Medical Device PLM – Design Control

Posted on August 24, 2016

Introduction

Medical device makers have to comply with many FDA and ISO regulations.  These regulations include CFR Part 820, Part 11 as well as ISO 13485 and ISO 14971 for risk management. PLM can enable compliance to these regulations in the areas of Record Control, Corrective and preventative actions (CAPA), Design History Files (DHF) and Material Control.  This post focuses on the challenges regarding Design Control.

med device in field graphic

Goal of Design Control

The goal of design control regulations is to prove that you have designed a safe product and that it meets user needs and fulfils all the requirements. The specific FDA regulation that talks about design control is 21 CFR 820.30 and ISO 13485 section 7.3 Design and Development. Both expect documentation and records of design though-out the product development process.

Terminology

Design Control uses some specific terminology of which I will cover here:

  • Intended Use – is the stated general purpose or function of the device.
  • Indications for use – is the stated disease or condition the device will diagnose, treat, prevent.  It is also good practice to state the unintended uses of the device.
  • User needs – are requirements from the users’ perspective, typically broad statements that are difficult to qualify and measure. They use works like easy, simple, friendly or better. For example: “the device must be easy and simple to operate. “ To get user needs questions like: How will the user or patient use the device, what is the use procedure, what is the device use environment and more.
  • Design Input – defines all the requirements, features and functions of the device. Unlike user needs, design input need to be objective and measurable. Some of the design inputs are typically derived from user needs. Design inputs don’t all need to be device specific since they can also come from regulations, industry standards and even market and competitive needs. When defining design inputs always keep in mind how you will verify them, since verification is an important step in design control.
  • Design Output – is a compilation of records containing the procedure and specifications for the finished device. In other words, it’s a recipe on how to build the device. This is also known as the Device Master Record (DMR). If you gave someone the device master record they should be able to build the device. The design output and DMR includes things like the bill or material, drawings of the parts and assemblies, instructions on how to assemble and build the device, standard operating procedures and much more.
  • Verification and Validation – Although they sound similar and are often misused, verifications relate to design input while validation typically relate to user needs. Regardless, they both need plans proving that the design input or user need is met. Careful consideration of how to validate and verify should be done as early as possible. The results of the validation and verification should be captured, stored and belong in the DHF.

Typical Industry Practice

Since it is a regulation to have a DHF and DMR the typical industry practice is to “design and print”, meaning do the design and then print to paper and store in a binder. Some “design and file” meaning that they store the file onto a electronic file system that is structured to look like a DHF binder. Other that use PLM’s systems create structured document records, mimicking a DHF binder and managing the files in the PLM document vault.

file cab

To keep track and traceability of the user needs, design inputs and outputs and their verification and validation plans along with the results a common industry practice is to use utilize Excel spreadsheet. In all cases this is a manual process that is very labor intensive and error prone. Even if the product is correct, having data that is incomplete or referencing a wrong version can trigger problems with audits.

 

Picture of Design Control Risk

Unfortunately, this is the landscape of many companies; file system, spreadsheet and silo systems. Anyone can very easily see the inefficiencies, data duplication, lack of traceability and opportunities for error. This is a picture of a design control full of risk.

chaos slide

 

DHF/DMR

Minerva’s Medical Device PLM running on Innovator can be used to reduce risk and improve design control. As part of a larger solution two elements are described here. The DHF/DMR and the Traceability Matrix. The structures of the DHF and DMR are created as a template. For a device all the deliverables are defined. The deliverables include things like documents, requirements, test specification, parts, Bom’s,etc. Each deliverable is then mapped to a location in the DHF and/or DMR along with a rule that states when that deliverable is complete. This can be based on workflow completion such as a release, user action or phase/gate completion. The combination of these two items allow the DHF and DMR to be created automatically as a result of users work. Baselines, complete DHF and DMR structures are created as a result of any change to a project or deliverable as well as a completion of a phase/gate.

Screen shot DHR-DMR

Traceability Matrix

The traceability matrix from Minerva is an unified view of the design control.  It utilizes Aras’ Content Modeling Framework (CMF) in an Excel like format to map the user needs, design inputs and outputs to their validation, verification results. The key differentiator to Excel spreadsheet is that the traceability matrix is a structured document with relationships to the Innovator business objects. As these business objects change the traceability matrix can receive alerts and updates. For example, when a requirement that is a design input changes, the change will be highlight in the traceability matrix notifying the users to review the verification plans and design output.

This is a summery of the DHF and DMR in the Medical Device solution. Template structures are created for the DHF and DMR. Deliverables and their corresponding closing rules as well as where they need to be placed in the DHF and DMR are created. A project is used to instantiated the deliverables and as work competes on the deliverables they are automatically placed in the DHF and DMR. When looking at the device product the DHF and DMR can be reviewed.

