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Quebec’s New Government:The Doctor is In

What is CADTH and What do they do?

Ontario Medical Technology Working Group Presents Report to OHIC

MEDEC.ORG

PULSESPRING/SUMMER 2014

Canada’s Innovative Medical Technology Industry Newsletter

#PM40787580

Health Minister Fred Horne is committed to bringing innovation to the province’s health care system - pg. 4

MedTech in Alberta

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PULSE

03 President’s Message

04 Adoption of Innovation in Alberta: Evolving in Real Time

06 Ontario Medical Technology Working Group Presents Report to the Ontario Health Innovation Council

07 Quebec’s New Government: The Doctor is In

09 Nouveau gouvernement du Québec : Un médecin aux commandes

11 Recent Highlights

12 Patent News

13 Top Ten Mistakes That Organizations Make

15 Report on the 5th Meeting of the IMDRF Management Committee and Open Forum

16 About CADTH: What is CADTH and

what do they do?

17 New Member Welcome

MEDEC.ORG

Contents

All rights reserved. The contents of this publication may

not be reproduced by any means, in whole or in part,

without the prior written consent of the association.

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PRESIDENT’S MESSAGE

As you can see from the cover of this issue of Pulse, we’re excited about the opportunities for improving the adoption of innovation through Alberta’s Strategic Clinical Networks, or SCNs.

We were honoured to have Alberta’s Health Minister join us at this year’s annual MedTech Conference where Minister Horne laid out some of his plans for the province’s health care system, but most importantly - outlined how he believed that the SCNs could be real gateways for the adoption of medical technologies and even offer opportunities to alter the way in which

procurement of innovative technologies takes place.

We’re very pleased that Minister Horne has recognized the value that our industry can bring to the health care system and we’re pleased to be a partner with his government.

That said, we’re also working with governments across the country to improve the procurement and adoption processes and I’m confident that our messages are getting traction.

For example - this issue also contains a story about the Medical Technology

Working Group presenting a report to the Ontario Health Innovation Council (OHIC). Through our relationships with government and our member representation on OHIC, I’m confident that the working group’s report will contribute to OHIC’s recommendations to the province in the fall.

I hope you enjoy this issue and have a fantastic summer.

Brian

Brian LewisPresident

Improving the Pathways for Innovation

3 MEDEC PULSE |

Brian Lewis President & CEO

Klaus Stitz Vice President, Regulatory Affairs

Nicole DeKort Vice President, Government Affairs, Ontario and Federal

Benoit Larose Vice President, Quebec

Iris Crawford Vice President, Finance & Operations

Debbie Gates Executive Assistant to the President & CEO

Natasha Alves Administrative Coordinator

Robert (Bob) Rauscher Vice President, Western Canada

Gerry Frenette Executive Director, Public and Member Relations

405 The West Mall, Suite 900 Toronto, Ontario M9C 5J1

416.620.1915 1.866.58.MEDEC

www.medec.org

MEDEC Staff

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The rapid adoption of innovative medical technology in Canada has been a focus of MEDEC’s

efforts over the last several years. Through our relationships with government and health system stakeholders, we have been encouraged by newly emerging initiatives that are shifting the conversation away from the cost of innovative medical technologies, to that of the value of innovative medical technologies to patients, the health care system and to the local economies that that are being enhanced by the industry. This article will focus on Alberta, with the purpose of providing an update on the province’s current health system redesign as it relates to the adoption of innovative medical technologies, and specifically on the emergence of Alberta’s Strategic Clinical Networks (SCNs) as the channels through which the increased adoption can occur.

In 2012, the Alberta government announced the concept of the “Living

Lab”, which in part aims to position the province as an environment “that facilitates the development and commercialization of technology, and industry partnerships with the health system.” The concept of the Living Lab was further solidified in January 2014 during a meeting facilitated by MEDEC, where the Alberta Government, as represented by the then Deputy Premier (and now Premier) Dave Hancock and Health Minister Fred Horne, indicated their intent to further develop a robust medical technology sector in Alberta, noting that they are well positioned to partner with industry through the Living Lab.

In order to fulfil its Living Lab concept, the province created the SCNs, which have been described by Alberta Innovates Health Solutions (AIHS) as “the engines for change in the health system. Teams composed of researchers, physicians, patients and managers working in specific areas of health

with the goal of finding new and innovative ways of delivering care that will provide better quality, better outcomes and better value for every Albertan.”

AIHS, which is the province’s health research and innovation agency tasked with playing a lead role in operationalizing the Living Lab concept, further says that the SCNs are “planning ahead and mapping out what patients need. That means when the time comes that you need care, there’s already a clear pathway for you to get the best care possible.”

The currently operating SCNs include: Addiction and Mental Health, Bone and Joint Health, Cancer, Cardiovascular Health and Stroke, Critical Care, Emergency, Obesity, Diabetes and Nutrition, Respiratory; Seniors’ Health; Surgery. Each of these SCNs has very specific goals and objectives, which can be accessed through http://www.albertahealthservices.ca/scn.asp.

COVER

SCNs are reshaping health care by:

1. Focusing on what patients need

2. Supporting local examples of good care, and then sharing them across the province

3. Using scientific evidence to guide care decisions

There are four main goals:

1. Improve patient experience

2. Arm Albertans with the skills and tools to stay healthy

3. Provide the best health care for genera tions to come

4. Ensure value from every health care dollar spent

Adoption of Innovation in AlbertaEvolving in Real TimeBy Bob Rauscher, VP Western Canada, MEDEC

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At the MEDEC MedTech conference in the spring, we were very pleased to host Minister Horne and he spoke of the possibilities for SNCs to become the primary gateways for innovative medical technologies to enter into the healthcare system. It is envisioned that this single gate of access linking needs coming out of the SCNs to innovative medical technology solutions will further link all stakeholders involved in research & development, health technology assessment, health policy & reimbursement and innovative procurement as facilitated through the SCNs.

