SAMED Annual Report 2017

SAMED
ANNUAL REPORT 2016 - 2017

AMPLIFYING
THE VOICE OF THE
MEDICAL DEVICE
INDUSTRY

STRENGTHENING THE VOICE OF INDUSTRY

Contents 2 SAMED is the voice of the medical device industry in South SAMED is uniquely positioned to advocate for policies that
Strengthening the voice of industry 6 Africa with member companies that develop, manufacture support patient access to innovative and life-saving medical
Message from our Chairperson and Executive Officer and sell innovative medical device and diagnostic devices. It is able to offer knowledgeable guidance in areas
products. Established in 1985, the association supports the critical to industry’s success: regulatory affairs, payment and
needs of members of all sizes.These include innovative, healthcare delivery, legal and compliance matters, global
entrepreneurial small companies, emerging growth and strategy and analysis as well as government and public affairs.
mid-size organisations as well as the largest innovators
and manufacturers.The association has grown significantly The activities of our association are guided by our strategic
in recent years and is now recognised as an important plan 2014-2018.
stakeholder in the South African healthcare sector.

SAMED Financial Report 8

SAMED Executive Committee 9 In September 2014, the SAMED Board
SAMED Board of Directors reviewed its strategic focus and decided
Move towards self-regulation
on the following key STRATEGIC
OBJECTIVES for the next four years:
SO19
11

The authentic voice of the South African medical 14 Increase the awareness of being the
device industry 14 authentic voice of the medical devices industry
• SAMED goes global 15
• SAMED engages with key partners to all stakeholders, thereby aiding in the
protection of the rights of patients and

consumers of our products.

Advocacy in action 18 Actively promote ethical
business and marketing
• Fighting for timeous payments from the public sector 1 8
SO2devices practices.

SO32
Winning the fight against the re-use of single-use

20 3

• Submissions, submissions, submissions… 20

Continually demonstrate value to members

Assisting members with their bottom line 22 and communicate that by means of representation, To proactively influence and drive,

• Reimbursement of members’ products 22 communication and development. appropriate regulations by engaging

• SAMED 2016 salary survey: key highlights 23 Although SAMED represents most of and educating stakeholders

the industry, membership should be and consumers of

SAMED’s offerings 26 seen as valuable to all firms our products.
in the industry.

Ensuring patient safety through appropriate regulations 28

• Navigating the complexities of combination

medical devices 29 SO4

Levelling the playing field in Africa 30

Lighting the path to local manufacturing 32 Actively promote the transformation
of our industry in particular, and
Accelerating small business 34 health services in general.

The place to be 36
• SAMED events 36

Life changing innovation 38
• How to mend a broken heart 38
• Changing lives for the better in Worcester,
38
South Africa

These objectives are encapsulated in our vision:

TO DEVELOP A SUSTAINABLE MEDICAL DEVICE
INDUSTRY BY RESPONSIBLY IMPROVING PATIENT ACCESS

TO INNOVATIVE HEALTH TECHNOLOGY.

PSG MEDICAL

STAAR
MEDICAL

4 OUR MEMBERS ARE AT THE FORE- FRONT OF EVERYTHING WE DO 5

ASSOCIATE MEMBERS: ASSOCIATION MEMBERS:

As an organisation, SAMED is in a better position The rapid advance and evolution of medical technology
today than at any time in its history to continue taking impacts on the relationship between SAMED members and
forward our goal of “advancing innovation responsibly.” their customers.The complexity of many products creates
Creating a policy and regulatory environment that nurture interdependence between suppliers and customers, which
the power of innovation has never before been more critical. necessitates working together to serve the best interests
The needs of patients are expanding faster than ever and the of patients.While these unique features of our industry
future holds boundless opportunities to continue improving are highly beneficial, the required relationships can also
the environment in which we work. However, without an be open to manipulation. It was decided that a dedicated,
efficient regulatory process, adequate coverage and payment, purpose-built code for our industry would allow SAMED to
many patients will not receive the much needed life-changing steer a prudent course and enable us to fulfil our vision: to
technologies that our companies provide. develop a sustainable medical device industry by responsibly
improving patient access to innovative health technology.
SAMED will continue its unwavering battle for
acknowledgement of the uniqueness of the medical device The process towards self-regulation inevitably required
industry.Through our engagement with key partners, we that SAMED withdraw from the Marketing Code
are seeing a changing attitude in how they engage with the Authority, a regulatory forum that jointly governed both
industry. SAMED regularly meets with national and provincial the pharmaceutical and medical devices industries for
government, regulatory bodies, doctor societies, private seven years.We are delighted to report that our members
hospital groups, procurement departments, other health strongly endorsed the new Medical Device Code of Ethical
product industry associations, the Portfolio Committee of and Marketing Practice at a well-attended meeting held in
Health and others like the South African Bureau of Standards Johannesburg on 23 February 2017.This upcoming year, we
(SABS), to pro-actively influence decisions that impact the shall continue to implement processes that will help garner
medical device industry. support from our members and other significant role-
players. In so doing, we shall be able to facilitate the Code’s
As SAMED continues to amplify the voice of the medical application so that it becomes a valuable facet of
device industry, our expanding membership (with 40 our industry.
new members in this past year alone) stands as a
testament to the extraordinary value we provide to our FINANCIALS
member companies. As a financially responsible association with good fiduciary

6 MESSAGE FROM OUR CHAIRPERSON 7
AND EXECUTIVE OFFICER
JEFF HAMPTON,
SAMED Chairperson TANYA VOGT, When the association looks back on this past year, we practices, SAMED values its responsibility in dealing with
SAMED can highlight some key milestones that yielded important members’ money. As such, we are audited to ensure
AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY Executive Officer benefits to SAMED members and the patients they serve. transparency and clarity around the association’s finances.
One of these was providing extensive input into previous
drafts of the regulations pertaining to medical devices and in COMMITTEES
vitro diagnostic devices (IVDs).Therefore, when these final SAMED operates several committees whose updates and
regulations were released and the Medicines Control Council successes are documented in this report.We would like
(MCC) announced subsequent requirements to licence to personally thank all committee chairpersons and their
medical device and IVD establishments, there were no committees for their contributions, robust debate, tireless
surprises for our members. In addition, SAMED established hard work and the real change they are generating within
a unique medical device working group with the MCC. our industry. In many ways, our members perceive SAMED’s
value through these committees, so we urge all to actively
Aside from increasing our membership, SAMED also participate and be part of the change they would like to see
offers more benefits to our members and stakeholders. in their industry association.
During the year under review, SAMED held a total of 30
workshops, training events, general member meetings as A WORD OF THANKS
well as our flagship annual conference. SAMED also held a We would like to thank the SAMED team for the unwavering
special procurement workshop with the Kwa-Zulu Natal work it does to ensure that the association runs smoothly
Department of Health and is planning to host another and effectively.We would also like to thank all the board
for supply chain managers of the Gauteng Department of members for their time and expertise, as well as the
Health this year. committee chairpersons for all their hard work.

