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

T: 416-620-1915 F: 416-620-1595
Toll-free: 1-866-58-MEDEC(63332)
E: [email protected] www.medec.org

MEDEC Code of Conduct

On Interactions with Healthcare Professionals
and Government Officials

1 The Goal Of The MEDEC Code

1.1 Canada’s Medical Technology Companies (“MEDEC”) is dedicated to advancing health-
care through innovative technologies, devices and diagnostics (“technologies”). MEDEC
believes that access to high quality, cost-effective healthcare technology is paramount to
the improvement of patient care. MEDEC represents companies that design, develop,
manufacture and market medical technologies and related services used in the treatment,
mitigation, diagnosis or prevention of a disease or abnormal physical condition.

1.2 Medical technologies are often highly dependent upon “hands on” Healthcare Profes-
sional interaction from beginning to end—unlike drugs and biologics, which act on the
human body by pharmacological, immunological or metabolic means. For example, im-
plantable medical technologies are often placed in the human body to replace or strength-
en a body part. Surgical medical technologies often serve as extensions of a physician’s
hands. In other circumstances, medical technologies are non-invasive reagents, instru-
mentation and/or software to aid in the diagnosis, monitoring and treatment decisions
made by Healthcare Professionals. Some medical technologies work synergistically with
other technologies, or are paired with other products that deploy technologies in the
safest and most effective manner. Many medical technologies require technical support
during and after deployment.

1.3 In pursuing this mission, MEDEC member companies (“Companies”) recognize that ad-
herence to ethical standards and compliance with applicable laws is critical to the Cana-
dian medical technology industry’s ability to continue its collaboration with Healthcare
Professionals. MEDEC member companies comply with applicable regulatory require-
ments, including those pertaining to the Health Canada Medical Devices Special Access
Programme.  Further to the requirements of the Regulations, member companies are pro-
hibited from promoting the sale of unlicensed devices. Where a physician has expressed
their intent to submit a Special Access application, member companies can supply the
information necessary to support the application in direct response to questions from
the physician, but may not facilitate the application beyond the provision of information
considered appropriate under the rules of the Program.

1.4 Companies encourage ethical business practices and socially responsible industry conduct
related to their interactions with Healthcare Professionals and Government Officials.

1.5 Companies also respect the obligation of Healthcare Professionals to make independent
decisions regarding Company products. MEDEC supports and respects the guidelines
and policies established by professional societies or organizations that outline the obliga-
tions of the profession, while interacting with the Canadian medical technology industry.

JUNE 2017 1
 1.6 MEDEC has revised and restated its 2005, 2010 and 2012 versions of this Code of Con-
duct. The 2015 version recognizes the changing business environment in Canada and
globally. It also recognizes that healthcare regimes are governed by different laws, policies
and practices. The 2015 MEDEC Code of Conduct represents a solid framework for the
Canadian marketplace. This Code is intended for interactions with Healthcare Profes-
sionals and Government Officials and includes, but is not limited to, those individuals or
entities that purchase, lease, recommend, use, train, arrange for the purchase or lease of,
or prescribe Companies’ medical technology products in Canada.1

All terms in this Code of Conduct are defined in the Glossary, Appendix D.

2 Scope Of The MEDEC Code

2.1 There are many forms of interactions between Companies and Healthcare Professionals
that advance medical science or improve patient care, including:

2.1.1. Advancement of Medical Technology. Developing cutting-edge medical technol-

ogy and improving existing products are collaborative processes between Companies
and Healthcare Professionals. Innovation and creativity are essential to the develop-
ment and evolution of medical technologies, often occurring outside the laborato-
ries of medical technology companies. Heart valves, orthopaedic implants, cardiac
rhythm devices, surgical tools and infusion pumps are just a few examples of the array
of complex medical technologies developed through research collaborations and con-
sulting relationships between Healthcare Professionals and Companies.

2.1.2. Safe and Effective Use of Medical Technology. The safe and effective use of
sophisticated electronic, in vitro diagnostic, surgical or other medical technology
often requires Companies to offer Healthcare Professionals appropriate instruction,
education, training, service and technical support.

2.1.3. Research and Education. Companies’ support of bona fide medical research, ed-
ucation and enhancement of professional skills serves patient safety and increases
access to new technology.

2.2 MEDEC recognizes that Companies may interact with Healthcare Professionals or Gov-
ernment Officials for many legitimate objectives other than selling, leasing, recommend-
ing, arranging for the sale or lease of, or prescribing products, and that some of these
relationships are not addressed in this Code. Any interpretation of the provisions of this
Code, as well as Companies’ interactions with Healthcare Professionals or Government
Officials not specifically addressed in this Code, should be made in light of the following
principle: Companies shall ensure ethical business practices and socially responsible in-
dustry conduct and shall not use any unlawful inducement in order to sell, lease, recom-
mend, or arrange for the sale, lease, or prescription of their products.

3 Compliance with the MEDEC Code of Conduct

The MEDEC Code of Conduct applies to all MEDEC member companies. Non-member com-
panies may use the MEDEC Code as guidance in their Company’s interaction with Healthcare
Professionals or Government Officials.

All Companies are strongly encouraged to adopt this Code and to implement an effective compli-
ance program – one which includes policies and procedures that foster compliance with the Code

The MEDEC Code of Conduct will be a “living” document, reviewed by the MEDEC Code of Conduct Committee
1

annually to ensure the Code is aligned with the business environment.

JUNE 2017 2
 with respect to their interactions with Healthcare Professionals or Government Officials related
to medical technologies. The main intent of a compliance program is to ensure that there is not
any “undue influence” on a sale or transaction with a Healthcare Professional or Government
Official.

Companies are strongly encouraged to follow the seven elements of an effective compliance pro-
gram, appropriately tailored for each Company, namely:
1. implementing written policies and procedures;
2. designating a compliance officer and compliance committee;
3. conducting effective training and education;
4. developing effective lines of communication (including an anonymous
reporting function);
5. conducting internal monitoring and auditing;
6. enforcing standards through well-publicized disciplinary guidelines; and
7. responding promptly to detected problems and undertaking corrective action.

