Medical device startups have many challenges ahead of them, including development and manufacturing. Yet there is a way to streamline such challenges by identifying effective facility utilization with regulatory, packaging, and sterilization solutions. In other words, comprehensive, quality incubator support with added efficiencies.

In a recent Medical Product Outsourcing (MPO) article, author Sean Fenske, editor-In-chief, interviewed Life Science Outsourcing’s own CEO John Nino for insight into how companies can proceed if they need a partner from product inception to market delivery and require clean room space, sterilization and diversified solutions. The discussion leaned into how startups can succeed in product development and manufacturing in more strategic and successful ways. The following are a few highlights from the article.

Go beyond the earliest stages of development

Medical device startups are poised to bring new, life-changing medical devices to market. Their innovative solutions can transform the medical landscape and carry medical solutions into a more effective healthcare future. Companies like Life Science Outsourcing (LSO) that offer extensive manufacturing and development services can help such startups in their earliest stages of development and beyond.

“We firmly believe in the value of being trusted partners from the inception of the device,” said Nino. “We can align our expertise with their vision from the start, ensuring the highest levels of efficiency, agility and regulatory compliance.” Doing so enables LSO to help startups deliver their product to market faster, which can be a highly influential factor in determining success or failure.

Developing a device from conception to market launch is much more than the manufacturing of the product. The right partner can help their clients not only navigate the entire journey, but also:

• Meet stringent regulatory standards
• Establish effective supply chains
• Ensure full traceability
• Create safe and effective packaging
• Maintain highest quality standards

Space and capabilities to ensure success

Startups can lean on the varied services of a provider like LSO, including renting space, to achieve their goals. This allows them to “focus on their core competencies while we handle the manufacturing intricacies,” explains Nino. LSO also offers capabilities such as:

• Classified cleanrooms that allow clients to observe the product assembly process
• Product engineering and prototyping to develop validated processes for market launch
• Experienced staff to achieve the highest standards
• Comprehensive in-house sterilization that supports faster time to market at reduced costs
• Proper ISO certifications and FDA registration
• A well-structured QMS that meets FDA and ISO 13485 requirements

A commitment to quality goes above and beyond being a service provider to being a true partner on the startup growth journey.  “All clients, regardless of size, receive the same commitment to quality, the same expertise, and the same dedication.”

Comprehensive services for long-term objectives

Many service providers can provide incubator space able to meet short-term needs. But comprehensive service partners such as LSO also provide a long-term partnership approach with end-to-end solutions.

“Our extensive services stretch beyond standard offerings, providing access to in-house sterilization and validation services, medical package testing, and highly-skilled operators and experts – including an on-staff microbiologist,” said Nino. “LSO is with startups from their initial R&D builds all the way to commercialization.” This includes hands-on support during regulatory audits and beyond.

An important part of working with so many startups is a specialized approach to prevent overlap from multiple clients and safeguards privacy and IP protections. LSO achieves this by:

• Scheduling management and facility usage to prevent overlap
• Stringent non-disclosure agreements
• Individual line clearances and physical separation of projects
• Being NIST 800-171 compliant to protect electronic IP
• Robust security and surveillance system
• Control mechanisms to restrict access
• Commitment to transparency and communication

In addition to all these safety measures, LSO staff have decades of experience and knowledge to work with both small and large clients and are committed to the highest standards of quality for each.

The right contract manufacturing partner

The right contract manufacturing partner can provide the expertise, services and guidance needed by startups or established medical device companies to effectively deliver product to market and allow their clients to feel confident with all aspects – whether that’s using physical space, assembly, manufacturing, packaging, sterilization, or distribution. In addition to those they implement strict security measures to protect sensitive information and position themselves as a partner to their clients’ end goals. Contact LSO today to learn how companies just like yours can start up, speed up, and scale up with comprehensive, end-to-end solutions that can take your products from initial concept all the way to successful market launch and beyond.

Looking for more information on medical device manufacturing? Read Medical Device Manufacturing Must Evolve to Keep Pace With The Times.

Founded in 1997, Life Sciences Outsourcing is an FDA-registered and ISO 13485-certified organization with services and capabilities spanning the entire medical device product life-cycle – from turnkey manufacturing, testing, validation, and sterilization to precision packaging, fulfillment, and distribution. Email us at info@lso-inc.com or call (714) 672-1090 today to get started.