HEALTHCARE AND MEDICAL INNOVATION
Innovative product catalyst revolutionizing life sciences and improving human health
Leveraging digital and regulatory research and innovation to empower the development of disruptive life science solutions
Developing and bringing an innovative product to the market is a long and expensive journey in life sciences. It requires a stepwise mix of high-level expertise in multiple domains, from science to market access, going through the regulatory and quality pathways. We aim to support, empower, and catalyze your innovative product development journey step by step. We can act as a strategic partner to propose technical, regulatory, market access, and financial scenarios adapted to your current context and stage.
Innovation and regulatory science multidisciplinary collaborations
Disruptive innovative products come with specific questions about assessing their safety, efficacy, and quality, from R&D to manufacturing and post-market surveillance in the real world. In a context where new guidelines are published yearly, opinions and directions may vary between agencies and institutions. At PLG, we propose to tackle innovation and regulatory science questions in a collaborative and concrete use-case–oriented approach, building partnerships with best-in-class universities and hospitals.
Start-up and investor support to healthcare innovation
Bringing an innovative product to the market is a challenge for start-ups and their investors, who are on a tight journey to fund all the product development phases. Integrating regulatory and compliance aspects starts as early as the concept idea – whether it would be the target product profile in pharma/biotech or the intended use for medical devices. Additionally, integrating medico-economic aspects in clinical studies as soon as possible is critical for a comprehensive approach.
At PLG, our mainstay is to assist innovators in the biotech and med-tech space, helping them overcome related challenges and deliver their best.
Our success stories empowering healthcare innovation
By combining research and innovation expertise with product development, strategy, and digital consulting, we have supported a dozen innovative healthcare and medical start-ups since 2023, leveraging different funding programs.
Notable examples include:
- The clinical evaluation of an innovative medical device for physical treatment of cancers
- The regulatory strategy of an innovative multi-sensor for diagnostic
- The global strategy of an innovative IVD for personalized medicine
- The market positioning of innovative biotechs for drug development
All of this is in the fields of oncology, immunotherapy, respiratory diseases, and neurosciences.
For more than half of the start-ups, we actively engage in collaboration through European proposals preparation, submission, or implementation and create acceleration workshops to progress in their innovation journey.
In parallel, we have been working with researchers from Dresden, Leipzig, Marburg, and Paris to analyze and share regulatory challenges to the development of AI in personalized cancer medicine (Bourraz et al., npj Precision Oncology, 2024), with a specific example of personalized chronotherapy of cancers which was presented in the 2024 FDA/CERSI Summit and Symposium.