Companies are encouraged to include an assessment of Code compliance in their internal moni-
toring and auditing process.

3.1 Certification

MEDEC will publish the names of those Companies who adopt the Code and become
“Code Certified”. To obtain certification, Companies will need to either complete train-
ing available through MEDEC or provide evidence of their own equivalent internal com-
pliance training programs. In addition, each Company will need to certify in writing that
they agree to follow the Code and have delivered Code compliance training to all of their
commercial personnel. This certification must be signed off at the executive level within
each Company and reissued on an annual basis to maintain certification.

Companies who are “Code Certified” will be allowed to use the MEDEC Code of Con-
duct logo when responding to customer procurement requests. MEDEC will encourage
Group Purchasing Organizations, hospitals and other customers generally to look for the
MEDEC certification when reviewing procurement response submissions.

3.2 Inter-Company Disputes

Any MEDEC member disputs outside the scope of sections 3 to 16 of the Code of Con-
duct, including but not limited to compliance with any legislation or directive which is not
within the jurisdiction of the Violations Review Committee, should be resolved between
the MEDEC members themselves through dialogue. The MEDEC CEO can be asked to
deal with these complaints with a view to resolving them between MEDEC members.

Companies are encouraged to report potential violations of the Code of Conduct to the
MEDEC CEO for resolution as provided in this Section 3 of the Code of conduct. Failing
that, such potential violations will be reported to the Violations Review Committee. The
primary role of the Violations Review Committee is to eliminate confusion with respect
to Code interpretation and ensure a level playing field among Companies. The Violations
Review Committee’s jurisdiction applies to complaints of violation of Section 3 to 16 of
the Code of Conduct.

4 Company-Conducted Product Training and Education

MEDEC recognizes the essential commitment that Companies make to provide Healthcare Pro-
fessionals or Government Officials with appropriate product education and training. Historically,
both industry and Healthcare Professionals or Government Officials have worked collaboratively
in providing education and training on medical technologies and therapies in order to improve
the health of patients. Companies have a responsibility to make product education and training

JUNE 2017 3
 available to Healthcare Professionals, a practice that is strongly encouraged. However, Companies
also recognize the need for Healthcare Professionals to preserve the freedom of the medical pro-
fession and maintain independence in ongoing education and assessment of Companies’ prod-
ucts and services.

4.1 When providing these programs and activities, Companies should adhere to the following:

• Companies should ensure that the primary purpose of the program is to address the
educational/training needs of the Healthcare Professionals. If meals and refreshments
are provided, they should be modest in value. Activities primarily promotional in na-
ture should not be considered as educational/training programs.

• Programs and events should be conducted in clinical, laboratory, educational, confer-

ence or other appropriate settings including the Company’s own facilities or commer-
cially available meeting facilities that are conducive to effective transmission of knowl-
edge. Where possible, programs requiring “hands-on” training in medical procedures
should be held at training facilities, medical institutions, laboratories or other appro-
priate facilities. The training staff should have the proper qualifications and expertise
to conduct such training.

• Companies may pay for reasonable travel, lodging (should an overnight stay be re-
quired), meals and refreshment costs incurred by attending Healthcare Professionals.

• Companies are not permitted to facilitate or pay for the meals, refreshments, travel,
lodging or other expenses of guests of Healthcare Professionals or for any other person
who does not have a bona fide professional interest in the information being shared at
the meeting.

5 Third-Party Educational Conferences

Bona fide independent, educational, scientific or policymaking conferences promote scientific
knowledge, medical advancement and the delivery of effective healthcare. These typically include
conferences sponsored by national, regional or specialty medical associations or societies, confer-
ences organized by accredited continuing medical education providers. All third-party education
conference decisions should be made based on objective criteria that does not take into account
the value or volume of purchases made by, or anticipated from, the recipient. Companies may
support these conferences in various ways:

5.1 Conference Sponsorships. Companies may provide conference sponsorships when

the event is primarily dedicated to promoting objective scientific and educational ac-
tivities and discourse. Such sponsorships may either be (a) provided to the conference
sponsor to reduce the overall conference costs; or, (b) provided to institutions or relevant
organizations to allow attendance by Healthcare Professionals to support professional
development, in which case the institution, organization or the conference sponsor se-
lects the attending Healthcare Professionals. Such sponsorships should be paid only to
organizations with a genuine educational purpose or function and may be used only to
reimburse the legitimate expenses for bona fide educational activities. Such sponsorships
also should be consistent with relevant guidelines established by professional societies or
organizations. The conference sponsor should be responsible for, and control the selec-
tion of, program content, faculty, educational methods and materials.

5.2 Direct Support of HCPs. Companies may not provide direct financial support to
Healthcare Professionals for professional development at third-party educational confer-
ences.

5.3 Meals and Refreshments. Companies may provide funding to the conference organiz-
er to support the conference’s meals and refreshments. Also, Companies themselves may

JUNE 2017 4
 provide meals and refreshments for all Healthcare Professional attendees, but only if it is
provided in a manner that is also consistent with the sponsor’s guidelines. Any meals and
refreshments should be modest in value.

5.4 Faculty Expenses. Companies may make grants directly to conference organizer for
reasonable honoraria, travel, lodging and modest meals for Healthcare Professionals who
are bona fide conference faculty members.

5.5 Satellite Symposiums. Companies may sponsor satellite symposiums at third party
conferences and provide presentations on subjects that are consistent with the overall
content of the conference, provided that all information presented is fair, balanced and
scientifically rigorous. Companies may determine the content of these events and be
responsible for faculty selection. Company support for such events must be disclosed in
all materials relating to the satellite event.

5.6 Advertisements and Demonstration. Companies may purchase advertisements and

lease booth space for Company displays at conferences. Any games of chance such as
sweepstakes or draws need to comply with applicable local laws and the MEDEC Code of
Conduct (see Gifts Section 8). Any benefit must not exceed the limits noted in the Gifts
Section 8.

