This year I once again had the pleasure of attending, chairing and presenting at the IQPC Pharmaceutical Packaging and Labelling Summit in Zurich on 18th and 19th June. Many thanks to Lucy Comer and the team at IQPC for organising the event.

I presented on the topic Managing Portfolio Complexity in Packaging – Dealing with Small Volume Products, looking at the growing challenge of complexity in packaging portfolios. As companies chase niche opportunities and products become more specialised, large volume packing runs are becoming increasingly rare. However, many pharmaceutical packaging facilities have been designed for higher volume product. Coping with portfolios dominated by small volume product significantly reduces operational efficiencies and drives a large hidden factory of support staff to maintain.

I reviewed some of the environmental factors causing this growth in portfolios and presented a three stage methodology to address the challenges of complexity. Firstly, the portfolio needs to be assessed and understood so that the characteristics and requirements of each SKU are clear. Secondly, sources of non-added value complexity need to be removed to standardise as much as possible. Thirdly, appropriate mechanisms, like postponement and late stage customisation, need to be introduced to provide the necessary complexity in a more effective manner. Finally, I reviewed the sorts of benefits in terms of efficiencies, lead times and costs savings that can be achieved by such a programme.

Other presentations from the event included:

The Role of Packaging and Labelling on Supply Chain Efficiency Prabir Das: Vice President – Packaging Development, Mylan

Prabir presented a broad overview of the interface between packaging and the supply chain. He talked about the commercial and environmental challenges facing packaging and how product characteristics impact packaging design and material selection. All of these issues should be addressed by the packaging system, which in turn should consider all of the requirements that need to be delivered by the packaging design. Prabir also talked about how packaging needs to protect the product, ensuring that the product is fit for use when it reaches the end-user. Finally, he looked at how technology will impact packaging in the future and what barriers will have to be overcome.

Evaluating the Use of Smart Packaging and Interaction with Smartphones Andrew Smith: Technical Packaging Director, GSK

Andrew presented on the use of smart packaging within the pharma industry. He discussed the benefits and opportunities presented by eLeaflets. Smartphone enabled leaflets permit the provision of enhanced product information, for example usage videos. Smartphones can also be used for alerts and compliance, security features and usage monitoring. This improves patient engagement and product security. Andrew reviewed the different types of technology that can be used as carriers to link to product information including tags, QR codes and barcodes. He highlighted the benefits and challenges of each technology and what potential application scenarios might occur.

Solutions to Optimise Your End-to-End Artwork Process Suzanne Ivory: Chief Operating Officer, Perigord

Suzanne presented on the challenges facing pharmaceutical artwork, particularly the impact on patient safety. She highlighted the need for clear processes with detailed instructions to ensure the desirable right-first-time outcome. The implementation of a comprehensive Quality Management System and the underpinning Artwork Management System are key capabilities to support the creation of correct artwork. She also discussed how the introduction of appropriate measures drives performance through focusing on addressing performance deviations. Finally, Suzanne discussed the areas of new technology emerging that will impact artwork processes and capabilities.

Ensure a Return on Your Investment by Implementing E-Labelling into Pre-exiting, Multi-functional Barcodes Tatjana Pathare: Senior Artworks and Regulations Specialist within the Serialisation Project, Roche and Christian Hay: Senior Consultant – Healthcare, GS1

Tatjana and Christian presented on the use of the serialisation barcode to provide a patient leaflet. They highlighted the opportunity of using GS1 Digital Link as the carrier for accessing the eLeaflet as it is an open standard platform. GS1 are now undertaking some pilots to develop this capability. Christian then followed up with a discussion on the ISO standard that is being drafted to support this use of the supply chain identifier to access digital information.

Digital Maturity Model for Packaging: Digitise, Automate and Connect in Pharma Simon Cavanaugh: Senior Account Executive – Global Business Group, ESKO and Steven Brookes: Solution Consultant, ESKO

Simon and Steve presented on the journey companies undertake to manage their digital assets in a comprehensive manner. As the volume of digital assets grows in a company, capabilities also need to evolve to manage assets effectively. ESKO has developed a roadmap tool to help companies with this journey. Simon also explained some of the different use cases they have witnessed for artwork introduction and reasons behind these process variations. Finally, Simon covered some of the other learnings ESKO have witnessed in client implementations, particularly around regulatory processes.

Maximise your Brand Engagement with Patient-centric Packaging and Understand How it Improves Patient Lives Gabriele Iannizzotto: Chairman, HCPC Europe

Gabriele presented on the work carried out by HCPC Europe and the annual Columbus Award for patient safety packaging. He discussed some of the numerous issues facing patients, which can be resolved through improved packaging design. He then introduced some of the previous winners of the Columbus Award demonstrating some of the patient safety / adherence features they included.

