Andrea Pilon Artman, MS, CQE, RAC, President & Principal Consultant
The medical device industry is evolving with many SMBs, entrepreneurs, and first-time entrants developing innovative medical devices to enhance public health. One of the biggest challenges they face in bringing their innovations to the market is regulatory compliance. Unlike the large companies with a dedicated team of regulatory experts, these medical device developers might be unfamiliar with the regulatory environment and the interactions required with agencies for the approval of their products. As a result, they are bogged down with the heaps of information and processes that they need to streamline for a better regulatory outlook, thereby failing to focus on the development aspects of their devices. This is precisely why SpectRA Compliance renders its ingenious regulatory consulting services to SMBs and entrepreneurs to help overcome regulatory challenges and bring their innovations to the market. The company strips down the relevant product data so that the clients are ready for any type of regulatory filing, thereby allowing them to divert their focus solely on product development. “We are very focused on bringing innovations to the market that help enhance public health,” remarks Andrea Pilon Artman, President and Principal Consultant of SpectRA Compliance.
Being a small outfit, SpectRA Compliance outdoes the bigger competitors in terms of the level of customer-centricity it brings to the table. The company holds direct one-to-one interactions with the clients to better understand their unique product development processes and develop resources, services, and strategies tailored to meet their specific needs. SpectRA Compliance educates them to understand the why and how of regulatory processes and build an environment to realize their objectives. “We streamline the information and processes for regulatory compliance making it beneficial for our clients to continue using it in future,” says Andrea.
The strong sense of innovation of SpectRA Compliance comes from its founder Andrea herself. A Bioengineering degree holder and regulatory science enthusiast, Andrea has an inspiring inclination towards innovation and its ability to mitigate the current gaps in the healthcare market. It was during her time as a reviewer for the U.S. FDA, where she developed a passion for regulatory science and policy. She has also held multiple positions in regulatory affairs, quality engineering, and regulatory compliance in a wide range of device industries, including cardiovascular and orthopedics. With vast expertise acquired through a decade long service in the medical device industry, Andrea has anchored SpectRA Compliance at the forefront of regulatory services.
We are very focused on bringing innovations to the market that help enhance public health
While most independent consultancies solely focus on just the regulatory aspect of product development, SpectRA Compliance stands unique by providing both regulatory and quality insights. The company leverages its expertise to understand the needs from the FDA standpoint to provide insights from the design control documentation and testing perspective. Andrea and her expert team offer the full spectrum of services required to obtain FDA approval from regulatory submissions to sustaining regulatory and quality programs. SpectRA Compliance provides regulatory submission support that ranges from a review of written documentation before final submission through complete authoring, submission, and regulator communication. With experience on both sides of the FDA table, the company also assists clients in FDA meetings and help meet strategic goals.
SpectRA Compliance leverages its deep expertise in robust regulatory infrastructures to streamline all regulatory activities and enhance day-to-day activities. Besides, the company helps develop a regulatory approach that can be transferred to any product in the future. Whether it is providing coaching or developing a complete strategy that requires just execution, SpectRA Compliance delivers the best services. Further, the company helps in the development and revision of quality management system documentation to create processes streamlined to fit client needs. SpectRA Compliance also supports post-market compliance, good documentation practices, training/education, and consumer support. “We don’t believe in outsourcing regulatory infrastructure, instead we guide them and provide tools that can be used later in their journey,” comments Andrea.
Illustrating the company’s ingenious consulting services’ efficiency, Andrea highlights an instance where the company helped a client submit a 510(k) application for FDA clearance. The client had been aspiring to get the regulatory submission done for five years but was unable to incorporate the information into a package for FDA review stalling the business. SpectRA Compliance stepped in and streamlined the process incorporating all the necessary information into the package rendering a holistic representation of the device. Utilizing her expertise as a reviewer, Andrea was able to pinpoint specific gaps present in the data from the FDA perspective. She identified areas that need more clarification and additional testing required to complete the process. From waiting for years to produce a robust application to FDA, SpectRA Compliance was able to fill all the gaps and submit it in less than three months.
With numerous such success stories up its sleeves, SpectRA Compliance continues to provide personalized support to clients for the regulatory environment. Moving ahead, the company plans to expand its clientele into different submission types and make new connections in the medtech community. Preserving its mission, SpectRA Compliance intends to find innovative companies that require regulatory services such that these efforts ultimately enable improvement in public health.