Not Amused

Today I attended a very informative webinar hosted by British Standards Institute (BSI) on their interpretation of the medical device regulation requirements under Article 117 for drug device combination products marketing in the European Union from 26 May 2021. My objective for attendance was to confirm my understanding of the Article and obtain an interpretation from a reliable source.

The well-presented session satisfied my objectives (thank you BSI), however what I do find very curious is there remains a plethora of promoted webinars, explaining the MDR requirements, still being presented, with large audience attendance. It is quite evident that the medical device industry was certainly not ready for 26 May 2020 and continues not to be ready. This apparent fact does not bode well for healthcare providers and patients.

The medical device industry has had THREE years to review, assess and implement the actions necessary within their organisations to maintain compliance with the regulations. Now, due to the unprecedented ramifications of the ongoing pandemic, the European Commission has granted yet another year until mandatory compliance. It does beggar belief that an industry who directly employs >675,000 individuals with an EU revenue valued at €115 billion and a 5-16% projected sales growth (CAGR 2017-2024) has been this remiss in assuring their products remain marketable.1

As a wife, parent, friend or relative of a possible consumer/patient of EU medical device products, I am not amused.

Profitable, cost effective, life enhancing products might be removed from the market due to a regulatory team’s inability to locate the supporting data or not enough regulatory resource, attributable to antiquated processes and systems or a poorly administered regulatory strategy that is unmanageable.

Those of us in the business of supporting the lifesciences industry are doing our very best to educate clients and potential clients, disseminate accurate information and eradicate the unawareness.

We can help.

Don’t wait in the dark any longer.

Please feel free to contact me or any of my colleagues KimYoung@instem.com

K Young

1https://www.medtecheurope.org/wp-content/uploads/2019/04/The-European-Medical-Technology-Industry-in-figures-2019-1.pdf

Who’s Zoomin’ Who

When reading various posts in different media channels, I have noticed a positive outcome in the current global life sciences environment, the idea of increased collaboration. There seems to be many published examples regarding fiercely competitive organisations who are, for the very first time, exchanging ideas, data, resources, and products to achieve a common goal.

Effective team collaboration requires specific interpersonal and communication skills, knowledge sharing and a defined strategy. Operating as a partnership has been identified to drive greater productivity and foster sustained healthy relationships between employees.

What are some of the common requirements for good team building?

  • Share a common purpose and goal
  • Trust
  • Use of open and effective communication techniques
  • Appreciation for the diversity of ideas
  • Team balance
  • Clarification of roles
  • Leverage cross-functional relationships
  • Open participation
  • Proactive engagement
  • Maintain a level of accountability

I pinched the following from a current regulatory affairs role posting (no, I am not looking!)

“…..the candidate must be confident to lead, willing to collaborate, and be curious….” “You will work across disciplines in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.”

What are some of the skills and behaviours necessary for a collaborative regulatory affairs team member?

  • Create a consensus about goals and processes for team projects
  • Actively listen to the other members
  • Investigate problems or issues without assigning blame
  • Forgive other members’ mistakes
  • Own errors
  • Willingly utilise free-association techniques to discover solutions to problems
  • Compromise when necessary
  • Delegate
  • Follow through with commitments
  • Meet deadlines
  • Show reliability
  • Acknowledge other team members’ contributions
  • Maintain a positive attitude
  • Be open to different ideas
  • Ability to build new strategic alliances, internally and externally

Collaboration delivers a positive influence on the overall company culture by bringing different voices, functional teams, specialties and opinions together to solve problems or to innovate something new. An inclusive workplace environment galvanises teams, frees creativity and allows working together to be both productive and sometimes fun. Employees perform better when they are able to tap into internal experts, data, and resources for the ever present problem solving, or task completion.

Collaboration helps staff to feel more connected to their roles and colleagues, reduces burnout at the workplace, makes their deadlines easier to meet, allows for more freedom, and in general makes all of us happier individuals.