What’s Holding Us Back? Identify your Supply Chain Bottlenecks and Risks Jeffrey Hardy: Director General, TRACIT and Suriya Prabha Padmanaabhan: Director of Programs, TRACIT

Jeff and Suriya led a discussion on the issues attendees are witnessing with illicit trade across their supply chains. They looked at each step of the supply chain defining key issues, causes and impacts. This is part of a wider survey they are undertaking across many industry sectors. The outcomes will be captured in a cross-functional business report on illicit trade.

Challenges for Global Pharma Companies to Implement Anti-counterfeit Strategy for Russian Track & Trace Regulation Dr Ettore Cucchetti: Chief Executive Officer, ACG

Ettore presented on the development of secure supply chains across various industry sectors and territories. He compared the maturity of security activities in life sciences against other sectors and examined how capabilities are likely to develop in the life sciences sector. Ettore also discussed each of the elements required for a full product traceability solution.

Putting Patient Safety at the Heart of FMD Leyla Hannbeck: Chief Pharmacist & Director of Pharmacy, National Pharmacy Association

Leyla presented on the patient safety issues associated with packaging and FMD, as witnessed in pharmacies. In particular, she highlighted the significant amounts of 'look-alike, sound-alike' errors that happen and how improved packaging design could alleviate these. She presented a number of case studies highlighting the issues where dispensing errors had occurred. Leyla also discussed the impact of FMD on community pharmacies and the preparation activities that have been undertaken to date.

Serialisation and the Future of Hospital Pharmacy Robert Moss: Director of Professional Development, European Association of Hospital Pharmacists

Robert presented on the impact of serialisation and other technological developments on hospital pharmacies. He discussed the problem of identifying the point of authentication in a hospital pharmacy. There are a number of points within the hospital environment where is could be carried out from goods receipt to patient use and each presents challenges. Regarding other technological developments, Robert explained how aggregation would have a significant benefit to hospitals by avoiding having to scan each pack in a case. Scannable single dose primary pack barcoding provides significant patient safety benefits, and EAHP have been advocating this for a number of years. Finally, Robert showed some of the automated drug dispensing and delivery equipment that is being developed.

Fulfilling the Needs of the Local Market with Need-based Packaging Innovation Rajesh Mishra: Associate Director – Packaging Development, Abbott

Rajesh presented on the challenge of designing products to meet local market needs. Focusing on India, he highlighted some of the issues created in a market that is high volume but low cost, with a very high degree of competition. In this environment, needs-based innovation is key to defining how to differentiate your product. Rajesh showed a few examples of packaging design that were developed to meet these challenges. He highlighted a key learning which was making sure that the design of the pack or device was easy to understand and use across many different demographic groups.

EU MDR and its Implications for Labelling and Artwork Karolina Komposh: Labelling and Artwork Manager, Croma-Pharma

Karolina presented on the new Medical Device Regulations. She provided an overview of the regulations, some of the major changes that have been introduced and the timelines to be achieved. She then explained some of the issues that are being discussed between industry and the regulators. As can be expected by such a large piece of legislation, there are many details that need to be further worked to develop practical solutions and time pressures are making these issues more acute.

End-to-End Solution for Managing Labelling and Packaging Artwork Ray Collia: Senior Account Executive, Loftware

Ray presented a clinical trials artwork case study on an implementation undertaken by Loftware. He outlined some of the challenges in clinical trials that can impact the development of clinical trial artwork. He also gave an overview of the business issues that the case study company were wanting to address. He highlighted the benefits that can be delivered through a suitable labelling and artwork system and explained key features of the Loftware system.

Preparing for the Worst : Negotiating with Sites That Have Not Prepared for FMD and Anticipating Brexit Huda Awidi, Regional Regulatory Affairs Manager – Labelling & Artworks – Middle East, Africa, Turkey & Pakistan, Mundipharma

Huda presented on the impact of Brexit and FMD on Middle Eastern / African countries. This is a complex range of countries with many local requirements. She covered the actions being taken to prepare for potential Brexit scenarios which will impact many things including, for example, product licenses due to changes to sites of release. Huda also discussed the implementation of FMD. There is a strong pull in the countries she represents for a serialisation solution, due to the levels of counterfeit product, but countries are at different levels of development. Products are supplied from 60 CMOs so agreeing processes and procedures is difficult. As some countries are implemented and some are not it has also made it difficult to share packs. Finally, Huda explained the methodology they have used to implement serialisation across the region and highlighted key learnings from their implementation.

Morning Workshop: From Manufacture to Use: Overcome the Challenges Encountered during the Three Stages of the Packaging Lifecycle Prabir Das: Vice President – Packaging Development, Mylan

Interactive Workshop: Moving Beyond Compliance – Transitioning from Serialisation to Securitisation Mark Willis: MDR and Compliance, Johnson and Johnson

In addition to the presentations by the speakers above, Prabir and Mark held workshop sessions on the Packaging Lifecycle and Transitioning beyond Serialisation respectively.

It was a pleasure to chair such an informative and engaging two day event, tackling a wide breadth of topics, many of which are constantly evolving as the Pharma Packaging and Labelling landscape responds to many wider industry changes. Thank you to all the speakers and attendees for making a productive and enjoyable session. I look forward to meeting again next year.