6 Sales, Promotional and Business Meetings

It is appropriate for Companies to conduct sales, promotional and other business meetings with
Healthcare Professionals or Government Officials to discuss, for example, product features, con-
tract negotiations and sales terms, insofar as the relationship does not impede on the Healthcare
Professional’s or Government Official’s ability to maintain professional autonomy and indepen-
dence. Such meetings should occur at or close to the Healthcare Professional’s or Government
Official’s place of business. It is appropriate for Companies to pay for occasional modest meals
and refreshments for Healthcare Professional or Government Official attendees in an environ-
ment that is conducive to the exchange of information. Where plant tours or demonstrations
of non-portable equipment are necessary, it is appropriate to pay for reasonable travel costs
of attendees. However, it is not appropriate to facilitate or pay for meals, refreshments, travel,
lodging or other expenses of guests of Healthcare Professionals or Government Officials or any
other person who does not have a bona fide professional interest in the information being shared
at the meeting.

7 Arrangements with Consultants

Many Healthcare Professionals and Government Officials serve as consultants to Companies
providing valuable bona fide consulting services, including research, participation on advisory
boards, presentations at Company-sponsored training and product collaboration. It is appropri-
ate to provide Healthcare Professionals and Government Officials with reasonable compensation
for performing these services. The following factors support the existence of a bona fide consult-
ing arrangement between Companies and Healthcare Professionals or Government Officials:
• All consultancy agreements should have full transparency and HCPs should notify their em-
ployer.
• Company consulting arrangements should be written, signed by the parties and specify all
services to be provided.
• Compensation paid to consultants should be consistent with fair market value for the services
provided.
• Consulting agreements should be entered into only where a documented legitimate need and
purpose for the services is identified in advance.
• Selection of consultants should be on the basis of the consultant’s qualifications and expertise
JUNE 2017 5
 to address the identified purpose and should not be related to the volume or value of business
generated by the consultant.
• Company-sponsored meals, refreshments and meeting venues that occur in conjunction with a
consultant meeting should be modest in value and should be subordinate in time and focus to
the primary purpose of the meeting.

• Companies may pay for reasonable and actual expenses incurred by consultants in carrying out
the subject of the consulting arrangement, including reasonable and actual travel, modest meals
and lodging costs incurred by consultants attending meetings with, or on behalf of, Companies.

• When a Company contracts with a consultant for research services, there should be a written
research protocol.

• Government officials may be brought in as consultants and their employer should be notified.

8 Gifts
8.1 Except in very few well defined situations below, Companies must not provide gifts to
Healthcare Professionals or Government Officials. The only acceptable gifts that can be
provided must be occasional and relate to the Healthcare Professional’s practice, benefit
patients or serve a genuine educational function, and must not be of a personal nature.
Some examples of gifts allowed are medical textbooks or surgical and anatomical models,
and any such gifts from a company may not exceed a fair market value of $100 CDN for
any one instance.

8.2 Companies may occasionally give Healthcare Professionals or Government Officials

items of minimal value (having a fair market value of $10.00 CDN or less) as long as such
are within the permitted categories above. Some examples are pens and notepads in the
course of a business presentation or training. Gifts must not be given in the form of cash
or cash equivalents (ie., gift cards or gift certificates); must be recorded accurately; and
must be provided in connection with a normal business relationship, without the expec-
tation of reciprocity.

8.3 It is not considered appropriate to give gifts to a Healthcare Professional or Government

Official for their significant life events such as a marriage, birth or birthday. However, in
the case of a death, each Company may make its own determination as to the appropriate-
ness of sending flowers or making a donation subject to the maximum fair market value
limit of $100 CDN or less.

9 Grants and Charitable Donations

Companies may make educational and research grants and charitable donations for philanthropic
purposes. It is not appropriate for Companies to provide grants and donations for the purpose
of unlawfully inducing Healthcare Professionals or Government Officials to purchase, lease, rec-
ommend, use, or arrange for the purchase, lease or prescription of Companies’ products. It is not
allowable to provide a grant or donation directly to an individual Healthcare Professional or Gov-
ernment Official except where allowable in Section 5. All grants and donations must be provided
directly to the Requesting Organization. All grant and donation decisions should be made based
on objective criteria that does not take into account the value or volume of purchases made by,
or anticipated from, the recipient. Companies should implement appropriate measures to ensure
that such grants or donations are not employed as an unlawful inducement. In addition, grant
and donation decisions should be made without the control or influence of the sales organization
and be appropriately documented. This section does not apply to Education and Research Fund-
ing provided as a Contract Value Add. These are covered in Section 10.

9.1 Educational Grants

JUNE 2017 6
 Educational Grants in accordance with Section 5, may be provided to educational insti-
tutions, professional organizations, and public healthcare institutions in support of bona
fide continuing medical education programs, grand rounds, patient education and public
education as long as all requirements of this Section are met. The Requesting Organi-
zation is responsible for controlling content, materials, budget, and selection of faculty.
Educational Grants cannot be provided to Healthcare Professionals, medical practices or
private healthcare institutions and cannot be used for recreation or entertainment or for
programs in which the majority of content is not educational. Educational Grants can
be monetary or medical technology, however, medical technology that is intended to be
multi-use can only be provided as a loaned grant specifically for the requested program.

9.2 Research Grants

Research Grants may be provided to research institutions for purposes such as supporting
genuine independent medical research for the advancement of medical science, or the
improvement of healthcare delivery and increased patient access to healthcare technolo-
gy. Research Grants must have scientific merit, well-defined objectives and milestones as
well as reporting obligations to the donor organization to confirm appropriate grant use
as per the applicable objectives and milestones. Research grants may not be unrestricted
and may not be linked, directly or indirectly, to the purchase of medical technology from
the granting organization.

