Why are you not ready?

This week I have been attending the numerous sessions presented during the MedTech Summit https://informaconnect.com/medtech-summit/

The topics for discussion serve as a stark reminder that our medical device industry remains inadequately prepared for application of the MDR and IVDR regulations. For example:

  • Path to Compliance: Industry EU MDR
  • EUDAMED update: Status and Future Timelines of Implementation of the EUDAMED Database
  • Strategies to Manage your Distributor Regulatory Risk
  • Meeting the New PMS Reporting Requirements of MDR & IVDR with Future-Proof Systems

Granted, I understand that 2020 has been a challenging, arduous and hellacious year but it appears, based upon some of the audience questions, that there are organisations who have not yet begun considering how they will implement actions to ensure compliance.

If an organisation is still asking basic questions today, at 233 days (5352 hours) until application of MDR, when will they actually be prepared??

I would really like someone to explain to me, just what is the problem with preparedness??

  • Is it a lack of understanding or awareness of the requirements?
    • Who lacks the understanding?
    • How do we get them to understand?
  • Is it a lack of resources?
    • How to approve the funding allocations?
  • Do they think application will be delayed again, therefore have even more time?
    • Wishing for another crisis? I hope not.

This lack of readiness does not bode well for the future of the European medical device market from 2021. Well at least in the immediate future.

  • Will those companies who are “ready” dominate the EU market?
  • Will the smaller SMEs disappear altogether?
  • What will happen to product availability?

I know that I have asked a lot of questions. If anyone has the answers, I would love to hear from you.

Back to the conference…..

kimyoung@instem.com

K Young

Are your EU distributors ready for 26 May 2021??

European Regulatory requirements1
DISTRIBUTORS of medical devices or in vitro diagnostic devices have specific obligations to fulfil under Article 14 of both the MDR and IVDR.2,3 Distributors will have to verify whether:

  • the device has the (CE) mark and an EU Declaration of Conformity has been issued;
  • the importer’s name is affixed on each device or is in the attached documentation (where applicable);
  • the device bears a unique device identifier assigned by the manufacturer (where applicable);
  • the device is labelled properly and has instructions for use (IFUs) in an official language of the country in which it will be marketed

 In addition, distributors are responsible for:2,3

  • ensuring storage and transportation of devices under appropriate conditions as defined by the manufacturer; and
  • notifying the manufacturer and competent authorities when they suspect a device has been falsified or presents a serious risk to patient health

These are the facts.

A question for medical device and IVD distributors: How will you ensure compliance?

As the regulatory operations teams working for medical device and IVD manufacturers are struggling to manage the myriad of internal MDR/IVDR data requirements,

  • Who in your organisation is managing and supporting all of your economic operators to ensure no disruption to your supply chain and revenue stream?
  • Are you assuming your distributors have got it covered as it is their responsibility?
  • Can you even link your economic operators to a specific device or even device family?
  • How will you exchange the necessary data between yourselves and your disparate distribution chain?

For those of you who cannot confidently answer these questions, I suggest giving me a call.

I can help sort you out.

Kimyoung@instem.com

+44 (0)7384 116106

K Young

Collaboration

How many of you have initiated contact with someone you haven’t met (in person) as you struggled to answer a challenging internal query? During this period of lockdown and working from home, I have found myself reaching for my contact lists, both internal and external, more often than in previous months. Sitting alone in one’s home office, bereft of professional human contact (pets, children and the postie doesn’t count), I find it is much easier to pick up my mobile phone, submit a Teams meeting request, or send an email in order to collaborate.

All of us, regardless of professional status, require help or assistance from time to time. One shouldn’t shy away from reaching out to a friend, colleague, acquaintance when in need of an authoritative opinion or advice of a specialist expert.

Internal Collaboration

Sometimes it is difficult to acknowledge expertise in areas with which we are unfamiliar. There are those that know a little about a lot of things and others who know a lot about a niche subject matter. Organisations do try to fill roles with individuals on both sides of the spectrum. Difficult as it may seem to acknowledge, no one knows everything! Your fellow team members are just that – part of your team.

External Collaboration

Utilising a closed collaborative system expects an organisation to develop and grow competitively in the long term; whilst commercialising new products and services within a protected boundary. Copyrighted collateral, intellectual property and innovative ideas are thus protected. This approach may work for some. Openness to utilising external resources and ideas throughout a functional process development, such as an MDR gap analysis review, allows a team to explore and possibly build new capabilities.

External collaboration might be as simple as colleagues exchanging ideas over a coffee (with social distancing of course) or as formal as zoom meeting with a prescribed agenda.

Collaboration barriers

  • No incentives or motivation
  • Status gap
  • Limited resources (time, funds, people)
  • Cultural differences
  • Competition

The Covid-19 lockdown, with its seemingly draconian policies and regulations, has provided a stark example of how it really is better if we work together.