A major focus in 2016 involved the issue of outstanding Finally, we would like to thank the members for their
payments to our members by provincial health departments. contributions and their questions in order to ensure we are a
This report mentions several of SAMED’s interventions more needs-orientated association.
aimed at trying to resolve the issue.We shall continue to
engage and advocate on our members’ behalf. We look forward to a prosperous 2017!

SAMED ANNUAL REPORT 2016 - 2017

SAMED once again has returned a sound set of financial SAMED EXECUTIVE COMMITTEE
results for the year ended 31st December 2016.The Audited
Financial Statements for the year were approved by the Jeff Hampton Leanne Cook Rob Millar Marlon Burgess Ruwaida Shaikh
Board on 14th April 2017 and reflect a surplus of R962,383
for the year comprising operating surplus R621,414 and SAMED Chairperson SAMED Vice-Chair SAMED Treasurer Chief Executive Country Director,
investment income of R340,983. For the eagle eyed – the (Chief Operating (General Manager – (Chief Executive Officer, Boston Scientific SA
R14 differential is attributed to a small finance cost! Whilst Officer, Medical Devices, Officer, MDG Health
subscription fees showed a 13% growth over 2015, the Baroque Medical) Johnson & Johnson Condor Medical) Solutions
income attributed to seminars was substantially down for Medical)
ROB the reported period due to the Regulatory congress held
MILLAR late in 2015. Overall income was up 7% year on year. On the SAMED BOARD OF DIRECTORS
expenditure line, expenses showed a 16% growth year on
SAMED TREASURER year mainly due to higher spend on committee activities and
legal and accounting fees.The Statement of Financial Position
SAMED shows cash and cash equivalents up by about R1 million and
FINANCIAL REPORT a concomitant increase in our equity now at R4,021,265
against R3,058,882 the previous year.The sound financial
status of the association allows for SAMED to provide seed
capital for an educational project that is intended to benefit
all members in future.Thank you again to all our members
for your continued support.

STATEMENT OF COMPREHENSIVE INCOME Jeff Hampton Leanne Cook Rob Millar Marlon Burgess Malan de Villiers

2016 2015 SAMED Chairperson SAMED Vice-Chair SAMED Treasurer Chief Executive MDMSA Board
R R (Chief Operating (General Manager – (Chief Executive Officer, Representative
Officer, Medical Devices, Officer, MDG Health
Revenue 394,254 Baroque Medical) Johnson & Johnson Condor Medical) Solutions
Conference fees 44,211 Medical)
Meeting and workshop fees 408,871 4,268,679
60,486 421,367 9
8 Subscription fees 4,809,730 5,128,511
23,751
Regulatory income 4,211
(4,094,908)
Other operating income 5,302,838 1,037,814 Albert Denoon Reiner Gabler Robyn Howes Sophie le Cordeur Anthony Lowther
Other income 197,812
Expenses 49,250 - Chief Executive Chief Executive SALDA Board MISA Board Managing Director,
(4,730,674) 1,235,626 Officer, Officer, Representative Representative Ascendis Medical
Operating profit 621,414 Baroque Medical Gabler Medical
Investment revenue 340,983
Finance costs (14)

Profit for the year 962,383

STATEMENT OF FINANCIAL POSITION AS AT 31 DECEMBER 2016

2016 2015
R R

Assets 26,866 37,576
Non-Current Assets
Property, plant and equipment 178,470
-
Current Assets 44,979 3,039,668 Dr.Terence Moodley Madeleine Pearce Clive Potter Ruwaida Shaikh Tanya Watson
Trade and other receivables 100,662 3,218,138
Other financial assets 4,059,385 Public Affairs Senior Quality & Director, Country Director, Reimbursement
Cash and cash equivalents 4,205,026 Manager, Regulatory Systems SA Biomedical Boston Scientific SA Manager,
BD Manager, Medtronic
Philips Healthcare

Total Assets 4,231,892 3,255,714 RESIGNED
BOARD MEMBER
Equity and Liabilities 4,021,265 3,058,882 Vassie Ponsamy
Equity Managing Director
Retained income 210,627 196,832 — Sub Saharan Africa
4,231,892 3,255,714 Region,
Liabilities Smith & Nephew
Current Liabilities
Trade and other payables SAMED ANNUAL REPORT 2016 - 2017

Total Equity and Liabilities

AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY

ROB Rapid advances in the development of medical technology
MILLAR influence the relationship between SAMED members
and their customers.The complexity of many products
CHAIR, SAMED CODE COMMITTEE has created an interdependence between suppliers and
customers and the need to work together to serve the best
For more than three decades, SAMED has been interests of patients. However, the pharmaceutical industry’s
committed to ensuring its members adhere to ethical relationship with its clients does not have these features in
business and marketing practices.This, turn, ensures that common.While these unique features of our industry are
healthcare professionals make informed decisions based highly beneficial, the required relationships can also be open
on clinical criteria regarding the best medical devices their to perversity.The SAMED Board decided that implementing
patients require. a dedicated, purpose-built code for our industry would allow
us to steer a judicious course.With this in mind, the SAMED
Board decided to resign from the MCA on 29 September
2016 to reinforce and apply its dedicated Medical Device
Code of Ethical Business and Marketing Practice.

The SAMED Code of Business Practice Committee was re-
established with the objective of updating the Medical Device
Code of Ethical Marketing and Business Practice.

During a well-attended member meeting on 23 February
2017, at a, SAMED presented its new Medical Device

SO1 MOVE TOWARDS 11
SELF-REGULATION

There’s a special beauty to Improved compliance with applicable laws and regulations, Code of Ethical and Marketing Practice, which its members
lasting relationships adherence to ethical standards and being mindful of endorsed.The Code Committee outlined its plans to have an
changes in the South African and international healthcare independent investigative arm.This will enable the association
Bard has spent the last 100 years partnering with patients and physicians to develop, manufacture and supply advanced environment enhances the reputation and success of the to deal with transgressions of its code more efficiently,
healthcare products and services in the areas of urology, oncology, vascular disease and surgical specialty areas. medical devices and IVD industry. For this reason, the thereby ensuring that the medical devices industry is not only
SAMED Board decided that its members should proactively better regulated but also more accountable.
Year after year Bard commits its people and resources to create better outcomes for you and your patient. Bard has self-regulate and embrace their own code, known as the
pursued new ideas, inventive solutions and imaginative approaches, for improving healthcare system efficiencies, Medical Device Code of Ethical Business and Marketing 1
lowering the costs of care, achieving quality outcomes and delivering value to patients. Practice as from 1 January 2017.

At Bard, our core values of Quality, Integrity, Service and innovation drive every aspect of how we operate - helping our SAMED developed its code of business practice about
company to become a global leader in health care. More than mere words, these values represent our commitment, our 12 years ago.This code provides clear guidelines in the
compassion and caring to make a meaningful, lasting difference for the health and healing of people around the world. marketing of health products and how its members should
conduct themselves in their interactions with healthcare
Building 11 | Greenstone Hill Office Park | ADVANCING LIVES AND THE DELIVERY OF HEALTHCARE ® professionals and procurers of their products.
Emerald Boulevard | Greenstone | 1645 | WITH QUALITY, INTEGRITY, SERVICE AND INNOVATION
Johannesburg Six years ago, SAMED entered into an agreement with the
Tel + 27 (0)11 524 9900 pharmaceutical industry to create a joint South African
Fax + 27 (0)86 539 9510 Code of Marketing Practice under the Marketing Code
www.crbard.com Authority (MCA). However, it soon became apparent that
the two industries – medical devices/technologies and
Bard is a proud SAMED member company pharmaceuticals – are very different.