Instead of managing requirements as one big Word document Innovator can manage each detailed requirement separately. This is important since requirements can come from many different sources. Requirements can also be classified by type and can be used for user needs and design inputs.

traceability matrix screen shot

This is a depiction of how the traceability matrix is modeled as a structured document in the content modeling framework of Innovator. An user need can have many design inputs both of which are represented as the requirement business object of Innovator. A design input can have one or more design outputs where the output is represented as many different type of business objects. A typical design output will be a part, assembly or document but can also be FMEA or Risk Analysis. A user need and design input can have one or more validation and verification plans respectively. The verification plans are represented by test specifications business objects. A verification or validation plan can produce one or more results.

As always I’m interested in your experience and feedback.  If you would like to know more or would like a product demonstration contact Minerva at www.minerva-plm.com or me directly sjo(at)minerva-plm.com.

 

Demo of Design Control – DHF and DMR

Demo of Design Control – Traceability Matrix

Publishing ARAS events in Slack, why it can boost your efficiency ?

Posted on April 27, 2016

Slack is a new efficient way to communicate when working in teams.

ARAS innovator already provides the “In Basket”, where you can see and participate to projects and changes, but adding slack into the picture can become a wonderful efficiency booster !

Slack is adding another dimension to ARAS, it allows multiple people to see live what happens to some specific objects into live feed. Allowing better re-activity and efficiency instead of viewing a pile of mails looking all the same where usually you have specific filters to “move” (if not re-move) them out of sight from your inbox.

Why should I publish something to multiple people if ARAS already determines who is the best to do something ?

That’s a really good question that usually is raised by “doers”, people who actually do things. Where some of those tasks might interest other people, like managers or other team member working on similar topics. So publishing in Slack some events can leverage the capability of a “Team” to react as a “Team” instead of individuals reacting differently without crossing their informations.

At Minerva, we use Slack during our development phases to keep track of what happens to our Continuous Integration and also having at the same place (#ProjectChannel), the bug raised by our customers. It allows us to react live and reduce the lead time for fixing, usually to “immediate”. It has improved our capacity of fixing bugs in an efficient way as the person who knows the bug will manifest himself and take the ticket for him. Avoiding meetings to dispatch little, trivial things when a developer is still developing on the same feature.

So how to plug Slack into ARAS ?

Just need a slack webNew Integrationhook, from your slack Channel just click to the tools / Add an app or Integration.

Select Build you own on the top right of the website and then, “Something just for my team”

 

When you will have requested a webHook, you will have a URL.Incoming WebHook

https://hooks.slack.com/services/HASH1/HASH2/HASH3

This URL is the entry point for sending information into slack, you can use this URL from anywhere actually, the combination of HASH is unique and is linked to your Slack domain.

 

 

PartLifeCycle_Post_Transition

In ARAS, you need to create a Method or add the following content to any of your method that might be place into a PRE or a POST into LifeCycle of Workflow.

Server Side, C# method content

//SEND SLACK NOTIFICATION
Innovator inn = this.getInnovator();
string title = HttpUtility.HtmlEncode(this.getProperty("keyed_name",""));

WebRequest request = WebRequest.Create ("https://hooks.slack.com/services/HASH1/HASH2/HASH3");
request.Method = "POST";
string payload = "{"channel": "#YourTeamChannel",";
payload += ""username": "NameOfYourBot", ";
payload += ""text": "";
payload += "New vote:<https://www.minerva-plm.com/ARAS_11_SP6/?StartItem=Part:"+this.getID()+"|"+title+"> ";
payload += "sent for Review";
payload +=""}";
byte[] byteArray = Encoding.UTF8.GetBytes (payload);
request.ContentType = "application/x-www-form-urlencoded";
request.ContentLength = byteArray.Length;
Stream dataStream = request.GetRequestStream ();
dataStream.Write (byteArray, 0, byteArray.Length);
dataStream.Close ();
WebResponse response = request.GetResponse ();
dataStream = response.GetResponseStream ();
StreamReader reader = new StreamReader (dataStream);
string responseFromServer = reader.ReadToEnd ();
reader.Close ();
dataStream.Close ();
response.Close ();

return this;

 

You need to add this bit of Code wherever you need to send a notification. This example is valid to be plugged on a Part LifeCycle transition, cause I’m returning a link pointing to a Part itemType, but you can enhance (Documentation here) the content you send in Slack with picture, document, etc.

 

Easy to use and configure, doesn’t mean Mickey Mouse system !

Posted on September 17, 2014

Yesterday I was looking at the following video from Aras showing how different customers go in the same direction about Aras Implementations. Small increments bringing continuously business value to their users, typical Agile approach allowed by Aras Innovator. To me there are two main elements in this video. The first is about the Agile approach, the second is the reason of this blog post: Get trained.

I’ve got two types of situation where we need to push people to get training:

  • Companies where they believe we are the techies, so we are the ones to know how the system works and that’s it
  • Companies who think Aras is a very simplistic solution that can be run with almost no resource and with which we can do everything

For the first type of companies, in all our project we see the same thing. if you want your project to succeed please get trained on Aras Innovator. Even if you are not technical. Make sure for example to understand what means “in Aras Innovator, everything is an Item”.

