Providence Enterprise
The Trusted Electro-Mechanical Manufacturer of Class I and II Medical Devices

The year 2020 was a year like no other. Looking back at this year, one can safely say that it was a pivot point for many industries, particularly the healthcare industry. At the fulcrum of this ‘wind of change’ was this year’s infamous COVID-19 pandemic. The impact of the pandemic was seen on multiple fronts. On the one hand, healthcare providers had to deal with an ever-increasing number of COVID-19 patients; and on the other, country-wide lockdowns forced many medical device manufacturers to suspend their operations. These two apparently unrelated situations started creating the biggest ever hurdle for the healthcare industry: the shortage of crucial medical devices amid the burgeoning number of patients.

To overcome this situation, many medical device companies are now partnering with non-medical OEMs to ramp up the production of healthcare and medical devices. However, most of these endeavors are getting tangled in the regulatory protocols as the manufacturing processes of non-medical OEMs typically don’t follow the safety standards necessary for making medical devices. Thus, it is becoming imperative for medical device companies to bring more experienced and capable contract medical device manufacturers onboard.

Enter Providence Enterprise—a leading contract manufacturing company for the medical and healthcare, food and beverage equipment, smart appliances, industrial, and automotive industries. Providence Enterprise is currently working in full steam with its three FDA registered ISO 13485 certified factories to support the rapid production of pump and motor-driven smart medical devices, such as ventilators, respirators, infusion pumps, drug delivery pumps, and more. Besides, the company also has access to ISO 8-100K cleanroom molding, ISO 7-10K cleanroom assembly, and sophisticated surface mount technology (SMT) lines to most effectively meet every need of medical device companies. To further support and speed up the manufacturing processes, Providence Enterprise’s experienced R&D team is continuously collaborating with partner companies at every step of the medical device production—right from the design phase to through to mass production of IoT, Bluetooth, and sensors technology-enabled medical devices. “We are now operating in overdrive and manufacturing smart, electro-mechanical medical devices that use pumps and motors,” states Brett Freeman, president of Providence Enterprise USA, Inc.

Nevertheless, it’s not just the manufacturing, technological, and management capabilities that put Providence Enterprise ahead of its competitors. It is how the company handles each of its client engagements, which makes the company a go-to partner in the market. To elaborate, Freeman shares a case study. A fast-growing North American company approached Providence Enterprise to manufacture insulin pumps.

Providence Enterprise’s experienced R&D team is continuously collaborating with partner companies at every step of the medical device production—right from the design phase to through to mass production of IoT, Bluetooth, and sensors technology-enabled medical devices

Even though the client had an existing automated manufacturing unit in the U.S. and a Chinese supplier for producing the insulin pumps, the overall manufacturing yield was still low to meet the market demand. When Providence Enterprise was chosen as a potential manufacturing partner, they set up a semi-automated production line to not only flatten the demand and supply curve but also provide higher yields and bring production stability, along with improved traceability within a reasonable price bracket. Besides, the production lines were also networked to a secure, online portal that allowed the client to monitor their operations in real-time. “Our efforts in this engagement resulted in higher production yield that surpassed the client’s expectations pertaining to quality, consistency, and reliability,” highlights Freeman.

Notably, it is because of these illustrated contract manufacturing capabilities that Providence Enterprise has been able to earn numerous prestigious certifications over the years. Some of the certifications include ISO 13485: 2016 medical device quality management system, ISO 27001 information security system, ISO 9001: 2015 quality management system, ISO 14001: 2015 environmental management system, and many others. It is also important to note that Providence Enterprise has witnessed a 15 percent growth in 2020, which only bolsters the company’s reputation as one of the most resilient contract manufacturing companies.

But, as it seems, Providence Enterprise is not going to contain itself with these competencies only. The company is rather poised to take more challenges head-on and emerge as a true leader in the contract medical device manufacturing industry. “We have recently added silicone rubber molding capabilities that would widen our manufacturing capabilities for any device and equipment types,” notes Freeman. The president also highlights that Providence Enterprise will continue to offer its services to food and beverage equipment, smart appliances, industrial, and auto motive partner companies with the same zeal as it does with manufacturing Class I and II medical devices. And through all these efforts, Providence Enterprise is laser-focused on setting many new benchmarks in the contract manufacturing segment in the coming months.