Be4ward is a niche consultancy company helping pharmaceutical, biotech and medical device companies and their supply base improve their serialisation, labelling and artwork capabilities. We help clients define the most efficient business processes, organisation design and, being completely independent, help them select and implement the most appropriate service providers and IT systems to meet their needs. Be4ward helps these companies improve patient safety and drive additional value from their product range.

Should you have any questions or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email [email protected]

For more information on our areas of expertise, go to our free download section.

The new EU Medical Device Regulation and In Vitro Diagnostic Regulation are here and companies need to be deciding how they will address them. Approved by the European Parliament in May 2017, these new regulations are the biggest change to the legislative framework for medical device and in vitro diagnostic products in decades. As discussed in my previous blog on the subject, one aspect of this new legislation is the requirement to appoint a Person Responsible for Regulatory Compliance. This requirement has an impact on manufacturers and authorised representatives supplying medical device and in vitro diagnostic product in the EU market. Companies will need to implement many new or enhanced capabilities to meet these obligations.

For companies faced with these challenges, it begs the obvious question ‘So where do we start?’

Define your strategy
The logical first step is to define the company’s strategy for how to tackle the new regulations. Typically, strategy development would include:

1. Understanding of the current and new legislation.
2. Impact of the legislation on the company's operations, including any opportunities that might present.
3. A gap analysis of each relevant aspect of the company’s operations against the requirements of the new legislation.
4. An assessment on existing and pipeline product registrations, testing and labelling.
5. Initial high level designs of potential new processes, capabilities and IT solutions.
6. High level roadmap for re-registrations, testing or re-labelling and implementing new processes, capabilities and IT solutions.
7. Cost and resource impact estimation.
8. Plan for the next phase of activity.

Some considerations when defining your strategy
From our experience of delivering large and complex legislative-driven change, there are a number of things to think about when defining your strategy:

Take a cross functional approach: The impacts of the regulations are cross-functional so make sure that you have all relevant functions involved in defining your strategy. Avoid the temptation to ‘slice and dice’, allowing each function to independently develop their approach. The company needs a holistic response so develop your strategy as a true cross-functional activity. All stakeholder groups involved in the delivery of the legislation need to contribute effectively or the whole process is at risk of failure. Therefore, all parties must buy into their roles in the processes and actively contribute to them. This will rarely happen if they are simply passive bystanders in the design of the capabilities or the delivery of the resulting activities.

Define and agree some governing principles: Providing guidance to the team on what would be permissible or not, defining the ‘rules of game’ to all parties. This provides a boundary and decision-making framework for solutions being developed and should be approved and managed by the governance team.

Ensure effective cross-functional governance: Given the cross-functional and cross-organisational nature of the regulations, establishing the right inclusive leadership and governance is key to the long-term success of the activity. A cross-function governance team should therefore be established to steer the definition, establishment and ongoing delivery of your strategy. This governance body should include membership from all the stakeholder groups involved.

Build in flexibility: The implementation of solutions to address new legislative drivers is complex, not least because through the implementation journey, the legislation evolves.  Unforeseen situations and challenges will arise, timelines may change, Delegated Acts may introduce further local requirements. Therefore, solutions defined need to have sufficient flexibility to cope with further emerging requirements. This is not easy, but is a key challenge of which solution design teams must be made aware.

Look for standard approaches: In large and complex operations, it may be necessary to implement solutions at multiple locations. It can therefore be beneficial to develop standard approaches for solutions that can be replicated at each of these locations rather than ‘re-inventing the wheel’ at each one. This provides two benefits – it can be more efficient in preparing the solutions and learnings across the organisation can be shared. However, if taking this approach, local requirements must be highlighted and built into the developed solutions.

Put a capable, dynamic and motivated leader on the problem: These regulations are complex and evolving, touching many parts of an organisation. With the challenges facing the leadership that is charged with implementing such capabilities, they need to have a broad range of skills, the drive and motivation to anticipate risks and issues, as well as ensure they are effectively managed proactively. Furthermore, there will be many technical challenges to address so the leadership of the program needs to have the technical strength and breadth to succeed in managing these.

Involve local country teams and management early: Good change management practice encourages the involvement of those impacted early in the activity. The local country teams will be key in supporting implementation and ongoing operation of solutions implemented, as well as undertaking a significant role in product re-registration and labelling updates. Involving them early will ensure solutions are fit for purpose and that they buy into the activities you need them to do.

Refresh your strategy as appropriate: The implementation of the new regulations will take many years and requirements will probably evolve. The environment you operate in and your company will likely change in this time as well. Your strategy is therefore not a one-time activity. It needs to grow and evolve as the surroundings change. Hence you need to build in regular reviews of the strategy to ensure it remains pertinent and comprehensive.