9.3 Charitable Donations

Companies may make monetary or Medical Technology donations for charitable purpos-
es such as supporting patient education, public education, or the sponsorship of events
where the proceeds are intended for charitable purposes. Donations should be made only
to organizations. Such organizations may include hospital foundations but do not in-
clude Healthcare facilities. Donations of Medical Technology intended for clinical use are
not allowable except where the donation is intended to support a humanitarian mission/
disaster relief effort organized through a charitable organization. Charitable donations
should not be made in response to a request by a Healthcare Professional or Government
Official unless the Healthcare Professional or Government Official is an officer or em-
ployee of the organization and submits a written request on behalf of the organization.

10 Request for Proposals (RFP) and Tenders

10.1 Industry will follow all applicable conduct requirements in an RFP.

10.2 It is not unlawful for healthcare facilities to request “value added” items, grants or dona-
tions from Companies in conjunction with an RFP or tender process. Therefore “value
added” requests are not unlawful inducements. However, MEDEC does not consider all
“value added” requests as procurement best practice, unless the “value add” relates to the
product and services requested in the RFP and are clearly defined (documented) within
the RFP document. More detailed information can be found in Appendix A, MEDEC
Value Add Position Paper dated May 2016.

11 Entertainment and Recreation

It is not appropriate for Companies to provide or pay for “Entertainment” for Healthcare Profes-
sionals or Government Officials regardless of whether the Healthcare Professional or Govern-
ment Official is a consultant, speaker or otherwise.

12 Meals and Travel

Modest and reasonable meals and travel may be provided to Healthcare Professionals or Govern-
ment Officials as an occasional business courtesy when part of a bona fide exchange of scientific,

JUNE 2017 7
 educational or business information. The time, duration of meals, and the venue in which they
are provided should always be subordinate to the business purpose. Modest travel expenses are
generally defined as economy class with exceptions permissible for legitimate reasons. It is not
appropriate to provide meals or travel to spouses or guests of Healthcare Professionals or Gov-
ernment Officials or for any other person without a bona fide professional interest in the event.

This similarly applies to meals and travel in the following sections: 4. Company Conducted Prod-
uct Training and Education, 5. Third-Party Educational Conferences, 6. Sales, Promotional and
Business Meetings and 7. Arrangements with Consultants.

13 Product Evaluations
Product evaluations are defined as situations where Companies leave products and services for
use for a limited time by Healthcare organizations free of charge.

In accordance with procurement policies or guidelines of the Healthcare Professional’s organi-

zation, companies may provide products to Healthcare Professionals, at no charge, as part of the
sales and customer evaluation processes.
• Product evaluation purposes in the interests of a potential customer in order to ensure that
the potential customer’s requirements are satisfied;

The following are required to be in place at the start of the evaluation period:
• The length of the loan must be known and limited to a reasonable evaluation period.
• The arrangement must be documented between the institution and the Company stating
the duration and subject of the evaluation, as well as its purpose.

Under no circumstances should a product evaluation be undertaken with the intention to unlaw-
fully influence an RFP.

14 On-Site Product Demonstrations

On-site demonstrations are situations where Healthcare organizations utilize or observe equip-
ment in their own clinical environment on a trial basis in the presence of a Company as part of the
equipment selection process. The equipment remains in the possession of the Company over the
course of the demonstration. The Company must assess if providing an on-site demonstration is
appropriate in each circumstance.

Prior to the start of the on-site demonstration, the arrangement must be documented between
the Healthcare organization and the Company which will contain the details and purpose of the
demonstration, including the duration of the demonstration, the equipment and the scope of the
on-site demonstration.

Upon the conclusion of the demonstration, the equipment should be removed by the Compa-
ny, or stored at the Healthcare organization’s location in a manner so that it cannot be utilized
without the presence of the Company. Please reference the MEDEC Medical Imaging On-Site
Product Demonstrations Guidance Document, Appendix B.

15 Site Visits
Where site visits to clinical or manufacturing sites are necessary in order to evaluate products,
Companies may fund reasonable expenses which are in line with this code and the member orga-

JUNE 2017 8
 nization’s travel policies for the visit under the following conditions:
• Whenever possible site visits should occur in Canada. Companies should fund expenses
only for attendees with a bona fide professional interest in the equipment.

Please reference the MEDEC Medical Imaging Staging an Effective Site Visit Guidance Docu-
ment, Appendix C.

16 Third Party Intermediaries

In many instances Medical Device & Technology companies engage third party intermediaries
(TPI) for the commercialization, distribution or sale of products and services to Healthcare Pro-
fessional (HCP). Such entities may fall under the description of distributors, agents, subagents,
wholesalers, brokers or independent sales agents. [See glossary for definition.]

Companies are liable for actions and activities of such third party intermediaries. Therefore, spe-
cial attention should be given to ensure that TPIs undergo a full due diligence prior to retaining
such third parties. Due diligence needs to be updated on a regular basis (at least every 3 years).
More frequent updates are necessary whenever major changes occur with the TPI such as owner-
ship changes, mergers, acquisitions, changes in executive leadership.

MEDEC emphasizes that it is the responsibility of each Company to train TPIs on the various
foreign and local anti-bribery and health care compliance policies including training on the Com-
pany’s own internal compliance program.

MEDEC provides further guidance through the “Joint Guidance for Medical Device Diagnostics
Companies on Ethical Third Party Sales and Marketing Intermediary (SMI)”. In addition, training
tools and other Due Diligence Resources are accessible through the MEDEC website.

Note: This 2017 MEDEC Code of Conduct supersedes and replaces all previous MEDEC Codes of
Conduct. Companies will communicate the princi-
ples of this Code to their employees, agents, dealers
and distributors with the expectation that they will
adhere to this Code. All Companies have an inde-
pendent obligation to ascertain that their interac-
tions with Healthcare Professionals comply with all
applicable laws and regulations. This Code of Con-
duct is intended to facilitate ethical behaviour, and
is not intended to be, nor should it be, construed as
legal advice. The Code is not intended to define or
create legal rights, standards or obligations.

