Delivering a 3D-printed device into an uncertain regulatory environment

Written by Mohit Chhaya

In this interview, Mohit Chhaya, CEO of BellaSeno GmbH (Leipzig, Germany), discusses the concept of bioresorbable implants, combining regenerative medicine with 3D printing and the challenges of delivering a 3D-printed device into an uncertain regulatory environment.

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Mohit Chhaya is a Co-Founder and CEO of BellaSeno GmbH and has over 10 years’ experience in biomedical engineering and additive manufacturing technologies. Chhaya was instrumental in raising a total of >€5 million of private and public financing and successfully brought BellaSeno from its initial conception to full ISO 13485-certification within 2 years. Chhaya also directed the development of BellaSeno’s preclinical as well as clinical validation and regulatory strategy. In this role, Chhaya has successfully delivered multi-partner industrial projects with value >€3 million and successfully launched one of world’s first CMO service focused on resorbable implants made using additive manufacturing.

Chhaya is named a co-inventor in 6 PCT patents, was named an MIT (MA, USA) Technology Review’s Innovator Under 35 for his achievements in the MedTech industry, one of the products developed under Chhaya’s leadership was awarded the highly prestigious Edison Award in 2020 and Chhaya has won >3 Young Achievement Australia entrepreneur awards for his work in pioneering social media analytics in 2008.

In prior roles, Chhaya worked as a Post-Doctoral Researcher at Technical University of Munich (TUM, Germany) where he was part of a team that got awarded an Exist Research Translation grant by the German government. As part of his duties, Chhaya shaped the global regulatory strategy for innovative scaffolds for lymph-node regeneration. Chhaya also worked as a Data Analyst at Moody’s Analytics (NY, USA) for 2.5 years which gives Chhaya a broad knowledge of capital and derivatives markets.

“… our vision is to change the current paradigm of healthcare from sustaining life to regenerating health. What we focus on are inherently safe materials that have been used in the community for a long time and then focus on the engineering aspects to give the properties of the intended application.”

Chhaya was interviewed at 3DMedLIVE 2019: 3D printing in surgery. To access more exclusive interviews and content from 3DMedLIVE 2019, watch this space on 3DMedNet >>

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Interview segments:

  • Introduction [00:03]
  • 3D printing technologies and regenerative medicine [00:44]
  • Engineering strategies to benefit the surgical community [01:47]
  • Delivering a 3D-printed device into an uncertain regulatory environment [02:30]
  • The future of bioresorbable implants and custom devices [03:35]


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The opinions expressed in this feature are those of the interviewee and do not necessarily reflect the views of 3DMedNet or Future Science Group.