There are concepts, facts or ideas I may know, that you may not be aware. I could possibly support resolution of one of your challenging activities. Please reach out, even if just to chat. No obligation.

kimyoung@instem.com

K Young

Reference:

https://innovationmanagement.se/?s=duval

Virtual Time Out

Apologies to everyone for the lack of RIMtelligence blog traffic over the last few weeks.

The need for quality, family holiday time, superseded my weekly and ever scintillating blog writing. Even with all of the various restrictions, the holiday was absolutely fantastic, (in spite of my breaking one toe on each foot the day before travel), especially as self-isolation was not compulsory upon our return.

My arrival home, at 03.35 Sunday morning, was immediately followed by attendance at the 2020 annual #RAPSConvergence. I have to say, the virtual approach to this years conference created a very different atmosphere for session participation, solution provider engagement and overall networking opportunities. I would be interested in reader opinions, both positive and negative of the RAPS affair.

Virtual webinars are proliferating at an amazing rate. Please join me on Wednesday 30th September for an informative 60 minutes: https://lnkd.in/dk4Pp9P

During this webinar, I will discuss the less considered yet critical topic of how managing Global UDI data requirements directly impacts the multiple medical device industry stakeholders (manufacturers, healthcare providers, competent authorities and patients) and approaches considered across industry for organisational system implementation.  UDI compliance requires the right regulatory operational strategy to ensure an increase in efficiencies and at a lower cost. Our key objective is to enable those in senior decision making roles to make informed choices as to which methods best suits internal regulatory processes, product portfolio and market requirements.

Looking forward to your virtual participation.

kimyoung@instem.com

K Young

Reality of Regulatory Reliability

A Regulatory professional’s role in the life-science industry demands a special adherence to a code of ethics.

  • Regulatory Compliance
  • Competency
  • Objectivity
  • Integrity
  • Honesty/Credibility
  • Accountability
  • Equitability
  • Dignity and Respect

Our employers, employees, peers, and all external parties with whom we interact, not only expect compliance with these ethical codes, but also rely on our competent guidance to support the life-cycle management of life-enhancing medicinal products. This reliance is based upon the knowledge that regulatory processes are developed and implemented with this aim in mind.

Reliability

the quality of being able to be trusted or believed because of working or behaving well

Regulatory reliability is critical in today’s evolving and demanding regulatory environment. As per the above, reliability is realised only when one is working or behaving well. A well-resourced, focused, and a highly regarded regulatory team with the proper executive leadership can be an effective way for an organisation to support “working well”. This team is fundamentally no different than any other risk averse discipline that requires targeted investment.

Unfortunately, without examining all causes, organisations often fault the regulatory professional when reliability suffers a decline. Facilitation of a forward-looking investment approach is de rigueur to achieve the highest level of regulatory reliability, essential for your organisation.

Please ensure that your regulatory teams are supplied with the correct tools and resources to execute their multiple responsibilities.

Safeguarding regulatory reliability will equal organisational success.

kimyoung@instem.com

K Young

References:

https://www.raps.org/who-we-are/advancing-the-profession/code-of-ethics

https://dictionary.cambridge.org/dictionary/english/reliability

Mistakes Cost

August is holiday season for the northern hemisphere regions. Those of you down “under” (Santiago, Cape Town, Sydney, Christchurch) are hopefully enjoying a lovely winter. 😊

Summer holidays in the UK are a very much anticipated annual ritual. Whether one spends the holiday time pootling around the garden, sightseeing locally, visiting friends and family or yachting across the Atlantic, time away from daily work tasks (even when working from home!) is necessary to recharge mentally and physically. The worldwide travel advisories due to the Covid-19 crisis have made for a difficult and frustrating time for those of us who wish to holiday abroad.

As such, I have found myself, over the past few weeks, dealing with a significant magnitude of data information entry:

  • Data entry for multiple refund requests for cancelled holidays
  • Submitting personal track/trace details to destination governments x 2
  • Submitting personal track/trace details to UK government for return arrival
  • Data entry for new groups of 10 and 6 persons for separate trips
  • Keeping track of all the various reservation numbers – new and cancelled
  • Keeping track of the refunds received

Yes, at one point thought I would require an excel spreadsheet to track all of the changes…..

The process was fraught with challenges and of course, human beings invariably make mistakes:  

  • Clicked wrong button during refund requests which lead to multiple phone queries to update status
  • Destination government forms were unwieldy, difficult to understand, unclear where the individual data points were to be captured, all undertaken without clear guidance
  • Spelled my husband’s name incorrectly (LOL) thankfully discovered prior to boarding pass issue
  • Needed to double and triple check each “numbered” entry such as birthdates and passport details from the individual source documents

I am a regular user of on-line forms and databases. I can image how those individuals not familiar with such processes would struggle to complete each field accurately.

