regulatory changes in medical devices: scalable, diverse, managed solutions

A whitepaper on preparation, anticipation, remediation

Regulatory & Notified body response:

Within an evolving, dynamic landscape, where precise submissions and responses are demanded, it can be reassuring to know our individual consultants and project teams understand commercial objectives and deliver technical expertise.

Real understands that a quick, accurate response to a regulatory or notified body is necessary to ensure your products continue to improve the lives of patients.

This has been demonstrated by our response to a customer’s request for support.

Situation

A global healthcare organisation was issued with a number of warning letters in connection with their products in a particular therapy area.

Owing to a succession of compliance issues identified, the organisation required reviews of validation, processes, software, computer systems, CAPA and quality processes themselves.

Updates were necessary for some documentation: root cause investigation, complaint handling and training.

Agreements were made with the Regulatory body as actionable follow up to be initiated by the organisation, meaning a significant up-scale of specialist labour would be necessary.

Scale:The provision of a large scale consulting project within a specific therapy area carries a number of intrinsic complexities.

A significant quantity of technical experts, numbers going into the hundreds were needed.

Background

However the talent-pool was already stretched.

This pool is fundamentally limited, as there is no way to instantly train or develop expert-level skill-sets within Quality, Regulatory or Compliance.

An unfortunate industry wide trend of product failure and recall in this therapy area had entailed other organisations programmes placing pressure on talent supply chains, making up scaling the consultant workforce an ambitious proposition.

SolutionReal immediately understood the regulators actionable development points would require significant Consultant force.

An Account Manager appointed a Delivery team to source talented Consultants in this area.

Real’s delivery team is unique in its focus: each delivery team member works exclusively, 100% FTE, on building a Consultant network across a specific skill set.

The outcome of this structure was that the Delivery team was already in possession of talented Consultants within a small talent pool.

7 offices across Europe, with over 120 fulltime staff working on the sourcing of talent in the life sciences, equipped Real with the market presence required to upscale under difficult circumstances.

Our Delivery Team on boarded more internal resource as the upscale requirements presented themselves.

The outcome was that Real provided over 60% more Consultants than the organisation’s second placed Consulting partner allowing the customer to have confidence in their reconciliation plan.

DiversitySecondly, the organisations production and quality management facilities were spread across many sites and in numerous countries.

Any model for supporting the issue reconciliation in a useful, holistic manner could not ignore the idiosyncrasies of Consulting in these diverse regions, cultures, social and legal environments.

The consultants and project teams put in place must have correct language skills, awareness of cultural practice and must themselves be compliant with local labour-laws.

An end-to-end solution must recognise and manage these variables; any service addressing only one location, would be less efficient and counterproductive to the organisations own efforts to manage and direct the programme.

SolutionReal placed Consultants and permanent staff at over 1000 organisations in 14 countries in 2014.

We have 17 years of Consulting experience within the Life Sciences, working with small start- ups, global healthcare companies, their service providers and surrounding institutions.

Our status as a publicly listed firm (LSE: FTSE250) ensures we are legally obliged to deliver our services in a risk-assured and compliant manner.

Our Delivery team’s specialisation means we have developed a deep understanding of each of the cultures, languages, regions and legislation of the regions we operate in.

By delivering our Consultants through a broad network of offices, we used the accumulated experiences of previously placing Consultants in these areas.

This meant that our Consultants were always able to start onsite, no matter where, and were equipped with the appropriate cultural awareness, experiences and language skill sets to immediately meet the organisation’s challenges.

Management, Engagement & Direction

Scale and complexity can sometimes also entail longevity.

Consultants were engaged for an average of 15 months in order to see through and complete the full burden of work.

Over a longer consulting period the team must be engaged, offer stability and consistent presence of intellectual capital.

Unstable teams lead to time-lost through on boarding, training and familiarisation of Consultants, as an empty seat must be filled by a new Consultant.

In parallel to the soft-human aspects, the organisation required hard-structures in place, through which they would be empowered to objectively understand, manage and direct the consultant force.

SolutionReal’s Account Management team consisted of a single point of contact for all operational queries and a senior member of the European Leadership team for initial escalation.

A fail-safe escalation point was nominated in one of our Executive Board members ensuring that any requests or feedback would be listened to.

A broader role of these meetings was to perpetually benefit from insight into the organisation’s performance expectations and organisational culture.

Real’s experience enabled them to adapt their service to pre-empt the organisations requirements, amplifying the management and leadership’s savings.

Management structures were setup with the Consultants, which included periodic meetings, performance appraisals and welfare checks, in addition to clear on-boarding support, which reduced the time from Consultant hire to productivity.

The result: 98% project completion and 96% of Consultant extensions were accepted.

ConclusionThe preparation, anticipation and remediation of Regulatory or Notified body action is a business critical concern which ensures patient safety; but at its most extreme can bring product lines to an end.

Patient safety, product quality and process excellence are inseparable entities which demand effective, stable and precise Consulting solutions.

When executed well, organisations will benefit from efficient and effective impacts in patient safety, business capabilities and improved relations with inspecting bodies.

Real has a track record of delivering industry-leading Consultation, which can take account of scalability, diversity, and is proactively managed to the client’s brief.

Who is Real?

- Real offers a complete suite of regulatory and compliance consulting services to support organisations in achieving or remediating compliance with Regulatory and Notified bodies.

- From individual consultants, mock audits, project teams to strategic outsourcing, we provide a solution tailored to your requirements.

- Our suite of services allows a complete outsourced delivery, consultants to fill workload peaks and knowledge gaps or managers to provide structure and direction.

About the Author

Gareth Rose has 10 years experience of Life Science staffing.

Since graduating in Dual Honours from the University of Sheffield, he has won industry awards for his service levels in Life Science staffing.

His international career has seen him work in the UK, The Netherlands, Germany and Switzerland, leading and managing delivery teams in each region.

He is currently Head of Service and Client Development within Real and develops individualised solitions for customers.

Gareth‘s professional interests are performance excellence, customer experience and strategy.

g.rose@realstaffing.com