Healthcare systems are continuously evolving.
In a time of increasing regulatory oversight, healthcare delivery reform and value-based purchasing of health services, industry stakeholders, either providers or purchasers, need to critically appraise health technologies to determine optimal safety, outcomes, and value for money in the context of equity and equality.
Healthcare providers, including suppliers, and purchasers of health technologies need to be strategic in the way they access markets when introducing new products and/or services to achieve optimal positioning and commercialization.
As policy makers and payers demand value for money, achieving market access by demonstrating safety, quality, cost effectiveness, relative budget impact and health outcomes are a lower cost is a critical success factor.
Health Technology (HT) may be defined as any intervention developed to prevent, diagnose, or treat medical conditions, promote health, provide rehabilitation, or organise healthcare delivery.
With policy makers in both developed and developing countries under extreme budgetary pressure, opposing perspectives and perceptions amongst stakeholders often differ, influencing their own understanding of what defines “value”.
In South Africa, introducing new business and/or technology to the healthcare market may seem like a daunting task, but it’s not an impossible one. BRANDTECH can help you with navigating these complex processes systematically and efficiently.
Read on for more information:
Regulations and licensing
Regulations and Licensing
In accordance with Regulation 19 of the General Regulations made in terms of Medicines and Related Substances Act, 1965 (Act no. 101 of 1965), as of August 2017, any importer, manufacturer, distributor, exporter and/or wholesaler needs to apply to the South African Health Products Regulatory Authority (SAHPRA) for a license to manufacture, import or export, act as a wholesaler or distribute medical devices or IVDs.
This includes guidance on completing the SAHPRA prescribed application forms, and submission of relevant regulatory documentation. Applicants are also required to furnish proof of your Quality Management System (QMS), represented by a Quality Manual. Should there be any subsequent changes to relevant information in the original application, licence(s) need to be amended accordingly.
BRANDTECH can assist with the medical device establishment licensing process including:
- Interpretation of SAHPRA guidelines and requirements.
- Completion of relevant application forms.
- Drafting of the company quality manuals and standard operating procedures.
- Relevant communication templates used with SAHPRA.
Health Technology Assessment and Reimbursement
Health Technology Assessment and Reimbursement
New health technologies are perceived negatively as cost drivers and policy makers and payors of healthcare tools such as health technology assessment (HTA) to inform reimbursement policy decisions, including the appraisal of clinical evidence, cost effectiveness, budget impact and ethical, legal, social and operational implications.
HTA is a potentially lengthy process, therefore preparation of a comprehensive submission may go a long way in expediting final decision making. Use of HTA in not exclusively a funder domain but is also increasingly used by hospitals (informs technology purchasing decisions) and medical practitioners (informs adoption decisions and tariff determination), so is therefore critical that their role in the process is considered as well.
BRANDTECH uses a tried and tested framework employing a phased approach for building a market access strategy and HTA submission for reimbursement. Progress through each phase may be contingent on the outcomes of previous phases, for example, the quality of evidence and/or the level of specialist endorsement.
The goal of a market access strategy is to deliver a health technology to the market with thorough knowledge of its clinical positioning, economic outcomes, and impact on all stakeholders. The outputs of the process are presented via a value dossier, used by funders, and equally so by other stakeholders and decision makers such as hospital buyers and the relevant healthcare practitioners (society).
At BRANDTECH, we understand market access and will endeavour to support the development of your market access strategy and reimbursement via:
- Customer segment analysis of perspectives of value of a new technology.
- Clinical review and appraisal of best available evidence.
- Health economic evaluations and modelling.
- Preparation of Value Dossiers for reimbursement application.
- Facilitation of key stakeholder research, engagement, and presentations (e.g. Funders).