Transforming technology into a compliant and commercially viable medical product is one of the biggest challenges in modern healthcare. Adopting medical instruments in different medical settings requires time, money, resources, data and - more importantly - support from clients within the system. Commercial success is based on companies that manage collaboration between many critical business functions - including R&D, regulatory, manufacturing and clinical - to provide a regulatory-approved solution for use. patients and deliver better clinical outcomes more cost-effectively.

Understand the market

A commercial medical device should show clinical and economic evidence of worldwide success. In an ideal world, products should provide better outcomes for patients and more effective solutions for healthcare systems. Providing the appropriate level of evidence required for regulatory approval is a long and complicated process. It relies on first proving the validity of the medical concept, identifying key clients who are likely to adopt the technology soon, and working with them to coordinate research that will demonstrate the impact of the device on patients. in real life. Even if regulatory approval is obtained, companies should continue to study patients to ensure that the data remains valid.

Placing medicines on the market is a process that can take many years. It relies on the goodwill of non-prescription doctors to promote new approaches to medical problems, as well as strong evidence of positive outcomes in patients. 

Medtech devices can be especially successful when used in a wide range of medical conditions - we call such devices "platform technologies". For example, Sky Medical's own gecko increases blood flow rates in patients who have limited mobility for some reason. It has applications for hospital patients (unable to move during surgery) as well as for inactive patients around the house. The device is therefore likely to be used for a variety of conditions that can be treated with increased blood flow, such as VTE and chronic wound care.

These types of devices can be very useful for healthcare systems. The wider the application options, the more effects the device can have. However, this does not mean that the path to regulatory success is less complicated or cumbersome.

Overcome regulatory barriers

Any application for any other use should be considered to require the patient's own data. Evidence that a medical device can improve blood flow in dealing with a medical condition cannot be used in other scenarios.

Clinical and economic evidence is needed to support each of the various indications in which the device may be useful to the patient. Like regulatory approval, it must be achieved for each different clinical application. For medical devices involving electronics and batteries, these devices have the additional complication of having to comply not only with clinical regulations but also with regulations on electrical safety, environmental laws and biocompatibility.

Because regulatory laws vary from country to country, medical companies should also take into account that regulation will vary from country to country. In addition, the regulatory environment is constantly changing.

How regulation affects production

This can have a direct impact on the production, distribution and supply chain problems that companies face; Each country supplied may require specific declarations regarding compliance with the rules of content or packaging. This makes it difficult to move stocks quickly from one country to another and may require additional investment in supplies. Excess stocks can be a big leak, and this is reinforced because medical companies need to ensure a steady and reliable supply of equipment that serves the needs of patients.

For these reasons, close and regular communication between business, financial and production groups is essential. This includes checking delivery times for product components and equipment assembly, along with an ongoing forecast of product sales in the area. It is also clear that it is important to invest in the production process to ensure that each device is of high quality and reliable.

Cooperation leads to successful innovation

Close collaboration enables companies to make informed decisions that will help medical devices function more successfully across healthcare systems. Having a multidisciplinary team equipped with relevant knowledge and skills for cooperation in research and development, regulation and production is a must for successful launch of equipment. It's a communication challenge just like a clinical one - if you can create an environment where business functions can work together, you've created space to support innovation.