JUNE 2017 9
 AppendixA

MAY 2016 POSITION PAPER

Value-Adds in Competitive Tendering

IN GENERAL

Healthcare systems in Canada use tendering processes for the procurement of medical
devices and diagnostics technologies. These tendering processes are becoming increasingly
complex with growing requests for value-adds and are requiring a significant allocation of
resources. The medical device industry is concerned about the direction of requests for these
value-adds and the “uneven playing field” that may result due to them.
This paper outlines MEDEC’s position regarding the definition of appropriate value-adds1 in
a fair and transparent sourcing process.

MEDEC POSITION
What is a Value-Add?
It is MEDEC’s position that medical technology companies and their customers (i.e., Canadian
hospitals) should not be expected to buy business through value-add or in any other form of
A value-add is a product, transactional relationship. There should be no unlawful inducement through unrelated or
service, or funding of any indirect grants or donations.
nature that is solicited
Non-RFX2 Value-add Requests
in an RFX or offered by a
supplier company as part In the event a university, hospital or other institution would like to request a grant or donation,
of an RFX response at no or other grant or donation not related to a specific product or service sourcing need, MEDEC
additional charge or on recommends that these requests follow a transparent process completed outside of an RFX
process, one that respects all stakeholders’ business protocol guidelines as well as MEDEC’s
concessionary terms. Code of Conduct.

RFX Value-Add Requests

All RFX proponents should be bound by the same guidelines.

Acceptable Sourcing Protocol:

• Any request for a value-add must relate to the product(s) or service(s) requested in
the RFX.
• The value-add request should be clearly defined and documented within the RFX
document.
• An example of a directly related value-add would be supplier support to optimize
patient outcomes for the proposed product(s) and/or service(s), such as training and
education.
• Value-adds should not be a mandatory requirement of the RFX.
• When a proposal contains a separate price envelope, the values-adds should be
presented exclusively in this price envelope or form their own envelope so that it does
not influence the quality evaluation of the product. Furthermore, objective and strict
evaluation grids should be used to counter balance the influence of the value-adds in
the final overall evaluation.
 MAY 2016 POSITION PAPER

Acceptable Supplier Protocol:

• Value-adds offered by a supplier should be clearly documented as part of the RFX

response.
• The value-add should be limited to product(s) or service(s) provided for a related
purpose and be reasonably necessary or useful for proper installation, use, or
servicing of the product. It should contribute to more effective patient care.
• Value-adds should adhere to the MEDEC Code of Conduct, Canada’s anti-bribery and
MEDEC POSITION anti-corruption laws, and each company’s own code of conduct and ethics. Value-Adds
should not promote an anticompetitive environment in any manner.

Medical technology Unacceptable Value-Adds:

companies and their
• Unrestricted value-adds, and value-adds that include items such as: cash payments
customers (i.e., to individuals or institutions, unrelated capital equipment, direct benefits to specific
Canadian hospitals) should individuals, and/or donations or grants which do not relate to the medical device
not be expected to buy industry or the products or services in the RFX are not appropriate.
business through value-add • Value-adds linked to, or in any way connected with, the purchase of products not
requested on the RFX are not appropriate.
or in any other form of • An RFX requesting specific value-adds unrelated to the products or services being
transactional relationship. sourced are not appropriate.
• Mandatory value-adds are not appropriate for fair business practice.

Glossary

For the purposes of this position paper a Value-Add is defined as follows:

A value-add is a product, service, or funding of any nature that is solicited in an RFX or
offered by a supplier company as part of an RFX response at no additional charge or on
concessionary terms. The value-add provides additional benefit(s) to the contracting body or
its affiliations over and above the specific product or service requested in the RFX.
The term “RFX” (Request For <business opportunity>) is used to represent any type of formal
procurement process, such as Request for Information (RFI), Request for Proposal (RFP),
Request for Quote (RFQ), or Request for Tender (RFT) from a Canadian healthcare institution,
system or governing body.

ABOUT MEDEC
MEDEC is the national association
representing the medical technology
industry in Canada. Our members
are committed to providing safe and
innovative medical technologies that
enhance patient care and advance
patient outcomes. The medical
technology industry in Canada
employs over 35,000 Canadians in MEDEC
close to 1,500 corporate facilities, 405 The West Mall, Suite 900, Toronto,
and has sales of nearly $7 billion per Ontario M9C 5J1
annum. We are committed to ensuring T: 416-620-1915 F: 416-620-1595
that Canada has a strong and vibrant Toll-free: 1-866-58-MEDEC(63332)
medical technology industry. E: [email protected] www.medec.org
Appendix B
405 The West Mall, Suite 900
Toronto, Ontario M9C 5J1
t: 416.620.1915 f: 416.620.1595
toll free: 1-866-58-MEDEC
www.medec.org

Diagnostic Imaging – Updated March 2016

GUIDANCE FOR CONDUCTING AN EFFECTIVE ON-SITE PRODUCT

DEMONSTRATION & EVALUATION

This document has been developed by MEDEC in consultation with healthcare

organizations to provide guidance to Membership and to prospective purchasers on how
to prepare for and conduct effective on-site product demonstrations and evaluations.

The objectives of this document are to: i) promote consistent, fair and transparent
processes within the vendor community, ii) encourage accountability for public funding
and optimal allocation of resources and iii) ensure that all stakeholders (hospitals,
independent healthcare facilities, purchasing organizations, and vendors) maximize the
benefits afforded by on-site product demonstrations and evaluations through a
consistent understanding of the key requirements.

A “Checklist” has also been included in the Appendix to assist the Demonstration Co-ordinator
in preparing for and documenting key elements of a successful demonstration process.

Definition:

On-site product demonstrations & evaluations are situations where healthcare organizations
evaluate equipment in their own clinical environment on a short term basis in the presence of
the vendor company as part of the equipment selection process. The equipment remains the
property of the company over the course of the evaluation. The company in consultation with
the healthcare facility shall determine if providing an on-site demonstration/evaluation is
appropriate in each circumstance.

For equipment where the care, custody and control does not remain with the vendor, policies
and documentation related to “loaning equipment” will apply.

