, especially since all are delivered free of charge. Manufacturers are commercial enterprises, and whether the relationships/transactions evaluated are “Quid Pro Quo” can be difficult.

Thus, another meaning of compliance in this industry is to set boundaries between commercial and public activities.

Now, you may understand why the compliance management system in MedTech is so detailed and complex. One of the reasons to state them is that, in some cases, it is tough to identify either acceptable commercial activities or inappropriate commercial activities or bribery. You may have felt fatigued by the rules/processes to comply with. However, you may appreciate that they are necessary to protect MedTech companies and bring healthy growth to achieve their initial missions.

The same improvement of our products can be made with a change of environment, not a principal, but detailed rules of compliance can be changed over time for a better fit.

I would appreciate it if this could help you better understand the background of the compliance rules you face every day in your job.