For the second type of companies, yes Aras is simple in order to setup quick proof of concepts. But PLM is complex on its own. Even with a very simple solution you need to understand that if it has to manage complex problems the system can’t be simplistic. It’s a long journey to have a PLM with a very wide implementation scope. And you need to understand the software in order to control this process.


 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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Aras Innovator & Resilience

Posted on September 10, 2014

I thought I’d have a lot more time to write article during the last Aras Community Event but this has once again been a very intense event with lots of discussions with other people interested in Aras Innovator. During the event you have one main presentation or sometimes there are three tracks : Basic, Technical and Business. I usually go to either Business or Technical presentations. Basic are usually more made for prospects or eve, people who have never heard of PLM. But I was interested in one basic conference where the speaker was Aras CEO, Peter Schroer: “Resilient PLM”

Here is the presentation text :

“For long life products such as aircraft, automobiles and plants you need a PLM system that can manage product changes, and control product traceability and compliance for the full lifecycle. Learn how the Aras approach to creating resilient systems can be used to manage very long life products while also preserving the IT investment you have made in customizing and integrating your PLM system. From upgrades to customizations, the Aras model ensures that you can always take advantage of the latest PLM features and newest technologies.”

I honestly wasn’t sure about the definition of Resilience when I came into this presentation. Here are the wikipedia definition:

General : “Resilience is the ability of a material to absorb energy when it is deformed elastically, and release that energy upon unloading”

Applied to IT : “Resiliency is the ability to provide and maintain an acceptable level of service in the face of faults and challenges to normal operation

I sometimes organize a webmeeting called “do more with PLM” which explains what a PLM system requires to easily customize a solution to do more than simple PLM.

Here is the presentation made by Peter Schroer explaining Resilience and how it has always been taken into account when building Aras Innovator.

 

Update on the Februray 26th of 2015:

Here is the video of Peter Schroer talking about PLM Resilience

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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One week before ACE 2014 in Chicago !

Posted on April 21, 2014

Almost three month without writing an Article. That’s a lot, and that reflects how much work we have these days. Minerva is significantly growing in terms of Aras Innovator related activities which is a very good sign for the future. Our actual customers are helping us to convince other that Aras Innovator is more than PLM. Next week I’ll be at the Aras Community Event 2014 which comes back to Chicago after 3 years being held in Detroit. Chicago was in 2010 my first Aras Community Event. I received there the Aras Collaborate & Contribute Award in recognition of some Open Source projects that I was running at that time. Since then, we have received another award the next year and also one of our customer got one. So, once again, Aras need your votes to select the winners. Please vote for your favorite projects!

VOTE HERE

This year’s nominees:

  • Honda of America – Material usage sheet
  • Aitech – Express ECO process looping option
  • Sandia National Laboratories – Smart file extension handling for file check-ins
  • MAN Diesel & Turbo – HTML5 client beta feedback and enhancements
  • Carestream Health – Electronic component engineering solution use cases and prototype definition
  • Young & Franklin – Item released view for effectivity in main grid
  • Nissan – Apache 2.0 reverse proxy support
  • Dongfeng Motor Parts – Express DCO version management
  • GE Aviation – CA SiteMinder security timeout and administration
  • Orio/Saab – Dynamic updates to technical publications
  • Elysium – 64-bit HOOPS converter integration with MultiCAD Gateway
  • The Woodbridge Group – Product costing and pricing solution
  • Minerva – New form layout for advanced search on PolyItem
  • Carnaud Metalbox Engineering – PDF conversion of complex Creo file structures
  • Sikorsky – PLM to ERP data federation test harness
  • Esterline Aerospace & Defense – Mass part configuration release process simplification
  • Spartan Motors – BOM configuration loading simplified for deep hierarchy structures
  • Lear Corporation – Impact Matrix add instance and substitute markup functionality
  • Tohatsu – Double-byte database collation performance enhancement
  • Hitachi, Ltd. / Power Systems Company – Japanese enterprise search with recommendation engine
  • GETRAG – Item versioning with single item instance from user desktop
  • Maxion Wheels – Form and grid browser rendering improvements
  • SRCTech – Classification driven Lifecycle promotion
  • Laird Technologies – Classification-based Lifecycle extension for programatic execution
  • Hitachi Metals – Relationship grid sorting across results pages
  • Pentair – Permission-based classification dialog display
  • EURO-PRO – Check-in Manager extension for preliminary CAD documents without CAD models
  • GE Aviation – New ERP integration platform foundation
  • Soplar SA – Multi-Item ECO lock and unlock during workflow
  • PCC Structurals – Internet Explorer 64-bit support


 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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Setting up firefox client for Aras Innovator v10 takes 2 confirmation clicks !

Posted on January 30, 2014

On some of our projects, we explain to our customers that communication on the project is key and has an important impact on company’s change management for their users. And I feel like we could say that to Aras also. If you’ve ever installed Aras Innovator and configured the Internet Explorer client on your computer, you may have noticed that there are settings of Internet explorer to change, a URL to add to friendly websites and the sdns.exe utility program to run in order to setup the .net framework security.  With the latest version of Aras Innovator, V10, based on Aras communication (or maybe my misunderstanding) I thought that there would be pretty much the same things to run. But no! There’s almost nothing to do. You just need to accept the install of an add-on when you start Aras 10 from firefox for the first time. It’s an enormous improvement.

aras10ff

That was a small post just to say thank you Aras for the good work on that one !