We are excited about the possibilities that are being presented through the SNCs and we truly welcome the government’s acknowledgement about the important role that our industry can play in achieving their health system goals. MEDEC will continue to collaborate with all of the involved stakeholders in Alberta, including AIHS, to contribute to the formation of a framework through the SNCs leading to what we hope is a transparent, robust, competitive and well aligned system that facilitates rapid uptake of innovated medical technologies to address the needs of patients.

The Living Lab concept in Alberta in part aims to position the province as an environement “that facilitates the

development and commercialization of technology and industry partnerships with the health system”

– Institute of Health Economics

Source: Cy Frank, Alberta Innovates, Health Solutions

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One of MEDEC’s strategic pillars - Serving as a Thought Leader, directs our association to collaborate with government and other health partners on strategies to support the transformation of the medical technology

industry and the health care system. In Ontario, we work to fulfill this strategic imperative through a number of channels, with one very important avenue being the Ontario Medical Technology

Working Group.

The Ontario government established the Medical Technology Working Group in the spring of 2013 to provide ongoing policy ad-vice to government and develop/propose strategic directions and initiatives relating to our industry.

Following the establishment of the Working Group, a few months later – in November 2013 – the Ontario government launched the Ontario Health Innovation Council. This 15 person council (which includes industry representatives as well) was created to accelerate the adoption of new technologies in our health care system and support the growth and competitiveness of Ontario’s health technology sector. Knowing that the OHIC was going to be established, the MTWG decided to focus its efforts on preparing a report, including recommendations, which could be presented to the OHIC and used for consideration as the OHIC develops its plan to give to the Ontario government.

The Ontario Medical Technology Working Group consists of a number of representatives from industry, government and academia, and MEDEC is well-represented by a number of member companies, as well as MEDEC President and CEO Brian Lewis and VP Government Affairs, Nicole Dekort. The goals of the working group are to:

1. Create a strong medical technology business environment in Ontario to ensure its continued growth and advance prosperity in Canada;

2. Position Ontario as a global leader in life sciences and a destination of choice for medical technology investment and development; and

3. Maximize the industry’s contribution to high quality and sustainable healthcare.The Medical Technology Working Group sought to better understand the challenges and barriers to achieving those goals and asked its industry members to examine these issues and inform the membership of its findings in the form of a brief report. The group

presented the report this spring to the OHIC; here is a summary of its recommendations:

Improving Communication FlowImproving Communication Flow - Industry and the healthcare system could both benefit from improved dialogue and information exchange. This theme emerged in many of the groups’ discussions, across nearly all issues related to the medical technology industry.

To improve upon this, the group recommended that the government should identify an entity within Ministry of Health and Long-Term Care to establish a health innovation office/officer and also consider mechanisms for technology solution seekers and solution creators that would enable flow of information amongst health system partners.

Adoption Pathways and Alignment of Research and Development (R&D) Investments with Health System PrioritiesPaths to the adoption of innovative technology into the health care system can be complex at times. There is also a need to improve the alignment between the R&D investment into new medical technology and the governments’ health system policies and priorities.

Procurement of Innovative Medical TechnologiesProcurement objectives related to innovative technologies could be made clearer for the industry, and strategic objectives in procurement could be better aligned to consider the value of technology across the entire health care system.

Some key themes from the report’s recommendations on improving procurement include the need to make it a more collaborative and transparent process – engaging with industry to seek solutions through pre-RFP dialogues, establishing procurement mechanisms to acknowledge the value of medical technologies and reducing the complexity of procurement processes.

While the report is complete, we believe that the Ontario Medical Technology Working Group is an opportunity for industry to continue to work together with government to develop strategies that can both improve patient outcomes and contribute to health system sustainability through innovative medical technologies. Thank you to all of the MEDEC members who contribute to this Group and we would encourage you to read the full report here: http://www.medec.org/webfm_send/2395

For more information on the Ontario Health Innovation Council visit: (OHIC) please visit ohic.ca

SERVING AS A THOUGHT LEADER

Ontario Medical Technology Working Group Presents Report to the Ontario Health Innovation Council

Ontario Medical Technology Working Group Presents Report to the Ontario Health Innovation Council

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Amedical degree at age 22. Completion of his neurosurgery specialization at 28. Chief surgeon of Montreal’s St. Luc Hospital by 32, followed by other senior roles with major hospitals. And then a high-

profile entry into Quebec politics as a star candidate, where he was quickly appointed as Quebec Minister of Health and Social Services.

Now 56, Dr. Philippe Couillard’s various career accomplishments are, by any measure, impressive. He now takes on perhaps his greatest challenge to date: the newly minted 31st Premier of Quebec.

On April 7, 2014 - a mere 19 months after being ousted from power - the Quebec Liberal Party secured a majority government provincial government in Quebec.

One could argue that for Dr. Couillard this was, relatively speaking, the easy part. The hard tasks of governing and implementing tough choices now face the new Premier.

To this end, Dr. Couillard has been blunt about what lies ahead for the province given the province’s deficit situation and plan for belt-tightening: “We’ve been overspending for a long time,” he recently said, noting it was now “time for difficult decisions.”

But what choices and direction will he take? And will a known health innovation champion and practitioner be able to incite the changes required to improve health outcomes for Quebecers?