Stage One: Pre-Demonstration & Evaluation Requirements

1. Notice of Demonstration

Upon short list notification and a request to provide product demonstrations, MEDEC members
will use best efforts to arrange such demonstrations as soon as they are able. Based on the
availability of the appropriate equipment and resources, this planning and co-ordination could
take up to 4 weeks.

In the event that the demonstration or evaluation needs to be cancelled by either party, a
minimum of 5 business days written notice will be provided.

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toll free: 1-866-58-MEDEC
www.medec.org

GUIDANCE FOR CONDUCTING AN EFFECTIVE ON-SITE PRODUCT

DEMONSTRATION & EVALUATION (cont’d)

2. Demonstration & Evaluation Agreement

Any required Demonstration Agreement should be communicated well in advance of the

demonstration date and signed by both parties prior to commencement of the demonstration.

3. Key Information and Requirements prior to Demonstration & Evaluation

In order to optimize the demonstration, the following information should be shared and agreed
to by all parties prior to the demonstration or evaluation:
 Identify and book accordingly the types of procedures that wish to be evaluated so that
the demonstration equipment can be appropriately configured
 Where appropriate, consider reducing the number of patient bookings during the
demonstration period to allow for a better evaluation by staff
 Identify evaluation criteria, key stakeholders & clinical specialties to participate in demo
 Each organization (hospital & vendor) to identify a key contact to facilitate
communications between the parties (name, title, phone number & email address)
 Mutually agree to the dates of the demonstration, allowing sufficient time for equipment
set up and testing prior to clinical demonstrations, time for staff training, days for the
demonstration and time for equipment to be packed up and removed from the facility.
Times required may vary based on the type of equipment being evaluated.
 Site to communicate to vendor any requirements for screening for entry into OR Suites
or Specialty areas (ie. proof of insurance, NDAs, security checks, immunizations…) in
advance of the demonstration
 Site to provide appropriate room/space for set-up & testing of demonstration equipment
(a lead lined room is required for c-arms and mobile x-ray machines) as well as a secure
location should the equipment be required to stay at the site outside of the
demonstration hours
 Site to identify a key contact person for networking information and set up and to provide
required networking information, such as: IP Addresses, IP Subnet, IP Gateway, DICOM
Modality Worklist information & other information as requested by vendor
 Shipping & Receiving: Site to provide the correct “Ship To” address, identify the type of
dock available and the opening & closing hours of the Shipping/Receiving Department
 Site to provide a no-charge Purchase Order for the demonstration equipment unless
mutually agreed that this is not required

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 405 The West Mall, Suite 900
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t: 416.620.1915 f: 416.620.1595
toll free: 1-866-58-MEDEC
www.medec.org

GUIDANCE FOR CONDUCTING AN EFFECTIVE ON-SITE PRODUCT

DEMONSTRATION (cont’d)

 Vendor guarantees that all medical devices provided for demonstration have been
properly licensed by Health Canada, and that the product being demonstrated fits the
exact specifications of that quoted by the vendor.
 With the co-operation of the healthcare facility, vendor is responsible for the delivery,
installation and removal of the equipment

4. Duration of Product Demonstrations & Evaluations

The following are suggested guidelines for the duration of the demonstration and evaluation
period, depending on the type of equipment:
Ultrasound 3 days maximum
C-arms, Mobile Radiography 1 week maximum

Each demonstration will identify in advance a mutually agreed upon delivery date,
installation/set up period, training period and a removal date.

Note: For mobile radiography, the first day (typically a Monday) will be used for product delivery,
set up & staff training with clinical demonstrations to begin on day two.

5. Escalation of Member Issues about an On-Site Product Demonstration

Should any concerns related to On-Site Product Demonstration requests arise amongst MEDEC
Members, the member organization will contact MEDEC, who will in turn, address these
concerns with the purchasing organization, explaining why/how their request does not fit with
MEDEC’s on-Site Product Demonstration Guidance.

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toll free: 1-866-58-MEDEC
www.medec.org

Appendix: Diagnostic Imaging On-Site Product Demonstration & Evaluation Checklist

Stage One: Pre-Demonstration Most Responsible Date Completed
Person
Written notice of Dates available to Vendor Manager Up to 4 weeks prior
Return Signed Demo Agreement to Vendor (if required) Stakeholders Up to 4 weeks prior
Communicate to vendor any requirements for screening for entry into OR Suites Manager Up to 4 weeks prior
or Specialty areas
Provide no charge PO for shipping and tracking the demo equipment Purchasing Up to 4 weeks prior
Provide complete shipping and delivery instruction Manager Up to 4 weeks prior
Identify the type of dock and Hours that is available at the Shipping/Receiving Purchasing Up to 4 weeks prior
Department - notify Vendor
Identify key stakeholders that will be participating / evaluating during the Stakeholders Up to 4 weeks prior
product demonstration - communicate to Vendor & staff
Book down the regular patient work load on the system being evaluated Manager Up to 4 weeks prior
Provide Vendor with evaluation schedule - start times, rooms etc. Senior or Charge Tech Up to 2 weeks prior
Book room for testing & setup of demo equipment (a lead lined room is required Manager Up to 2 weeks prior
for c-arms & mobile x-ray machine setup), and confirm a secure location for the
equipment if required to remain on-site outside of demonstration hours

Stage Two: Clinical Demonstration & Evaluation Day Most Responsible Date Completed
Person
Vendor rep(s) to register/sign-in according to facility policy
Vendor rep(s) to observe facility policy pertaining to infection control Senior or Charge Tech Day before start
Confirm Bookings reduced to accommodate Demo
Move system from biomed to final evaluation room BIOMED / Vendor Day before start
Allow vendor access to system 1 hour prior to start time Senior or Charge Tech
One Hour system training and overview prior to first case Stakeholders / Vendor
At the end of each day or as pre-determined by the customer and vendor, Stakeholders / Vendor
review to ensure required cases have been completed
At end of the demo, the customer ensures (with support of the vendor) that all Senior or Charge Tech /
patient data is removed and the equipment is cleaned according to vendor Vendor
provided recommendations

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 Appendix C
405 The West Mall, Suite 900
Toronto, Ontario M9C 5J1
t: 416.620.1915 f: 416.620.1595
toll free: 1-866-58-MEDEC
www.medec.org

Updated: March 2016

GUIDANCE FOR STAGING AN EFFECTIVE SITE VISIT

PURPOSE OF DOCUMENT

This document has been developed by MEDEC to provide guidance to its Membership in
responding to site visit requests by prospective purchasers. The objectives of this
document are to: i) promote consistent, fair and transparent processes within the vendor
community, ii) encourage accountability for public funding and optimal allocation of
resources and iii) provide guidelines for effective and efficient Site Visits for all involved
parties (ie. vendors, purchasing organizations, and hospitals).