The 2 clicks are the one to accept the add-on and another one to restart firefox ! (you may have more if you, like me, have tried it with an unsupported version of firefox !)


 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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Aras Innovator 10 preview by Minerva

Posted on January 28, 2014

Hi everyone and happy new year !! Yes I know it’s quite late to wish you the best for 2014 but that’s how I hoped to start 2014 on this blog. And as Aras Corp just got us a present to kick-off the year. I made a super quick and short presentation of the new interface which you can use with either Internet Explorer or Firefox. And guess what! the first on-site meeting I’ve had with a customer, I had two people in front of me using Aras Innovator on Firefox + os X! Pretty nice.

I hope this quick video will push you to the download page ! It’s free to download and it doesn’t bite !


 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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Tutorial Aras Innovator : Foreign Properties

Posted on December 23, 2013

Last week I was working on Aras Innovator to build a presentation adapting the solution to our customer’s need. And I came to use Foreign properties and thought that it would be nice to show in a tutorial as it was very easy and quick to do. The aim of foreign properties is to show in a form properties that are belonging to another itemtypes connected through the itemtype property relationships. As shown in the following drawing, The project is pointing on a customer (relationship n to 1) using a property based relationship. On the project form, usually, what appears is the keyed name of the customer (in the tutorial it is equal to the name). But you sometimes want to add some elements either to show them in a form or to make queries based on these items without having encapsulated queries.

foreignproperty

The tutorial

So here is the quick tutorial. Let me know if you have other small topics of interest.

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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Customer references are even more valuable during your project

Posted on December 20, 2013

Quite often when prospects are qualifying Aras Innovator, they ask us for references. If they have enough interest into Aras Innovator, we can provide them a contact. Even at this point, you don’t really need us. Look at the Aras Community Events description, you will have customer references presenting and you can easily get in touch with them without having us as an intermediate. The other thing you can do is attend one of these events. There is one Global Aras Community Event every year around may 1st. And ther is a European Aras Community Event in late october. You also have more local Aras Community Event organized by Partners.

But PLM solution benchmark should not be the only time you look for references testimonial. And I encourage to talk to all our customers. We have a sales representative who always tells me “don’t talk about the issues some of our customer may have”, but I can’t hide that, Aras is a very powerful solution and you need to do things correctly to get all the benefits. Ask some of our customers why sometimes they did not make the right choices.

Lean approach and specification management

Based on some recent experiences, I would say that one of the common feedback you would get from references is go for a lean implementation. And I can see that the best ACE presentations always mention it. Insitu’s presentation was exactly talking about that. Also do not over specify. I will talk soon about document management in IT projects. It’s crazy how much documentation some company can build before starting a project and then have a hard time maintaining these documentations. Ask our references, they’ll tell you where you should put the effort. We’re not changing the whole IT implementation process, we still build documentation, but we always thinking about how much it will cost to maintain.

Key-users management

Key-users management is one of the top aspects of a PLM implementation. It’s change management and if you haven’t done many IT projects, you need to be humble about it. Ask multiple references, find out where they have had issues. We see customers who think they know exactly how their users are and how they work. You can have a lot of surprises, so ask references they’ll tell you what were their surprises.

Training

When we talk to our new customers, it’s not easy to evaluate the training they need to have. We constantly have our hands in Aras. Aras is fairly simple to use. Mainly because it’s pretty much always the same interface for any kind of process you handle with the solution. We’ve seen companies doing all the training internally by themselves with just presentations and coaching and it worked perfectly well. So instead of planning everything upfront and challenging us on how much training you would need. Once again call references. They’ll be glad to help you out with all these topics.

What’s blocking you from calling a reference??


 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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ACE Europe 2013 – Day 2

Posted on November 3, 2013

I took the time to rest a little bit in the very nice and still warm city of Roma, Italia for the week-end before publishing this article about the second day of ACE 2013 which append Wednesday 30th of October. This second day was providing a lot of information on the Aras roadmap. Most of it must have been said at ACE in Detroit in May, but I think we’ve ha a fresher look at the coming version 10 of Aras.

Aras 10 fresh look

Aras 10 fresh look

A whole new set of icons has been included, shortcuts have been added. Colors are still the same but it honestly finally gives a realy fresh look at Aras Innovator.

Aras News & Roadmap

Here are my quick note taken during Rob McAveney’s speech about Aras news, presenting also Aras Innovator’s roadmap.