Questions around sovereignty again took centre stage during the election, which he faced head on. Somewhat lost in the election coverage, however, was Dr. Couillard’s persistent health narrative, specifically the bold ideas he continually pushed on the campaign trail. These provide a glimpse of what residents, stakeholders, and industry leaders alike can expect:

• Revising the method of funding establishments in the health and social services network

• Improving access to healthcare by modernizing hospital facilities

• Creation of 50 “super clinics” across Quebec, which will reportedly be designed to be “agents of health” that will be open 24/7

Health Technology Assessment – Part of a Required System for Emerging Technologies

HTA

• Revamping the financing of health care institutions to boost the volume of critical services, such as laboratory testing, radiological procedures and inpatient care within the first year of mandate

• Overhauling hospital funding which will be based on each institution’s volume of care and productivity

• And a commitment to allow Quebecers to visit clinics with their health card for tests in medical imaging and a promise to providing access to enhanced MRIs, CT-scans and ultrasounds

These are not half measures. More accurately, these promises, taken together, could be considered an overhaul.

Moving forward, there is also renewed optimism regarding Quebec’s role in the federation and how the province may engage the Harper Government on health issues.

Dr. Couillard is an ardent federalist: “We are Quebecers first but we are also proud to belong to the Canadian federation.” This recent quote mirrors his previous hands-on involvement in the 2004 $41B Health Accord negotiations as Quebec Minister of Health and Social Services with then Premier Jean Charest.

As for Prime Minister Harper, early indications are that he wants to forge good working relations with the new Premier and new Quebec government, something that he chose not to do with previous PQ Premier Marois. With a looming federal election, the Prime Minister will be building into his re-election calculus the new realities of Quebec government. With a pro-federalist government now in power, and the thorny sovereignty question sidelined indefinitely, there is certain to be more bi-lateral opportunities to serve both governments’ interests leading up to the next federal election.

It is therefore perhaps not a stretch to assume that the Quebec and federal governments may take a refreshed approach to targeted engagement regarding, for example, the federal government’s health innovation push.

His recent cabinet choices also seemingly tell a story regarding the road ahead: he will be joined by two other medical doctors at the cabinet table two critical Ministerial roles: Health and

By Bob Rauscher

Quebec’s New Goverment: The Doctor is In

Photo par Paul VanDerWerfCC BY 2.0

By Gordon Taylor Lee

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Education. The two portfolios combine for almost 75% of the provincial budget. Having three MDs at the nexus of decision-making

ensures that the government will have deep experience upon which to draw when making healthcare budgetary approaches within

the context of an overall austerity approach.

Premier Couillard’s first major test was the government’s first budget. Presented on June 4, the budget included a $3.1 billion

deficit in addition to $198 billion in total provincial debt. The Liberal government’s “tough love” plan outlines several measures to

cut spending across the board in the hopes of balancing the province’s finances by 2015-2016. While the budget included $2.3 billion

in health and social services – one of only a handful of investments - what is clear is that the government is scrutinizing every dollar

in attempt to return to the black.

As the austerity budget highlighted, fulfilling election promises will not be easy. Even the academics commissioned by the new

administration to look into Quebec’s financial situation have said balancing the provincial budget next year will be “more difficult

than anticipated.” This will likely mean even tougher political choices down the road.

But Dr. Couillard has already started to tackle the challenges he has inherited. And he will undoubtedly bring the precision of a

surgeon in addressing the difficult healthcare and fiscal decisions that lie ahead.

Gordon Taylor Lee is a Senior Vice President with FleishmanHillard and a member of MEDEC’s Federal Affairs Committee.

It is therefore perhaps not a stretch to assume that the Quebec and federal governments may take a refreshed

look to targeted engagement regarding, for example, the federal government’s health innovation push.

managed through a single gate.

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Reçu médecin à 22 ans, il termine sa spécialité en neurochirurgie à 28 ans. À 32 ans, il est chirurgien-chef au Service de neurochirurgie de l’Hôpital Saint-Luc de Montréal, puis il accède à divers autres postes

supérieurs dans de grandes institutions. Il fait ensuite une entrée remarquée sur la scène politique québécoise en tant que candidat vedette, et il est rapidement nommé ministre de la Santé et des Services sociaux de la province.

Maintenant âgé de 56 ans, Dr Philippe Couillard a tout lieu d’être fier de ses nombreuses réalisations professionnelles, tout simplement impressionnantes. Il s’attaque actuellement à un défi de taille, probablement le plus important de sa carrière, à titre de 31e premier ministre du Québec, nouvellement élu.

Le 7 avril 2014 – à peine 19 mois après avoir été délogé du pouvoir —, le Parti libéral du Québec réussit à se faire réélire et forme un gouvernement majoritaire.

Certains prétendent que cet exploit constitue en somme la tâche la plus facile du Dr Couillard. Le plus ardu reste à venir : le nouveau premier ministre doit désormais gouverner et faire des choix difficiles.

Dr Couillard a été franc. Il a dit ouvertement ce qui attendait la province étant donné sa situation déficitaire et il a ajouté que le temps était venu de se serrer la ceinture : « Nous avons fait des dépenses excessives pendant longtemps, a-t-il indiqué récemment, précisant qu’il fallait maintenant prendre des décisions difficiles. »

Mais quels seront ses choix et quelle direction prendra-t-il ? En tant que praticien reconnu comme un champion pour ses innovations en santé parviendra-t-il à provoquer les changements nécessaires pour améliorer les résultats pour la santé des Québécois ?