For the purpose of this document, a “purchasing organization” is defined as an organization with
an official interest and participation in the decision making process, including hospitals, clinics,
purchasing groups, local or regional health boards, etc. A modality is considered to be product
areas such as Angiography, CT, MR, Computed Radiography, Digital Radiography, PACS, etc.

MEDEC Members understand the occasional need for prospective purchasers (“purchasing
organizations”) to evaluate products at clinical and/or manufacturing sites, as an important part
of the equipment selection process. Ensuring quality site visits and an optimal experience is of
paramount importance to the MEDEC members as well as to the purchasing organizations. If
deemed appropriate by members, they may agree to fund such evaluations and visits in
accordance with the following limitations and directions:

1. Site Visit Planning

In order to allow adequate time to organize site visits and effectively meet the purchasing
organization’s objectives, a minimum of (4) four weeks written notice is requested for all site
visits. It is also recommended that specific site visit dates be published as part of each
tender, and that site visit dates and participants (along with the participants information –
contact info, travel documents, etc required for travel if applicable) be confirmed upon
publication of “short listed” vendors. This will allow MEDEC members to co-ordinate travel
to best accommodate the purchasing organization.

Site visit plans may be shared by vendors in order to improve efficiency of scheduling for all
participants involved but may not be used to increase the recommended number of
attendees.

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www.medec.org

GUIDANCE FOR STAGING AN EFFECTIVE SITE VISIT (cont’d)

2. Site Visit Location

Every effort will be made to conduct site visits locally where local sites best represent the
Member’s product of focus for procurement. For multi-modality purchases, the site visit may
include one location per single modality.

3. Number of Purchasing Organization Representatives Permitted on Site Visits

Purchasing organization representatives should be employees or team members with

clinical privileges at the purchasing organization or relevant hospital. As visits are for the
sole purpose of clinical evaluation of products, site visits should only include clinical
personnel such as physicians, technologists, administrative directors, physicists and bio-
medical engineers. For PACS or RIS-related Visits, Clinical IT, IT Admin and/or IT
Consultants are encouraged to participate.

It is also recognized that in some instances, a non-clinical representative from the

purchasing organization may be required to attend the site visit to ensure fairness and
integrity of the process. To respect patient privacy during the site visit, only clinicians can be
present in patient treatment areas; all non-clinical attendees are requested to stay outside of
rooms where patients are undergoing treatment (eg. angiography suites).

All of the guests listed above will be included in the total number of Purchasing Organization
attendees whose travel and expenses can be covered by the members as outlined below:

a) Single modality projects cannot exceed a total of 3 purchasing organization

representatives.
b) Multi-modality projects cannot exceed a total of 5 purchasing organization
representatives.
c) Bulk buy/multi-site projects cannot exceed 7 purchasing organization representatives.

Note: Multi-site organizations are considered a single purchasing organization for the same
modality regardless of the number of sites represented.

Should the purchasing organization request additional representatives, that is allowable

however the purchasing organization will be responsible for paying all associated travel and
other expenses for such representatives.

There may be some consideration for the addition of a maximum of one more representative
to the above limits if there is a need for multiple sub-speciality representation. The additional
representative will represent the combined interests of the multiple sub-specialties and will
be mutually agreed upon by all members.

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www.medec.org

GUIDANCE FOR STAGING AN EFFECTIVE SITE VISIT (cont’d)

4. Number of Visits

Only one (1) visit per single modality project should be made. Members should request that
the representatives required for equipment selection be identified at the time of the site visit
request and that all travel information be provided to ensure timely booking of any travel
arrangements that may be required. To support fairness, the purchasing organizations must
utilize their best efforts to ensure that the identified representatives do not change
throughout the equipment selection process.

5. Duration of Site Visits

The duration of site visits shall be no longer than is necessary to evaluate the products and
their clinical and technical capabilities. MEDEC Members shall provide the purchasing
organization with an itinerary prior to the commencement of the site visit that clearly
identifies the equipment and model that is being demonstrated.

The MEDEC Code of Conduct applies, and will be followed regarding any activities and
interaction on site visits.

6. Screening Policies for Entry into OR Suites or Other Specialty Areas

Any requirements for screening at host sites (ie. proof of insurance, NDAs, security checks,
immunizations…) must be communicated by the Vendor, to the Evaluation Team well in
advance of the Site Visit.

7. Travel Expenses and Meals

MEDEC Members will offer the same travel arrangements to Purchasing Organizations as
are offered to their own employees. Business Class or First Class travel is not permitted nor
is it reimbursable by MEDEC members.

Meals may be provided as an occasional business courtesy when part of a bona fide
exchange of scientific, educational or business information. The time, duration of meals, and
the venue in which they are provided should always be subordinate to the business purpose,
and fall within each Company’s compliance policies. Should the purchasing organization have
a more restrictive policy than MEDEC’s, it is the purchasing organization’s policy which will be
applied.

This MEDEC Site Visit Guidance shall apply to all site visits whether the customer or vendor
is paying for the travel.

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www.medec.org

GUIDANCE FOR STAGING AN EFFECTIVE SITE VISIT (cont’d)

8. Escalation of Member Issues about a Site Visit

Should any concerns related to Site Visit requests arise amongst MEDEC Members, the
member organization will contact MEDEC, who will in turn, address these concerns with the
purchasing organization, explaining why/how their request does not fit with MEDEC’s Site
Visit Guidance.

