June 2019 | Seabrook Technology Group

Monthly: June 2019

Realize Live 2019 Learning Points: The Four Questions to Ask at the Inception of Digital Transformation

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Participation in large educational and networking events can be rewarding – or exhausting – or maybe a bit of both.  While networking and catching up with old friends (or making new ones) is often what is remembered, I want to take a few moments to highlight an important learning point that I absorbed at Realize Live in Detroit this month (June 10-13, 2019). 

The ever-changing landscape in the healthcare industry has placed abounding pressure on medical device manufacturers. Change is consistent in all industries. Rate of change, however, has increased dramatically in recent years – and nowhere is this more evident than in MedTech, as digitalization is becoming vital to manufacturing processes. 

According to a late 2018 poll in Today’s Medical Developments magazine, the following pressures were listed by medical device manufacturers as “most pressing:”

  • Pricing pressures
  • Access to funding
  • Changing regulatory environment
  • Retaining/growing a skilled workforce
  • New product development
  • Increased market competition
  • Ability to invest in technology

–  www.todaysmedicaldevelopments.com. 12.28.18

The medical device market is experiencing and extreme burden to innovate – not only with new products, but also with new processes.  While large medical device manufacturers continue move forward in a digitally-evolving industry, the Small-To-Medium Medical Device Manufacturer (SMB) is entangled at a crossroads of status quo (with a risk of becoming obsolete) vs. transformation into the digital manufacturing landscape (with initial financial investment, but a hopefully-rapid ROI).   

For manufacturers of all sizes, creating a collaborative, connected manufacturing process improves quality and reduces time and expense.  Moving an enterprise from digitalization concept to established business practice, however, can be daunting.  According to Siemens Digital Enterprise Consultants T. Doering and H. Sand at Realize Live 2019, SMBs must thoroughly understand the transition before they begin to plan and implement this transformation to digital manufacturing. To fully understand this transition, an SMB must ask and answer the following:

  • Why:  Why transition to digitalization? What are the primary drivers for the organization to transform to a digital manufacturing environment (i.e. cost, efficiency, customer demand)?
  • What:  What is the organization’s current state (financial health, culture, etc.) and target for completion (what will be considered “successful” implementation)?
  • When:  When will this transition be completed? What is the organization’s timeline for transformation – and what steps need to be taken to complete this timeline?  Is there a “road map” for the organization’s digital transformation?
  • How:  How does digital transformation align to the goals of the organization?  How will digitalization coincide with strategic initiatives?  How does the digitalization process begin – and with what projects?

 – Realize Live, Digital Enterprise Consulting.  Timo Doering and
Hans Christian Sand.  June 11, 2019

Introduction of a Manufacturing Execution System (MES) can begin to answer some of these questions, and Opcenter Execution Medical Device and Diagnostic (formerly CamstarTM Medical Device Suite) is industry top-of-the-class.  Opcenter Execution MDD enables medical device and diagnostics manufactures to meet the challenges of product quality and compliance – without sacrificing profit.

Opcenter Execution MDD (formerly CamstarTM Medical Device Suite)

  • creates a paperless manufacturing environment,
  • enforces industry best practices and compliance,
  • eliminates non-value-added activities, and
  • creates self-auditing electronic Device History Records (eDHR) and Electronic Batch Records (eBR)

leading to more rapid time-to-market, greater flexibility and agility, improved product quality, safety and reliability, and increased efficiency (effectively lowering costs).

It has been our experience that companies that utilize Opcenter Execution MDD can quickly realize powerful reduction in paper cost, cycle times, manufacturing-related complaints, scrap, product review and release time. In addition to the many benefits, the ease of implementation is often painless, regardless of the size and scope of the enterprise.  Additionally, as a leader in the industry, Opcenter Execution MDD is small-business friendly and serves an extensive customer base with enormous success.

In our next blog, we will address a trending topic among Realize Live attendees (and many in the medical device manufacturing industry):  Compliance vs. Innovation – Are They Mutually Exclusive?  Look for this article coming soon!

Questions about transforming your manufacturing to a digital environment?  Seabrook Technology Group celebrates its 30th year in 2019!  Consisting of a team of global experts and industry thought leaders, Seabrook brings end-to-end manufacturing solutions (people, processes, technology) together in a harmonized fashion to enable operational excellence for medical device manufacturers.  Our team consists of MESA Certified Consultants​, a CamstarTM Certified Team​, APICS, CPIM Certified Consultants​, PMP Certified Consultants​, and FDA Regulation Experts.  Our entire team brings their passion for Integration, Manufacturing Intelligence and DHR Requirements skillsets to their work.  Seabrook Technology Group is a global, privately held company which was founded in 1989.   ​

IRELAND OFFICE (HQ):  Mainline Place, Sarsfield Rd., Wilton, Cork, T12 DY80, Ireland  Tel: +353 21 4800 840 | [email protected]

INDIANA OFFICE: 600 Corporation Drive, Suite # 108, Pendleton, Indiana 46064, USA Tel: +1 317 426 0699 | [email protected]

Med in Ireland Announced

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Med in Ireland, the largest medical technologies event in the country, is scheduled to be in Dublin on 10 October 2019. According to the event’s website, Med in Ireland “…showcases companies that serve the MedTech sector in areas including medical devices, sub-supply, precision engineered components, diagnostics, connected health, (and) research and development. For more information, visit the Med in Ireland website.