Une chose est certaine : Dr Couillard ne reculera pas devant le défi. Il a su aborder de plein fouet les questions sur la souveraineté qui ont de nouveau été au cœur de la campagne électorale. Toutefois, la couverture des élections a négligé les propos persistants du Dr Couillard en matière de santé, particulièrement les idées audacieuses qu’il a sans cesse mises de l’avant durant la campagne. Voici donc en bref ce à quoi peuvent s’attendre les résidents, les parties prenantes et les

Health Technology Assessment – Part of a Required System for Emerging Technologies

HTA

dirigeants de l’industrie :

• Révision du mode de financement des établissements du réseau de la santé et des services sociaux

• Amélioration de l’accès aux soins de santé grâce à la modernisation des installations hospitalières

• Création de 50 « super cliniques » dans l’ensemble du Québec, qui devraient être de véritables carrefours de la santé ouverts 24 h sur 24, 7 jours par semaine

• Modification du financement des établissements de soins de santé de manière à augmenter le volume des services indispensables dans différents secteurs tels que les laboratoires, la radiologie et l’hospitalisation, au cours de la première année du mandat

• Réforme du financement des hôpitaux qui sera basée sur le volume des soins donnés par l’établissement de même que sur la productivité

• Engagement à permettre aux Québécois de se présenter dans des cliniques avec leur carte santé pour des examens en imagerie médicale et promesse d’un accès rehaussé à la résonance magnétique, à la tomographie par ordinateur et à l’échographie

Il n’y a pas de demi-mesures. Plus précisément, ces promesses, considérées dans leur ensemble, pourraient être vues comme une révision complète.

Par ailleurs, renaît un certain optimisme quant au rôle du Québec dans la fédération et à la manière dont la province pourrait engager le gouvernement Harper dans des enjeux de santé.

Dr Couillard est un fédéraliste convaincu : « Nous sommes d’abord Québécois, mais fiers de faire partie de la fédération canadienne. » Cette récente déclaration reflète bien sa participation active dans les négociations de l’Accord de 2004 sur la santé de 41 G$ en tant que ministre de la Santé et des Services sociaux du Québec dans le cabinet du premier ministre de l’époque, M. Jean Charest.

Et tout semble indiquer que le premier ministre Harper veut

By Bob Rauscher

Nouveau gouvernement du Québec:

Un médecin aux commandes

Photo par Paul VanDerWerfCC BY 2.0

Par Gordon Taylor Lee

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établir de bonnes relations avec le nouveau premier ministre et le gouvernement du Québec, alors qu’il avait préféré s’en abstenir avec la précédente première ministre, Mme Marois, du PQ. Avec l’imminence des élections fédérales, le premier ministre prendra en compte dans sa tactique pour se faire réélire les nouvelles réalités du gouvernement du Québec. Maintenant qu’un gouvernement profédéraliste est en place et que la question épineuse de la souveraineté est écartée pour un certain temps, il y a assurément plus d’occasions bilatérales de servir les intérêts des deux gouvernements d’ici la prochaine élection fédérale.

Il n’est peut-être donc pas exagéré de supposer que les gouvernements du Québec et du Canada prendront une nouvelle approche à l’égard de l’engagement visé au sujet, par exemple, de la position du gouvernement fédéral relativement à l’innovation en santé.

La composition du cabinet du Dr Couillard semble aussi assez éloquente. Deux autres médecins se sont vu confier des ministères d’importance, soit la Santé et l’Éducation. Ces deux portefeuilles représentent près de 75 % du budget provincial. Comme trois médecins occupent des postes décisionnels stratégiques, le gouvernement jouit d’une vaste expérience dans laquelle puiser pour déterminer les approches à favoriser pour le budget en soins de santé dans un contexte d’austérité global.

Le premier budget du gouvernement a constitué la première grande épreuve du premier ministre Couillard. Présenté le 4 juin, le budget comportait un déficit de 3,1 milliards qui s’ajoutait à la dette totale de la province qui atteint 198 milliards. Le plan de fermeté du gouvernement libéral décrit plusieurs mesures visant à réduire les dépenses dans leur ensemble dans l’espoir d’équilibrer les finances de la province d’ici 2015-2016. Alors que le budget comprenait 2,3 milliards en santé et services sociaux – un des rares investissements –, il est manifeste que le gouvernement examine chaque dollar dans le but de revenir à l’équilibre budgétaire.

Comme le budget d’austérité le mettait en évidence, il ne sera pas facile de remplir ses promesses électorales. Même les experts mandatés par la nouvelle administration pour examiner la situation financière du Québec ont dit qu’il « serait plus difficile que prévu » d’équilibrer le budget de la province l’an prochain. C’est donc dire que des choix politiques encore plus rigoureux sont probablement à venir.

Mais Dr Couillard a déjà commencé à s’attaquer aux défis dont il a hérité. Il fera sûrement preuve de la précision proverbiale d’un

chirurgien pour faire face aux décisions délicates à prendre en matière de soins de santé et de fiscalité.

Gordon Taylor Lee est vice-président principal chez FleishmanHillard et membre du Comité des Affaires fédérales de MEDEC.

Il n’est peut-être donc pas exagéré de supposer que les gouvernements du Québec et du Canada prendront une nouvelle approche à l’égard de l’engagement visé

au sujet, par exemple, de la position du gouvernement fédéral relativement à l’innovation en santé.

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Recent Highlights2014 MEDEC MedTech Conference

This past spring, we once again held our annual MedTech Conference. Thanks to all of the presenters and attendees for making this year’s conference a real success.

We were pleased to host a number of our partners including government officials like Alberta’s Health Minister, Fred Horne, Ontario’s Minister of Research and Innovation, Reza Moridi and Cindy Evans from Health Canada and Hospital/Innovation leaders like Dr. Dave Williams.