  • Visualization
    • strong investment in 3D PDF. With the server side converter, you checkin 3D models and get 3D pdf output
  • Office connector
    • Minerva has a connector which is still sold and working on customer side. I still have not seen and tried the Aras Office Connector. If you had, let us know how good this is.
  • CAD Integration
  • Feature activation
    • Features activation will be easier to manage with a new licence key management.
  • Trubiquity File exchange
    • I’m not sure to have all the details about it but it feels like there are some great dropbox-like (but secured) features added to Aras which I should look into soon !!
  • Configurable InBasket (9.4 SP1)
    • management features : look at your employees tasks
    • Expand with new columns and new types of activities
  • Platform support
    • v9.4 => SQL server and Windows Server 2012 / IE10 / Windows 8
    • v10 => IE10 not ealier version because of HTML5. Offers access to Mac OSX. Drops support for earlier windows and sql server versions
  • Complete restyle of Aras 10.0 with new icons giving a real fresher looks.
  • Shortcuts

I’m sorry, the sentences are not very long. These are more notes. Feel free to ask questions on specific items If you want.

Building a PLM skyscraper

Richard Mayrs – IT Manager @ Schrader Electronics

We met Richard at the first tech session on Tuesday and I understand and approve why is stated in his presentation that you should get people inside your company trained technically on Aras. There are so many things you can do with Aras without having to have 10 years of experience on the solution. That’s what I’m always telling customers. Have your tech resources trained on Aras you’ll really get them producing real value quickly for your IT environment.

Change Management with Patrick Willemsen

Patrick from Aras came back on the various options you have to manage enterprise change with Aras Innovator from the OOTB solution, and how you could quickly adapt it to your needs.

Other presentations and Closing

For the rest of the day multiple presentations were run in parallel. I was able to attend:

  • Secure social and Visual collaboration which was really nice to follow. If you’ve read Oleg’s blog this year about why Social PLM 1.0 may have failed. John Sperling has shown nice features which embedded with the Aras Innovator security framework may be a nice answer.
  • Solution Showcase: this was much smaller than for ACE in Detroit but still we could see some interesting things like our external collaboration service at Minerva for which you may have some information soon…

Finally Rob McAveney was back for even more information on what could be the next steps for Aras. It requires a lot of resources and we know its complicated and risky to work on everything so Aras and the partners will do the best possible to extend Aras Innovator capabilities using lean strategies in order to fulfill customers needs.

Aras Innovator PLM Roadmap

Andreas Muller from Aras Corp, closed the event by announcing next years’ ACE Europe Event in the same location which is a very convenient place to do so! Hope there will be eve, more people.

 


 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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ACE Europe 2013 – Day 1

Posted on October 30, 2013

The first day of ACE Europe is over and it was full of interesting discussions. A mix of technical discussion to start with followed by real life example of implementation in the afternoon. I’ll try to sum up.

Partner’s tech meeting

I won’t go into details regarding the tech meeting. It’s not a closed meeting as we could see some customers attending the meeting. It’s just that it is technical and you may need to be familiar already with the Aras technology to understand it. The interesting things is all the aspects of the actual developments. Many topics are on the table these days. Aras is hiring, and we encourage any good ressource to join Aras because there are really nice features or solution that needs to be developped and Aras is a good environnement to work at.

Here are some of my notes :

  • we started with a presentation roundtable (note: there is a good mix of customers and integrators)
  • an MRO module is planned for long term strategy (to answer multi-BOMs management)
  • 3 potential strategies to build an MBOM
    • manually
    • through the Process planner
    •  transactionnal
      • part of the manufacturing module
  • effectivity project (mid-term, will come after the manufacturing moodule)
  • issue of transporting languages between instances (nothing planned for now)
  • sequence for manuf & maintenance = Manufacturing -> Effectivity -> MRO
  • cannot use teams with workflows today
  • Report designer (2nd tab in reports) is taken out of the solution.

Welcome & Updates

The official conference started with some updates from the company by Martin Alleman.

Guest Keynote

An interesting presentation was made by Ton Zijlstra. Here are the slides.

Peter’s speech: The Future of PLM

Peter’s speech are always interesting. You can always get pretty much the same enthusiasm from his speech but at the same time you can see an evolution and I feel like now Aras has set a real position on the PLM market which they didn’t have 3 years ago when I attended my first ACE event. To me this speech is the best sells speech you can get from Aras. There’s no lie, no fake sales speech and it’s mainly based on experienced. Peter has been for 25 years in the PLM industry and by listening to him you can understand that Aras has benefited a lot from this experience.

Implementing successfull transformationnal change

The last presentation was made byDavid Sherburne from Carestream Health. David is used to come and present his PLM journey with Aras Innovator. The slides had quite a lot of content so I’ll wait for the slides to be published and I’ll update this post.

This presentation was followed by 3 different smaller presentations. I’ve chosen to attend the presentation of Alessi PLM Project to replace a legacy system containing PDM & CAD by Aras keeping the CAD.

Sorry I’ve been a little late to publish this post. I think the day2 report will be published tonight, once back in Paris !


 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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Four more years ?

Posted on October 25, 2013

No this is not about politics! It’s just a small anniversary for me this week-end as I will close my fourth year of blogging about PLM. I started 4 years ago (for Prodeos at the time before it was acquired by Minerva). And I hope this will continue as long as it brings value to our readers. The target has not changed. I’m still trying to discuss general topics about PLM, to provide some technical hints, some stories of my experiences as a PLM consultant and finally since this is our preferred solution, I’m talking about Aras! It doesn’t really hurt to talk about a software you can freely download.