Your strategy will help you chart your course
As can be seen from the above, developing your strategy is a key point in your journey to address the issues presented by EU MDR/EU IVDR. It will help your company understand what needs to be done and how resources will be marshalled to address those challenges. The strategy processes need to be timely, giving enough time to undertake the strategy process itself effectively but also giving enough time to subsequently implement the new requirements, and it is an ongoing process tuning the company’s response as situations change. Appropriate flexibility and risk mitigation needs to be built into your solutions and deployment plans. A good strategy will help facilitate a successful response to the legislation across your organisation.

If you are impacted by EU MDR / IVDR, start planning how to transition to the new requirements and avoid supply interruptions. Our Executive Briefing, An Introduction to the EU Medical Device Regulation (EU MDR) can help you understand the legislation and develop a strategy for transition.

Should you have any questions about this or any of my other blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email. [dt_sc_email emailid="[email protected]"/]

Be4ward is proud to sponsor Making Pharmaceuticals UK Exhibition and Conference this year. The event will take place April 24 – 25, 2018, at Ricoh Arena, in Coventry, UK. We hope to see you there.

The team at Be4ward will take the opportunity to present at the event. Neil Wetherall, Consultant, will be speaking on April 25, at 14:00 in Room A. Neil Wetherall will focus on the EU Falsified Medicines Directive –An Update on the Latest Status and Key Learnings From Implementation. I will also be speaking on April 25, at 15:00 in Room A. I will focus on the EU Medical Devices Regulations – An Update on Latest Status and Implications for Combination Products.

This event is proudly sponsored by Be4ward and will be attended by Be4ward.

For more information, follow the link to the event organiser website.
Making Pharmaceuticals UK

Be4ward is a niche consultancy company helping Pharmaceutical, Biotech and Medical Devices companies and their supply base improve their serialisation, labelling and artwork capabilities. Be4ward help clients define the most efficient business processes, organisation design and, being completely independent, help them select and implement the most appropriate service providers and IT systems to meet their needs. Be4ward helps these companies improve patient safety and drive additional value from their product range. Corporate website: www.be4ward.com Contact: [email protected]

Billed as the most significant change to the medical device legislation in decades, the Medical Devices Regulation (MDR) – Regulation (EU) 2017/745 – and In Vitro Diagnostic Medical Devices Regulation (IVDR) – Regulation (EU) 2017/746 seek to increase the safety and effectiveness of medical devices available in the EU market. One aspect of this new legislation is the requirement to appoint a Person Responsible for Regulatory Compliance. This requirement has an impact on manufacturers and authorised representatives supplying medical device and in vitro diagnostic product in the EU market.

Who will be required to appoint a Person Responsible for Regulatory Compliance?

The regulations require that manufacturers and authorised representatives have permanently, and at their disposal, at least one person responsible for regulatory compliance. This isn’t necessarily an employee, but a service that is provided by a person that must be accessible to the organisation. The person is responsible for ensuring the conformity of devices are checked prior to release, including that technical documents and certificates of conformity are accurate.

What are the obligations for organisations not established in the Union?

Regardless of your location around the world, if your organisation is supplying medical device and/ or in vitro diagnostic product in the EU market, you will be required to appoint a Person Responsible for Regulatory Compliance.

What are the qualifications of a Person Responsible for Regulatory Compliance?

Accepted qualifications for a Person Responsible for Regulatory Compliance are either of the following:

‘(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;

(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.’[1]

What are the responsibilities of a Person Responsible for Regulatory Compliance?

A Person Responsible for Regulatory Compliance is responsible for ensuring that:

‘(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;

(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);

(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;

(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.’[2]

What do I need to do from here?

Companies should incorporate the potential requirement to appoint a Person Responsible for Regulatory Compliance in their compliance plans. To understand if your organisation is impacted, a review of the general obligation statements in relevant articles should be performed.

For companies obligated to appoint a Person Responsible for Regulatory Compliance, you should identify an individual that meets the qualifications. There’s a possibility that larger companies have already got the capabilities to meet this role. However, the likelihood is that many smaller companies will have to search outside their organisation to find a Person Responsible for Regulatory Compliance.

Once a Person Responsible for Regulatory Compliance has been identified, companies will need to focus on how they will introduce this new responsibility within their organisation. Companies should consider updating the relevant processes to transition to this new way of working. Overall, this will better enable companies to meet the timelines of the legislation and the re-registration of their products by May 2020 and May 2022.

Summary

As can be seen from the above, it is essential to ensure that you meet the general obligations for a Person Responsible for Regulatory Compliance in the new regulations. An assessment and action plan will help ensure a successful outcome for your organisation.

If you are impacted by EU MDR / IVDR, start planning how to transition to the new requirements and avoid supply interruptions. Our Executive Briefing, An Introduction to the EU Medical Device Regulation (EU MDR)  can help you understand the legislation and develop a strategy for transition.