During the two day event, numerous industry issues were tackled such as vendor credentialing, Unique Device Identifiers (UDI) for Medical Devices, pro-curement and the ever-popular regulatory affairs sessions.

Stay tuned for the soon to be announced dates of the 2015 MedTech Conference, as well as our ongoing MEDEC Speakers Series events.

L to R: Neil Fraser, Medtronic of Canada, Reza Moridi, Ontario Minister of Research and Innovation and Timothy Squire of Fasken Martineau follow-ing the Minister’s remarks at the 2014 MedTech Conference

Minister of International Trade Visits Baylis

Following the recent announcement of the Harper government’s free trade agreement with the Repub-lic of Korea, Minister of International Trade, Ed Fast, along with Mississauga MPs Wladyslaw Lizon and Burlington MP Mike Wallace visited MEDEC member, Baylis Medical in Mississauaga to highlight the bene-fits of the agreement to Canadian businesses.

It was also a great opportunity for the team at Bay-lis to highlight some of their successes and provide suggestions to the government about how the envi-ronment could be improved for their business.

L to R: Kris Shah of Baylis Medical, Ed Fast, Minister of Internation-al Trade and Mike Wallace, MP tour the facilites at Baylis Medical in Mississauaga

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The procurement landscape in Canada is evolving constantly entand Quebec is no exception. MEDEC is investing a lot of energy to remain involved in all aspects of procurement issues in the province. Here are the highlights of MEDEC’s priorities in this critical industry challenge.

Patent NewsRightly, companies rely increasingly on innovation to ensure their success on a global scale. To remain competitive in both domestic and interna-tional markets, it is essential for companies to be aware of the new technologies, particularly those protected by third party patents. The following table is intended to present recent examples of granted patents or published patent applications in a particular field related to medical devices.

RECENT ISSUED PATENTS OR PUBLISHED PATENT APPLICATIONS IN REMOTE HOME CARE MONITORING SYSTEMS

PATENT NUM-BER

DESCRIPTION ASSIGNEE(S) INVENTOR(S) PRIORITY APPLICATION DATE

PUBLICATION DATE

US 8725291 A remote monitoring of the daily dispensing of prescription drugs by at-home care, an elderly or clinical trial patient is proposed. The system consists of a dispensing unit equipped with weight a scale or balance which communicates with the monitoring application residing in the wireless terminal, such as cellular phone over the Personal Area Network (PAN) wireless interfaces such as Bluetooth. The monitoring application provides supervision over the medication dispensing process as well as communication with unauthorized medical supervisor using wireless Wide Area Network (WAN) con-nection to the Internet.

IPComm Afsar M.,

Cheon B.,

Czaja S.,

Marqusee C.,

Stawski I.,

Welch W.,

Yi B.

13/09/2010 13/05/2014

US 8723684 A bio-information monitoring system which comprises a wireless sensor of bio-information and a first wireless network node. The first wireless network node collects the bio-information and the bio-in-formation is monitored in response to a command from a second wireless network node to the first wireless network node.

National Tai-wan University

Chang W. D.,

Jiang J. A.,

Lin T. T.,

Wu Y. C.

13/10/2009 13/05/2014

By Serge Lapointe

Serge Lapointe is a Partner and Patent Agent at Fasken Martineau’s Montreal office. Please feel free to contact Serge for obtaining copies of any of these documents or should you have any questions on this particular topic or on intellectual property in general. He can be reached at slapointe@fasken.com

TW M424912 The present invention provides a bladder urine volume monitoring alert system, including a bladder urine volume detection device and a remote monitoring device.

Nan Kai University Of Technology

Chen J.H.,

Chi W.M.,

Lin C.S.

22/09/2011 13/05/2014

CN 103607477 The invention relates to a home-based care operating system based on an IPTV (Internet protocol television) set-top box established by using the internet. The system can realize medical data monitoring, analysis, health status monitoring and early warning and the like.

Guangxi Kin-gon Software Co

Chen Z.,

Li Z.,

Lin J.,

Luo S.,

Pan G., Xiao X.

12/12/2013 26/02/2014

WO 2013109517 A remote monitoring system for monitoring a plurality of medical devices at a patient care or home care facility. The system includes a device integration server in communication with wireless relay modules for receiving data packets from the medical devices. The system also includes a data management system and an outbound web server. The data management system is configured to log data for the medical devices. The web server is configured to provide webpages including the data of the medical devices for display on a remote monitoring computer, subject to authentication of an associ-ated data request from the monitoring computer.

Tyco Health-care Group Lp

Wiesner J.,

Harrington S. B.,

Gaines R. B.,

Bankert S.,

01/10/2011 25/07/2013

US 8380542 A home health point-of-care and administration system and method that has at least one mobile device is provided. A global positioning system (GPS) application operating may be employed in conjunc-tion with the communication device to monitor the actions of visiting staff member. Such information is provided in individual visit records transmitted to a remote server system.

CellTrack Tech-nologies Inc.

Wons M. K.,

Wegner S. A.

Kaboff A. W

24/10/2005 19/02/2013

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For many, the thought of trying to navigate the maze of government is daunting. Many organizations try to engage the government without understanding the

legislative process or how officials and the government make decisions. Even sophisticated, well-oiled organizations sometimes stumble along the way.

This is a look at the top 10 mistakes we see organizations make on a regular basis.

1. No Engagement

This is very common. Organizations in this instance do not regularly engage government. They know they should be engaging the government but are often so distracted with other day-to-day work that this task just sits on the “to-do-list” - that is until something goes terribly wrong. Some organizations trust government to run efficiently and always act in their best interests. The truth is that government acts upon the information it has available, if you do not engage, you lose agency.