10 most read articles:

That stats I have from Google Analytics are based on a period starting when the articles were moved from Prodeos to Minerva (mid 2011). But it is still pretty relevant of articles bringing a nice content for all.

 


 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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Yes you still have offline users in your PLM environnements ! Help them !

Posted on October 23, 2013

Following a discussion with a PLM manager at one of our largest french Defense & Security companies, I remembered discussions we had about the full-online or online/offline necessary sync that would lead the future of software and webapps a few years ago with friends. These friends were entrepreneurs working on a pretty cool iphone app called meetmytunes. Now one of them is working at Evernote and it’s clearly related to his position at the moment we had the discussion. It was the time (3 to 4 years ago) when the web was constantly growing in terms of coverage in France, 3G was already there and so the discussion was about. Are we going full-web or do we still need to care about the moments you may not be connected to the web?

Disconnection use-case

The use case can be multiple. One of the latest I’ve heard of was when people were sent on the field to test systems like automatic speed detector on roads. They check all data and enter these results in systems that are not necessarily connected to any web network. So most of the time the answer is Excel or Access. The problem is that these solutions are not controlled enough to avoid data retyping and cleaning once the person is back in the company. More recently we’ve been discussing with some companies maintaining systems on boats. I don’t think that the Wifi password is written when you get in your room on a military ship (I could be wrong though).

Sync apps or just delayed-import

This problem of being sometimes disconnected has been answered by some software with a synchronization strategy. Many solutions are available to synchronize files like dropbox, owncloud,… and some others are used to synchronize content like Evernote for example.

If not synchronized automatically the old method is just to import the data once back at the company. This doesn’t have to be a complicated task it can be just an import button to click which would be somehow pretty much the same process after all.

Problem of data-structure update

The problem there is: what happens if the data structure changes in the company. How do you make sure you still enter data in the right  format for the system they will get imported in? It might not be a big issue but you need to make sure that any evolution on the company hosted system should have an impact on these offline tools that are being developed. But the data modeling is an interesting topic in this case, we are willing to synchronize different type of information which can be composed of meta-data but also of files. And these elements may have different handling rules once back in PLM.

I’ve discussed this topic with various consultant working with some of the big editors and most of them told me “yeah we’ve done that for this customer, our software can do it”. But I haven’t had the same feedback from PLM consumers. So I’m not giving any direction to take for now. We know we work on it at Minerva to provide a standard solution still flexible to be used by any industry. How is your experience with Offline data management and its synchronization back to your PLM instance?


 

 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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Quick Excel macro to rebuild an Excel Bill Of Materials

Posted on October 21, 2013

Let’s start this new week by sharing a small Excel macro which I have used for a while considering the use of a fairly constant format of BOM from our customers. This macro allows me to recreate BOM relationships from an Excel file in which we find a list of items with their BOM Level. It is quite easy to read for humans. We quickly understand that when a line level 3 and has the following level 4, there is a parent-child relationship between the two parts. However, for excel there is no relationship defined. Only our eyes and our understanding of the concept of BOM allows us to deduce the BOM structure. Here is an example of such BOM.

BOM

In order to migrate to a structured PLM solution, we need to recreate the relationships. It is necessary that we can indicate for each line which is the parent element.

First, I add a column after the “Level” Column to inform the Part Number of the parent element. I then apply the following macro (which needs to be configured for your file, initial constants to change. Hint: starting line is the first child, here it’s line 3).

Sub rebuild()

' initialize constant for your excel file '
Dim StartingLine As Integer
StartingLine = 3
Dim Column_Level As Integer
Column_Level = 1
Dim Column_ParentRef As Integer
Column_ParentRef = 2
Dim Column_PartRef As Integer
Column_PartRef = 3

' other technical variables '
Dim j As Integer
Dim StoreParents(40) As String

'initialize first parent Part Number '
initParent = Cells(StartingLine, 5)

' Start rebuilding BOM '
j = StartingLine
While Cells(j, Column_Level) <> ""

    If (CInt(Cells(j, Column_Level)) > CInt(Cells(j - 1, Column_Level))) Then

        ' level has increased so parentref is previous line part ref '
        StoreParents(Cells(j - 1, Column_Level)) = Cells(j - 1, Column_PartRef)
        Cells(j, Column_ParentRef) = Cells(j - 1, Column_PartRef)

    ElseIf (CInt(Cells(j, Column_Level)) < CInt(Cells(j - 1, Column_Level))) Then

        ' level has decreased so parentref is the stored partRef of new level - 1 '
        Cells(j, Column_ParentRef) = StoreParents(Cells(j, Column_Level) - 1)

    Else

        ' no level change, we keep the same ParentRef '
        Cells(j, Column_ParentRef) = Cells(j - 1, Column_ParentRef)

    End If

    ' move to next line '
    j = j + 1

Wend
End Sub

You should get a file with the parent references added. I purposely list an item level 3 followed by a level 1 to show that we can move up multiple levels at once without problem.

