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Do you have a question related to medical device component design and manufacture? Meet our panel of experts, who are standing by to assist you:

Andrew E. Fisk, PhD  
Andrew E. Fisk, PhD, Director of Technology & Innovation

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Recent questions and answers

I am working on a new ablation device for treating arterial fibrillation, most of the literature suggests platinum as the preferred material for the tip. The project budget is really tight, are there any alternatives I can use for my tip?

Dr. Andrew E. Fisk

Platinum cost is definitely a concern in the industry. Depending on the application you could potentially use another material; I would need a little more information on the type of therapy and necessary properties in order to recommend one. One way you can reduce the project costs is to use an alternate material like stainless steel for the prototypes. I imagine you will have a few iterations of the design while you work out joining and assembly techniques, these prototypes could be made out of stainless and it would significantly reduce the development costs. Another alternative would be to speak with the tip vendor on the possibility of reclaiming the Pt used for the prototypes when you are done. You may be able to recoup some of the material cost when you are done testing the pieces.

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I am a student working on a project involving pacemakers and pacing regimes. Are there any books you would recommend to get me familiar with pacemakers?

Dr. Andrew E. Fisk

I would recommend “Cardiac Pacemakers Step by Step” as a good starting guide. Cardiac Pacing in Clinical Practice” and “Cardiac Pacing and Defibrillation” are 2 more advanced books that describe pacing regimes and procedures.

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I am working for a small start up developing a stimulation device. Could you explain some more about how TiN can increase stimulation efficiencies? Your web site says you can make smaller electrodes, won’t that decrease my efficiency?

Dr. Andrew E. Fisk

The TiN coating is specifically designed for the therapy used. It sounds like you have a specific therapy in mind, if you could describe this a bit more I may be able to help recommend a coating morphology that would suit your needs. If you are supplying proprietary information you can check the “proprietary” box on the web form or contact me directly.

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Your web site shows that you provide TiN coatings by PVD. We currently have our surgical tools coated with TiN by CVD. How is your process different and what advantages are there?

Dr. Andrew E. Fisk

Thank you for your inquiry. The structure of our TiN coating is different from what you are currently using. The coating we provide is a high surface area TiN coating used to increase efficiency of stimulation and sensing electrodes in devices like pacemakers and neurostimulators. If I understand your application correctly you want to increase the hardness of your tools. This process can be done by PVD or CVD and there are several companies that provide this service.

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Mike Barrilli

Pulse partners with our customers in all phases of product development from proof of concept through validation, product launch, and production volume. We have reserve capacity and quick turnaround procedure for pre-production small lots.

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Mike Barrilli

Yes. Pulse can provide the level of documentation that the customer requires, such as FAI reports, lot inspection reports, SPC results, special testing, etc.

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Mike Barrilli

Yes, ISO 9001 is the basis for both standards. By maintaining certification to both we can provide service to customers whose Quality Systems require certification to ISO 9001 rather than ISO 13485.

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Mike Barrilli

Pulse took guidance from industrial regulations like 21 CFR 820.75, Medical Device Directive 93/42/EEC, ISO 13485 7.5.2, ISO 9000 3.8.5/3.8.6, Global Harmonization Task Force SG3/N99-10, and ISO 14971 to develop a Validation Master Plan for qualification of core process equipment. Pulse develops and executes IQ/OQ/PQ on all core equipment. Pulse also performs product validation for customers based on customer specifications and acceptance criteria.

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Mike Barrilli

Pulse has invested significantly in new manufacturing technologies and working with leading global equipment manufacturers to develop quick and cost effective manufacturing processes. Pulse has the latest CAD and CAM software to speed process development and process validation.

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