Health Valley Event 2014: Marieke Hettinga, Windesheim
Health Valley Event Presentatie Rob ten Hoedt
1. Health Valley Event De Vereeniging te Nijmegen 16 th March 2011 Rob ten Hoedt President Medtronic Europe
2.
3.
4. New Recognition: Value of EU MedTech – EU Commission «Exploratory Process» 2009-10 1. Public health challenges Holistic approaches Scope and role of Medical Devices sector Public health policies Involvement, education and training of the different actors Patient Safety & Quality of Care Fight against counterfeit medical devices 2. Encompassing innovation 3. Value of and access to medical devices 4. Industrial challenges Innovative technologies/products Involvement for innovation Procurement procedures and reimbursement Research and development Market Availability Measuring value of medical devices technologies Inclusion of medical devices within the scope of the national health insurance systems and funding systems Public procurement Late payments Generation of data Information to patients and clinical practices Global context for research investments FINANCIAL CHALLENGES Industrial environment Regulatory framework Involvement in decisions on access Patient empowerment Transparency Governance in the evaluation and decision making processes “ The Exploratory Process strongly endorsed the need for a clear political vision of the role of the medical device sector in the health of citizens and the economy. … the European Union should act to make Europe the global leader for medical devices by promoting innovation, efficiency and sustainable health outcomes. … A strong medical device sector in Europe will play a central role in supporting the broader EU aspiration that citizens live a longer and healthier life.”
5. Key Trends in European Healthcare Environment Increased focus on prevention Increasing expectations of citizens Increase of chronic and multiple diseases Shift from public to private funding Shift to community and homecare Increasing role of purchasing & paying institutions Declining “power” of healthcare professionals Increasing e-solutions Increased demand for medical technology and services * Ageing populations * Budget deficits * Growing shortage of healthcare workers
6.
7. MedTech Represents a Small % of Total Healthcare Spending Source: Espicom; WHO; World Bank, LEK analysis Medical devices represent <5% of overall spend and offer limited potential cost savings Huge opportunities elsewhere Devices Pharma Operating and other costs 0 100 80 20 60 40 CY08 Device Spending as a % of Total HC 4% 3% 3% 3% 3% 2% 2% 2% 4% 5% Sweden US Hong Kong Taiwan UK Singapore Canada Germany Norway China 2 3 1
8.
9.
10.
11. Brussels, 28 January 2011 – A report of the Boston Consulting Group (BCG) shows medical device recalls in the U.S. and Europe occur at the same rate while the approval process in Europe is significantly faster. The decentralised oversight in Europe, which is the essence of the regulatory system, allows people to benefit from the latest innovative products while guaranteeing the highest level of patient safety and fostering innovation. The findings of the BCG report are in line with an earlier report by Dr. Josh Makower, one of America’s leading medical technology entrepreneurs, which detailed how patients in Europe get access to new therapies an average of two years before patients in the United States due to regulatory challenges at the FDA. By analysing publically available data on severe recalls of medical devices in Europe (equivalent to a Class I recall in the US) the study shows that the number of recalls in Europe is identical to that in the United States, and the therapeutic mix and type of recall is also similar to that in the US. The report states that ‘this initial assessment of comparable recalls between the US and Europe does not suggest that different approval processes, and earlier approvals, in Europe come at a cost in terms of patient safety’. In reaction to the study John Wilkinson, Chief Executive of Eucomed comments: “This is the second study within the last few months that clearly indicates that the current EU regulatory system makes innovative medical technology available to people the fastest in the world while ensuring the highest safety standards. We are currently in the process of a recast of the EU medical device legislation and we believe that the current concept of decentralised oversight must remain. The notified body based system requires improvements in implementation but the system does not need a major overhaul. This BCG study shows that the regime of certification with CE marking has given patients and consumers in Europe the fastest access to the most innovative devices with the highest quality and safety standards in the world.” The report was prepared by Scott Davis, Erik Gilbertson and Simon Goodall of The Boston Consulting Group, a global business management consulting firm, and sponsored by Advamed, the U.S. Advanced Medical Technology Association. Eucomed: Research shows medical device recalls in Europe and U.S. are at similar rates
12.
