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As originally asked by Rory A. Carrillo.

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Nick MacKinnon
Founder, VP Clinical Strategy at eTreatMD
Check out mastercontrol and m-files. They are reasonably well established solutions.

Bijan Elahi
Award Winning International Medical Device Risk-Mgmt Educator, Consultant and author
I have used DOORS for many years, both in very large and very small companies. It’s quite a nice tool for RM. But to get the most out of it, you need to have (or hire) expertise in the DOORS scripting language — DXL. I also use their publishing tool to produce nice Word reports. DOORS Publisher is a powerful and useful tool.

Jérôme Tomaselli
Président chez CVO-EUROPE
Hi

Don’t forget GxpManager. It has been created for life science industries and it has also a specific application for Medical Device
It’s very cost effective and a powerfull tool for RM !

[http://www.gxpmanager.com|leo://plh/http%3A*3*3www%2Egxpmanager%2Ecom/uxiH?_t=tracking_disc]

Irena Saundeen
Enterprise Account Manager at Siemens PLM Software
HI Rory: You will want to add Polarion to your list of vendors to review, we have RM solutions to the tough challenges medical device companies face today including the must achieve compliance with diverse standards and regulations; FDA 21 CFR Part 820, Part 11 or IEC 62304 and do it faster. [http://www.polarion.com/products/medical/|leo://plh/http%3A*3*3www%2Epolarion%2Ecom*3products*3medical*3/zUCS?_t=tracking_disc]

If you’re going to the Medical Devices Summit West 2013 – June 13/14 we will be there.[http://www.opalevents.org/p/72/|leo://plh/http%3A*3*3www%2Eopalevents%2Eorg*3p*372*3/0BzX?_t=tracking_disc]

All the Best,
Irena Saundeen

Rory A. Carrillo
Product Development, Quality, and Regulatory Consultant for Healthcare Products
Everyone, thank you all for all your great feedback so far. I purposefully left the question broad in order to illicit a variety of feedback.

Just to be clear, I have used several different requirement management tools. ReqPro, DOORS, RM Trak and the like. They all have there pros and cons. After not only using several tools while leading product development of highly complex electro-mechanical and software systems, I’ve decided that a web-based tool provides advantages in terms of ease of setup (@Nuno mentioned this in his last comment). Since I am now doing consulting for a lot of early stage startups, this is easiest for them to get started. The other advantage is that a lot of my clients have developers that work remotely, and a web-based database won’t run as slow as a client trying to talk to some database on a server thousands of miles away (and if the developer needs to be on VPN in order to get access to all the database elements then this will likely slow down the process as well).

Ideally the RM tool will enable me customize the architecture however I see fit. I’ve done this several times and I agree with previous comments about there is not one solution that work perfectly out of the box. I have been able to develop an architecture that allows everything from design input requirements, to hazard and risk analysis, to design output elements and V&V protocols and reports to be properly captured, maintained and traced. I’m currently in the process of developing another architecture for a client but with an application that wasn’t designed for RM tracking whatsoever.

With all that said, I am always looking for new tools to help me develop this process as this is a very important piece of product development that not a lot of people understand, especially those in the start-up world. So finding a tool that is cheap, easy integrate, and easy to use is key for helping me “sell” this as a necessity.

Lastly, I have never had to do any validation on these tools and do not anticipate that I wil need to. These RM tools are advertised as simple development tools that the development team uses. Outputs of these systems are exported in a fashion that enable me to maintain everything within the DHF as if it were never used. These tools can be viewed similarly as Microsoft Word or Excel which help capture the requirements or whatever DHF elements it may be, but it no way is it creating the product or being used to make decisions on the performance, safety and/or efficacy of the product.

Again, thank you all for your feedback. I would appreciate feedback from those who have used a particular tool in the past and what their likes and dislikes have been using the product.

Cheers!

Nuno Almeida
CEO at Nourish
Hi Bernd, allow me to be blunt: there are enough people in the world that have grown fed up of using cumbersome incumbent tools for new tools to have quite an easy ride entering the market. DOORS was also started with a small handful of companies in the past.

We’re testing the product with very large, with very stringent requirements for safety, traceability and formal checking. By enabling true cloud deployment the team can focus on their project and not be distracted by issues such as infrastructure, complex licensing etc. We are working on getting a handful projects off the ground to prove the tool (I didn’t claim it was market ready), but believe me: our lead customers are dying to minimize their dependency on legacy tools and are quite keen for us to get this product proven so they can use it themselves.

Having many years of industry use is a weakening criteria for selecting software tools (albeit a common one). This product is being put together by a team with 20+ years experience in developing very high integrity software (e.g. using formal methods) for all standardization requirements (medical devices, aerospace, space, railway), this is not just another startup.

For those with interested in knowing more, please do get in touch.

Bernd Grahlmann
Requirements Management and IBM Rational DOORS (Telelogic DOORS) consultant & trainer at www.grahlmann.net
@Earl:
I am afraid that you will have to look at CSV (Computer System Validation) – check on the FDA web site …
‘Strictly speaking’, whatever tool and process you use for requirements engineering / management / development – including ‘interface’ with validation & verification, change and configuration management … – (even if it is Word/Excel based) you will need to ‘validate’ that the tool together with the process … satisfy your ‘requirements’ …

Some of my presentations give more details: [http://www.grahlmann.net/presentations.htm|leo://plh/http%3A*3*3www%2Egrahlmann%2Enet*3presentations%2Ehtm/_iI7?_t=tracking_disc]

You may want to add IBM Rational DOORS to your short list and – no matter which tool you chose – you may want to take an experienced consultant, at least, for the initial setup …

Hope that helps,
Bernd

Earl Vickers
DSP Audio Algorithm Engineer, Speech Enhancement, Machine Learning
I’ve been looking into this, and my short list includes inteGREAT, Top Team Analyst, Jama, and Requirements Center. (I don’t have significant hands-on experience with any of these.)

