NoddingBear

I’ve used both Beahm and non-Beahm (Machine Solutions) hot boxes for catheter development and have found that Beahm hot boxes are a notch above the rest. Simply put, their housing is smaller with the same capabilities and Beahm hot boxes seem easier to customize. Depending on the application, you can order various nozzles with the hot box, but if you don’t feel like purchasing it directly from Beahm themselves, then it’s easy to draft up your own and send it out to a local machine shop or an in house one, if you have one. I do have one disappointment with Beahm, which is that they do not always deliver equipment on time when I’ve purchased new equipment from them several years ago. Maybe they’ve ramped up since then?

Strengths: Hot Boxes

Needs to improve: Delivery Times

As in their name, the Sil-Pro staff are professionals in the silicone business. There are many companies who offer silicone tubing, but I’ve gone back to Sil-Pro time after time for their customer service. Often, the sizes I’m looking for will have existing dies/tooling, so the only costs are the initial setup and the tubing itself. On occasion, they won’t have exactly what I’m looking for, but that’s where Sil-Pro earns their keep. Their sales rep is more than happy to look up what existing tooling they have that will yield comparable results (depending on how liberal your tolerances are).

Strengths: Silicone Extrusions

Needs to improve: I haven’t found any weaknesses in the 30+ orders I’ve purchased from them over the past 4 years.

Yes, Exponent is indeed where you will find all your failure analysis experts in a variety of specialties, ranging from nanotechnology and flavonoids to skyscrapers and barges, but in my opinion, most medical device testing probably does not require the expertise of Exponent scientists, especially when cost is an issue. At the order of my boss, I spent $10k obtaining an S-N curve, when for a mere $3k, I could’ve done it just the same, learned something, and the company could use the fixture and housing in the future. Of course Exponent has their time and place (e.g., gas pipeline explosions, building collapses), but I would choose wisely where to spend the funds. Their expertise comes at a cost. Make sure it’s worth it.

Strengths: Failure Analysis, Material Analysis

Needs to improve: 1. Price 2. Price 3. Price

When it comes to determining magnetic resonance safety, there’s no one else I trust to perform the testing than Dr. Frank Shellock himself. There is one other company, located in Germany, that I know of, but I continue to go back to Shellock since he is considered the guru of MR, has written many of the standards for MR testing and analysis, and an advisor to the FDA on this matter. Most importantly though, his services are tried and true with all of his reports having been accepted by both the FDA, EU, and OUS regulatory agencies. Additionally, his work is very thorough in that even if it’s been years since he’s tested your device, if he reads something incorrect relating to it, he will personally contact you to notify you of the error and offer advice on how to fix it.

Strengths: Material Analysis, Quick Turnaround (Once Scheduled), In House Expertise, Thorough Follow-up

Needs to improve: One Man Show: If Frank Shellock is traveling for conferences, you’ll have to wait to schedule MR Compatibility testing

NAMSA is the company I go to when I’m looking to obtain a conservative pulse on the regulatory agencies. Since many of their scientists serve as advisors for the FDA, there isn’t a better person (including the FDA themselves) that can give you a clearer understanding of the environment and motivation behind new implemented standards. For example, we were recently tasked with the requirement of particulate testing. Although the idea is not new, the motivation behind it is. Since there is currently no established specification for non-injectable med devices (e.g., USP for injectables and drugs), it is possible to develop a unique specification according to our application. NAMSA was instrumental in this and took into account manufacturing, sterilization, shipping and distribution, packaging, shelf life, and use with other devices when developing the test method. In the end, our product produced particulates that met USP standards, which we could still use, but this process highlighted NAMSA’s attention to detail and dedication to their craft.

Strengths: Material Characterization, Histopathology, Biological Safety Evaluation, Particulate Analysis, Regulatory Consulting

Needs to improve: Depending on the test, expedite fees can be double or more of the actual test costs

I try to avoid using adhesives whenever possible, but sometimes there just isn’t any other way. If you find yourself in that case, Master Bond is a good resource. Their knowledgeable and responsive staff is readily available to answer questions about their products and capable of suggesting the epoxy that may fit your application (it’s even their slogan!). The most important part is that since they are medical grade, they come with regulatory body appropriate documentation.

Strengths: Medical Grade Adhesives, Knowledgeable Staff, Transparent

Needs to improve: I’m trying to think of one, but I really can’t, unless you count adhesives in general, but that’s not really Master Bond’s fault.

We order a centerless ground stainless wire (several distinct diameters ranging from .020” to .010” along 100+ mm) for one of our products and PWC has been able to consistently deliver products to specifications. Good thing stainless steel doesn’t have an expiration, so we were able to take advantage of the large volume discount, although our LEAN engineers are less enthusiastic about having to store that quantity.

Strengths: Centerless Grinding, Custom Coils, Processing with Stainless Steel and Precious Metals

Needs to improve: The price for low volumes are rather high

Heraeus is a capable custom coil supplier who can deliver coils at your average specifications, but their largest drawback is the piece price. They tend to be higher than others, but the quality is better than most. If cost is an issue, I would not hesitate to look elsewhere.

Strengths: Wire Formation, Coil Winding, Springs, Precious Metals

Needs to improve: Price per piece can be costly, especially for low volumes

Dymax is an appropriate UV adhesive supplier during the prototype phase. However, their equipment is simple and without fine tuning controls, which are necessary to produce consistent and predictable product. Nonetheless, their adhesives work well and the wide range of durometers has been helpful in catheter manufacturing, especially the lower durometers for flexible portions.

Strengths: UV Curable Adhesives and Equipment

Needs to improve: Production Level Controls

F&B carries a variety of casting waxes with different melt points, which has been instrumental in creating quick anatomical models without having to draft anything in SolidWorks or AutoCAD and then outsourcing it to a molding shop. Their wax is more than just for jewelry. It’s an inexpensive means for creating in vitro models and marketing demos.

Strengths: Waxes at Different Melt Points, Custom Blends

Needs to improve: For the most part, F&B is a great vendor, but if you are planning to purchase a special blend, do plan ahead.