5 years ago

For bio/med companies, technology has become a significant growth catalyst and adoption of cloud, digitization and process automation are more important now than ever. As a result, more software companies are providing solutions that are specifically designed with this industry in mind.

Among the fastest growing of these companies is MasterControl, which provides a software-as-a-service (SaaS) platform for life science companies and other highly regulated industries. To learn more about the organization and where it’s headed, we sat down with Martin Smyth, MasterControl’s Vice President—Marketing Strategy for a brief interview. Learn more about MasterControl here. This is what Martin Smyth had to say:

Tell us about your organization and your current initiatives:

  • MasterControl has been helping companies get regulated products to market sooner for over 20 years. We started as a document control company, evolved into a leading quality management system provider and eventually expanded our portfolio offerings to include unique solutions that help companies digitize, automate and connect quality and compliance processes at every stage of the product lifecycle.
  • We now have process-specific solutions for product development, clinical, regulatory, quality, supplier, manufacturing and postmarket. This connected approach is what we call product lifecycle excellence—or simply put, helping companies achieve new levels of operational excellence by converting paper-based or legacy systems to modern digital applications.
  • This year one of biggest initiatives will be our manufacturing product, which is a big leap forward for enabling fully digital production records like electronic device history records, equipment calibration and equipment maintenance that integrate seamlessly with the quality system. This essentially makes paperless manufacturing a reality and increases plant operational performance while increasing product quality.

What role does your organization play in the bio/med industry? What sets you apart?

  • We have a very large presence in the bio/med industry. Currently, we have over 500 customers in this category, including 32 of the top 100 medical device companies. We also have a strong presence in associations worldwide. The biggest differentiator for MasterControl is the connectivity and automation we offer.
  • Instead of focusing on just one process, such as quality, we want to give our customers complete control over the product lifecycle using multiple solutions working together to improve visibility, accelerate time to market and reduce risk. This is incredibly important for our customers as regulatory bodies now require enterprise-level of control and visibility of data within an organization—and, in some cases, its suppliers, partners and customers.

What do you see as the biggest challenge facing the bio/med industry today?

  • The industry is at a point where technology has an increasingly large presence in bio/med products, especially medical devices. This makes compliance more complex, and regulations worldwide are changing to reflect those changes. One example of this is the FDA’s efforts to strengthen its 510(k) review process. There are some benefits to these changes, such as more data being available to bio/med companies. But this introduces another challenge, which is making that data useful.
  • Since the information exists in disparate systems with little or no interconnectivity, it’s difficult to analyze the data. This is something MasterControl has thought a lot about and it’s central to our platform approach, which makes it easier to collect, manage, analyze and share product quality data across your organization.

What is in the upcoming pipeline for your organization? Where is your focus?

  • We’re working on improving the data analytics capabilities of the MasterControl Platform™. We already offer solutions to help companies from product development to postmarket review, now we want to focus on helping those companies use their data to improve their offerings. With more robust, cloud-based solutions we can offer our customers the ability to see how they’re performing generally, but also give them an indication of how they’re performing compared to others in their industry.
  • Since becoming a member of MedTech, we worked with the association on multiple planning committees and we were a vital part of planning the MedTech Annual Conference.