Many companies understand and are committed to ensuring they are compliant with the regulation that is currently in place, they do this while also offering and keeping up to date by servicing and supporting the latest in Medical technology. Over the last few years, the regulators in many countries are proposing more stringent controls and processes especially in emerging markets like South Africa and Botswana. These new requirements are causing a worrying by-product, which is that the Multi National corporations are being protected. These organizations have ample finance, support staff and infrastructure and are supported by a head office that has all the ISO, product registrations and certificates to constantly stay up to date with the changing regulations.
Seldomly will a MNC go out and source a start-up product or even a product outside of their own offering. Where does this leave the entrepreneurs and small-medium sized businesses? These businesses are key to finding new products that will benefit the patients in their geographical areas by bringing new technology to their market. Smaller businesses are also growth driven and offer a more niche offering, servicing hospitals, clinics and laboratories in outer lying regions that the larger competitor may not consider supporting.
These smaller companies are now being expected to be ISO accredited, have special licenses and suitable registrations just to offer a range of products whose revenue may not cover the costs of these regulations. The challenge that these smaller companies will encounter is not having the finance or human resources to obtain these registrations which will lead to the entire product range disappearing from the market. Smaller manufacturers with Niche products may not have the desire to enter emerging markets directly so their products will no longer be represented. These products in some cases are more cost effective, easier to use and clinically accurate in supporting their clinicians.
Further to this, there will be fewer start ups as regulators are wanting these accreditations in place before a trading license is issued. This will delay any new products entering a market. This has the ability to cause large scale price increases in the IVD market as there will be fewer players in the market offering less products.
For example, take a conference like MEDICA, most of those manufacturers being represented are looking for companies to represent them around the Globe. It is feasible that smaller companies will no longer look to take on these products due to the red tape being created by regulators.
We all understand that regulation needs to be tightened, as the results being given to clinicians need to be accurate as there is a patient at the end of every test and they deserve to know that the equipment that is testing their samples is accurate, well serviced and maintained so yes regulation needs to be present in the IVD industry. The growing concern is that this comes at the cost of the smaller entrepreneur or business.
A possible solution is regulators start to offer grants for certain size organizations or a grace period for start up companies, distributors and manufacturers so that they are not excluded from the market due to the existing trajectory of regulation.
By Adam Dodkins, Managing Director of Kat Laboratory and Medical
Adam Dodkins is the Managing Director of Kat Laboratory and Medical, a leading laboratory diagnostic company specialising in supplying high-quality laboratory equipment to Southern Africa. With over 15 years of experience in the industry, Adam has played a pivotal role in the company’s growth and innovation since joining in 2009.
Under his leadership, Kat Laboratory and Medical has established itself as a trusted partner for healthcare providers, delivering advanced diagnostic solutions that enhance patient care. Adam and his team are committed to fostering a culture of excellence and collaboration, ensuring that the company not only meets but exceeds the expectations of its clients.
With a strong background in business management, Adam aligns his strategic vision with a highly technical team which ensures their competitive advantage. He has spearheaded numerous initiatives aimed at expanding the company’s product offerings and enhancing operational efficiency. His dedication to quality and innovation which he gained from his Father, Keith Dodkins, who was previously the Managing Director has positioned Kat Laboratory and Medical as a frontrunner in the laboratory diagnostics sector.
Adam holds a degree in Business and Commerce from Monash University and is passionate about advancing healthcare technology in Southern Africa and is dedicated to improving access to reliable diagnostic tools across the region.
Outside of work, Adam enjoys most sports including golf, water polo and hiking, reflecting his belief in maintaining a well-rounded approach to life, family and leadership.