13. Founded in 1949 as a Minnesota Medical Equipment Service Company
14. Manufacturing and R&D Minneapolis, U.S.A. Tolochenaz, Switzerland Tokyo, Japan Galway, Ireland Puerto Rico Tijuana, Mexico Montréal, Canada Neuchâtel, Switzerland Netanya, Israel Kerkrade & Maastricht, The Netherlands Fourmies & St. Aubin, France Deggendorf, Germany U.S.A. Irvine, CA Los Angeles, CA Memphis,TN Santa Rosa, CA Danvers, MA Jacksonville. FL Sunnyvale, CA Santa Barbara, CA San Antonio, TX Fort Worth, TX 40,000 Medtronic Employees 120 countries
15. CHRONIC DEGENERATIVE DISEASES IMPLANTS >6 million patients/year $1.5 Billion/ yr on R&D Parkinson ’s Disease Essential Tremor Chronic Pain Gastroparesis Urinary Incontinence Dystonia Spasticity
16.
17.
18. Demographics Drive Demand As the Average Age of the Population Is Increasing… % of Population Over 65 Years of Age 2004 2040 Source: World Health Organization 25% 31% 32% 36% 40% 40% 17% 21% 21% 25% 25% 26% 0% 10% 20% 30% 40% 50% US UK France Germany Italy Japan
19.
20. The Burden of Chronic Disease Nearly Half of the Western World population will have Chronic Conditions by 2030 Partnership for Solutions 2004, Chronic Conditions: Making the case for ongoing care
21. Chronic Diseases Have Staggering Costs Chronic Conditions Account for 83% of Health Care Spending Partnership for Solutions 2004, Chronic Conditions: Making the case for ongoing care
40. MD Start Validation Process MD Start ability to accelerate the development process cheaply and quickly will help leap over the ‘funding gap’ between early stage ideas and current expectations for A round financing
44. 2 ways to capture European Innovation 1. Medtronic EUreka Medtronic’s centralized, streamlined process to capture and evaluate physician ideas in Europe across all therapeutic areas Inventor ideas that are not a fit for MDT may be reevaluated by MD Start 2. MD Start An independent incubator co-founded by MDT and other partners (including VC) to bring med tech innovations forward for further investment OR Physician/Inventor ideas
45. Medtronic EUreka Evaluation Process 1. Submit Your Idea Through www.MedtronicEUreka.com Immediate email confirmation 2. Your idea is shared with the appropriate therapy area evaluation team If more info is needed, they’ll contact you 3. We’ll let you know our decision on your idea as soon as we can You’ll hear from us within 3 months 4. If your idea is a “Fit” with MDT we’ll start to work with you on the next steps to develop your idea into reality If not, we can also share your idea with MD Start…
47. How EUreka’s success is measured # pages views # submissions # ideas transfered to MD Start # EUreka sourced ideas pursued by MDT In the past quarter: Nearly 60,000 60 18 More that 25,000 website visits 2 since EUreka launch More that 25,000 website visits
49. It takes more than “just” product innovation to bring solutions to the Health Care Systems
50.
51.
52. We leverage therapy expertise, process improvement techniques and collaboration with best practice networks to optimize care pathways Implement, pilot and institutionalize new process Identify opportunities and design blue print Heart failure therapy management Neuro stimulation enabled pain management Syncope diagnostic and management Aortic aneurysm treatment management … Diagnose current state and baseline performance Readiness
53.
54. Current care pathways are often ineffective and inefficient, as illustrated by the “PICTURE” registry Patients see in average 3 different specialists for their syncope mgt 13 tests performed per patient in the total study population (median #) … and still one third of patients remain undiagnosed Total recruitment 570 (100%) Standard ECG 556 (98%) Echocardiography 490 (86%) Basic laboratory tests 488 (86%) Ambulatory ECG monitoring 382 (67%) In-hospital ECG monitoring 311 (55%) Exercise testing 297 (52%) Orthostatic blood pressure 275 (48%) MRI / CT scan 267 (47%) Neuro. or psy. evaluation 270 (47%) EEG 222 (39%) Carotid sinus massage 205 (36%) Tilt test 201 (35%) Electrophysiology testing 144 (25%) Coronary angiography 133 (23%) External loop recording 67 (12%) ATP test 15 (3%) Other tests 52 (9%) No tests performed 1 (0%)
55. Handicraft culture vs. Industrial culture Ownership Individual Company Product development Integrated Separated Knowledge transfer Personal Explicit Collaboration Interdisciplinary Cross disciplinary Decision Individual Evidence based Value Procedure Product Treatment Tailor-made Standardized Handicraft Industry
56.