  • Is the data saved whenever I move to the next page?
  • Can I go back and change the information?
  • Why am I getting an error message?
  • Why do I have to re-enter the same data every time?
  • Did the form save correctly?
  • Will I be charged for a mistake?
  • I don’t understand what data the field is requesting
  • If the form is incorrect will I be denied entry at my destination?

The holiday data entry requirements were laborious due to its manual process, coupled with the nonintuitive nature of the form designs. For those non-Regulatory Affairs personnel in the medical device industry who are performing these same input tasks in relation to their holiday travels, try to imagine multiplying those data management requirements by 10xx as appropriate per 1000’s of device product codes.     

Misspelling my husband’s name for the holiday flight could have cost me £50. Misspelling and incorrect data entry for your medical device information will certainly cost your firm much more.

May everyone have a safe and restful holiday.

kimyoung@instem.com

K Young

Regulatory Data Analytics

Regulatory Affairs Analytics

Behind every regulatory operations workflow, registration submission, health authority interaction, there lies data ripe for analysis. This data is probably one of the most important resources a life science organisation can possess. Utilising analysis of this regulatory data can help drive change with positive outcomes to support increases in efficiency and revenue generation. There is a wealth of information available to your organisation if you are ready to embrace it.

It is vital for every regulatory strategic plan and decision to be grounded in solid data. Data analytics can provide you with key insights that help you make the best choices in the ever-evolving regulatory environment. Analysis of this data supports the regulatory team in:

  • the development of a clear idea of the right road to achieving targeted business goals
  • what is happening in real time with regulatory submissions
  • establishing the next steps to remain competitive

Set Realistic Goals

Setting goals for your regulatory submissions sometimes involves educated guesswork without the right information. Submission goals should not be a moving target. Using analytics, you will be able to assemble data from historic trends and previous regulatory interactions, enabling the team to have a clear idea of what the goals should and can be, right from the project initiation. This ensures that you do not miss opportunities to obtain faster approvals and thus achieving a revenue generating marketing status. Review of the analytics supports a transparent understanding of when achievement of certain described goals are not possible. Analysis may also show the weaknesses of your processes so that you can initiate timely improvement. 

Decision-making 

Regulatory affairs intuition and experience are invaluable, but some decisions that affect key business objectives ought to rely on actual data. Regulatory strategy and determination of possible registration outcomes rely on this background data.  Even when it comes to resource management, actionable data can help determine how best to deploy limited resources. Organisations utilising regulatory analytics are more likely to improve their decision-making process for optimal success.

Senior management relies on the regulatory function to provide guidance for cross-functional decision making, affecting the efficiencies across the organisation. Presenting the data in a visually captivating way, making the data more interesting (wow – interesting data!) and helps to address the need for faster, accurate reviews and an agile decision turnaround.

Curtailing Regulatory Risks

Making the right decisions based upon sound data should decrease the prospect for added risks. Avoidance of unacceptable regulatory risk may be achieved in the short and long term though data analysis. Regulatory teams should no longer make the wrong decision or subject a project to increased risk due to a lack of information or inaccurate information.  As we all know, failing to adequately determine regulatory risk may have catastrophic consequences in the form of field safety actions, market withdrawal or a reduction in health authority confidence.

Cost Effectiveness

Analytics can play a major role in decreasing the burden of regulatory costs. Measuring performance and effectiveness makes it easy to see which regulatory strategies worked and which presented sophisticated challenges. Saving time and resource in the pursuit of registration approval, key performance indicator for RA, becomes more manageable with the right data supporting decisions.

Regulatory Intelligence

Your regulatory processes capture data unique to your company, regions, teams, and product portfolios. No one outside the organisation has access to this information. The analysis output, when combined with publicly available information, can be leveraged to increase competitive advantages. A breakdown of the past helps to draw your plans for the future.

Data analytics is the cornerstone of regulatory information management software solutions. It is now easier than ever to obtain the pertinent data and reports that will support your regulatory business decision making objectives. Imagine a dashboard tool that creates easy to read and interpret visual representations of your valuable data.

Request a demo : https://www.instem.com/contact/demo.php

Contact me directly for additional information at kimyoung@instem.com

K Young

Thursday Thoughts: Webinars

Working from home during lockdown does have some advantages. During the past few weeks I have viewed or participated in a number of virtual discussion sessions and educational webinar presentations across different timezones. I do have to say that the quality of the content and level of professionalism has varied widely.

