Rachel Fallon, CTO Sky Medical, outlines the challenges and regulatory hurdles faced when adopting medtech devices into global healthcare systems.
Transforming a technology into a compliant and commercially viable medical product is one of the biggest challenges in modern healthcare. Adopting medtech devices into different medical settings requires time, money, resources, data and – crucially – backing from clinicians within the system. Commercial success relies on companies managing collaboration between multiple critical business functions - including research and development, regulatory, manufacturing, and clinical - to deliver a solution that has regulatory approval for use on patients and delivers better clinical outcomes more cost effectively.
Understanding the market
A commercially viable medical device needs to demonstrate both real-world clinical and economic evidence of success. In an ideal world, products need to deliver both a better outcome for patients and a more cost-effective solution for healthcare systems.
To provide the relevant levels of evidence required for regulatory approval is a long and complicated process. It relies on first demonstrating the validity of a medical concept, identifying the key clinicians that are likely to become early adopters of the technology and working with them to arrange studies that demonstrate the impact of the device on real life patients. Even when regulatory approvals have been achieved, companies must continue patient studies to ensure the ongoing validity of data.
Bringing medical products to market is therefore a process that can take place over years. It relies on the goodwill of already overstretched clinicians to champion new ways of addressing medical issues, as well as rock solid evidence of positive patient outcomes.
Multiple applications – multiple studies
Medtech devices can be particularly successful when applicable to multiple medical conditions – we call such devices ‘platform technologies.’ For example, Sky Medical’s own geko device increases the rate of blood flow in patients with limited mobility for whatever reason. This has applications for patients in hospital (unable to move when recovering from operations) as well as for immobile patients in the home environment. The device is therefore potentially applicable to a range of conditions that can be improved through increased blood flow, such as VTE and chronic wound care.
These kinds of devices can be hugely beneficial for healthcare systems. The wider the possibilities of application, the more impact a device could potentially have. However, this does not mean the route to regulatory success is any less complicated or onerous.
Navigating regulatory hurdles
Every application for each different use needs to be considered as requiring its own patient data. Proving that a medtech device improves blood flow to address one medical condition is not applicable to other scenarios. Clinical and economic evidence is needed to support each different indication where the device could be beneficial to the patient. Likewise regulatory approval will need to be achieved for each different clinical application.
For medtech devices that incorporate electronics and batteries, devices have a further complication of needing to comply with not only clinical regulation but also regulation around electrical safety, environmental legislation, and biocompatibility.
Because regulatory legislation varies from country to country, medtech companies also must consider that regulation will vary in every country. Additionally, the regulatory environment regularly changes.
How regulation can impact manufacturing
This can have a direct impact on the manufacturing, distribution and supply chain challenges that companies face; each country supplied may need specific regulatory compliance statements within or on the packaging. This makes it much harder to quickly shift stock from one country to another and may require additional investment in supplies. Excess stock can be a major cash drain, and this is further exacerbated because medtech companies need to ensure there is always a steady and reliable supply of devices to service the needs of patients.
For these reasons, close and regular communication between the commercial, finance and manufacturing teams is essential. This includes keeping a watch on lead times for product components and device assembly, together with a rolling sales forecast for product by territory. It is also clearly important to invest in the manufacturing process to ensure every device is high quality and reliable.
Collaboration leads to successful innovation
Close collaboration ensures businesses can make informed decisions that will help to roll out medical devices across healthcare systems more successfully. Having a multi-disciplined team equipped with the relevant knowledge and collaboration skills across research and development, regulatory and manufacturing is a pre-requisite to bringing a device successfully to market. This is as much a communications challenge as a clinical one – if you can create an environment where business functions can collaborate, you will have a space built to encourage innovation.