2. No Long-Term Plan

Not creating a long-term engagement plan with clearly defined reasonable targets is actually one of the biggest problems organizations confront. Many will draft a short, medium and long-term strategic plan but there is often very little government engagement or is the thinnest part of the plan. It’s called “government relations” for a reason. We all have those friends who only call when they need something. You don’t like it and neither does the government. You need to develop long-term meaningful relationships with the right people so that you may employ and deploy these relationships if the need arises. They are also a great help in gathering useful intelligence. We always counsel clients that a low intensity engagement over the long run will always serve you better. It’s more cost effective and will let you sleep better at night.

3. Wrong Spokesperson and Champions

Organizations need to choose a spokesperson wisely. They must be able to articulate the message well and portray the image you want to leave. When you engage the government it needs to be often and over a long period of time to be the most effective. If you keep changing the spokesperson you risk having to start the relationship all over again.

“Champions” are the government officials that are supportive of your cause and are willing to put some effort into helping you. Often this is very helpful and is in fact what you are trying to find and conscript as you engage. The mistake occurs when the group depends on the

Top Ten Government Relations Mistakes Organizations Make

wrong champions or one where their influence is waning. Mistakes such as the champion is not respected in his or her own caucus or they are not from the governing party are the most common.

4. Poor Timing

The worst error here is getting engaged when the fight is already done. The key is the earlier you get engaged the better. It’s the law of diminishing returns. With more time you will have access to better tools and more opportunity to implement your engagement plan. And it costs less. Typically when the government seemingly blindsides (although not necessarily intentionally) an organization (usually because they haven’t been engaging) with an initiative that negatively affects them, the following actions are taken. First an organization will try to figure out what the implications are, then call an emergency meeting and engage about the issues. By the time they agree that they need help and find and hire some government relations expertise, get a plan together, fix any underling problems, engage and train their spokespeople – they are late to the game and the fight is already over. The result is they have spent or overspent their government relations budget on this exercise so they stop engaging the government and go dark again – until the next issue.

5. Engaging Only the Political Side

Many people think that going straight to the top is the way to go. There exists a perception amongst many that getting to the Premier should be your goal. Many organizations expend great resources trying to accomplish this goal and then fall flat. The decision making structure has the Premier usually deferring to her Ministers for most issues. The Ministers heavily depend on the civil service for advice. There is a saying in government relations that “Nine times out of ten Ministers side with their officials.” Do you want a 10% or 90% chance of success?

6. Engaging Only the Bureaucratic Side

So here we have the flip side. Here is an example we see play out often. The organization has a good relationship with one civil servant - placing all its efforts and trust in a mid-level civil official with whom they often interact. When you only engage with one or a small number of civil officials whom have responsibility for your file, all too often this allows them to do their job well, which includes managing you. This diminishes your power as a stakeholder and exposes you to risk. What is surprising to know is that some civil servants may even have “a good relationship with your organization” as a personal performance measurement.

By Ron Ross

14

7. Wrong “Ask”

The “ask” is what you want the government official to do. This is where we see most organizations falter and it’s one of the most important aspects of your government relations strategy. Problems seem to develop when organizations develop their “asks” based solely on what they want instead of what government needs. This is a formula that creates an unwinnable situation even before you speak with government. Let’s look at the different types of “ask” mistakes:

• Don’t Ask for Anything - you finally get your meeting with the government then describe eloquently your organization and your issues and at the end you just get up and leave. The official is polite and smiled through the whole exercise but will not meet with you again.

• Laundry List - Often once a meeting is set, a whole laundry list of requests of government is made. It’s like asking for everything in a long-term plan in one fell swoop. This is the case of having too many priorities means having none.

• Asking for the Moon – As you can guess this is an issue of scale. If the government is facing budgetary pressures and downsizing, asking for a new initiative that will cost multi-millions may not get support.

• Just Fix It - The worst of the bunch and one that seems to aggravate government the most. This is where the organization outlines the problem and simply suggest it’s the government job to figure out how to fix it without suggesting how. This is also dangerous because the fix the government chooses might not be the one you like. An instance where the cure is worse than the malady.

8. Bad Pitch

Of course we are talking about the sales pitch here so the statements and promises that someone makes in an attempt to persuade someone else to buy something. Quite simply, it’s your message and delivery. The mistake occurs when organizations make a pitch that flies in the face of or goes in the totally opposite direction than the government is pursuing. In this instance the “ask” is easily dismissed and is not even considered. The key is to use the government message and intended goals and align it with your own. Use their words and goals to demonstrate that your “ask” is valid and worthy of consideration. The

government regularly make statements about what

is important and the direction they wish to advance

and what they want to accomplish. This is done through the Throne Speeches, public statements and even the budget.

9. Ignoring Opposition

Do not ignore opposition parties! This is why we work with all three parties. They can help or hinder your plans. A plan supported by government can easily fall off the rails if the opposition band together. An effective strategy An effective strategy is to educate all political parties on your issues, to ensure support within the entire legislature.

10. Not Celebrating Successes

Just accept the win! We have all seen announcements from different groups that pronounce, “This government announcement is a step in the right direction but the government needs to...” If you ask for A, B and C and the government gives you A - take the win. At least celebrate it on the day of the release. This frustrates government partners and diminishes your chance of future success. If you truly get what you want, make sure to explore every avenue to celebrate it. It will create such goodwill that you can tap into for future “asks”. The government will want to partner with you and seek you out.