1

The committee is currently working tirelessly to plan
its national launch of the code to key stakeholders. In
this regard, it has proactively sought meetings with key
government officials, including the Minister of Health, the
Deputy Director General, Health Regulation and Compliance
Management, the Chief Director: Sector-Wide Procurement
and the Registrar of Medicines to discuss the changes.
The sub-task team on certification and training is developing
a strong and exciting certification programme on the code
for members and healthcare professionals.This programme,
in conjunction with training workshops for both members
and stakeholders on the code, is set to be implemented in
the latter part of 2017.

1

12

1 MAKING AN IMPACT ON THE WORLD OF HEALTH. Across the healthcare continuum, BD is known for medical technology,
SAMED recognises that one of Government’s objectives is to devices and laboratory equipment—from medication management and parenteral drug delivery to diagnostics and solutions
regulate the healthcare industry effectively and efficiently.We for clinical research. What may be less known about us is the difference BD has made in untold millions of lives in ways as
are confident that our fortified code will enable our industry diverse as helping enable inoculation of children for the final eradication of polio, identifying infectious organisms and
to contribute to attaining this goal. providing the research tools to help advance the discovery of a vaccine for AIDS. Today our associates serve every corner of
the world, united by one purpose: advancing the world of health. And through our extensive experience with partnerships, our
1. SAMED Code Committee members present the new depth of insights and exceptionally broad portfolio of solutions from discovery to delivery, we aim to make an even greater
Medical Device Code of Ethical and Marketing Practice to difference in human health across generations. Discover the difference one company can make. Discover the new BD.
SAMED members on 23 February 2017
Learn more about the Difference of One at bd.com/One-Company
AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY
© 2016 BD. BD and the BD Logo are trademarks of Becton, Dickinson and Company. MC6419

SAMED GOES GLOBAL discuss emerging trends in healthcare compliance and recent emergencies; collaborating and harmonising the regulation Organization regulatory framework, which has been
challenges, and then formulate approaches to effectively of medical devices; good regulatory practices and global supported worldwide.
Through its international partnerships with key manage compliance on a global scale. convergence. As the representative from the South African
associations, SAMED advocates on behalf its members for medical device industry, SAMED presented on the subject: SAMED ENGAGES WITH KEY PARTNERS
increased harmony in trade, regulatory and reimbursement SAMED’s executive Officer,Tanya Vogt, was part of a panel ‘Industry view on effective Medical Device regulations’ at a
practices, thereby ensuring greater access and eliminating that discussed the key topic ‘Procurement in Emerging pre-ICDRA meeting. Through significant presentations at
trade barriers and length of time to reach the market. Markets: New Compliance Challenges.’Third party stakeholders’ conferences, SAMED is continuously
distributors and compliance remain big issues in emerging International organisations often contact drawing in key partners. In 2016/2017, SAMED represented
This year, SAMED participated in international events in markets. Associations were therefore urged to screen and SAMED to obtain information and insight into industry’s views and developments within our sector at
order to highlight key developments, issues and possible provide training to distributors in our market. the South African market. This year, SAMED met several local conferences.These events were held by the
solutions in the South African medical device market: various trade commissioners from the Canadian, Israeli and South African Pharmaceutical Regulatory Affairs Association
German high commissions as well as Enterprise Ireland, (SAPRAA); Southern African Health Technology Assessment
AdvaMed and MedTech to discuss various topics.These Society (SAHTAS); SANAS; South African Federation of
encompassed the recent developments in the South African Hospital Engineering (SAFHE) and the Clinical Engineering
regulatory environment, understanding the dynamics of the Association of South Africa (CEASA).
South African medical device market and opportunities to

1

THE AUTHENTIC 1. SAMED’s Executive Officer Tanya Vogt with Ms Monica 15
14 SO1 VOICE OF THE SOUTH Eimunjeze, Director, National Agency for Food and Drug
Administration and Control (NAFDAC) (middle) and Ms
AFRICAN MEDICAL Josée Hansen, Senior Advisor, Department of Essential
DEVICE INDUSTRY Medicines and Health Products,World Health Organization
at the pre- ICDRA meeting.

2

2. SAMED Executive Officer,Tanya Vogt with Dr Millicent
Simelane, former Deputy Director-General: Specialized
Services & Clinical Support, KZN Department of Health

The Global Medical Technology Alliance The MCC hosted the International Conference develop partnerships between our organisations. SAMED sits on the NAPPI Advisory Board
(GMTA) 69th World Health Assembly (WHA) of Drug Regulatory Authorities (ICDRA), (NAB) advocating on behalf of the industry.
met from 23 to 28 May 2016. SAMED’s Executive Officer which was held in Africa for the first time from SAMED sits on the international GMTA Board, NAB is an independent, non-profit organisation, which
Tanya Vogt participated in a panel at a WHA side-event 27 November to 02 December 2016.The meeting, which whose members are national or regional medical technology consists of healthcare industry role-players.The hot topic
discussing ‘Access to innovation for all: Is it possible?’The welcomed delegates from the World Health Organization associations.They represent innovative companies that during NAB meetings this past year focused on SAMED’s
panel explored the current challenges in motivating the (WHO) member states, facilitated focused discussions on currently develop and manufacture 85% percent of the view relating to combination medical devices. It stated that
development of innovative technologies that addresses the several key issues.These included regulating harmonious world’s medical devices, diagnostics and equipment.This where the primary mode of action resides with a device, the
burden of disease globally; specifically those that are African medicine practices; strengthening global regulatory board provides a forum for the development and advocacy product is deemed a medical device and is therefore not
poverty-related and neglected to ensure that technology systems; regulatory preparedness around public health of policies that support innovation in medical technology to subject to medicines regulations (which includes section 21).
is more accessible. address patients’ healthcare needs. GMTA is also officially
recognised by the Organization WHO and engages with it
The annual Global MedTech Compliance on matters relating to medical devices. During a meeting
Conference (GMTCC) brings together device and IVD of the GMTA Board on 23 May 2016, SAMED agreed to
industry regulators, compliance professionals, legal counsels, collaborate with GMTA on supporting better procurement
senior executives and industry observers. Participants analyse, of medical devices. It also gave input into the World Health

AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY SAMED ANNUAL REPORT 2016 - 2017

In addition, SAMED pointed out that since there has been South African Orthotics and Prosthetics
no call-up of these devices in terms of medical device Association (SAOPA): SAMED met with SAOPA’s
regulations, companies are not legally required to register executive committee on the Health Market Inquiry to discuss
such products with the MCC. SAMED fiercely contested this the cost of private healthcare and medical device regulations.
a few years ago, which resulted in the current NAB policy
allowing for combination medical devices to be given NAPPI
codes without medicines or section 21 registrations. SAMED
has continued to fight for recognition of these products by
engaging in meetings with private hospital groups and the
outcome of these discussions looks promising.

