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Culture of Compliance vs. Culture of Innovation: Are they Mutually Exclusive?

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Can innovation and compliance co-exist – or even support one another – in an environment like medical device manufacturing?

All organizations have a “culture” that is experienced, felt, reinforced, and – in most cases – can be manipulated for success or failure.  According to TrainingIndustry.com, “Corporate or organizational culture is the personality of the organization – derived from the sum total of all the norms, values, history, stories and expectations within the organization (http://www.trainingindustry.com Culture vs. Creativity: Is Your Organizational Culture Killing Ideas?).”

In the Medical Device Industry, culture often moves to one end of the spectrum – a culture of innovation versus a culture of compliance.  However, does an organization need to move to such extremes?  Can innovation and compliance co-exist – or even support one another – in an environment like medical device manufacturing?

Compliance

Compliance is defined as “the act or process of complying to a desire, demand, proposal, or regimen” or “conformity in fulfilling official requirements (Merriam-Webster).”

In manufacturing, compliance is an absolute necessity, as failure to do so can lead to a myriad of organizational, product, and legal issues.  To be compliant protects the manufacturer from product failure, safety risk and recall, and legal punishment.  While regulatory compliance can be seen as “the enemy,” to operate a compliant business creates a positive reputation for the business, mitigates risk, provides consistency in the manufacturing process, leads to a more productive manufacturing floor, and levels the playing field for all sizes of manufacturers.

Innovation

“If you are successful at solving important problems, peers you respect will call your work innovative and you an innovator.” – Leadership Expert, Scott Burken

Innovation is defined by Merriam-Webster as “the introduction of something new; a new idea, method, or device.” More specifically (and perhaps more accurately), author and leadership expert, Scott Burken, defines innovation as “… significant positive change. It’s a result. It’s an outcome. It’s something you work towards achieving on a project. If you are successful at solving important problems, peers you respect will call your work innovative and you an innovator (http://www.scottburken.com).”

According to Australia’s Business.Gov website, “Being innovative does not only mean inventing. Innovation can mean changing your business model and adapting to changes in your environment to deliver better products or services. Successful innovation should be an in-built part of your business strategy, where you create a culture of innovation and lead the way in innovative thinking and creative problem solving (http://www.business.gov.au).” 

As is the case with compliance, innovation, too is a necessity in the manufacturing enterprise, as implementing new ideas, creating dynamic products or improving existing services can be a catalyst for the growth and reputation of your business.  Additionally, medical device innovation is paramount to advances in healthcare and patient safety. 

Compliance & Innovation:  Friends or Foes?

As we’ve discussed in previous blogs, the ever-changing landscape in the healthcare industry has placed an enormous amount of pressure on medical device manufacturers. According to a late 2018 poll in Today’s Medical Developments magazine, the “changing regulatory environment” and “new product development” were listed as two of the “most pressing industry pressures,” along with pricing, funding, competition and technology – which one could argue are also related to compliance and innovation (https://www.todaysmedicaldevelopments.com. Dec 2018).

So, as we look at the two major driving factors of the medical device industry – innovation and compliance – must we look at them only as competing factors in the future of Medical Device Manufacturing?  Is it possible that regulatory compliance and innovation can work together to strengthen the medical device manufacturing industry? 

Compliance & Innovation: Mutually Beneficial?

“Regulation is necessary to provide assurance that the safety and efficacy balance is maintained, but regulators also must realise there is no public health value in inhibiting innovation.” – Dr. David Chesney

New regulations are a way to protect consumers, but they aren’t often popular with the industries at which they are aimed. Regulatory compliance forces companies to do something out of the norm. As regulatory compliance impacts an industry, organizations need to transcend their individual processes to innovate and create something new.  As has been seen in recent years, compliance has encouraged companies to think out of the box (digital twin, AI, IoT, Industry 4.0) and – in some cases – even work together.  Additionally, regulations that lead to innovation in manufacturing are often beneficial for product development, process efficiency, staff development, and much more.  Innovation in manufacturing can take many forms, from new technology and changes in the supply chain to product and process improvements. Continuous innovation in manufacturing encourages businesses to gain a competitive advantage and achieve:

  • “greater responsiveness to customer demands
  • faster turnaround times
  • reduced waste levels and downtime
  • improved product design and quality
  • greater potential for a wider product range
  • streamlined relationships with suppliers and customers (http://www.nibusinessinfo.co.uk)”

According to an interview with Dr. David Chesney (DL Chesney Consulting) in SiliconRepublic.com, “Regulation is necessary to provide assurance that the safety and efficacy balance is maintained, but regulators also must realise there is no public health value in inhibiting innovation. I suppose reasonable people can and will disagree on how that balance should be struck (https://www.siliconrepublic.com. Regulation Versus Innovation: Is There a Clear Winner in Biopharma? Feb 2018).”  

Regulations are designed to protect both consumers and organizations, but being compliant does not mean the end of innovation.  In fact, compliance is a crucial component as a manufacturing company looks to mitigate risk and move into a more efficient and effective enterprise.   “We are experiencing a moment when regulation becomes crucial for innovation to remain sustainable,” reports Forbes (https://www.forbes.com.  Why Innovation and Regulation Should Work Together. Aug 2018).

Compliance & Innovation: Meeting in the Digital Technology Environment

As seen with the implementation of a Manufacturing Execution System such as Siemens Opcenter Medical Device and DiagnosticsTM (formerly Camstar Medical Device SuiteTM), transforming to a digital platform opens the door to more regulatory requirements.  A digital platform such as this, however, allows for the inherent mapping of such requirements and creates a highly visual and easily accessible way to verify manufacturing compliance.  Implementing a top-class digital platform also encourages an organization to adjust processes in response to new regulatory rules. As regulations evolve, industries must adapt.  The good news is that – in addition to the flexibility to respond to regulatory changes, this software also allows for customer needs adjustment and manufacturing trend tracking.  Effectively, having a business that is compliant by design will aid in the adjustment to new technology, laws or customer expectations.

To do this, it is recommended that all key players are invited to the table – from the outset – to align individual and department goals from inception to execution.  By working as a singular unit aligned on an overall goal, organizations will be able to mitigate regulatory risks while staying at the technological and innovative forefront.

For manufacturers of all sizes, creating a collaborative, connected manufacturing process improves cost, time and quality.  Compliance and innovation must be achieved in unison and supported equally for an enterprise to stay competitive in today’s manufacturing economy.  Moving an enterprise from digitalization concept to established business practice can greatly aid in the satisfying marriage of compliance and innovation. 

Compliance & Innovation: Two Advantages with Opcenter Execution Medical Device and Diagnostics

Opcenter Execution Medical Device and DiagnosticsTM (formerly Camstar Medical Device SuiteTM) is industry top-of-the-class and enables medical device manufacturers to meet the challenges of product quality and compliance – without sacrificing innovation or profit.

Innovative and compliant-friendly, Opcenter Execution Medical Device and DiagnosticsTM 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 who utilize Opcenter Execution Medical Device and DiagnosticsTM can quickly realize significant 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 uncomplicated, regardless of the size and scope of the enterprise.  As a leader in the industry, Opcenter Execution Medical Device and DiagnosticsTM is very small-business friendly and serves a large customer base with great success.

Encourage your peers and colleagues to view compliance and innovation as mutually inclusive and supportive of the industry best- practices.  Implementation of a digital product such as Siemens’ Opcenter Execution Medical Device and DiagnosticsTM is the best example of compliance and innovation merging to offer best-in-class solutions for today’s medical device manufacturers.

Questions about transforming your manufacturing to a digital environment?  Let Seabrook help! 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]

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.

Camstar Medical Device Suite: The Class of the Industry for Medical Device Manufacturers

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Companies are moving faster than ever before.  Although product quality, regulation compliance, and risk mitigation are at the forefront of manufacturing, speed and innovation are becoming ever more important as companies seek to maintain pace with competition and customer demand.  These demands, when balanced with the need to contain cost, can be daunting for today’s medical device manufacturer. 