BOM_Built

And Voilà ! This is an easy piece of code but as many customer use this format. It can be quite handy to find that code quickly and apply it for a migration.


 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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PLM customization is scary for a lot of people !

Posted on October 9, 2013

I was recently in a meeting for an introduction of Minerva and Aras Innovator to a new lead from a warship manufacturer. I was the pre-sales guy and our account manager was here to. We talked about Aras, our lead told how easily he could install the solution without our help (that’s where we know we will have a good tech interaction if any Aras project starts with them. During the discussion he was asking many times if such solution already existed either made by Aras or by a partner. Some of his requirement already existed and I could see that some others where very simple to implement with a few methods. But he stopped me pretty quickly to say that they were not willing to customize the solution. It has to be only configuration on their side. And it brings me back to RFP answers where companies were wondering why I’d put an intermediate level between “development” and “configuration”. And you need to work with Aras to understand that some customizing are very light and here is why you shouldn’t be scared.

Upgrades

One of the first reasons companies are afraid of customizing is because of the upgrade. How much effort and what will be the cost of upgrading my customization which only my integrator knows how to upgrade? This is definitely not an easy position mainly for the buyer. With Aras, that’s a problem that has been taken into account in the subscription model which covers the upgrades. If you want more information about the upgrade process, you have it all here.

It is simple !

That’s the one first argument I always provide. Put Aras Innovator in some tech guys’ hand in your company and without much training he will be able to do a lot of customizing himself. And every time I visited Aras corp in Andover, I met with companies telling me what they customized and it’s pretty amazing how much they can do before calling for specialist.

Examples

Look at these old videos I’ve made a while ago showing quick developments, sometimes it does not have a real use but it shows you how easy and flexible the solution is.

I saw this video today and what is said is very true. Sometimes very small amount of customizing can create real and important value for the company. And Aras allows you to make this customizing.


 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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Building solutions for Aras Innovator

Posted on October 7, 2013

This is a strong trend at Minerva. We invest more and more time developing solutions adapted to specific industries or specific business processes. This comes from multiple reasons. The first is the fact that Aras focuses on its core solution and on the framework more than industry specific solutions which is a work left to partners and integrator. Then the Aras Innovator framework provides a sustainable environment for us to develop cost effective solutions and it is clearly helped by the subscription concept handling the Upgrades by Aras.

The Aras upgrade process makes our solutions cheaper to maintain

If you have already make an upgrade of Aras for your enterprise production instance within your subscription, you understand how much time and money you are saving at each upgrade. Included in the subscription, Aras takes most of the upgrade activities. This is something we had to take into account when starting to develop solutions. Every day in our projects (customers or products) we ask ourselves how sustainable our work will be. So developing these solutions takes into account the fact that these solutions will support the upgrades and we ensure through the subscriptions that these solutions will work after each new release of Aras Innovator

From Industries solutions to Business processes

The solutions at Minerva started mainly with the EHT template followed pretty quickly with the Medical template. One of the main reason of starting with these two industries is that we, at Minerva, have a strong experience in these industry. It was at a time we were delivering other PLM softwares. It made then sense to take the best things we’ve seen in the past, learn about the industries we used to talk to, in order to invest in developing solutions for these industry, based on Aras Innovator. We sometimes see that some elements of these solutions are not industry specific. We also realized that some business processes were not easily covered by other PLM solutions. We then, following customer’s request, focus on much smaller scopes to provide targeted solutions to cover specific business processes.

Gathering workgroups for new solutions

So far, we developed our products in a quite lean way, with a Minimum Viable product which we were able to sell and improve based on our customer’s experience and feedback. Now we can see that for existing customers we have similar requests. In order for us to reduce the cost for everyone and make sure to lower the cost of maintenance we took the initiative to create workgroups for specific topics. The first one has been for advanced external access features. It’s a different way of working which is more suited for existing customers. They know how Aras is to be implemented and how flexible the solution is. It then makes sense to have a different approach then for new customers.

If you are an existing customer and are interested in joining our workgroups let us know. You can submit topics and If we find a significant number of similar request, we may start to gather companies to work on it.


 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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Aras is hiring ! Minerva as well…

Posted on September 27, 2013

The Aras Innovator business is definitely growing. And we can see that as planned when I started working on this solution, this is not a solution dedicated for a certain size or type of company. This is a framework with pre-defined business models fitting a lot of basic requirements from the industry. The of most of our deployment is to quickly provide features that are robust, based on business standards at a low cost. And then, the Aras Innovator framework becomes an enabler allowing the company to become creative or just allowing them to include their best practices in the solution instead of being just industrial followers by implementing the standards provided by an editor. And this is where we (Aras and the integrator like Minerva) definitely need hands.