One of SAMED’s key strategic objectives is to SAMED sits on the Strategic Health Innovation

work more closely with all doctor societies to Partnerships (SHIP) steering committee. The

understand their needs. SAMED also needs to be actively Department of Science and Technology nominated our

engaged in relevant issues that will enable the medical Executive Director, Ms Tanya Vogt to represent it on the SHIP

devices industry to meet the growing healthcare needs and steering committee.

expectations of its stakeholders. During the year in review,

SAMED worked with several doctor societies such as: SAMED pushed for industry

representation on the Council

Wound Healing Association of Southern for Medical Schemes’ Task

Africa (WHASA): WHASA is currently developing Team, which is reviewing the Prescribed

a new educational programme with input from industry Minimum Benefits’ (PMB) Code of

16 and SAMED. SAMED has been in discussion with WHASA Conduct. SAMED succeeded in its action,
to establish a forum with industry to discuss matters of which resulted in a member of SAMED’s

common interest. Health Economics and Reimbursement

Committee, Ms Bulelwa Maponya being appointed to be

part of this task team and provide key inputs from the

industry’s perspective.

South African Society of Anaesthesiologists SAMED sits on the Global Health Innovation
(SASA): SASA has educated SAMED’s members on how Accelerator (GHIA) innovation stakeholder
to engage with medical device users and how to avoid forum with the Department of Trade and Industry, the
perversity and conflicts of interest. During SAMED’s annual Department of Science and Technology, Medical Research
conference, SASA outlined how important clinician advisory Council, National Department of Health, PATH and the
boards are in informing equipment-purchasing decisions. Industrial Development Corporation.This forum explores
ways to accelerate access to the most promising technology
innovations to better serve the health needs of resource-
limited communities.

AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY

MARLON ENGAGING AT THE HIGHEST LEVEL The committee and the Gauteng Department of Health and
BURGESS SAMED’s Government Procurement Committee has 1 Treasury will be working closer in future to investigate the
adopted a strong stance and engaged with different
CHAIR, SAMED GOVERNMENT components of the South African government. consignment stock process in the Gauteng region.
PROCUREMENT COMMITTEE
This committee’s first course of action was to communicate PARTNERING TO TRANSFORMING SYSTEMS
FIGHTING FOR TIMEOUS PAYMENTS FROM its concerns around the issue of outstanding payments to all Through our partnerships with key health departments,
THE PUBLIC SECTOR stakeholders. SAMED wrote to the Minister of Health, SAMED is trying to transform these systems to avoid a
all MECs and Heads of Departments from all provincial reoccurrence of outstanding payments.
health departments.
The National Treasury has implemented a centralised
With increased awareness of the issue by all stakeholders, procurement mechanism whereby it will procure all
SAMED then held key meetings with high-level government essential devices for government hospitals.This centralised
institutions.This included being invited to address all procurement system has already resulted in a number of
attendees at the National Health Council. At this event, successful transversal tenders. A couple of years ago, the
SAMED emphasised its partnership with government in National Treasury approached SAMED to assist in drawing
finding solutions to assist in the timely payment of suppliers up an essential equipment list for government hospitals.
as well as developing ways to resolve the issue of products SAMED is now looking at new ways to support the National
that are not invoiced for despite being used. Treasury in its programmes to prevent any obstacles in the
medical device value chain.
ADVOCACY IN 19
2 The KZN Department of Health in collaboration with
18 SO2 SAMED found it necessary to bring all stakeholders together
for an enlightening information sharing workshop to assist
ACTION the Department of Health in understanding the dynamics
involved in medical devices procurement.This is seen as a
A major focus this past year is the ongoing issue of The procurement committee also met with the task team on step in ensuring that the Department of Health improves
outstanding payments to our members by provincial health non-payment of suppliers’ invoices within the Department its medical equipment and devices procurement process.
departments. After SAMED received several member of Planning, Monitoring and Evaluation (DPME) that sits With a positive response to the workshop, SAMED intends
complaints, it conducted a survey among members to within the Presidency.This department provided all our to develop a similar event with the Gauteng Department of
establish the extent of this problem. members with contact details of each MEC and Heads of Health and the Gauteng Provincial Treasury.
Finances within the various provincial departments of health.
A total of 63 members responded to the survey. It emerged The DPME also shared the latest statistics with the Deputy 1. The MEC of Gauteng Department of Health, Dr
that various departments owe them R1.2 billion for invoices Minister within the Presidency. SAMED assisted some of its Gwendoline Malegwale Ramokgopa addressing medical
exceeding 30 days. The Gauteng Department of Health is smaller members in contacting the DPME, which resulted in device companies at a supplier consultation meeting
responsible for R695 million of this amount. the payment of their outstanding invoices.
2. SAMED and the KZN Department of Health hosted a
SAMED is concerned that this level of non-payment will The committee also met with the MEC treasury for Gauteng, successful procurement workshop on 9 December 2016
make it impossible for its members to maintain the status Ms Barbara Creecy, to explore ways of collaborating with the
quo. Small companies, in particular, may have to close department through the implementation of its open tender 2
their doors and/or stop selling to the public sector.This system.This system encourages transparency as all tenders
may potentially affect service delivery and patient access are conducted in an open forum. A positive outcome of
to products and care, resulting in fewer players and less this meeting was that the department gave SAMED a
competition.This would not only be a blow to the industry commitment to consider all our members’ invoices in their
but also to overall healthcare delivery in South Africa. April payment run with the aim of paying outstanding ones
by Mid-April 2017.

AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY SAMED ANNUAL REPORT 2016 - 2017

In 2015, SAMED became aware of a proposed guideline countrywide. Regulations pertaining to medical devices
by the South African Bureau of Standards (SABS) on the re- and IVDs were released on 9 December 2016.They clearly
use and re-sterilisation of single-use devices (SUD). Certain state that ‘single use’ in terms of a medical device means:
devices, which are deemed ‘single use’, are being reused “one use of a medical device on an individual or IVD on
on patients. In many instances, this occurs without their a sample during a single procedure and then the medical
knowledge or express consent. In the absence of rigorous device or IVD is disposed of and is not reprocessed and not
regulatory, safety and monitoring requirements for the re-use used again.”This now makes it illegal for any users of medical
of single-use medical devices, SAMED therefore strongly devices to re-use single-use devices.
advocated that users of SUDs adhere to the manufacturer’s
instructions and intended number of uses.This is to safeguard
the healthcare facility, patient and healthcare practitioner
during the use of these products.

