Executive takeaways for MedTech decision-makers
An evidence-aware briefing on seven forces reshaping neurology MedTech, with case examples, regulatory / reimbursement takeaways, and practical next steps for product and program leaders.
You’ll learn:
- The seven catalysts: AI/ML, advanced imaging, robotics/minimally invasive, digital health/telemedicine, precision medicine, neurostimulation, and BCIs. You’ll get a feel for what they enable today and where they’re headed.
- How to act: Each section gives critical insights, brief case examples, lessons learned, regulatory & reimbursement implications, and RQM+ recommendations you can apply on your own or with help from RQM+.
- Context that informs decisions: An executive overview with key milestones to frame timing and risk.
- Backed by citations: 30 full references to support claims and examples.
Who should read:
- MedTech manufacturers and innovators across neuro, neurovascular, neuro-oncology, digital/AI, and BCI.
- Leaders in Regulatory Affairs, Quality, Clinical/Medical Affairs, R&D, Product/Program Management, Market Access/Reimbursement, and Corporate Strategy—anyone steering pipeline, submissions, or go-to-market.
Outcome: A shared, cross-functional playbook to align teams, de-risk development, and focus investments where the evidence and adoption signals are strongest.
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About the Author
Jaishankar Kutty, PhD
Vice President, Regulatory, Reimbursement, & Market Access
With over 16 years of distinguished experience in the medical device industry, Jai brings robust expertise in R&D, clinical, and regulatory leadership from roles at BSI and St. Jude Medical to his position at RQM+. At RQM+, he leveraged EU-notified-body expertise to guide manufacturers through complex clinical and regulatory landscapes, specializing in clinical/regulatory strategy, clinical study design, retrospective data gathering, biological safety evaluations, interaction with regulatory agencies, and benefit-risk analyses. Jai ensures rigorous compliance and drives advancements in evidentiary foundations for legacy devices. At BSI, he spearheaded CE marking for cutting-edge cardiovascular technologies and played a critical role in securing MDD re-designation for the UK and achieving MDD/MDR designations for Dutch notified bodies. Jai contributed to groundbreaking advancements in surgical and transcatheter heart valve technologies, including innovations in septal closure, vascular closure, and renal denervation, setting new benchmarks for R&D and clinical excellence.
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