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Appendix D – Glossary

MEDEC Code of Conduct Glossary

Advertisement Includes any statement, pictorial representation or design, however made, that
is intended, whether directly or indirectly, to promote the use or supply of the medical technology

Bona Fide In good faith, without fraud or deceit

Charitable Donation The making of a financial or medical technology gift to a registered char-
itable organization with no expectation of benefit

Charitable Organization Organizations that are recognized as a registered charity, have re-
ceived a registration number from the Canada Revenue Agency and are exempt from paying tax
on their revenue and are operated exclusively for charitable purposes (i.e., the relief of poverty,
the advancement of education or other purposes that benefit the community in a way the courts
have said are charitable) and devotes its resources to charitable activities.

Company / Companies MEDEC Member company / companies

Consultant A Healthcare Professional who is engaged by a Company under a consulting agreement

Consulting Arrangement Any relationship in which services are provided to a Company by a

Healthcare Professional in exchange for remuneration

Continuing Medical Education (CME) A specific form of continuing education that helps those
in the medical field maintain competence and learn about new and developing areas of their field.
These activities may take place as live events, written publications, online programs, audio, video,
or other electronic media.

Education Communicating information directly concerning or associated with the use of Com-
panies’ medical technologies, e.g., information about disease states and the benefits of medical
technologies to certain patient populations

Educational Grant A financial or medical technology contribution made to an organization in

exchange for support of an educational activity.

Entertainment Includes, but is not limited to, dancing or arrangements where live music is the
main attraction, sight-seeing trips, theatre excursions, sporting events and other leisure arrange-
ments.

Evaluation Products Capital or disposable medical technology products provided by Compa-

nies at no charge to Healthcare Professionals for a limited amount of time in order for the product
to be evaluated for its ability to meet certain functional requirements and its ease of use.

Faculty Member a Healthcare Professional who is a genuine speaker at a Third Party Education-
al Conference including as a participant in a panel of speakers

Gift Something voluntarily transferred by one person to another without compensation

Government Official (GO) Includes any official or employee of a government agency or other
governmental unit, political party, party official or candidate, or public international organiza-
tion. Also includes officers and employees of government-owned companies, or companies sub-
stantially controlled by such governments.

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Grant A financial or medical technology contribution made to an organization in exchange for
support of an educational or research activity. Generally includes an expectation that something
of value will be received in return for the ability of the Grantor to withhold payment or request a
return of funds if the performance does not occur.

Health Care Institution Any institution, corporation, government body, agency or committee
and any other organization involved in; the purchase or other acquisition, supply or distribution,
assessment, funding or recommendation of Medical Technologies (other than the Company’s
contracted Third Party Intermediaries), the administration of Medical Technology.

Healthcare Professionals (HCP) Individuals and entities that purchase, lease, recommend,
use, arrange for the purchase or lease of, or prescribe Companies’ medical technology products
in Canada. This includes both clinical and non-clinical people who make product-related deci-
sions of the sort listed. This is a broad definition, intended to encompass anyone with material
influence over purchasing decisions. Note that there may be laws and other codes applicable to
relationships with Healthcare Professionals, including relationships with government employees.

MEDEC Canada’s Medical Technology Companies

Medical Technology Medical products, technologies and related services and therapies use to
diagnose, treat, monitor, manage and alleviate health conditions and disabilities

Reasonable Related to meals, travel, and accommodations, means in accordance with the Com-
pany’s corporate travel policies and the policies of the Healthcare Professional’s organization

Research Grant A financial or medical technology contribution made to an organization in

exchange for support of a research activity. A research grant is usually given with the expectation
that the data or manuscript will be made available to the Grantor.

Research Institution Any institution, corporation, government body, agency or committee

and any other organization involved in; investigation or experimentation aimed at the discovery
and interpretation of facts, revision of accepted theories or laws in light of new facts, or practical
application of such new or revised theories or laws whose studies are reviewed and approved by
an accredited Ethics Review Board.

Requesting Organization Organization responsible for soliciting support from Companies.

Can include Educational Institutions, Charitable, Research, or Professional Organizations

Satellite Symposiums scientific/clinical programs that offer educational content through fac-
ulty presentations, lectures, posters, etc. including CME and non-CME accredited activities

Site Visit An event during the sales process in which a Healthcare Professional travels to a Com-
pany’s location to participate in activities that cannot be provided at the Healthcare Professional’s
home location, such as: demonstration of non-portable equipment and observing the manufac-
turing process.

Special Access A program run through Health Canada that allows Healthcare Professionals to
gain access to medical devices that have not yet been approved for sale in Canada. Special Access
is requested in emergency use cases or when conventional therapies have failed, are unavailable
or are unsuitable to treat a patient.

Sponsor A person or organization that pays the cost of an activity or event in return for the right
to advertise and promote during the activity or event (Merriam-Webster).

Sponsorship The right to advertise during an event or activity purchased by a person or orga-
nization.

Training Training on the safe and effective use of medical technologies.

JUNE 2017 11
Third Party Educational Conference A conference or meeting conducted by or on behalf of
national, regional, or specialty medical professional associations, accredited CME providers, or
training organizations with a genuine educational purpose or function that is: a) independent
and b) of an educational, scientific, or policymaking nature and for the genuine purpose of pro-
moting scientific knowledge, medical advancement, or the delivery of effective healthcare.

Third Party Intermediary Any third party that sells, or resells, or assists in selling or reselling
any products manufactured or distributed by a Company, and receives a fee, commission, dis-
count or other compensation for such services. Terms typically used to describe such third par-
ties include broker, agent, principal agent, dealer, reseller, distributor, consultant, intermediaries,
business partner or any representative acting on behalf of the Company in a sales capacity

Value Add Free-of-Charge product or financial payment provided as a part of an executed sales
contract. Value Adds must be clearly indicated as such in the contract or tender response. Exam-
ples include: medical technology, warranty upgrades, service, training, and/or funding for educa-
tion, fellowships, or research.

JUNE 2017 12