WINNING THE FIGHT
20 SO2 AGAINST THE RE-USE OF

SINGLE-USE DEVICES

Since its inception in 1985, SAMED has advocated against SUBMISSIONS, SUBMISSIONS SUBMISSIONS…
the reuse of single use devices through presentations at
key conferences.These include events by the South African SAMED often advocates for its members through written
Federation of Hospital Engineering (SAFHE), the Clinical and oral submissions to the South African government.
Engineering Association of South Africa (CEASA) as well as We actively sought the views of our members on various
our own annual conferences and workshops by the Central key issues.These include the government’s procurement
Sterile Services Department (CSSD). regulations, the National Health Insurance (NHI) White
Paper, the Prescribed Minimum Benefit (PMB) Review, Health
On hearing about the proposed SABS guidelines, SAMED Market Inquiry into the cost of private healthcare in SA; the
developed written opposing submissions and engaged with Davis Tax Committee’s funding proposals for the National
the organisation. SAMED succeeded in its vigorous effects Health Insurance and the Integrated National Strategy for
in reaching out to its network of stakeholders to raise Health Research.Through these submissions, SAMED ensures
its concern about the reuse of SUDS in many hospitals that the views of our industry are heard.

AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY

TANYA and Economic Policies for MedTech Europe), as well as local from the Health Market Inquiry, including an exclusive due to the specific set of skills and experience they
WATSON reimbursement experts such as Professor Manie de Klerk, report that will deal with whether or not PMBs are provide, thereby resulting in improved outcomes.
who is Head of Clinical Policies at MMI Health. SASA’s CEO indeed a cost driver.
CHAIR, HE AND R COMMITTEE Natalie Zimmelman also explained how companies should SAMED’s suggestion to avoid fragmentation and
engage with users of their medical devices and how to SAMED proposed introducing clear PMB treatment movement of members between funders and thus
REIMBURSEMENT OF MEMBERS’ prevent conflicts of interests and perversity. guidelines, based on clinical studies or the best available increase costs entailed transferring e-files between
PRODUCTS evidence (as defined in the regulations). CMS should funders in future, while giving due consideration to
A key objective of this committee is to find ways to influence consider such guidelines as the minimum standard of consumer protection and confidentiality.
and intervene in managed health care policies.With the meaningful care.
Council for Medical Schemes (CMS) embarking on a process This year the committee is looking at compiling a document
to review the Prescribed Minimum Benefits (PMBs), this will SAMED indicated that one way of treating PMB that maps health technology assessment processes in both
affect the way in which schemes are required to fund PMBs. conditions is to consider various centres of excellence public (provincial and national) and private hospitals and
Another adverse effect of this review process is that people for the more prevalent and high-cost medical conditions. medical schemes in South Africa.
within the population who are currently being treated for a These centres would act as a vehicle to reduce costs
specific PMB condition may not be funded and will, therefore,
go untreated. SAMED’s HE & R Committee developed a SAMED 2016 SALARY SURVEY:
submission to the CMS highlighting some of the key issues KEY HIGHLIGHTS
and possible solutions as follows:
The annual SAMED salary survey is a major value-add
The current PMB list (i.e. what is contained therein and feature for SAMED members.
the descriptions of treatment) is extremely outdated.
With significant subsidisation from SAMED, the survey assists
ASSISTING members in making key decisions around remuneration and Key survey findings included: 23
22 SO2 MEMBERS WITH employee benefits.With 31 members participating this year,
this is the 15th year that the remuneration survey has been Actual salary increases granted
THEIR BOTTOM LINE conducted on SAMED’s behalf. SAMED members and survey participants’ average salary
increases were about 1.0% above the average inflation rate
of 6.1% for September 2016.The weighted salary increases
awarded for 2016 was an average of 7.1%, which aligns with
current national trends in salary movements.

PERCENTAGE OF ORGANISATIONS THAT AWARDED SALARY INCREASES
WITHIN CERTAIN RANGES FOR THE PERIOD UNDER REVIEW

EMPLOYEE CATEGORY

SAMED’s Health Economics and Reimbursement This means it is behind in terms of treatment regimes SALARY General Top Middle Professionals Technicians, Lower Level All Staff
(HE & R) Committee focuses on influencing the and its responsiveness to South African healthcare INCREASE Management Management Management Clerical & Staff
reimbursement and health technology assessment of needs. SAMED recommended that any new knowledge Administra- -
medical devices and technologies in both the private and on conditions and treatments, as well as treatments with RANGE - 27
public sectors.Through this committee’s efforts, members medical devices should be taken into account. tive 21 28
are educated on how to effectively have their products Under 4% 22 27
reimbursed by medical schemes and hospitals in South Africa. It was also recommended that descriptors as well as 7- - - - 22 -
procedural and professional codes should be updated 4.1% to 6% 21 9
The committee presented two highly effective workshops and further defined by developing a national coding 20 27 33 31 38 7 -
this year. During the first workshop, Netcare and Discovery system.This could be prioritised through a public-- 6.1% to 7%
informed SAMED members on how to introduce new private partnership, where the Council for Medical 27 13 21 32 25 7 -
technology into hospital groups and ensure private funders Schemes, the National Department of Health, industry 7.1% to 8%
will cover it. Consultant Hasina Cassim provided valuable tips and associations are consulted to ensure updated and 26 46 20 19 13 - 9
and advice.The second, held in November, looked specifically appropriate coding is in place in light of the NHI’s 8.1% to 9% -
at ‘Medical Devices: Market Access & Procurement — Past, e-Health initiative. 7 7 13 6 6 -
Present & Future.’ 9.1% to 10%
The PMB review seeks to address PMBs in terms of 13 7 13 6 6 -
This workshop incorporated insights from international the belief that they drive costs. However, SAMED 10.1% to
experts such as Yves Verboven (Director Market Access emphasised that the CMS should factor in any findings 11% -----

11.1% to -----
12%
- - -66
12.1% to - - - -6
14%

Over 14%

AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY SAMED ANNUAL REPORT 2016 - 2017

Average projected increases When you’re healthy and strong,
you can grow up to do anything.
The figures in the table below relate exclusively to
organisations that intend to carry out reviews during this Johnson & Johnson wants every child to have a bright future.
particular 12-month period. That’s why we’re dedicated to life-saving ideas and
life-enhancing programs. Through fresh thinking, one-of-a-kind solutions
PERCENTAGE OF ORGANISATIONS INTENDING TO AWARD INCREASES WITHIN and collaboration, we help children grow healthy and strong.
CERTAIN RANGES FOR THE PERIOD UNDER REVIEW We could call it innovation, but we simply think of it as caring.

SALARY INCREASE RANGE

EMPLOYEE CATEGORY Under 4.1% to 6.1% to 7.1% to 8.1% to
4% 6% 7% 8% 9%
Nil Over 9%

General Management - 29 50 7 7 7 -
Top Management - 29 50 7 7 7 -

Middle Management - 32 47 7 7 7 -

Professionals - 32 47 7 7 7 -

24 Technicians, Clerical & Administrative - 32 47 7 7 7 -

Lower Level Staff - 23 46 8 15 8 -
ALL STAFF - 25 50 9 8 8 -

Working Hours Emergency call-out Allowance
A number of organisations have introduced policies An emergency call-out allowance is paid by 17% of
permitting flexible working hours (flexitime) and working participating organisations.
from home. There is an increased tendency in permitting
work from home or telecommuting. A total of 44% of
organisations indicated that they have a policy, which provides
for employees to work from home.

