Exemplas and Medilink came together once again to provide an insightful half day of knowledge sharing around the medical device and healthcare industries. This event was held on 17th June 2024 at Hill Dickinson Leeds and was available for all MedTech and Healthcare SMEs based in West Yorkshire, for free through West Yorkshire Business Boost Export.
The day began with an introduction from Tom Elliott, Managing Director of Medilink North of England, who highlighted the benefits of working with Medilink and the benefits that can be accessed, including consultancy support and a whole host of others.
Value Based Healthcare
Gemma Badger, Senior Associate at Hill Dickinson, shared her knowledge of Value Based Healthcare, answering the question: Value Based Healthcare – what is it and how is it relevant to you?
Key takeaways
Value Based Healthcare offers a potential response to the challenge that healthcare systems worldwide are facing; while the cost of care continues to rise rapidly and unsustainably, patient outcomes are not improving at the same rate, even in healthcare systems spending the most. OECD estimates that growth in health care costs is outpacing growth in GDP – between 2000 and 2019 health costs as a % of GDP grew from 9% to 12%. The value-based approach aims to achieve better outcomes and experiences for patients by using powerful data insights to measure outcomes across settings and pathways and organising care around patients rather than processes.
The concept of Value Based Healthcare can seem complex but there are lots of very intuitive elements which can be built into propositions. It is a patient-centric approach which aims to align all stakeholders in the healthcare system, bringing benefits for each of them through aligning incentives.
The term Value Based Healthcare has been used for many years since its first conception in 2006, with a lot more enthusiasm recently with healthcare systems in some parts of the world now starting to design their approaches around value. Manufacturers in the MedTech industry should understand what the term means to be able to offer solutions, which incorporate value in line with the approach.
There are very few examples currently of value-based approaches being implemented at scale, but throughout the supply chain and the network of healthcare stakeholders, there are incremental steps which can be taken towards a more value-based approach
For more information about Value Based Healthcare from Hill Dickinson: https://www.hilldickinson.com/insights/videos/value-based-healthcare-whats-it-all-about
Demystifying MDSAP
Damon Williams, Sales Manager at BSI Regulatory Services, ran through MDSAP from ‘before’ to the potential developments in the future in MDSAP: Accessing Five Global MedTech Markets.
Key takeaways
The Medical Device Single Audit Program (MDSAP) is the first audit program of its kind, having been introduced officially in 2019, under the common goal of promoting greater alignment of regulatory approaches and technical requirements. It satisfies the requirements of multiple regulatory jurisdictions:
- Australia
- Brazil
- Canada
- Japan
- United States of America (USA)
Audits for MDSAP are conducted by Auditing Organisations, such as BSI. ISO 13485 and/or ISO 9001 surveillance audits can be combined with the MDSAP surveillance audit following initial certification, to save your business time on your audits – by overlapping the audit of each process surveillances where possible.
Benefits of MDSAP
- Streamlined Audits: Consolidates multiple global regulatory audits into a single, efficient process, reducing audit-related costs and disruptions to operations.
- Global Market Access: BSI Group Americas inc. is a recognized Auditing Organization. In addition to the 5 MDSAP member countries.
- Reduced Regulatory Burden: Eliminates the need for separate audits conducted by different regulatory authorities.
- Enhanced Reputation: Bolster a manufacturer’s reputation for quality and safety, instilling confidence in customers and regulatory authorities alike.
For more information about MDSAP from BSI: https://www.bsigroup.com/en-US/medical-devices/Our-services/Medical-Device-Single-Audit-Program/
Sign up to West Yorkshire Business Boost Export to access £2,000 of match funded grant funding to help access or grow international markets. You’ll also receive an export action plan from one of our export managers and if you’re in the MedTech or health sector you will receive additional funded support from Medilink: https://wybusinessboost.co.uk/enquiry/
Check out our upcoming free to access workshops delivered by Chamber International here: https://wybusinessboost.co.uk/export/export-workshops/