This article is adapted from a two hour presentation. Please contact us if you are interested in having this presented to your group.

Ron Ross is Vice President of Pathway Group Inc.

The truth is that government acts on the information it has available, if you do not

engage, you lose agency and will often be at a disadvantage.

15

IMDRF-5, the fifth meeting of the Management Committee (MC) of the International Medical Device Regulators Forum (IMDRF) was chaired by the United States and was held in San Francisco from March 25-27. The MC currently consists of regulators from Australia, Brazil, Canada, China, the European Union, Japan, the Russian Federation and the United States. Representatives of the World Health Organization (WHO), Asian Harmonization Working Party (AHWP) and Asia-Pacific Economic Cooperation (APEC) also participated.

In a closed session on the first day, the MC discussed the significant progress achieved on the six on-going work items and in an open session in the afternoon the Management Committee provided Affiliate Organizations and invited observers the opportunity to give brief reports and presentations.

The second day was an open Stakeholder Forum with 150+ participants representing regulators, the medical devices industry, medical professionals, patients and the research community.

Participants were presented with:

• Updates on the regulatory situation in the eight jurisdictions of the MC members,

• Reports on IMDRF’s priority work items, and

• Information on New Work Item Proposals that were made to the MC.

The day concluded in the afternoon with three interactive workshops on the Medical Device Single Audit Program (MDSAP), Software as a Medical Device (SaMD), and WHO Global Initiatives.

On the third day in a closed session, the MC discussed feedback from the open Stakeholder Forum and workshops and made decisions regarding the current and proposed Work Items.

Progress on IMDRF Work Items / Decisions on New Work Item Proposals

Medical Device Single Audit Program (MDSAP)

The MC approved the proposed N11 document “MDSAP Assessment Outcomes and Recognition/Re-recognition Decision by Regulatory Authorities” of the MDSAP Working Group (WG) for a two-month public consultation.

The MC approved the MDSAP overview flowchart to be posted on the IMDRF website.

National Competent Authority Report (NCAR)

The MC agreed to provide the NCAR WG via teleconference recommendations for possible revision of the proposed N14 document “Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form” on NCAR exchange criteria and report form.

Recognized Standards

The MC agreed to post on the IMDRF website an updated slide presentation on the study it conducted on recognition of standards by IMDRF members.

The MC also agreed to explore possible future New Work Item Proposals regarding standards recognition.

Regulated Product Submission (RPS) / UDID

The MC agreed that the Work Item Extension on “Common Data Elements to describe a Medical Device through its Regulatory Life-Cycle” will start work immediately with a joint subcommittee of RPS and UDI regulators for initial drafting.

The MC also agreed that the Work Item Extension on UDID will focus on harmonized formats and definitions of data sets, which will be performed by this joint subcommittee as part of the Common Data Elements Work Item.

The joint subcommittee will seek input from the non-regulatory authority members of the RPS and UDI WGs before submitting a proposed document to the MC for public consultation.

Software as a Medical Device (SaMD)

The MC approved the proposed N12 document “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls” of the SaMD WG for a two-month public consultation.

Any additional SaMD Work Items will only be discussed after conclusion of the public consultation on the proposed N12 document.

The MC did not adopt New Work Item Proposals – “Processing of used medical systems” – from DITTA and “Integrating patient registries and innovative tools for medical device evaluation” – Medical Device Epidemiology Network MDEpiNet – at this meeting.

IMDRF-6 will be held in Washington, DC on September 16 – 18, 2014.

For further details visit the IMDRF website http://www.imdrf.org.

By Klaus Stintz, VP or Regulatory Affairs at MEDEC

REGULATORY AFFAIRS

Report on the 5th Meeting of the IMDRF Management Committee and Open Forum

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T he medical device landscape is changing rapidly and

Canadian health care leaders need timely access to

clinical and cost-effectiveness information that can

help them make smart decisions about the appropriate

use of health technologies.

The Canadian Agency for Drugs and Technologies in Health

(CADTH) is one organization that health care decision makers

rely on for balanced information on the optimal use of health

technologies, including medical devices. Established in 1989

and funded by Canada’s federal, provincial, and territorial

governments, CADTH is a pan-Canadian, independent, not-

for-profit agency that produces and brokers health technology

assessments (www.cadth.ca).

WHAT IS HEALTH TECHNOLOGY ASSESSMENT

HTA is an important type of research that informs policy and

practice decisions – it examines the safety, clinical and cost-

effectiveness, social, legal, and ethical implications around the

use of a health technology. A health technology can be a drug, a

medical device, a medical/surgical procedure or a diagnostic test.

CADTH has done many assessments of medical devices – both

large, comprehensive reviews that include recommendations

from an expert committee and smaller rapid reviews that answer

urgent questions in a timely manner. One example is our current

in-depth review of point-of-care (POC) technology that is used

to monitor the international normalized ratio (INR) for patients

taking warfarin or other anticoagulants. The goal of the project

is to identify clinical settings where the use of POC INR testing

could be considered and if there is a preferred POC INR testing

strategy. We recently completed a stakeholder feedback period

for this project and final recommendations will be posted on our

website in late spring.

HOW DOES CADTH DECIDE WHICH TECHNOLOGIES TO REVIEW?

We prioritize topics in two ways. One is reactive, where our

customers – staff in health ministries, hospitals or health

authorities across Canada – ask a specific question about

a technology through our Rapid Response service. We

then provide the evidence, according to their needs and

timelines.

We’re also proactive and are regularly scanning the horizon

for devices and procedures in the pipeline, so we can produce

the evidence and advice that policy makers will need in order

to plan effectively for the future. We also rely on the Liaison

Officer in each of our participating jurisdictions, who works

closely with our customers, to identify local issues and

priorities.

