Does SaaS Present Quality Risks in Medical Device Manufacturing?

20 Apr 2018 12:22 PM By Dan Telep

The medical device market is currently one of the most competitive and bullish arenas in the business world. Globally, it’s predicted to reach $343 billion by 2021, growing at a CAGR of 4.6%. There are various factors feeding into that growth, but the real catalyst is the aging demographic of baby boomers (people born between 1946 and 1964). According to the American Association of Retired Persons (AARP) there are over 76-million baby boomers in the US alone, and the number of Americans age 65 and over will double in the next 30 years. All of this is creating enormous demand for medical services, as well as for medical devices. Medical device manufacturers have been traditionally conservative in their approach to business software. Compliance with the FDA and other regulatory bodies is mandatory, and necessitates some of the most rigorous quality assurance programs in manufacturing. This, in my opinion, is one of the foremost reasons why Software as a Service (SaaS) offerings are only now being adopted in the medical device arena. As the space heats up, however, device companies are realizing that the writing is on the wall: the old ways of running a business are falling to new, more competitive modes of manufacturing. Modern device manufacturers are under mounting pressure to become agile in the face of volatile market dynamics. It’s imperative to react quickly to counter price and cost pressures, to adapt without fuss to a constantly evolving regulatory environment, and to accelerate innovation and production schedules. In addition, to compete successfully in the future, device companies need to incorporate nascent technologies, such as Big Data and the Internet of Things.

SaaS in Medical Device Manufacturing - Benefits

As noted in a previous blog, I spent several years waiting for SaaS to mature to the point where I felt comfortable endorsing it. That point was passed in 2017, when the various technologies and protocols that enable the current SaaS environment hit critical mass. In my opinion, the risks historically associated with SaaS are now about the same as the risks associated with any other IT paradigm, including on-premise solutions. The benefits of SaaS, on the other hand, are enormous. A properly implemented ERP incorporates data from across the enterprise into a single repository, and combines quality assurance and regulatory experience with state-of-the-art manufacturing capabilities. This helps companies achieve and maintain compliance with quality standards, while embracing new technologies and collaborating effectively along global value chains. An ERP such as Infor CSI (Syteline) incorporates decades of feedback from medical device manufacturers, and makes sure that all of your audit information – batch records, production data, inventory, etc. – is fully compliant with regulations. In addition, SaaS provides a level of security that’s difficult, and expensive, to achieve in a stand-alone ERP deployment. Companies such as Microsoft Azure hire teams of top-notch security experts and networking personnel, who work 24/7 to guarantee that crucial company data is protected by robust security infrastructure, constant back-ups and network redundancies. In conclusion, the perception that SaaS is riskier than in-house IT is now, in my opinion, untrue. There are, of course, always risks involved when creating, transmitting and storing data, but when using an established ERP such as Infor CSI (Syteline), accompanied by carefully considered policies, procedures, contracts and controls, the advantages of SaaS (including the ability to move a significant portion of IT expenditures from capex to opex) are too many, and too important, to ignore. For more information on using ERP including SaaS in medical device manufacturing, please contact the team at Essential Software Solutions.