I’ve been told that we might need to validate the requirements management software in addition to our own software – I don’t know if this is true, but if so, it would be a big burden for a small start-up. Does anyone know if we need to validate that the requirements tool satisfies FDA 21 CFR Part 11 requirements for electronic records and electronic signatures?

Bernd Grahlmann
Requirements Management and IBM Rational DOORS (Telelogic DOORS) consultant & trainer at www.grahlmann.net
Ooopppsss … I am not even sure where to start answering / commenting …

@Rory:
You say that the company is looking for a web based tool. Is the company just trying to avoid ‘client’ installations or what is the driver that they are looking for a web based tool? A Citrix based installation of, for instance, IBM Rational DOORS would as well basically take out the ‘client’ installation part.

Furthermore, what kind of ‘size’ are we talking about – i.e., is this a medical device company of any substantial size, potentially even with several globally distributed engineering locations?

@Michael:
Given without any kind of ‘explanation’ / ‘reason’ … your comment is at best showing that you have no clue about DOORS and/or have never seen it being setup and used well …

@Nuno + all:
Sorry, but, in particular, if we are talking here about a medical device company of any substantial size, I would NOT recommend to go for a tool which has not been on the market and been used by a good number of companies on realistic projects. Cindy made a very important point on this.

@Cindy:
You raised a lot of good ‘requirements’ 

@Cindy + all:
Nothing against the INCOSE survey (or any other survey), but:
1. I would never just trust answers given by (marketing guys of) some tool vendors …
2. There is NO Requirements Engineering / Management / Development tool out there which out-of-the-box will satisfy your needs. You will always need, at least, a database structure (which IMHO should be based on your scope diagram / system decomposition / requirements breakdown structure), a traceability schema, a process with procedures and guidelines, templates and most likely a bit of ‘customisation’.
IBM Rational DOORS is no exception to this rule. Out-of-the-box DOORS will not ‘offer’ what you need and there are millions of ways to use DOORS badly. Having said this, I have successfully implemented Rational / Telelogic DOORS, in particular, for some of the biggest medical device companies, by adding those important ‘parts’. You may want to look at some of the corresponding presentations: [http://www.grahlmann.net/presentations.htm|leo://plh/http%3A*3*3www%2Egrahlmann%2Enet*3presentations%2Ehtm/_iI7?_t=tracking_disc]

Please, feel free to contact me if you are interested in more details, help, …

Thanks,
Bernd

Dr. Bernd GRAHLMANN
RM & DOORS Expert/Trainer/Consultant
Tel.: +41 792967651
Bernd (at) Grahlmann . net

Cindy Ellis
Principal Systems Engineer at Advanced Sterilization Products (ASP)
Hi Nuno, I’d rather not say until I have some hands-on experience with it. It is one of the tools included in INCOSE’s tools survey (and one that got a very high score in that survey), but the INCOSE data appears to be several years old, so it can’t really be used to compare current versions of tools. The survey does have a good list of questions to ask of a vendor, however. I’m not sure if it’s appropriate to post a link since I’m not associated with the site or survey…you can find the survey and the list of respondents using “Incose RM tool survey” as the search term.

Nuno Almeida
CEO at Nourish
Hi Cindy, can you be share which tool your team is using? Ours is all of that and enables requirements to be formally checked (relevant for all safety critical applications, and in line with how INCOSE is evolving).

Cindy Ellis
Principal Systems Engineer at Advanced Sterilization Products (ASP)
Not a direct answer…but commentary on your question:
Selecting the best RM tool for your needs will depend on a number of factors unique to your situation. From your question, I can deduce 3 requirements:
1) Manages requirements (obvious, but serves as the top level requirement for other specifications),
2) Suitable for medical devices containing hardware and/or software (implies the need for compliance to FDA design control requirements and 21 CFR Part 11)
3) Web based (implies no need for client software installation, but unclear as to database location)
You may have more requirements that aren’t stated above, such as the ability to integrate with existing tools, etc. Other features that may be important are the ability to import or export requirements from various text-based formats, the ability to trace to test protocols and data, and its ability (or need) to be configured to your specifications. Once you know your requirements for the tool, you can get feedback from vendors or other users as to how well various tools perform.
I would generally suggest a tool that meets or exceeds INCOSE standards. Also, unless you’re willing to be the equivalent of a beta tester, you should think carefully before going with a brand new product.
My company is just getting started with a specific RM tool that appears to meet our requirements, but I don’t have direct experience with it yet, so I can’t recommend it.
Best of luck with your search.

Michael Ban
Medical Device Tech
Don’t use DOORS!!!

Sean Daly
Scrum Master
I recently evaluated more than 20 different commercial RM tools. You might want to take a look at Jama Software.

Nuno Almeida
CEO at Nourish
Hi Rory, yes I do. It’s in final stages of development (it’s a company I’m mentoring and we’re being hush-hush until we’re ready to launch it in a big scale. Please get in touch via email and we can have a chat nalmeida at almeidaconsulting dot co dot uk.

Peer Koltermann
Medical physics and IT, business management and consulting
We designed INTERPACT, what is a MedicalPhysics-Management-System, check on www.p2pmpi.com . The same system we can design for other purposes like e.g. medical products.