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Here we present summary of SIX recent case studies, derived from our ongoing market research projects highlighting recent development in the Pharma world.
Navigating the Complexities of Medical Device Regulations
Early implementation of active regulatory solutions can improve market readiness, ease compliance, and cut costs.
Focusing on
- Medtronic‘s strategy to improve efficiency and strengthen cybersecurity.
- Stryker‘s approach to simplify compliance while accelerating market entry.
Key Findings
- 90% of professionals face time and cost as top regulatory challenges.
- 64% increase in regulations since 2015 complicates market approvals.
- 36% of manufacturers struggle with asset management amid evolving cybersecurity requirements.
Navigating the Complexities of Medical Device Regulations
User-Centric Design: Enhancing Medical Device Usability
Apply proactive risk management early to identify issues, enhance safety, and reduce recalls.
Focusing on
- Abbott‘s plan to improve usability and reduce design-related recall risks.
- GE HealthCare‘s strategy to streamlines usability testing
Key findings
- 15% increase in medical device recalls in Q1 2024, driven by design and interface issues.
- 6.9% CAGR for usability engineering services from 2024 to 2035.
- 77 usability studies identified, with user satisfaction and ease of use as key metrics.
User-Centric Design: Enhancing Medical Device Usability
Effective Market Access Strategies for Medical Devices
Fragmented healthcare systems, increasing regulatory hurdles, and complex pricing/reimbursement models create significant barriers to market access for medical devices
Focusing on
- Boston Scientific : Advancing Leadless Cardiac Rhythm Management.
- Philips’s 2025 expansion of diagnostic imaging in emerging markets.
Key Findings
- 80% of drug launches fail due to poor targeting.
- 60% of applications face reimbursement delays.
- 75% of payers reject due to weak value communication.
Effective Market Access Strategies for Medical Devices
Sustainability in Medical Device Manufacturing: A Competitive Advantage
Apply proactive risk management early to identify issues, enhance safety, and reduce recalls.
Focusing on
- Baxter International Inc.‘s sustainability initiatives.
- Siemens Healthcare Diagnostics S.r.l : Sustainability for Competitive Advantage.
Key Findings
- 80% of medical device firms face stricter environmental regulations, increasing compliance costs by 25%.
- 70% of healthcare investors prioritize sustainability, influencing capital allocation and stock performance.
- 15% cost savings from energy-efficient practices reduce dependence on volatile raw material prices.
Sustainability in Medical Device Manufacturing: A Competitive Advantage
The Role of Data Analytics in Medical Device Development
Driving Healthcare Innovation Through Data Analytics in Medical Devices & Imaging
Focusing on
- Zimmer Biomet : Data-Driven Innovation in Orthopedic Devices.
- Canon Medical Systems USA, Inc. – The Role of Data Analytics in Diagnostic Imaging.
Key Findings
- 30% Workflow Inefficiency AI optimizes diagnostics, reducing delays.
- 25% High healthcare Costs Predictive models cut wasteful spending.
- 20% Outcome Variability RWE and QALY enhance treatment consistency
The Role of Data Analytics in Medical Device Development
Improving Clinical Trial Efficiency: Strategies and Insights
Apply proactive risk management early to identify issues, enhance safety, and reduce recalls.
Focusing on
- Covance (Labcorp) – Improving Clinical Trial Efficiency.
- ICON plc – Enhancing Clinical Trial Efficiency.
Key Findings
- 40% Trial Delays Slow recruitment and inefficiencies increased development timelines.
- 30% Higher Costs Ineffective trial management led to resource wastage.
- 25% Dropout Rate Poor patient engagement reduced study completion rates.
Improving Clinical Trial Efficiency: Strategies and Insights
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Author Information
The individual reports are part of Inferre Consulting‘s market research projects which is led by Ritav Brahmbhatt. Content of this publication is prepared by Ritav Brahmbhatt and summarized here by Avisek Ghose.
Disclaimer
The information provided in this newsletter does not constitute financial or investment advice. Always consult with a qualified professional before making any investment decisions.
This presentation is based on publicly available information and does not contain any proprietary data or commercial interests. The insights shared are intended solely for educational purposes. No financial support or sponsorship was received from any pharmaceutical companies or related entities for the development of this content.
The authors took extreme care for citing credits wherever applicable, however, in case of missing citation(s) and/or any other discrepancies, please inform the authors, Avisek Ghose and Ritav Brahmbhatt with valid documentation(s).
Author: Avisek Ghose
Published on 12 March 2025
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