Every day, I receive numerous emails touting an opportunity to be enlightened by an expert, or even better a panel of experts, on all manner of topics associated with our regulated industry. Webinar and discussion group themes range from exceedingly targeted for a narrow segment of the regulatory affairs population to subjects affecting cross-function teams, product portfolios, regions, legislation and work environments. Determining which to watch is a bit like viewing your Amazon Prime catalogue, some offerings are free with your subscription whereas others require an additional one-time fee for limited access. Then there is the conundrum of the advertised title and synopsis not corresponding to the presented content. Sorting through the tidal wave of choice is almost a full-time effort.

Today it’s simple:

The link below (readily accessible via this blog) relates to MDR readiness of regulatory information data management for medical device manufacturers and economic operators.

https://get.instem.com/medical-device-regulation-compliance/

Please contact me for additional information kimyoung@instem.com

K Young

We are Family

What exactly is a medical device family?

Or device group?

Or medical device family group?

What criteria does your company use to assign individual devices to a family?

Who is responsible for maintaining the structure of your device families?


Harper Lee quote from To Kill a Mockingbird

You can choose your friends but you sho’ can’t choose your family…”

Human families come in all shapes, sizes, colours, genders and ages. However; in the case of medical device categorisation, the definition of a “family” of product codes is entirely up to you.

So which definition do you use?

ISO 13485:2016

https://www.iso.org/obp/ui#iso:std:iso:13485:ed-3:v1:en

​Medical Device Family is a group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function.

Health Canada​

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-interpretation-sections-28-31-licence-application-type.html

Medical Device Family

A group of medical devices that are made by the same manufacturer, that differ only in shape, colour, flavour or size, that have the same design and manufacturing process and that have the same intended use.

Medical Device Group Family

A collection of medical device groups that are made by the same manufacturer, that have the same generic name specifying their intended use, and that differ only in the number and combination of products that comprise each group.

Health Sciences Authority (HSA) Singapore

https://www.hsa.gov.sg/medical-devices/registration/grouping/family

Family grouping requirements

Medical devices under a family have to meet all of the following requirements:

  • From the same product owner
  • Have the same risk classification
  • Have a common intended purpose
  • Have a common design and manufacturing process
  • Have variants that are within the scope of permissible variants

Therapeutic Goods Administration (TGA) Australia

https://www.tga.gov.au/kind-medical-device

Devices are taken to be of the same kind if they have the following characteristics:

  • the same sponsor
  • the same manufacturer
  • the same classification
  • the same Global Medical Device Nomenclature System Code (GMDN code)
  • for Class III, Class AIMD medical devices and Class 4 IVD medical devices (other than an immunohaematology reagent that is a Class 4 IVD medical device) the same unique product identifier (UPI)

Replacement Reagent and Instrument Family Policy (US FDA Guidance)

https://www.fda.gov/media/111186/download

An instrument family consists of similar analysers made by one manufacturer that yield the same analytic result from samples of the same specimen within stated tolerance limits. A device family refers to a group of two or more devices manufactured by or for the same manufacturer and having the same:

  • Basic design and performance characteristics related to device safety and effectiveness that share a common Design History File (DHF) (See 21 CFR 820.30(j)),
  • Intended use and function, and
  • Device classification and product code.

Common Data Elements for Medical Device Identification (IMDRF)

http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-rps-common-data-elements.pdf

Model

The value used to represent one medical device or a family of medical devices to group many variations that have shared characteristics.

Unique Device Identification system (UDI system) Application Guide (IMDRF)           

http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-190321-udi-sag.pdf

Regulatory Authorities should be aware that this guidance does not specifically cover certain emerging issues with UDI systems, such as: tools and device categorization nomenclature for grouping similar devices

Applied for scope of designation and notification of a Conformity Assessment Body – Regulation (EU) 2017/45 (MDR) Notified Bodies Operations Group (NBOG)

https://www.nbog.eu/nbog-documents/

This NBOG’s best practice guide applicable for MDR provides a list of codes that reflect the design and intended purpose of the devices for which the NB would apply for designation scope and the manufacturer would request for conformity assessment.

Example

Organisational Business Unit/Marketing Defined

All medical devices managed and marketed under a broad business directed umbrella ie. Paediatric Orthopaedics, Wound Dressings, or US Dental without a requirement for same intended use, class or DHF.


If you are struggling to respond to any of the questions regarding family designations for your medical device portfolios, then you have an immediate need to initiate a programme in order to prepare a consistent approach for your supervening global identification data reporting requirements. Choosing inconsistent family categorisations will have a negative impact on your device identification data output efficiencies, such as UDI compliance and regional registration groupings.

A structured global identification scheme requires a positive investment in a data management strategy that centres on the accurate and consistent collection of the substantial volume of medical device identification data.

Choose your families wisely.

For more information on increasing data management efficiencies please feel free to contact me at Kimyoung@intem.com

K Young

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