I hope you found this information useful and helpful. Should you have any questions about this, or any of my other blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email. [dt_sc_email emailid="[email protected]"/]

References

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April on Medical Devices

[1] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April on Medical Devices

[2] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April on Medical Devices

Be4ward is proud to sponsor Making Pharmaceuticals Europe Exhibition and Conference this year. The event will take place March 13-14, 2018, at Brussels Expo, in Brussels, Belgium. This event will be attended by Be4ward and I will be taking the opportunity to present. We hope to see you there.

The team at Be4ward will take the opportunity to present at the event. Andy Cumming, Consultant, will be speaking on March 13, at 11:30 in Room B. Andy Cumming will focus on the EU Falsified Medicines Directive –An Update on the Latest Status and Key Learnings From Implementation. I will also be speaking on March 13, at 12:10 in Room B. I will focus on the EU Medical Devices Regulations – An Update on Latest Status and Implications for Combination Products.

For more information, follow the link to the event organiser website.

 

Be4ward is a niche consultancy company helping Pharmaceutical, Biotech and Medical Devices companies and their supply base improve their serialisation, labelling and artwork capabilities. Be4ward help clients define the most efficient business processes, organization design and, being completely independent, help them select and implement the most appropriate service providers and IT systems to meet their needs. Be4ward helps these companies improve patient safety and drive additional value from their product range. Corporate website: www.be4ward.com
[dt_sc_email emailid="[email protected]"/]

The new EU Medical Device and In Vitro Diagnostic Device regulations were approved by the European Parliament in May 2017.  One aspect of the new legislation is the definition of an Economic Operator. This definition impacts a number of organisations involved in the supply of medical devices and the clarification of the obligations of each of these Economic Operators.

The new regulations are the biggest change to the legislative framework for MD and IVD products in decades.  The impact on device manufacturers and other Economic Operators is significant, with new or changed requirements across the entire product lifecycle.  Companies will need to implement many new or enhanced capabilities to meet these obligations.

Who are the organisations that are classed as Economic Operators?

Article 2 of the new regulations define an Economic Operator as:

‘A manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3)’

Article 2 then defines these four groups of organisations as:

‘‘Manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.’

‘‘Authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.’

‘’Importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market.’

‘’Distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.’

Obligations of Economic Operators

Chapter 2 of the regulations includes a series of articles that detail the general obligations of:

These articles set out, in a series of statements, the expectations of each of these Economic Operators with regard to the regulations.  Organisations need to review these statements to determine if they, and their partners, will be in compliance with the new regulations, or if new or enhanced capabilities will be required.

Other types of Manufacturer

There are some further sub-categories defined within the scope of ‘Manufacturer’ over and above the traditional device manufacturer:

Dependent upon the specific activities being executed by suppliers of any of the above, they could be subject to some or all of the obligations of manufacturers. To be compliant it is important to understand how your operations are affected by these requirements and what further actions you may need to take.

What do I need to do from here?

From the above it can be seen that companies will have to review the general obligation statements in relevant articles against their operations.  The first step is likely to be a gap analysis of the requirements including:

  1. Understand the general obligation statements from relevant articles in the new regulations.
  2. A gap analysis of each relevant aspect of the company’s operations against these statements.
  3. Initial high level designs of potential new processes, capabilities and IT solutions.
  4. High level roadmap for implementing new processes, capabilities and IT solutions.
  5. Cost and resource impact estimation.
  6. Plan for the next phase of activity.

This will then allow you to resource and execute the updates required.

It is important to consider the impacts on partner organisations as well as your own.  Are there significant changes that they may need to make that can put supply of your products to customers at risk?  May you need to change some suppliers to ensure your value chains remain compliant?

Summary

As can be seen from the above, it is essential to ensure you meet the general obligations from relevant articles in the new regulations.  This needs to be a holistic approach considering which articles impact your operations and also where there are impacts on external partners.  A detailed assessment and action plan will help ensure a successful outcome for your organisation.

References

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April on Medical Devices

About Be4ward

Be4ward has many years of experience in delivering large and complex legislative-driven change. We have written this document to capture some of our learning throughout that journey and hope it will be useful to you, the reader.

We hope you find this information useful and helpful. We are always searching for ways to improve our work, so if you have any feedback, please do not hesitate to contact us. [dt_sc_email emailid="[email protected]"/]

I had the opportunity to attend, chair and present at the IQPC Combination Products Forum in Munich on 24 and 25 October.  Many thanks to Romy Tuin and the team at IQPC for organising the event.

I presented on The Implications of the New EU Medical Device Regulations on Combination Products. I discussed how the regulations of medical devices and In vitro diagnostic devices are undergoing the most significant change for decades. I outlined the objectives that the legislation seeks to address and the challenging timelines for implementation. I also explained how the legislation impacts the whole lifecycle of medical devices that are marketed in Europe and the complex group of actors impacted. It is clear the legislation introduces some significant changes to the way the EU marketed MD/IVD lifecycle needs to be managed and it will present a number of challenges to products that are within scope.