57.
58.
Editor's Notes
Medical Devices account for >5% of total healthcare spending in all the countries analyzed In contrast, operational expenses comprise a much higher proportion of overall costs, often over 80% of total spending
One increasingly important group of “customers” are HTA agencies that are demanding to see evidence of the clinical and economic value that our products bring, as a condition for recommending they be used in their respective health care system. HTA agencies have been proliferating in Europe and elsewhere around the world for over 10 years. We have a team of professionals who build working relationships with established and emerging HTA agencies, engage with them when they review our products, and influence HTA policy to ensure it is appropriately tailored to medical devices (as opposed to pharmaceuticals).
Like the NHS, Medtronic is celebrating its 60 th year
Innovation
Insatiable demand for an inelastic good that appears to be “free” Health care costs expected to compound at 7-8%
MD Start’s mission is to accelerate the development of revolutionary medical devices. MD Start provides inventors with a way to develop their ideas without having to abandon their patient or their research.
After you submit to our portal you will receive a confirmation email. Your submission will be shared with the appropriate therapy area leaders across Medtronic. If more information is needed to proceed with your idea, we will contact you using the contact details you provide on the submission form. We will review submissions as they come in and will get back to you as soon as we can, but at the latest we will inform you of our decision within 3 months. If we are interested in pursuing the development of your idea, you will receive a notification and you will be contacted directly by the appropriate therapy leaders within Medtronic. If, after review, your idea cannot be pursued by Medtronic at this time, you will also be notified. It is up to you if you want MDT to share your idea with MD Start, you can always say no thanks
Syncope is technically defined as a transcient, self limited loss of consciousness, usually leading to collapse. The onset is relative rapid and the recovery usually prompt. The underlying mechanism is transient global cerebral hypoperfusion. In simple language, syncope is a sudden blackout / T-Loc which is normally brief, does no permanent damage and which arises from a temporary reduction in the blood supply of the brain. Three main causes for blackouts: cardiovascular (insufficient blood reaches the brain), Neurological (ex. Diseases such as epilepsy), psychogenic (resulting from psychological disorder) Syncope can result from many cardiovascular causes: -cardiac causes - Structural heart diseases - Heart rhythm problems - Vascular causes - Reflex causes - Situational causes (coughing, straining, dehydration, …) - Postural causes (standing up too quickly)
The first specialist consulted for syncope in almost 23% of patients was an emergency medicine consultant. Cardiologists were the first specialists consulted in 43% of cases and neurologists in 11%. The last specialist consulted before the referral for implant of the ILR was a cardiologist in 72% of cases, with no other specialties represented in more than 10% of cases. Cardiologists were the most frequently consulted specialists, with general practitioners second-most consulted physicians overall. Forty-seven per cent of the study population had consulted a neurologist at some point. Overall, patients had seen an average of three different specialists for management of their syncope. The median number of tests performed per patient in the total study population was 13. The tests performed most frequently were echocardiography, ECG, ambulatory ECG monitoring, in-hospital ECG monitoring, exercise testing, and orthostatic blood pressure measurements. About half the patient population had undergone an MRI/CT scan (47%), neurological or psychiatric evaluation (47%), or electroencephalography (EEG; 39%). In contrast, carotid sinus massage or tilt tests were only undertaken in one-third of subjects. The ILR was implanted during the initial phase of the diagnostic work-up (up to four diagnostic tests) in 128 patients (22%). In PICTURE, the EEG rates are most likely explained by the high percentage of referrals to neurologists. The clinical picture of syncope frequently includes neurological symptoms and is often mistaken for epilepsy, which probably explains why neurologists are frequently consulted. Conversely, epilepsy may be mistaken as syncope, but in such patients a Reveal may be a faster way to arrive at the correct diagnosis, if a Reveal recording can be obtained during a typical episode.Furthermore, almost half the patient population had undergone an MRI / CT scan, neurological or psychiatric evaluation. There were, however, simple diagnostic tests that could have been used more widely and would have been included in the initial phase of evaluation, e.g. carotid sinus pressure and orthostatic blood pressure measurements.
![[object Object],[object Object],[object Object],[object Object],[object Object],Agenda](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)