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 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.
“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.
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