HOW DOES CAN YOU FIND OUT MORE ABOUT CADTH PROJECTS?

There are lots of ways to stay informed about our projects.

You can sign up for “New at CADTH” to receive a monthly

email that summarizes our newly released products,

including rapid reviews. You can also subscribe to our

E-Alert to be notified about time-sensitive news, including

feedback periods. And we’re active on social media too, with

Twitter, LinkedIn, Slideshare, and YouTube pages.

If you have questions about HTA or CADTH, please contact

the Liaison Officer in your jurisdiction or send an email to

requests@cadth.ca.

By Andrea Tiwari, Communications Officer, CADTH

About CADTH What is the Canadian Agency for Drugs and Technology in Health (CADTH) and What do They do?

17

New Member Welcome

NEW MEMBERS

Anexxa Medical Technologies Inc. is a surgically focused Canadian medical distribution

company committed to bringing “best of class” products to our clinicians and patients.

At CareFusion, we are united in our vision to improve the safety and lower the cost of healthcare for generations to come. Our 16,650 worldwide employees are passionate about healthcare and helping those that deliver it - from the hospital pharmacy to the nursing floor, the operating room to the patient bedside.

Our clinically proven product families include Pyxis® for medication and supply dispensing, Alaris® for infusion, AVEA® ventilators, Jaeger® for respiratory diagnostic instruments, AVAmax® and PleurX® for interventional procedures, V. Mueller® and Snowden-Pencer® surgical instruments, and ChloraPrep® skin antiseptic.

To make global healthcare better, we partner with our customers to help them improve medication management, lower costs in procedural areas, reduce risk of infection, advance the care of ventilated patients and turn the endless amount of data generated in healthcare into actionable information.

The Applied Research & Innovation Centre (ARIC) at Centennial is our link between industry partners and Centennial’s diverse array of faculty, staff and students. At ARIC we solve immediate industry needs, meet specific goals and find innovative solutions.

Our goal is to help SMEs develop their products or services to become and stay competitive in a challenging and rapidly changing global economy. We work in response to “market pull” and industry needs, enabling SMEs and other partners to

bring their research challenges to Centennial to develop a solution.

UBIFRANCE North America - the French Trade Commission. We assist French compa-nies to export and invest in Canada and America. Our team has both the knowledge and the experience to facilitate business to business trade relations between Four coun-tries.Our role is to:

- Provide French companies with information on business opportunities, market access and analysis- Organize trade missions for French companies looking for importers, distributors, clients and partners- Organize trade and promotional events- Help Canadian businesses to source French products and technology

Established in 1997 to help US medical device companies export to Europe, Emer-go Group has grown to become a leading consultancy with more than 2,500 medical device and IVD clients worldwide. Today, we maintain offices in 25 countries, offering a wide range of compliance and market access services. Among other things, we assist

companies with global regulatory strategy, device registration, quality management system compliance, clinical trial consulting, in-country regulatory representation and distributor qualification.

18

NEW MEMBERS

New Member WelcomeFleishmanHillard in Canada embodies the guiding principles of our firm’s founders: mutual respect, integrity, teamwork and “client comes first” customer service. We have deep experience with and knowledge of our major econom-ic sectors — natural resources and energy policy, the food and agribusiness industries, and public affairs and government relations. Our team is dedicated to the practice of international public relations and communications with a local touch. Our work sets us apart. We create strategies informed by our collective experience across all of our offices and major sectors of our industry. We bring together teams with the right expertise, regardless of geography, to generate the best results for our clients. Our people provide insights, add value and are our greatest resource.

Fresenius Kabi is a leading international health care company focusing on products for the therapy and care of critically and chronically ill patients inside and outside the hospital. We develop, produce and market pharmaceuticals and medical devices. Our product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the medical devices for administering these products. Within transfusion technolo-gies, Fresenius Kabi offers products for whole blood collection and processing as well as for transfusion medicine and cell therapies. Fresenius Kabi employs around 30,000 people worldwide.

NATIONAL Public Relations is the largest public relations consultancy in Canada with offices in Victoria, Vancouver, Calgary, Toronto, Ottawa, Montreal, Quebec City, Saint John, Halifax, St. John’s, New York and London. The Firm serves leading corporate, government and institutional clients and offers the full range of communications services, including corporate communications, investor relations, public affairs, employee engagement, public consultation and participation, marketing, technology and healthcare communications, as well as digital communications. It provides medical communications, public relations and clinical trial support services to a wide section of the leading pharmaceutical and medical devices companies internationally under the name AXON Communications. NATIONAL is a subsidiary of RES PUBLICA Consulting Group. At the international level, the Firm is affiliated with Burson-Marsteller, part of WPP Group, a world leader in marketing communications.

NRC Medical Devices supports Canadian medical device companies in their quest for new sources of productivity, competitive advantage and growth by providing customized research and technology solutions. We help our clients develop small, low cost innovative medical technologies that provide rapid, sensitive, accurate and low-cost solutions aimed at saving lives, reducing the health care burden and stimulating economic opportunities for Canada.

Tornier designs, manufactures and markets devices for joint replacement and soft tissue repair that enable surgical specialists to improve patients’ lives by restoring motion and physical vitality.

Our specialization and commitment to research, combined with a strong partnership with the world’s top orthopaedic and podiatric surgeons, inspires surgical innovation and creativity. This approach, coupled with an unrelenting focus on education and training, has produced a history of firsts including the development of pioneering implants in Europe, and the introduction of the reversed shoulder in the United States.