It is relatively easy to come up with an idea for a product compared to creating a team that would work on it or successfully launching it into the market.
To achieve a consistent and flawless collaboration system, all of the tools and features have to be made step-by-step, which costs millions of dollars and even more hours. Luckily, this painful problem has been eased with a handful of companies that can help do all the tasks in parallel rather than sequentially.
How did Orcanos come to be? What was your journey like since your launch in 2005?
Orcanos started its way as bootstrap focused on ALM and provided consulting and services. After a couple of years of working in this complex discipline, we understood the real pain of organizations producing and performing in heavy-regulated industries – a lack of integration leads to miscommunication between the compliance departments and the R&D teams that costs billions of dollars and years of delay in time-to-market!
In 2017 we introduced the unified SaaS solution with a vision for one software and integrated process for all, based on our state-of-the-art infrastructure that could support specific industry needs related to compliance and regulation alongside ALM and QMS. Orcanos started implementing its new product in 2017 in medical device manufacturers and later in the automotive and aerospace industries.
Can you tell us a little bit about what you do? What are the main issues you help solve?
We are creating a new way for companies to comply with regulations that reduces time-to-market and saves billions of dollars because it allows them to do everything in parallel and not sequentially as it always was. The integration we bring alongside a proactive approach based on real-time continuous audit is forming a new method for key departments to develop and produce safe and regulation-compliant products to market. We aim to be a leader in the compliance management arena and provide robust and scalable solutions injust one automated centralized platform.
By forming a new method, we can solve a lot of problems and grow companies. We save billions of dollars for our customers by putting 4-7 systems on one platform that are seamlessly integrated and communicate. For example, During the product life cycle, from its initiation as an idea until its end of life, our customers must document every event/change related to the product and evaluate its impact on its safety.
This requires the involvement of many people in the organization and the need for a collaborative platform that can capture both the engineering data (ALM), Quality (QMS), and manufacturing (MES) up to the last phase of the Post Marketing. The Orcanos way combines automated audit real-time risk management capabilities concerning the most updated standards and regulations.
Why do you think certain companies are sometimes unaware of the risks they are exposed to?
I would say that innovation penetrated products but not processes in heavy-regulated industries such as medical devices, pharma, and automotive. No matter what industry you are in and the size of the company, the requirements of the regulations are going higher and higher, putting more pressure on the quality of the products to protect the public. That requires much more time for various processes, but the world's time to market is coming shorter than ever. Vendors are required to quickly and safely introduce new technologies and products to the market.
This tension meets most companies when they still use printed paper to manage and control documentation. There is no automated audit within the process. Employees get tired and frustrated, which increases the chance of human errors, brings inaccurate processes, which the external auditors later inspect, and causes delays in time-to-market. Using a digital platform covering 90% of the activity documented in the ALM and QMS can save millions for those organizations in re-engineering, recalls, and potential safety harm.
How did the recent global events affect your field of work? Were there any new challenges you had to adapt to?
A solution like Orcanos is necessary for day-to-day work while keeping the execution and quality of the company's program efficient and on time. During the COVID-19 pandemic, we have seen organizations’ importance in keeping their employees' operations from remote locations and homes. That increased the need for a cloud-based solution vs. an on-prem install base.
Also, the need to have a robust collaborative working environment becomes essential to keep the communication between spread teams fluent and transparent. We have seen strong adaptation to consolidated solution vs. singular where one system can replace several systems to reduce the cost and integrations between working processes, to allow a bigger picture of the project state.
Besides quality management solutions, what other cybersecurity solutions do you think are essential for every organization?
Recent years show an increase in cybersecurity attacks, and vendors must comply with specific standards to be cleared by the regulatory authorities. Specifically, the medical device and automotive industries and generally regulated products address cybersecurity regulatory requirements.
That means that vendors need to protect the data and the product functions from cybersecurity threats. Orcanos, as a vendor, needs to comply with ISO 27001. This means we must meet each requirement with traceable evidence both at the technical level and in the quality procedures of our organization.
What other parts of our daily lives do you hope to see digitized or automated in the next few years?
Orcanos’ vision is to provide all the necessary tools for any manufacturer to address more departments involved with the development, quality, and production of their product – making a new language from ideation to production.
We intend to penetrate the Pharmaceutical, Automotive, Aerospace, and Medical devices industries in the next few years. We have seen the need in those industries for better process automation and collaboration tools to increase productivity and reduce risk.
Since health is your main field of focus, how do you think the wellbeing industry is going to evolve in the upcoming years?
Since the Obama administration's new health program, we have seen an increase in home health solutions. Helping the healthcare industry provide services and monitoring by keeping the patients outside of the hospital area and saving millions. More wellbeing products based on the mobile health solution are coming.
However, the regulation is still building the standard requirements for such products so they will be safe, secured, and accurate, which is the direction we see the industry is going. Also, the need to reduce the size of essential devices to be placed locally in physician clinics is another direction the industry going. So, the evolution is towards mobility and security.
In this age of ever-evolving technology, what do you think are the key security practices both businesses and individuals should adopt?
We see massive use of biometric technology from our understanding of the market and the projects we are working on with our clients. It is still in its infancy, but we believe that more devices and technologies will be based on biometric authentication to identify patients' records and adopt the services and product function to each user safely and securely.
The IoT also goes into transformation. We believe that interpretability will become a significant issue that must be addressed to ensure smooth data transition across platforms, healthcare providers, and devices.
And finally, what's next for Orcanos?
Orcanos is moving forward with its next-gen product that will be released by mid-2023 and will bring a new way to comply with regulations. We bring together automated regulation auditing, real-time risk management, and integration capabilities that simplify the complex processes in one adaptive SaaS platform.
Besides saving tons of money and time, we aim to become the source of knowledge and practices for our clients through our marketplace. We will be able to place treasured knowledge owned by specialists who will make it available to our market as an add-on to the Orcanos SAAS platform they are using.