Katie Brinkman Joins Hohenstein Medical as Biocompatibility Program Manager

Hohenstein Medical Welcomes Katie Brinkman as a Biocompatibility Expert

Hohenstein Medical, a prominent division of Hohenstein Laboratories well-regarded for its testing, research, and certification services tailored for the medical device sector, has made a significant addition to its team. They have appointed Katie Brinkman as the new manager for their biocompatibility program. This move is anticipated to enhance their service offerings in the biocompatibility realm, an area vital to ensuring the safety and efficacy of medical devices.

Brinkman boasts over 15 years of extensive experience in biological sciences, particularly in the intricate field of biocompatibility that is critical for medical devices. Her clinical-focused approach to evaluating biological risks is expected to play a crucial role in shaping Hohenstein Medical's strategies moving forward. Her primary responsibilities will involve spearheading the advancement of biocompatibility services, emphasizing chemical characterization, biocompatibility consulting, and the development of ethical, non-animal testing methods aligned with the highest international standards.

In her new role, Brinkman will facilitate the strategic positioning of Hohenstein's biocompatibility program, which includes overseeing ISO 18562 gas pathway testing and advising on biological evaluation plans and reports. This responsibility indicates Hohenstein's commitment to adapting to evolving industry regulations and emerging trends in medical device testing.

Dr. Timo Hammer, the CEO of Hohenstein Medical, expressed enthusiasm about Brinkman's arrival. He stated, "We are thrilled to welcome Katie to our team as we continue to uphold the highest international standards for regulatory studies and lab competence. We are dedicated to building a team that embodies excellence, and Katie’s expertise aligns perfectly with our mission."

Prior to joining Hohenstein Medical, Brinkman served in various biocompatibility roles at notable organizations such as Cook Research Incorporated, NAMSA, Abbott, and Ethicon Endo-Surgery, Inc., a Johnson & Johnson subsidiary. She has a rich history of authoring many biocompatibility and toxicological risk assessments that support global regulatory submissions. Her extensive experience encompasses all stages of the medical device lifecycle -- from initial product development, through design changes, to compliance with the European Union Medical Device Regulation (EU MDR) and post-market evaluations.

Commenting on her new position, Brinkman shared her enthusiasm: "Biocompatibility is nuanced and intricate, and I am excited to join Hohenstein Medical to merge my technical expertise with Hohenstein's commitment to individualized customer support. I aim to create a program that facilitates a seamless biocompatibility process for our clients."

Brinkman’s background includes notable achievements such as her certification as a Biological Safety Specialist by NAMSA and deep knowledge of ISO 10993 and related standards. Her proficiency will significantly enhance Hohenstein Medical's biocompatibility program, which reflects a comprehensive approach to testing that combines chemical, physical, and biological assessment services. This level of accreditation is exceptional, distinguishing Hohenstein from other labs in the medical device testing industry.

With an integrated methodology that adheres to FDA guidelines and international standards, Hohenstein Medical functions as a trusted partner for manufacturers looking to navigate the complexities of regulatory compliance and safety evaluations. Their capabilities extend beyond mere testing to encompass complete consulting services, addressing various aspects such as the specific intended use of a product and its regulatory classification.

Hohenstein Medical is dedicated to aiding manufacturers in achieving peace of mind through meticulous, aligned studies for a range of medical products, including both single-use and reusable items. The laboratory’s expertise ensures that every piece evaluated meets stringent safety standards, facilitating smooth market entry for new devices.

As Hohenstein Medical continues to evolve and expand its services, the appointment of Katie Brinkman is viewed as a strategic step towards reinforcing its position in the medical device testing landscape. The company remains committed to delivering exceptional service by combining deep industry knowledge with innovative solutions designed to meet their clients' unique needs. For more information about Hohenstein Medical and its extensive range of services, visit their official website.