Introduction of a Manufacturing Execution System (MES) can ease these pain points, and CamstarTM Medical Device Suite is industry top-of-the-class.  Specifically, CamstarTM Medical Device Suite enables medical device and diagnostics manufactures the ability to meet the challenges of product quality and compliance – without sacrificing profit. 

CamstarTM Medical Device Suite creates a paperless manufacturing environment, enforces industry best practices and compliance, eliminates non-value-added activities, and creates a self-auditing electronic Device History Record (eDHR) and electronic batch record (eBR) – leading to a more efficient and effective production.  Specifically, Medical Device Suite can help manufacturers by offering the following benefits:

Reduced Cost and Risk of Compliance.  Medical Device Suite creates and electronic device history record (eDHR) and electronic batch record (eBR), thereby eliminating the cost of labor for manual creation, review, research etc. of a paper-based DHR.  In addition to the lowered cost, there is also a significant reduction in product quality issues and customer complaints. 

Increased Productivity and Profit Margin.  The CamstarTM Medical Device Suite eDHR and eBR enables operators to focus time on product production and quality rather than collecting data, reviewing documents, and completing paperwork.  In addition to a more-efficient manufacturing floor, costs are also reduced by elimination of paper, scrap reduction, and increased manufacturing velocity.

Enhanced Decision Making.  Because CamstarTM Medical Device Suite includes actionable intelligence from dashboards, preconfigured reports, and the collection and correlation of data, companies utilizing this MES gain significant knowledge regarding the entire manufacturing process – allowing for enhanced, accurate decision making.

Increased Throughput and Yield.  Real-time visibility of the entire manufacturing process and work in process (WIP) is a significant advantage of CamstarTM MES.  This visibility allows for better process enforcement and right-first-time production – leading to a reduction in scrap and rework.

Product and Process Traceability.  With CamstarTM Medical Device Suite, a product, lot or unit can be traced across the supply chain, factory, multiple factories, or entire enterprise.  Traceability data includes forwards and backwards genealogy of materials consumed, processes and equipment utilized, exceptions, rework, signatures, and more. 

Exploring paperless manufacturing is an opportunity for small-to-medium manufacturers to increase their competitive advantages. Stepping into the paperless revolution creates a more secure and more accurate process, while leading the way to greater revenues.  CamstarTM Medical Device Suite is by far the most widely used and well-known MES in the industry.  It allows an organization to improve its competitive position, ensure compliance, and reduce product risks – all while significantly lowering costs.  It has been our experience that companies that utilize the CamstarTM Medical Device Suite can quickly realize significant reduction in paper cost, cycle times, manufacturing-related complaints, scrap, and product review and release time. In addition to the many benefits, the ease of implementation is often easier than expected, regardless of the size of implementation.

As a leader in the industry, CamstarTM is very small-business friendly and serves a large customer base with great success! Details and much more information will be presented in a webinar hosted by Seabrook Technology Group and Siemens on Thursday, June 20 from 11:15 a.m.-12:00 p.m. EST.  Register for this FREE WEBINAR by visiting https://www.eventbrite.com/e/paperless-manufacturing-webinar-tickets-61428515343

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]

Camstar Medical Device Suite: Top of the Class in Paperless Manufacturing

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Digitalization is changing everything. This evolution is seen throughout the manufacturing industry, and nowhere is it more vital than in the Medical Device Manufacturing field. As seen in this video, Camstar Medical Device Suite is the MES of choice for Medical Device Manufacturers. By eliminating an outdated paper-based system and implementing Camstar Medical Device Suite, companies soon realize the benefits of a fully electronic, self-auditing MES that streamlines the process, reduces cost and enforces product quality and compliance.

See why Camstar Medical Device Suite is the choice for Medical Device Manufacturers throughout the world.

Learn Camstar details and gain greater knowledge about paperless manufacturing solutions by attending an upcoming webinar hosted by Seabrook Technology Group on Thursday, June 20, 2019 from 11:15 a.m.-12:00 p.m. EST. Register for this FREE WEBINAR by visiting this link.