Standby Allowances
An allowance to staff required be on standby (i.e. available
for call-out) during off-duty hours is paid by 25% of
organisations. Note that this allowance is separate from
the amount paid (usually overtime pay) when a call-out is
actually required.

AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY

© Johnson & Johnson Services, Inc. 2015

Upon membership, medical device companies on medical devices and diagnostics as well as the healthcare
automatically become part of a larger association that has environment in South Africa.
the expertise and commitment to advocate for and protect
the rights of its members. Members have access to advice and support regarding
the regulation and reimbursement of devices, both abroad
NETWORKING AND WORKSHOPS and locally.
Members have access to regular member meetings and
workshops on a range of industry issues.This enables them Members have access to contacts across government
to benefit from opportunities and also connect with other healthcare departments, tender boards, private sector
individuals and businesses. . healthcare groups and healthcare professionals.

ADVOCACY AND RELATIONSHIPS WITH Members benefit from incoming distributor and tender
KEY STAKEHOLDERS enquiries (local and overseas), information requests and
SAMED engages with policymakers, regulators, politicians, trade delegation requests.
doctor societies, funders and international organisations in
developing and proposing patient-centered policies that INTERNATIONAL LINKAGES
enable people to live healthy and productive lives. It also SAMED keeps members abreast of global best practices with
provides solutions that significantly drive the productivity and its links to GMTA, AHWP, Eucomed and Advamed.
efficiency of healthcare systems.
STAKEHOLDER NEWSLETTERS
In addition, SAMED subscribes to the Government Gazette SAMED endeavours to keep all stakeholders informed of
and Tender Bulletin.The parliamentary monitoring group recent developments within the sector and how these may
collects and provides privileged and reliable data to members affect them. Just a few of these developments relate to

26 SO2 SAMED’S OFFERINGS

on a wide variety of issues, which enables them to make best practices in procurement, the risks of re-using single- +27 31 305 4441
informed business decisions. use devices, global fee tenders as well as the unintended
consequences and the impact that outstanding payments
SAMED synchronises standards and regulatory requirements have on the medical device industry.
within the field of medical devices manufacture and supply.
In this regard, it has links with other stakeholders and TRADE DELEGATIONS
international agencies.These include the Code Technical SAMED hosts both incoming and outgoing trade delegations
Advisory Committee for the Marketing Code (CTAC), the upon request.
Internal Task Group (ITG), the Strategic Health Innovation
Partnership (SHIP), and the Non-Communicable Disease COMPANY REPRESENTATIVES IN THE
(NCD) alliance, the Pan-African Harmonisation Working CLINICAL ENVIRONMENT (CRICE)
Party (PAHWP), the Asian Harmonisation Working Party CRICE, a SAMED initiative, is the industry standard for
(AHWP), the Global Medical Technology Alliance (GMTA), professionals representing medical device companies in the
MedTech,World Health Organization (WHO) and AdvaMed. clinical environment. Masoom Training Solutions administers
the CRICE system.
INDUSTRY-RELATED INFORMATION
UPDATES The CRICE programme
In the news — Members enjoy regular, industry-related continues to expand, with 403
information gathered from numerous sources, including companies participating to date
government (PMG, legislation) and the private sector. and 8087 enrolments nationally
News Roundup —The SAMED News Roundup supplies
our members with the latest local and international news

AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY

MADELEINE 2016 was a pivotal year, not only for South Africa’s management systems, members of the committee and other of action resides with the device component) if the product
PEARCE regulatory environment but also for SAMED’s Regulatory stakeholders met with SANAS (the South Africa National meets the definition of a medical device.This issue has been
Committee. In the year under review, the South African Accreditation System) at a forum in September.The aim of ongoing for a number of years but came to a head this year
CHAIR, SAMED REGULATORY COMMITTEE National Department of Health’s mandate — given to the this meeting was to understand the steps required to allow with the release of medical device and IVD regulations. In
Medicines Control Council (MCC) to regulate medical companies to become certified locally to the ISO13485 terms of provisions of the regulations, it is readily apparent
devices — resulted in the gazetted release of the medical standard for quality management systems for medical devices. that any unregistered medical device that might have been
device and IVD regulations on 9 December 2016. SAMED is currently participating in the SANAS working sold in the Republic at the time of the commencement of
group for ISO13485. the Regulations is considered to be sold legally until a call-up
The MCC instructed medical device companies to start the notice referred to in sub-regulation 28(2) for that medical
process of listing their activities and products.This licensing SAMED advocated strongly against the requirement that device — has expired.This includes combination medical
initiative commenced on 24 February 2017 and is due by 24 companies needed to submit a site master file with their devices, which currently are legally being sold until the MCC
August 2017. Responding to this instruction, the committee application.The guidelines for the site master file were for calls them up to be registered.
partnered with an associate member, the Southern Africa pharmaceutical companies and not in line with how our
Laboratory Diagnostics Industry Association (SALDA) in businesses operate.We motivated to the MCC for the SAMED and the regulatory committee have taken several
presenting a series of monthly regulatory forums. During development of quality manual guidelines.This was heeded steps to resolve this issue on behalf of its members. Firstly,
and a guideline recently been released for comment. the committee approached the Regulator to determine
1 On the international front, the SAMED Regulatory the way forward for combination medical devices, which
Committee continues to be involved in a variety of forums are currently registered as medicines. SAMED has indicated
that promote internationally harmonised medical device to the MCC that in accordance with the aforementioned
regulation. Harmonisation ensures that best practice for Regulations and Guidelines, combination medical devices
safety and quality is implemented in South Africa.This will should be regulated as devices.Thus, they should not be

ENSURING PATIENT SAFETY
SO3 THROUGH APPROPRIATE
28 29

REGULATIONS

1 these events, which often attracted more than 100 SAMED avoid ‘special’ requirements demanded of the industry by regulated in terms of the regulatory pathway applicable to
members, participants gained knowledge about the imminent the Regulator, which could add unnecessary costs and medicines that the MCC has historically applied to such
1. Dr Joey Gouws, Registrar of Medicines, MCC addressing regulation of the industry.The need for regulatory guidance regulatory burden companies that provide much needed products. SAMED indicated that the section 21-approval
SAMED members at a Regulatory Forum within our industry is evident, so SAMED has extended the medical technology to South African healthcare institutions and registration requirements that have been applied to
forums to the Western Cape and Kwa-Zulu Natal to reach and patients. In our quest to promote such harmonisation combination devices — and specifically to the products
as many members as possible. in South Africa, we participated in the Asian Harmonisation referred to herein should no longer apply to such products
Working Party, and the Global Medical Technology Alliance already in the market. Secondly, SAMED has continued to
A recent development was the formation of the medical (GMTA).The latter gives input to the International Medical engage with all hospital groups and stakeholders to allow
device-working group.This specialist sub-committee of Device Regulators’ Forum (IMDRF), standards of practice for them to procure and use these products in their hospitals
the ITG (Industry Task Group) had its first meeting in regulation are decided.The committee also interacts with without MCC registration.The MCC has also just released a
October 2016.The working group will focus on involving other groupings such as Medtech and WHO, among others, guideline on ‘borderline products’ for comment.This guideline
representatives from the regulator and industry to look to ensure we are up to date on latest developments in is intended to provide recommendations to applicants
at issues that arise in the medical device industry. With medical device regulation. wishing to submit applications to register a borderline
regulations directing companies to implement quality medicine, medical device or a combination of a medicine and
NAVIGATING THE COMPLEXITIES OF medical device. SAMED will obtain input from its members
COMBINATION MEDICAL DEVICES to comment on the guidelines.

