On  25 October, SAMED leaders came together for the SAMED CEO Pulse forum, aimed at taking the pulse of medtech. Our member leaders were joined by representatives from the Department of Health, the Department of Trade, Industry and Competition (dtic) and the CSIR.

The future of medtech was at the forefront of discussions. Part of that future included the Health Products Master Plan which was presented by dtic consultant, Vic van Vuuren. The engagement was an opportunity for SAMED leaders to contribute to the ideation and practical consideration for a successful sector master plan – which aims to attract investment, scale local manufacture and reduce the current trade deficit. The CEO Pulse forum was also an opportunity for leaders to share the burning issues that currently affect the sector and to brainstorm innovative solutions that would help propel the sector forward.

One of the main challenges highlighted by the leaders was non-payment from the government. This has been a long-standing issue that has led to a lot of frustration and uncertainty within the medtech sector. It was raise with the dtic representative as a barrier for creating capacity, attracting international support and growing the South African medtech market. It was a risk to sustainability and it was a hurdle for the attractiveness of the Health Products Masterplan. SAMED was soon to relaunch an update data collection mechanism for tracking outstanding governments debt in efforts to have the right data needed to drive a response from provincial and national health and treasury departments.

The discussion also shed light on the lack of government support for local manufacturing. Other sectors had attractive market conditions through policies and incentives that attracted local manufacture. Other countries were offer increased support and favourable conditions to attract the local manufacture to their country and if South Africa’s government could not offer equally attractive conditions, it was unlikely that international principal companies would invest in local manufacture. Creating favourable conditions would also assist the current pool of local manufacturers to scale their production, however, a greater emphasis on local demand would be needed to ensure that the continued success. The dtic representatives took notes of these challenges and invited SAMED as a collective to comment on the draft Health Products Master Plan, which they hoped to finalize by the end of the year.

Unsurprisingly, the medical device regulations, pending product registrations and associated fees was a key concern for medtech leaders. Depending on the way in which the regulator planned to apply fees (per line item or per family) would determine the feasibility for continued business and the lack of a call up roster, left companies unable to adequately budget and plan for the impending implementation. It was also raised that the more unique requirements are imposed for South Africa, the less attractive the market becomes – i.e. asking for unique labelling requirements added to the ultimate cost of the product which in turn would affect the products market position and ultimately patient access. It was essential that SAHPRA considered not only the fees they were proposing, but  other significant costs that medtech companies had to cover in relation to ISO13485 accreditation. SAMED committed to raising all these concern in its submission, but implored leaders to ensure that their regulatory personal completed the Data with Integrity questionnaire which SAMED would use to inform the submissions – without the data, SAMED would not have the leverage needed for its position.

Another burning issue for members was Discovery Health as a barrier to entry for new players and technologies. Their significant market share meant certain private hospitals and hospital groups required their reimbursement approval before allow the technology to be procured. This leverage was in turn used by Discovery in price negotiations with suppliers and members felt that Discovery often adopted a “take-it-or-leave-it” approach to negotiations. The unsustainable price negotiations were to the detriment to the the medtech companies and ultimately, to the patients and users of the technologies. The SAMED Board is committed to strengthening the working relationship with Discovery and was meeting with the Discovery Health leadership to discuss industry’s concerns.

The uncertainty of National Health Insurance, including the potential for a change is guard with the elections left medtech leaders feeling uneasy. The members asked for SAMED to continue to provide updates on this important piece of legislature which would change the entire health landscape.

Members were urged to continue to send through other burning issues, not just now but also throughout the year as this keeps SAMED on the pulse of industry changes, challenges and opportunities. All inputs received would be used to develop and evolve SAMED’s strategy and activities for 2024.

It is clear that the leaders of medical technology companies and SAMED remain committed to overcoming the challenges facing the sector and finding innovative solutions to improve healthcare delivery in South Africa. As always, SAMED remains committed to the success of an ethical, sustainable and transformed medical technology sector.