Aras is a cool place to work at

I’ve been several times at Aras in Andover, MA. I remember back in 2009 when I first came to the Aras Office for my very first training on the solution. Several minutes after I came. Some guy I didn’t really came to talk to me about how Aras could have great opportunities in France. Unfortunately I had to stop the conversation pretty quickly as the training was starting. Looking at Aras website again a little bit later I realized that “this guy” was Peter Schroer, the CEO of the company. Since then, many times I’ve been able to exchange with Peter, and it’s great to know that the CEO of this company is all about continuously creating value for Aras Innovator without going crazy about sexy marketing trends which are not realistic. He focuses on providing real value to the Aras customers. Year after year, the team at Aras is getting bigger, I could see a lot more new young faces these last two years ( oh yes, I may be the only french guy to go skiing in New Hampshire every year). This must be a really nice place to work at!

Integrators can work with very large account

That’s the really surprising thing that I’m living at Minerva. We are pretty small for a service company. But we have chosen the right technology for our customers allowing us to deliver more with less ressources. And it works with large account. Our customers are some of the largest industrial companies in Northern Europe. What you develop when you work for Minerva impacts a lot of people and walking in some large engineering department and watching people validating workflows activities you have set up a few month earlier is quite exciting. Next thing you know, some guys in China and Brazil are doing the same actions at the same time. Aras really help us to make our work effective for our customers.

Join us

=> Aras : http://www.aras.com/company/careers.aspx

=> Minerva : http://minerva-plm.com/about/minerva/jobs-at-minerva

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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5 most read articles in july 2013

Posted on July 31, 2013

Here are the most read articles from our blog this past month. They were not necessarily written during this month. This indicates sometimes the articles with value that is still up to date.

If you don’t want to miss any article from our blog, feel free to subscribe by typing your email address here  : 


 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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Element14 API usage with Aras Innovator – Manufacturer Parts up to date in your PLM

Posted on July 19, 2013

This is again a demonstration that PLM can have a very wide coverage of features in a company. In this case it was following an Aras project we’ve implemented for a customer where they needed for their logistic support activities to be able to select within a BOM-as-maintained, a part to replace, navigate to the approved manufacturer list and add the manufacturer part to an order by right-clicking on it and selecting “add to order”. You can view this process on this link. The issue is that you needed to update the manufacturer part’s data. What if you could get these data live from your supplier? Some distributors like element14 are providing Rest APIs to browse their catalog. So we used it and worked with federated items in Aras to easily query they catalog and get the pricing information and also datasheets or other related documentations. Here is the video presenting this integration:


 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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Getting people trained and interested in the solution

Posted on July 8, 2013

This is a recurrent discussion we have at Minerva when we talk about actual and past projects. We discuss the good experience we are having on actual projects and the ones we’ve had on past projects. Even if sometimes, some situations have been difficult and exhausting for us. We take all these as experiences and bring these info in our lessons’ learned list. With Aras Innovator we have the chance to be able to offer services for a very wide range of enterprise. We have subscribers from 5 users to 1,000. And the resources available can be very different from one customer to another. We realize that even in larger groups, a lack of general/technical interest on the solution can be a risk for the quality of the relationship during the project. The PLM is not another software of your environment, it’s a company-wide IT solution that needs to be understood at least for the following reasons:

to evaluate the solution

This is the key factor for us working with Aras Innovator. Aras is free to download, then save yourself long presentations, download the solution and install it. You’re not so into IT and you don’t know how to install it or don’t have the machine to do so? we’ll provide you with a trial access for free. The goal, is to understand the concepts of Aras. But then, when you go further into discovering Aras Innovator, you need to learn about the architecture and how deployments are made. This is key for you to trust or not the solution. Have you started a  requirement list with items like “the page should not take more than 8 sec to open”? If so, it means that you haven’t tried the solution.

to take decisions

Then, based on the experiences we’ve had on implementation and evolution, we realize that when the person we’re talking to is able to understand the business but also the technical concepts of Aras Innovator, he is more able to make alternative suggestions. He knows the user better then we do, he manages his budget, there are alternatives for which we would not have all the input to suggest these. If you want to be confident about your decisions, get trained or learn by yourself the solution.

to evaluate your supplier

The relationship with our customer is key. The best projects are not necessarily the biggest budgets. It’s mainly when there is a good quality in the relationship and good level of trust. And this level of trust is due to the fact that our customers know the solution and know how we are performing on the solution. We can clearly identify that when the company has no interest in understanding the solution, the relationship is not so good. And we have a clear split between fixed price project and time & material based projects. And honestly I think time & material projects are saving 15% to 20% of the project cost when they understand the solution. The price of the risk !

to extend the solution

If you know a little bit the business model of Aras, it’s a subscription based business model which basically means that the more solutions you build for your users, the most cost-effective your solution is. But how can you see where new solutions can be built in your organisation if you don’t know how the solution works. You need also to look at what other companies have been implementing, use the community to get more insights and more ideas.

A good document to start from:

Here is an interesting presentation I recently found. And I think it is a quite interesting view of elements companies’ IT people should know about Aras when they are involved in evaluating or implementing the solution


 

Yoann Maingon

Yoann Maingon is an Entrepreneur and a PLM enthousiast. He is our main blogger at Minerva as he has been publishing articles about General PLM concepts and Aras Innovator for more than three years.

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