The presentation can be accessed via the following link: The Implications of the New EU Medical Device Regulations on Combination Product Packaging

 

Other presentations from the event included:

Beyond the Molecule – Optimising Combination Product Development Using the E-Health Wave

Steve Dew, Associate Director Combination Products and Medical Devices, Biogen

Steve presented on how digital health is expanding and how this needs to be built into the development of your combination products.  Some of the topics covered included:

Steve also presented a number of examples of combination products being developed by healthcare providers.

 

Platform Technologies For Antimicrobial and Potential Next-gen Ophthalmic and Cancer Fighting Drug-Devices

Drew Rogers, Global Director for Healthcare & Medical, Trelleborg Sealing Solutions and Mark Paulsen, President, Silicone Consulting LLC

Drew and Mark presented on the use of silicone in the medical device industry.  They talked about the use of implantable silicone devices impregnated with drug product to support different applications.  They provided an overview of two studies they have been involved in, testing the effectiveness of impregnating silicone tubes with various drug products to help enhance the effectiveness of the impregnation process.

 

MHRA Perspective: Understanding The Regulatory Landscape For Combination Products

Dr Stefania Ragone, Pharmaceutical Assessor Licensing Division, MHRA

Stefania presented on the regulatory environment for combination products in Europe. She drew attention to two significant aspects of the European regulations:

Stefania discussed the requirements of the regulations and, through a number of examples, some of the pitfalls to avoid when preparing submissions.

 

Using Design Control to Aid in the Development of Combination Products

Margaret Kelly, Device Development Project Leader, Novartis

Margaret presented on the use of design controls in a medical device development process.  She walked through a typical development process to show how this would fit to a design control framework and how you can use the design history file to collate the information gathered in the development of the device.  This led to a conversation on how the device and drug development processes interlink and how they should be managed.

 

Cockpit’s Guided Compliance For Medical Device And Combination Product Development

Edwin Schumacher, Managing Partner, Synergio

Edwin demonstrated Synergio’s guided compliance tool for product development – Cockpit.

Edwin provided an overview of the product’s key features and benefits and, by way of a specimen project, demonstrated the functionality of the system.

 

Optimising and De-risking Device Development of Combination Products

Peter Czuczman, Global Project Leader Drug Device Product Development, BTG

Peter presented on the work he is undertaking in BTG to de-risk device development for combination products.  Initially Peter gave an overview of the legislative environment and the implications presented for product development.  He then discussed how you can take the regulatory frameworks to develop your drug and device development processes, de-risking the processes by making sure the regulatory requirements are built in.

To conclude, Peter explained which standards support which parts of the development process and how a suite of standard tools can underpin the process and make it more repeatable.

 

Applying The TRIZ Methodology To Medical Device Innovations

René Dathe, Head of Quality Medical Devices Shared Function, Novartis

René’s presentation covered the use of the TRIZ methodology in Novartis and how it can be applied to medical device innovation.

The TRIZ methodology is an alternative problem-solving methodology that was originally developed in Russia and can be applied to technology driven problems.

René explained a case study they used to test the methodology using an auto-injector product design.

 

Harmonizing the Integration of Drug Developments and Device Approaches

Lori-Ann Woodard, Senior Manager Quality Compliance Combination Products, Teva Pharmaceuticals

Lori-Ann presented on how to align the legislative requirements for devices and drug products.  In particular Lori-Ann looked at what you need to do to have one comprehensive QMS in your company, depending on whether you base your QMS on the requirements for drug products or devices.

Lori-Ann also looked at how key milestones in the drug products and device development methodologies can be aligned to give one seamless development approach.

 

Navigating the Different Regulatory Pathways for Combination Products Across the EU and US

Lars Hyveled-Nielsen, Regulatory Project Director, Regulatory Affairs, Zealand Pharma

Lars’ presentation focussed on which regulations apply to medical devices and drug products in the EU and US.

Lars explained how single-use devices and multi-use devices have different regulatory approaches in the EU.  Lars explained the different requirements for each.

Lars also explained the regulatory requirements for combination products in the US and how these differ from the EU.

 

Human Factors Engineering for Combination Products

Heidi Manijeh Mehrzad, Principal Human Factors Specialist, HFUX Research

Heidi provided a comprehensive and wide-ranging presentation on the requirements for human factors studies in medical devices.  Heidi explained the requirements for such studies and how they fit into the overall device development process.

Heidi highlighted the benefits from a well-thought-out human factors study approach and discussed numerous best practices to consider, in defining your human factors study approach.

 

How to Compile a Clinical Evaluation for Combination Products

Florian Tolkmitt, Independent Regulatory Affairs and Clinical Evaluation Expert

Florian talked about the clinical evaluation requirements for combination products. Florian provided an overview of the requirements for clinical trials in the new EU MDR regulations.

Florian outlined the processes and documentation requirements that companies will need to apply to their clinical evaluations through the new regulations and discussed a number of challenges that companies will need to meet.