Technology tools, that fit naturally in regulatory workflows, must also support the human behavioural elements of teamwork, such as trust, appreciation, camaraderie, empathy, and sense of achievement. An integrated Regulatory Information Management system can effectively support your teams’ collaboration initiatives by allowing everyone real-time, synchronous access to data, ideas and plans in a shared workspace, transparent across departments.

Multiple benefits may be realised such as faster task completion for remote team members, up-skilling opportunities, sharing talents, feeling inclusive, not feeling siloed, able to see the big picture, and reduced individual pressure.

An optimally engineered and collaborative regulatory operations workplace is not a nice to have, but essential for organisational survival and success.

Please contact me for more information on how I can support your continuing or transition to collaborative activities. KimYoung@instem.com

K Young

Article 16 and Then Some

Let’s say I am a medical device importer or distributor and have just begun to think about how to incorporate MDR Article 14 and applicable EUDAMED requirements into my day-to-day processes, when the regulatory manager at manufacturing company AXV asks me about compliance to MDR Article 16 “Cases in which obligations of manufacturers apply to importers, distributors or other persons”.

What? Not only do I have these new MDR obligations as an importer or distributor, but I might even have even more requirements as a manufacturer? But, wait, I’m not a manufacturer!

Yes, an importer or distributor will assume MDR manufacturer obligations for compliance if:

  • Placing the device on the market under their own name (unless a different agreement is reached with the manufacturer)
  • Change the intended purpose of a device already on the market
  • Significantly modify a device already on the market

However, if you attach a local translation of required information or repackage the device without changing its original condition (example sterility) then you are not a manufacturer. Well, I say, great stuff as my facility does not perform any of those activities. Article 16 then continues…..

— At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in the above paragraph shall inform the manufacturer and the competent authority of the member state of the intention to make the relabelled or repackaged available and upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged devices, including any translated label and instructions for use. Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate issued by a notified body designated for the type of device, attesting that the quality management system of the distributor or importer complies with the following:

  • Assurance that any translation is accurate and up-to-date
  • Relabeling and repackaging activities are performed adequately to preserve original condition of the device
  • QMS system includes process for corrective actions relating to safety issues

OK, I manage a distribution warehouse, receiving different medical devices from multiple manufacturers, occasionally we shift stock into different packaging as per my end customer’s requirements and maybe add a bit of local language labeling over the original. Do I need to comply with all of these regulations?

The short answer is an emphatic – you need to find out.

The HPRA of Ireland has published a very comprehensive guide, specifically for medical device distributors: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/ia-g0004-guide-for-distributors-of-medical-devices-v1.pdf?sfvrsn=13

A special note to those individuals working in medical device industry. You need to contact everyone in your European supply chain NOW.

Help them navigate through the quagmire of regulations, certifications and guidances. They do not have the experience with these activities, you have a regulatory team skilled in legislation interpretation and impact communications.

The success or failure of your European medical device supply chain ultimately rests with you, the manufacturer.

Kim.Young@instem.com

K Young

Thursday Thoughts: Ugly Data

Do you currently support your lead revenue generating, life-enhancing product with a collection of bench studies from 20 years ago? Can you effectively follow the history of the product data from when it was called project Heart to Heart3, then on to Tech4567 and finally PaceMaker Elite Mach 76A with titanium?

We all know that true beauty comes from within and is recognised via the eye of the beholder. In the case of medical device regulatory supporting data, the eyes beholden the beauty are notified bodies, competent authorities, external auditors and health regulators. Adding a pretty new frock or snazzy tie will not improve inadequate inherent beauty or the mandatory quality of your most precious enterprise asset.

Even if, at first glance, the regulatory data may look quite fetching, lulling you into a false sense of security…..remember “beauty is only skin deep, ugly goes clean to the bone”. Now is the time to take that deep dive into the data stores to uncover the ugly hiding underneath which may place your medical device products at a risk of non-compliance.

