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Sterling Medical Devices Aims to Improve Speed to Market Amid Changing Regulatory Landscape

Image courtesy of Sterling Medical Devices 150407-0042-web.jpg
Focused on medical device development, Sterling Medical Devices will showcase at MD&M BIOMEDigital how it is using software to manage all activities and assets across the entire product development lifecycle.

COVID-19 compacted a lifetime of change into a few short months, spurring immense disruption within the medtech and biotech sectors. Fold rising chronic disease and global demand for personalized care into the mix, and the healthcare system is facing mounting challenges.

Today, more than a year since the pandemic’s start, we’re at the dawn of a new era of digital and data-driven devices that make up a connected health ecosystem. In early 2020, 80% of physicians in the United States did not interact with their patients in a virtual setting. Six months later, 95% had increased their use of virtual technology. Such rapid adoption of new technology at scale comes with supply chain challenges, evolving regulations, and a myriad of new barriers to address.  

The need for global connection is vital to further advance toward an integrated healthcare system. That’s why Informa Markets – Engineering, the organizers of the industry-leading events BIOMEDevice and Medical Design & Manufacturing (MD&M), will present MD&M | BIOMEDigital, an all-new virtual conference and exhibition that will serve as an educational gathering for medical device engineers driving the progression of the world’s biotechnology. Taking place April 6-7, the virtual event will provide a critical meeting point for the global community featuring a virtual expo floor of 80 companies driving frontline product innovation and a robust conference agenda offering technical sessions curated around today’s challenges from micro molding for medical devices to integrating technology into your next device.

Register here and access exhibitor profiles, exclusive networking opportunities, and technical sessions that matter to you.

I spoke with Dan Sterling, president of Sterling Medical Devices, a first-time exhibitor in the MD&M and BIOMEDevice family of events, to discuss what software and systems attendees can look forward to learning about at their booth.  

Sterling Medical Devices is an industry leader in helping bring medical device projects from concept to market consistent with the latest regulatory standards. Can you speak to Sterling’s portfolio of software and systems that are resolving medical device design and engineering challenges?

Sterling: Sterling Medical Devices invests in the latest IT infrastructure, so our clients don’t have to. With expertise in product development and project management, supported by tools like Polarion, we’ve designed a proven, highly efficient process for product development and new-feature implementation—with necessary testing.

With second-to-none product development processes and an efficient team of collaborators, we meet all standards while ensuring customers are happy with the outcome. It comes down to offering expertise across multiple disciplines and interacting at the right time to mitigate risk and accelerate development.

We are at the leading edge of it all; we have a diverse set of experiences to bring devices to market quickly and cost-effectively. With a focus on innovation, operational excellence, and quality, we are committed to helping our clients resolve medical device development challenges while accounting for the users’ needs.

The pandemic has transformed healthcare in many ways. Can you speak to the medical device regulatory challenges faced as a result of COVID-19 and how these challenges are shaping the future for this sector? 

Sterling: The COVID-19 pandemic has had a disruptive impact on the supply of medicines and medical devices across the world. Temporary accommodations are being made to regulatory requirements, some of which are likely to become permanent (e.g., the US FDA formalizing an enhanced supply chain compliance and capability evaluation or the growth of remote inspections in the U.S. and Europe).

One thing is certain; there will be a new normal. As the quality, regulatory, and compliance teams at medical device, pharmaceutical, and diagnostics firms work to cope with the quickly changing landscape pressures, they must adapt quickly and find ways to use their limited resources efficiently. One area of opportunity is balancing resources between in-house capabilities and outsourcing relationships to manage the temporary volatility and, more importantly, the longer-term strategic regulatory landscape.

As an exhibitor at the all-new virtual event MD&M BIOMEDigital, can you share what software and systems attendees can look forward to engaging with at your booth?  

Sterling: You will be able to learn about our recent projects in the areas of system, software, electrical-mechanical design, and development as well as our work in regulatory affairs and human factors engineering.

We also look forward to showcasing Polarion ALM, a browser-based regulatory-compliant software program that synchronizes the management of all activities and assets across the entire product development lifecycle. This enterprise-grade application lifecycle management solution also facilitates complete traceability, requirements management, and project management.

What excites you most about connecting with your community at the upcoming virtual event? 

Sterling: We are eager to share our expertise with more people—helping them deliver innovative solutions.

How does Sterling plan to leverage the industry-leading virtual event to further the healthcare industry?

Sterling: We expect to identify opportunities for the cross-pollination of ideas between different organizations and medical device manufacturers, developers, and designers. We look forward to connecting with fellow industry professionals to gather more insights about the needs and challenges of customers, demonstrating our expertise in bringing superior products to market, quickly and cost-effectively, and sharing best practices as we build long-standing relationships with fellow leaders in the field.  

To schedule a meeting with Sterling Medical Devices at MD&M BIOMEDigital, please register for the event here and reach out to Dan Sterling, president of Sterling Medical Devices at dan@sterlingmedicaldevices.com.

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