SAMED has always maintained that the Medicines Control
Council does not have jurisdiction over the registration of
combination medical devices (i.e. where the primary mode

AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY SAMED ANNUAL REPORT 2016 - 2017

ROBYN Africa Forum. Following discussions between the two Copyright © 2017 PerkinElmer, Inc. 400347_08. All rights reserved. PerkinElmer® is a registered trademark of PerkinElmer, Inc. All other trademarks are the property of their respective owners. WE AUTOMATE
HOWES organisations last year, they plan to host four forums
every year. YOUR SCIENCE
SALDA BOARD REPRESENTATIVE
This forum is largely an informative session for SAMED NOT JUST YOUR SAMPLE PREP
Through the Southern African Laboratory Diagnostic members. Its main objectives include developing an
Association (SALDA), which is an associate member of information database about African countries’ requirements In scientific research labs, your procedures, protocols, and personnel are changing
SAMED, members have access to up to date African for medical devices and IVDs, sharing information for all the time. You have to be nimble and flexible, doing more with less—and your
regulatory news. As a body that represents laboratory importation and registration purposes, doing business in liquid handling has to work right along with you. So we deliver true walkaway
medicine in Southern Africa, SALDA, uses its relations with Africa as well as sharing access to market information. automation, freeing you up for more data analysis, more experimentation, more
science. We’ve even automated your setup process, making it easy to learn and use.
This year, the forum’s membership has grown and it has also Best of all, we can automate your science because we get your science—from first
enabled SAMED members to operate in these emerging assay to final analysis. PerkinElmer automated liquid handling solutions. We’ve
markets.While a lack of clarity and consistency with the automated the most important application of all: Yours.
regulatory requirements often exists in each African country, For Research Use Only. Not for use in diagnostic procedures.
the forum has been able to foresee changes in regulations/ www.perkinelmer.com/AutomatedLiquidHandling
requirements before they have been implemented.This
provides members with the latest information as it happens.

The first forum was held on 2 March 2017 at Siemens after
the SAMED/ SALDA Regulatory Forum. Avanthi Govender
Bester, Regulatory Affairs Manager, Africa, BD and Chris Visser,
Regulatory Affairs Manager Africa, GE Healthcare provided

30 SO3 LEVELLING THE PLAYING
FIELD IN AFRICA

the African Society for Laboratory Medicines (ASLM) and an update on regulatory and importation requirements for
the Pan African Harmonisation Working Party (PAHWP), to Southern, Eastern,Western and Northern Africa.Three more
inform SAMED members on any key developments in the forums are set to be held this year.
continent’s regulatory environment.
1. Avanthi Govender Bester addressing SAMED members
Encouraged by the success of the Africa Committee, SALDA on African regulations
and SAMED decided to convert the committee into an

1

AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY

MALAN The Medical Device Manufacturers of South Africa Objective 5: Interact with the various stakeholders in In January this year, MDMSA members also participated in
DE VILLIERS (MDMSA) is currently a SAMED member. In 2014, this the networks of innovation in South Africa to optimise and promoted their products to the Arab market during a
association decided to utilise SAMED’s infrastructure but the development and local manufacture of innovative, very successful Arab Health Trade Mission, which the DTI
MDMSA BOARD REPRESENTATIVE focus on promoting the local medical device manufacturing appropriate and sustainable medical devices for both funded for the second year running. Another opportunity for
industry.This affiliation has resulted in MDMSA participating local and export markets. MDMSA to increase awareness of the organisation occurred
in many of SAMED’s initiatives and committees, inter alia in March, when it ran an information booth and was
Regulatory, Procurement, and HE and R.The association’s Objective 6: Encourage and grow participation of granted a speaking slot at a conference of the South African
ethical business standards are aligned through MDMSA’s PDI’s in the medical device industry. Federation of Hospital Engineering (SAFHE) and the Clinical
pledge to abide by the Medical Device Code of Ethical Engineering Association of South Africa (CEASA). MDMSA
Business and Marketing Practice. SAMED has not only Once MDMSA realised that the objectives of its board is also hosting an exciting local manufacturers’ conference at
supported MDMSA with secretariat services but will also would only be realised through better funding, it approached Africa Health in June. It has negotiated with 12 companies to
fund a dedicated resource for the organisation this year, the Department of Trade and Industry (DTI).This join MDMSA in having exhibit stands at the event.
which will take MDMSA to new heights. government body uses its various schemes to assist South
African associations with support funding. After preparing Both SAMED and MDMSA sit alongside other organisations
This past year the MDMSA Board developed key objectives and submitting a strategic plan based on its objectives, the on the Global Health Innovation Accelerator (GHIA)
to grow its organisation: DTI approved sector specific assistance scheme funding for stakeholder forum. This forum investigates ways to
MDMSA.This funding will greatly assist the association in accelerate access to the most promising technology

1

LIGHTING THE 1. MDMSA booth at the South African Federation of 33
32 SO3 PATH TO LOCAL Hospital Engineering (SAFHE) and the Clinical Engineering
Association of South Africa (CEASA) conference
MANUFACTURING

Objective 1: Market the Association and grow meeting its objectives in the coming year. innovations to better serve the health needs of resource-
the membership. limited communities. Other organisations represented on
MDMSA has welcomed the release and subsequent the forum include the Department of Trade and Industry;
Objective 2: Promote the availability of funding and implementation of medical device regulations, which enable the Department of Science and Technology; the Medical
incentive programmes offered by the DTI to support local companies to compete in the global market. MDMSA Research Council;The National Department of Health; PATH
Development. Give input into DTI specific medical is concerned that the cost of these regulations is higher and the Industrial Development Corporation (IDC).
device local and export strategy. for local manufacturers. It has, therefore, written to the
MCC requesting a review of the fees. MDMSA has also MDMSA is acutely aware that it needs to persuade as
Objective 3: Interaction with relevant parties to examined ways in which it can lower costs with respect many local manufacturers as possible to become members.
promote development of and adherence to national to ISO13485 accreditation for its members. Having a local Increased membership will strengthen its standing when
and international regulatory standards and to promote auditing capability would be very helpful in this regard. In lobbying for a greater share of the devices’ business in South
and encourage among its member’s ethical principles addition, MDMSA has raised its concerns with the MCC Africa. All MDMSA members therefore have an obligation to
and practices. regarding disinfectants being classified as medicines and not recruit more local manufacturers into the fold to ensure it
as combination medical devices. If a company has products has a more powerful, sustainable voice in the industry.
Objective 4: Promote procurement of products that are classified as both medical devices and medicines, it
developed and manufactured in South Africa both becomes onerous on the company, as it needs to have two
within SADC and for export markets. quality management systems.

AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY SAMED ANNUAL REPORT 2016 - 2017

companies prosper. They include Colin Leshou, Gauteng
Provincial Manager, Small Enterprise Development Agency
(SEDA); Pierre Delaney, Director, KPMG;Vuyisile Mshudulu,
Deputy Director: Creative Industries, Department of Small
Business; Ben Bierman, Managing Director, Business Partners
and Ts’episo Makgothi, Chief Director: Strategic Partnerships
and Customer Care, DTI.

SAMED will continue these forums to expose its smaller
members to key customer groups and companies that could
help their businesses expand.

ACCELERATING

34 SO4

SMALL BUSINESS

By leveraging the resources of the entire association, The South African government will be implementing the
SAMED’s Small Business Forum focuses specifically on the new Draft Preferential Procurement Regulations 2016, which
unique needs and challenges of its early emerging growth includes a 30% qualifying small enterprise requirement for all
enterprises.The forum’s main objective is to create an tenders. Simultaneously, SAMED aims to create a database
opportunity for small business members of SAMED to of small-owned companies (especially level 1-3 B-BBEE
raise and discuss issues they are facing in the industry. In companies) that will be advertised to other members and
addition, the forum focuses on ensuring that the medical key stakeholders.
device industry is aligned with national strategic goals in
transforming the economy.

SAMED has hosted three highly informative forums that
have featured several speakers who are not only experts
in their fields but also policymakers who could help small

AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY

SAMED EVENTS
SAMED had its busiest event year yet in 2016.With 30
workshops, general member meetings, breakfast briefings
and annual conference, SAMED has aimed to assist members
with pertinent developments within the industry. Our
successful regulatory forums with SALDA evoked a positive
response from members, with over 100 attendees at most of
the monthly meetings.

SAMED’s flagship event, the annual conference, took place
at the end of August.With its theme ‘Partnering for Patients’
and attended by more than 200 delegates from government,
the industry and the private sector, this was our most
successful conference to date. Presentations by both local

36 THE PLACE 37
TO BE
AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY
and international experts highlighted the need for proper
health technology assessment, regulation and procurement
systems to promote patients’ access to affordable, high quality
and appropriate products to improve the country’s health
outcomes.Value-based procurement of medical devices and
ethical interactions with health care professionals was high on
the agenda, particularly around ensuring that patients are the
ultimate beneficiaries in a changing health system.

“The effectiveness of technology should be measured by
patient outcomes and its total value to the healthcare system
and not cost, irrespective of patients’ financial circumstances.”
— Jeff Hampton, SAMED Chairperson at the 2016 SAMED
Annual Conference.

SAMED ANNUAL REPORT 2016 - 2017

HOW TO MEND A BROKEN HEART

would not require open-heart surgery.“I was very relieved
that I could get the TAVI instead of open-heart-surgery. I
trusted my doctors’ decision and even though the risk was
low, I was still very nervous,” Katja recalls.

Aside from being the youngest person to ever have TAVI,
Katja is the only person with a heart transplant to have
undergone the procedure. It involved inserting a narrow
tube (catheter) into an artery in her groin until it reached
her aortic valve and then temporarily placing and inflating a
balloon in the tight valve to stretch it open.Thereafter, using
another balloon catheter, the new valve was placed in her
heart before the balloon was deflated and removed.Within
30 minutes, the surgery was completed and Katja had a new,
functioning aortic valve. She recovered fully and returned to
the gym just six weeks later.

LIFE CHANGING Synthes’ donation,Worcester Hospital will be able to assist the diseased cartilage and bone are removed.“Other 39
an additional 67 recipients at no cost to them, reducing the benefits include gains in functional activity, particularly
38 waiting time by approximately 3 months.” mobility, as well as an overall improvement to the individual’s
life,” he says.The 67 recipients will be selected from the
INNOVATION Vosloo adds that due to a number of socio-economic factors, current orthopaedic surgery list and their selection will be
such as increased levels of unemployment and poverty in based on international criteria.
the Worcester region, many of the individuals who require
arthroplasty surgery to improve the quality of their life This is the first time that De Puy Synthes has embarked on
are not able to afford the cost of the procedure and are a donation of this scale in South Africa.Westley Turnbull, Sales
therefore reliant on the public health system. Director for the company, says that the donation serves the
sole purpose of improving the lives of 67 patients in need.
Dr Theodore Franken, head of the Orthopaedics Clinical “This donation is made in celebration of the late Nelson
Unit at Worcester Hospital, will drive the project and says Mandela’s birthday, known around the world as Mandela Day,
that the recipients of the joint replacement surgery will and serves to emulate his character by serving those in need.
benefit in many ways. This resonates with our company Credo, which guides us to
care for the communities in which we live and work,”
He highlights that pain relief is the key benefit for any adds Turnbull.
individual who undergoes joint replacement surgery, because

When a valve in Katja Jensen’s heart stopped working CHANGING LIVES FOR THE BETTER IN
properly, doctors said surgery would be too risky. However, WORCESTER, SOUTH AFRICA
doing nothing was not an option, either.
The lives of 67 residents in Worcester, South Africa, will
After Katja started experiencing chest pain, shortness of soon be changing for the better – following DePuy Synthes
breath and dizziness, she found out that her aortic valve had Companies of Johnson & Johnson generously pledging
narrowed to one-third of its normal diameter.The symptoms to donate 67 arthroplasty implant sets to the patients of
were the result of a restricted blood flow from her heart Worcester Hospital, in commemoration of Mandela Day,
into her body and it was clear that something had to be celebrated globally on 18 July 2015.
done. Normally, repairing the aortic valve of a 25-year-old
would require heart surgery, but Katja’s case was unique. Speaking at the official donation handover, Elbie Vosloo, CEO
of Worcester Hospital, acknowledged that although the
“I was born with a heart defect and had a transplant when facility has a state-of-the-art and well-functioning orthopaedic
I was 11,” she remarks.“As I’d already been opened up a department – with a specific interest in arthroplasty – it has
few times and will probably need a transplant again in 10-15 a waiting list of over 350 patients who require arthroplasty-
years, the doctors wanted to avoid another operation.”The related surgery.“Worcester Hospital is able to assist
surgical team decided that the safest option was to replace approximately 100 patients per year with joint replacement
Katja’s aortic valve with an artificial one, using a procedure surgeries, consequently leaving a waiting time of four years,
called transcatheter aortic valve implantation (TAVI), which which is ever-increasing,” comments Vosloo.“With De Puy

AMPLIFYING THE VOICE OF THE MEDICAL DEVICE INDUSTRY SAMED ANNUAL REPORT 2016 - 2017

Tel: +27 (0)11 704 2440
E-mail: [email protected]
Website: www.samed.org.za