 

Be4ward is a niche consultancy company helping Pharmaceutical, Biotech and Medical Devices companies and their supply base improve their serialisation, labelling and artwork capabilities. Be4ward help clients define the most efficient business processes, organization design and, being completely independent, help them select and implement the most appropriate service providers and IT systems to meet their needs. Be4ward helps these companies improve patient safety and drive additional value from their product range. Corporate website: www.be4ward.com Contact: [email protected]

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A brief overview of the EU MDR and EU IVDR regulations

Following approval in March 2017 by the European Council and in April 2017 by the European Parliament, the Medical Devices Regulation (MDR) – Regulation (EU) 2017/745 – and In Vitro Diagnostic Medical Devices Regulation (IVDR) – Regulation (EU) 2017/746 – were published in the Official Journal of the European Union on 5 May 2017. Both regulations entered into force on 26 May 2017, hence the new MDR rules will apply from 26 May 2020 and the IVDR rules from 26 May 2022.

Billed as the most significant changes to medical device legislation in decades, these regulations seek to increase the safety and effectiveness of medical devices available in the EU market and address weaknesses in the regulations revealed in several high profile incidents. Medical device and in vitro diagnostic device manufacturers large and small who supply product to the EU market will be impacted and need to start planning now on how to transition to the new requirements.

The requirements for a quality management system as defined in the regulations

Article 10(9) of the EU MDR regulations and Article 10(8) of the EU IVDR regulations state that:

‘Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.

The quality management system shall cover all parts and elements of a manufacturer’s organisation dealing with the quality of processes, procedures and devices.  It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.’

The article then lists a series of aspects that the quality management system (QMS) shall address.

To achieve product certification under the new regulations, companies will need to be compliant with these new requirements.

For some companies, particularly those where their products have been incorporated into the new regulations but were not subject to previous versions of the legislation, a QMS may be a completely new requirement.  This can be a significant undertaking and must be planned accordingly.

ISO 13485 and the implications on the regulations

ISO 13485 Quality Management for Medical Devices was updated in 2016 and contains new requirements and more emphasis on a risk-based approach to the overall QMS process.  Previous versions of this document have outlined the standard that many organisations have used as the basis for their QMS.  The requirements of ISO 13485 and the new regulations have some overlapping provisions but for companies wishing to retain ISO certification, compliance with both will be necessary.  At the time of writing this article it was anticipated in the industry that the ISO standard and the new regulations would be harmonised.

However, in the short term, this presents a situation where regulatory and quality professionals need to ensure that their QMS is updated for both the requirements of ISO 13485 and the new regulations.

What do you need to do to meet the requirements?

From the above it can be seen that companies will have to review and update their QMS to meet the new requirements.  The first step might be to have an independent audit readiness assessment of your QMS to determine how effective your current capability is.

From there, the next logical step would be to define your approach to your QMS.  Typically, this would include:

  1. Assess the audit readiness gaps with your existing QMS
  2. Understand the requirements for quality management systems in the new regulations.
  3. A gap analysis of each relevant aspect of the company’s QMS against the audit findings and new requirements.
  4. Initial high level designs of potential new processes, capabilities and IT solutions.
  5. High level roadmap for implementing new processes, capabilities and IT solutions.
  6. Cost and resource impact estimation.
  7. Plan for the next phase of activity.

This will then allow you to resource and execute the updates required.

It is important to consider in your implementation activities that your goal should not just be to have your new QMS in-place but also ensure that it is fully in-use.  This latter condition is often the most challenging, necessitating significant change management activity across your organisation.  However, without ensuring in-use, you cannot consider that your QMS is audit ready.

Summary

As can be seen from the above, ensuring your QMS is compliant with the new regulations is not an insignificant activity.  Your updates need to be timely to meet the needs of both ISO 13485 and the new regulations and could have significant impact across your operations.  A well thought out implementation approach will help ensure a successful outcome for your organisation.

References

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April on Medical Devices

About Be4ward

Be4ward has many years of experience in delivering large and complex legislative-driven change. We have written this document to capture some of our learning throughout that journey and hope it will be useful to you, the reader.

We hope you find this information useful and helpful. We are always searching for ways to improve our work, so if you have any feedback, please do not hesitate to contact us at [email protected].

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The Combination Products Forum, taking place on the 24 - 26 October in Munich, will address challenges surrounding:
This is the only conference in Europe that is dedicated to ensuring your teams can comply with the multitude of regulations governing the development of combination products.
This event will be attended by Be4ward and I will be taking the opportunity to present. We hope to see you there.
For more information, follow the link to the event organiser website.
Be4ward is a niche consultancy company helping Pharmaceutical, Biotech and Medical Devices companies and their supply base improve their serialisation, labelling and artwork capabilities. Be4ward help clients define the most efficient business processes, organization design and, being completely independent, help them select and implement the most appropriate service providers and IT systems to meet their needs. Be4ward helps these companies improve patient safety and drive additional value from their product range. Corporate website: www.be4ward.com Contact: [email protected]

The new EU Medical Device and In Vitro Device Regulations are here and companies need to be deciding how they will address them. Approved by the European Parliament in May 2017, these new regulations are the biggest change to the legislative framework for MD and IVD products in decades. As discussed in my previous blog on the subject, the impact on device manufacturers and other economic operators is significant with new or changed requirements across the entire product lifecycle. Companies will need to implement many new or enhanced capabilities to meet these obligations.