Your regulatory data may need a complete makeover

I am pretty handy with a paint brush, email me at KimYoung@instem.com

K Young

Internal Intelligence Supports Change Strategy

Regulatory change strategy may be defined as “the comprehensive elucidation of a project designed to achieve a specific regulatory goal, such as to obtain a new approval or clearance of an amendment.”

As global regulatory requirements evolve and become increasingly more complex, a solid regulatory strategy for changes, followed by a determined execution, can maximise the opportunity to achieve the identified regulatory goals and provide the ever-elusive competitive advantage for revenue generation.

A suitable approach to regulatory strategy for product changes begins by engaging with internal cross-functional stakeholders to identify those product attributes that may have regulatory impact such as revised intended use, new target market, additional clinical study requirements, etc. Regulatory teams will then conduct a regulatory intelligence analysis on possible precedents, document the proposed strategy, verify the strategy’s viability and finally by reassessing (and when necessary, updating) the strategy as and when circumstances change.

Consideration must be made on what was been done before, what worked for other organisations and, just as importantly, which prior executed strategies were not successful. Key risks, barriers, critical assumptions, issues or questions must be confirmed or resolved. The strategic process must proactively recognise any challenges that may be responsible for delays for the proposed change implementation. Opportunities for positive engagement with the impacted global regulatory authorities should also be encouraged.

Internal regulatory intelligence is a key source of data for strategic planning. Regulatory teams are required to access and review historical product and registration data such as:

  • All registration history for the impacted products and regions
  • Average time from submission of change request to health authority approvals
  • Previously received queries from HA concerning changes and acceptance of company responses
  • Quality and quantity of interactions with specific HA personnel
  • Which products in a different product family with the same or similar change were managed successfully
  • Which implemented regulatory change strategies in the targeted regions were not successful and required re-submission or withdrawal
  • Lessons learned

Without a centralised repository for product and registration data, regulatory teams will struggle to obtain the strategically valuable key information unique to their organisations that is essential to provide regulatory guidance to business executives. Do not allow a flawed regulatory strategy, due to lack of accurate internal data, be accountable for your change not to happen.

KimYoung@instem.com

K Young

PFS – Combination Product or Not?

I recently read with interest a comment by a regulatory colleague about how a pre-filled syringe (PFS) should continue to be regulated as a drug with a primary package rather than a combination product for the principal reason that the product has been on the market for many years and has been proven safe and effective.

Well…. if a syringe without content is regulated as a device, then why would prefilling the device with a drug change its regulatory requirements for registration/approval? Does prefilling the device supersede the product’s device categorisation even though the syringe maintains the same intended use?

GMDN: General-purpose syringe/needle

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

To what standard do we regulate changes to this “primary package” for the PFS? Same as for a hard shell capsule?

At what point does the product change categorisation
from a drug with a primary package
to this device?

I understand, regulatory affairs personnel occupying various roles in pharmaceutical companies without a medical device portfolio may find the compliance requirements related to both FDA’s 21 CFR 3.2(e)(1) and MDR Article 117 onerous and inconvenient. However, these requirements that one may consider an inconvenience are in fact necessary to apply a globally recognised and consistent regulatory approach to support the continued validation of the safety and efficacy of this combined drug/device product.

Please feel free to contact me to discuss your drug/device combination product RIM requirements. KimYoung@instem.com

K Young

Can you Identify your Critical Suppliers?

Can you identify your critical suppliers, link each to their respective product codes and global registration status? Many medical device regulatory affairs teams struggle to connect these dots.

Firstly, who is a critical supplier and why are they important?

“2.2 Critical supplier: A critical supplier is a supplier delivering materials, components, or services that may influence the safety and performance of the device. Note: In the context of the audit of medical device manufacturers, a critical supplier is a supplier of a product or service, the failure of which to meet specified requirements could cause unreasonable risk to the patient, clinician or others, or could cause a significant degradation in performance. This can include suppliers of services, which are needed for compliance with QMS or regulatory requirements, e.g. internal audit contractors or Authorised Representatives.”

