The COVID-19 outbreak, which is a disease caused by a coronavirus that has spread to more than 100 countries in a matter of a few months, is resulting in massive shortages of the medical equipment required to save the lives of the exponentially growing number of infected patients. As COVID-19 attacks lungs and respiratory systems, hospitals in many countries—including the United States and much of Europe—are facing desperate shortages of ICU ventilators to treat the sickest patients who cannot sustain normal respiratory function.
The news has broken out that Italy has tendered for 5,000 ventilators and Germany ordered 10,000 ventilators for intensive respiratory care. The UK will need 20,000 and the US will require up to 600,000 lung ventilation machines if the pandemic goes from bad to worse. This coronavirus has required respiratory device manufacturers to immediately increase their production by 30–40%. We at Auriga have asked our experts what moves to expect from the medical device market and how medical device software vendors can help.
How to Cope with the Scarcity of In-house Resources
The COVID-19 pandemic is an unprecedented challenge for manufacturers of life-saving medical equipment and everyone is concerned about whether they will be able to meet the rapidly growing demand. Some companies are boosting production while others rush to modify their production lines and start manufacturing medical ventilators. In the critical situation the world currently faces, in-house resources can no longer cope with the increased workload.
Yuri Kirkel, EVP at Auriga, shared his thoughts:
While the medical device release cycle can take up to five years under normal circumstances, for obvious reasons, companies are being pressed to bring new products to market much faster. Rapid prototyping plays a vital role in reducing the time to market while maintaining quality. At the same time, delivering a new solution is just the first step; existing devices with average product lifecycles of about 20 years require adequate maintenance, support, and regulatory updates. Sustaining engineering is no lesser a priority for providing efficient patient care.
One practical solution for optimizing processes and resources is mobilizing the full in-house capacity to develop new products using simulation and emulation techniques to “shift timelines left” and offload prototyping and sustaining engineering to reliable partners. I expect that more MedTech companies will invest in software services in the near future and Auriga is there to help our medical device and software customers utilize the best practices we have learned over 20 years in the industry.
How to Choose a Trustworthy Software Services Provider
If in-house resources are scarce and outsourcing was never previously on the agenda, finding and choosing a reliable and trustworthy vendor might be a challenging task, particularly in the current stressful environment. Vyacheslav Vanyulin, Auriga’s CEO, explained what distinguishes a reliable software development partner:
In the midterm, medical device manufacturers have very few options: enhance and support existing products or prototype and develop new, low-cost solutions. Moreover, we will probably witness numerous acquisitions when companies will have to make acquired assets compliant with the strict standards of internal product lines. We know firsthand how important it is to have skilled software experts on board in all of these cases and our knowledge is supported by numerous projects delivered in areas of sustaining engineering, prototyping and algorithm development, porting to new platforms, and developing complex embedded testing frameworks.
Our current MedTech clients often mention that the choice of an outsourcing partner is defined by what the contractor can actually offer. A trustworthy provider can demonstrate verified customer references, a certified QMS system, and experienced specialists ready to discuss not only the project but the product itself. We are proud that our customers choose us for these reasons.
Software for Medical Devices: Сommon Tasks a Service Provider Can Leverage
There are several important elements in medical device software development that manufacturing companies can entrust to a third-party provider, regardless of whether the device is an ICU ventilator machine, patient monitor, or infusion pump. In our practice, such elements may include new products that we can prototype at pace in close cooperation with the customer, user interface and other secure elements in terms of IP, cybersecurity modules, and even algorithms.
- UI/UX is unfairly considered the least important element, although our experience and customer feedback prove it is often a crucial factor that can determine the success of an entire product. The user interface is not just a pretty picture but a matter of usability that affects hospital personnel’s decisions.
- Real physical electronic components (actuators, sensors, motors, etc.), control mechanisms and systems of medical devices. Auriga simulates them to cut development costs and reduce time-to-market. Several years ago, we developed a fully functional simulation system to quickly evaluate and test the new features of syringes and large-volume infusion pumps.
- Cybersecurity is what medical device manufacturers value, particularly as IoT and AI gain momentum. We at Auriga see medical device cybersecurity as an increasingly important issue and have partnered with Parasoft on test automation and static and dynamic code analysis to develop more secure and safer healthcare solutions.
- Finally, there are algorithms; this is the most critical element and is rarely entrusted to third-party providers. Nevertheless, we have such projects in our portfolio. For example, we have developed an automated cardiac defibrillation algorithm for an innovative defibrillator monitor and worked on patient monitoring algorithms for top medical device manufacturers.
In Summary
COVID-19 is a global concern that is affecting nearly every industry, and healthcare is at the forefront of this challenge. This coronavirus will make manufacturers of ICU ventilators and other medical devices rethink their approach to new product development and sustaining engineering of existing products. Today, it is more vital than ever to set rational priorities, optimally allocate resources, and balance in-house and external expertise to respond to the serious threat represented by the coronavirus pandemic. More than ever, MedTech companies are looking into partnering with reliable and highly experienced vendors that can both supplement their shortages of internal skillsets in certain areas and help take over non-mission-critical functions while the core personnel focus on new product development.