For companies faced with these challenges, it begs the obvious question ‘So where do we start?’

Define your strategy
The logical first step is to define the company’s strategy for how to tackle the new regulations. Typically, strategy development would include:

1. Understanding of the current and new legislation.
2. Impact of the legislation on the company's operations, including any opportunities that might present.
3. A gap analysis of each relevant aspect of the company’s operations against the requirements of the new legislation.
4. An assessment on existing and pipeline product registrations, testing and labelling.
5. Initial high level designs of potential new processes, capabilities and IT solutions.
6. High level roadmap for re-registrations, testing or re-labelling and implementing new processes, capabilities and IT solutions.
7. Cost and resource impact estimation.
8. Plan for the next phase of activity.

Some considerations when defining your strategy
From our experience of delivering large and complex legislative-driven change, there are a number of things to think about when defining your strategy:

Take a cross functional approach: The impacts of the regulations are cross-functional so make sure that you have all relevant functions involved in defining your strategy. Avoid the temptation to ‘slice and dice’, allowing each function to independently develop their approach. The company needs a holistic response so develop your strategy as a true cross-functional activity. All stakeholder groups involved in the delivery of the legislation need to contribute effectively or the whole process is at risk of failure. Therefore, all parties must buy into their roles in the processes and actively contribute to them. This will rarely happen if they are simply passive bystanders in the design of the capabilities or the delivery of the resulting activities.

Define and agree some governing principles: Providing guidance to the team on what would be permissible or not, defining the ‘rules of game’ to all parties. This provides a boundary and decision-making framework for solutions being developed and should be approved and managed by the governance team.

Ensure effective cross-functional governance: Given the cross-functional and cross-organisational nature of the regulations, establishing the right inclusive leadership and governance is key to the long-term success of the activity. A cross-function governance team should therefore be established to steer the definition, establishment and ongoing delivery of your strategy. This governance body should include membership from all the stakeholder groups involved.

Build in flexibility: The implementation of solutions to address new legislative drivers is complex, not least because through the implementation journey, the legislation evolves.  Unforeseen situations and challenges will arise, timelines may change, Delegated Acts may introduce further local requirements. Therefore, solutions defined need to have sufficient flexibility to cope with further emerging requirements. This is not easy, but is a key challenge of which solution design teams must be made aware.

Look for standard approaches: In large and complex operations, it may be necessary to implement solutions at multiple locations. It can therefore be beneficial to develop standard approaches for solutions that can be replicated at each of these locations rather than ‘re-inventing the wheel’ at each one. This provides two benefits – it can be more efficient in preparing the solutions and learnings across the organisation can be shared. However, if taking this approach, local requirements must be highlighted and built into the developed solutions.

Put a capable, dynamic and motivated leader on the problem: These regulations are complex and evolving, touching many parts of an organisation. With the challenges facing the leadership that is charged with implementing such capabilities, they need to have a broad range of skills, the drive and motivation to anticipate risks and issues, as well as ensure they are effectively managed proactively. Furthermore, there will be many technical challenges to address so the leadership of the program needs to have the technical strength and breadth to succeed in managing these.

Involve local country teams and management early: Good change management practice encourages the involvement of those impacted early in the activity. The local country teams will be key in supporting implementation and ongoing operation of solutions implemented, as well as undertaking a significant role in product re-registration and labelling updates. Involving them early will ensure solutions are fit for purpose and that they buy into the activities you need them to do.

Refresh your strategy as appropriate: The implementation of the new regulations will take many years and requirements will probably evolve. The environment you operate in and your company will likely change in this time as well. Your strategy is therefore not a one-time activity. It needs to grow and evolve as the surroundings change. Hence you need to build in regular reviews of the strategy to ensure it remains pertinent and comprehensive.

Your strategy will help you chart your course
As can be seen from the above, developing your strategy is a key point in your journey to address the issues presented by EU MDR/EU IVDR. It will help your company understand what needs to be done and how resources will be marshalled to address those challenges. The strategy processes need to be timely, giving enough time to undertake the strategy process itself effectively but also giving enough time to subsequently implement the new requirements, and it is an ongoing process tuning the company’s response as situations change. Appropriate flexibility and risk mitigation needs to be built into your solutions and deployment plans. A good strategy will help facilitate a successful response to the legislation across your organisation.

Be4ward is a niche consultancy company helping pharmaceutical, biotech and medical device companies and their supply base improve their serialisation, labelling and artwork capabilities. We help clients define the most efficient business processes, organisation design and, being completely independent, help them select and implement the most appropriate service providers and IT systems to meet their needs. Be4ward helps these companies improve patient safety and drive additional value from their product range.

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.

For more information on artwork, go to our free download section.