Compilation of MDR compliant technical documentation necessitates identification of all sites, including suppliers where design and manufacturing activities are performed.

Annex VII of the MDR requires your notified body to “identify links between, and allocation of responsibilities among, the various manufacturing sites, and identify relevant suppliers of the manufacturer, and consider the need to specifically audit any of those suppliers”

“…if not already covered by the audit programme, audit the control of processes on the premises of the manufacturer’s suppliers, when the conformity of finished devices is significantly influenced by the activity of suppliers and, in particular when the manufacturer cannot demonstrate sufficient control over its suppliers”. Notified bodies are expected to perform unannounced audits of your named suppliers, where applicable.

Ensure you connect the dots.

Cross-functional deliberations on the strategy and approach for ensuring medical device suppliers are identified, controlled and managed appropriately via QMS will only succeed if the data is accurately connected within your regulatory information management (RIM) system. Global and regional regulatory operations teams support this process by maintaining adequate linkage, tracking and data retrieval of supplier information per product code.

Feel free to contact me at kimyoung@instem.com for information on how to support supplier data management.

K Young

And now…EUDAMEDgate

Emergo’s blog and EUDAMED.eu Richard Houlihan have announced that specific portals of the postponed European EUDAMED database will made available prior to the officially published May 2022 date of implementation:

  • Actor registration: March 2021
  • UDI/Device: May 2021
  • Certificate/Notified Body: May 2021

Even without knowing whether data entry will be voluntary or mandatory 1st quarter next year, if these dates are accurate for module implementation, the medical device industry and all associated actors, need to get into 6th gear to ensure compliance.

Please note: NO official announcement from the European Commission confirming these details is currently available.

For what purpose has the EC “leaked” this information? This situation is very similar to the original EUDAMED postponement 7 months ago when during a Medical Device Forum meeting, a cavalier announcement from a committee member caused multiple repercussions around the regulatory world. It would be a week following that single comment before any official communication was issued by the EC or MDCG.

Why is this process not transparent? Multiple rumours, unsubstantiated statements, and speculation does very little to support a smooth MDD to MDR transition for industry, competent authorities, and all key stakeholders.   

The EUDAMED database and related compliance activities may be implemented earlier than previously expected. Now is the time for regulatory operations teams to engage with their cross-functional colleagues to determine when and how they will implement the regulatory data requirements within their business.

During these extremely challenging times of the COVID-19 crisis, regulatory teams are continuing to struggle uphill to support business compliance.  Do not allow a lack of technology keep you at sea level.

Please contact me at KimYoung@instem.com for additional information on software solutions for EUDAMED data.

K Young

Join our own Kim Young, along with FDAnews, on May 20th

We are excited to be sponsoring the upcoming FDANews webcast titled Sustained Medical Device Regulation Compliance: Ensure Your Regulatory Processes and Tools are Fully Optimized.

Join us on May 20th at 1:30 PM US EST to understand how to optimize your processes and tools to ensure that your regulatory operations can help get new products to the global market with improved speed, efficiency, productivity, and quality while also ensuring continued regulatory compliance and life-cycle management of your legacy device portfolio.

For more information and to register, click here.

Thursday Thoughts….

Communicating Regulatory Information

Everyone, especially senior regulatory executives, has a preference for communication styles. Does your line manager request a departmental update via a one-hour presentation with lots of colourful graphics, an email composed of <200 words or a 10-minute telephone call? Regulatory professionals spend enough time justifying their role without supplementing any negative perception by presenting information to key stakeholders utilising the wrong approach. Each of these information dissemination scenarios are difficult to fulfil if your regulatory data is inaccessible or at worse, inaccurate. The ability to easily access your up-to-date regulatory data in multiple formats and layouts will provide you and your team with the ability to prepare personalised communications for each audience. Once your regulatory data is effectively sorted, communications become a piece of cake (or pie)!

More discussion on this topic soon.

Please contact me to discuss topics related to regulatory communication challenges at KimYoung@Instem.com

K Young