clinically-relevant

Consider visiting in person during implantation and explantation days so that you can keep an eye on the lab staff.

Strengths: Huge organization backing up their work. Access to world experts.

Needs to improve: Maybe it was just this past time, but they really messed up my most recent biocompatibility test program. Harvesting was not handled in a professional manner and it felt like we needed to stay right on them to ensure that the work was done right.

I've only used them for testing medical devices, but clearly they have knowledge of many other industries too.

Strengths: John and Greg are really smart guys and know a huge amount about the various ASTM standards that you need. The lab is chock full of machines, and we rarely have to wait to get our samples started.

Needs to improve: I know that all of this experience and equipment isn't cheap, but sometimes it can be cheaper to sub out testing elsewhere.

Definitely travel to their headquarters in Massachusetts. Bring a sample and they may be able to test it in their lab.

Strengths: Instron excels at providing mechanical test systems--servohydraulic, screw-type, or the new ElectroPuls. At my facility, we have more than two dozen of their test frames.

Needs to improve: Pricy, especially the ElectroPuls. Their software has vastly improved over the years and is at least as easy to use as MTS'. Lead times can be long.

Turn around time is quick.

Strengths: Greg has seen it all. He brings a deep understanding of metallurgy to root cause analysis/failure analysis.

Needs to improve: MSI is small, which is great for customer service, but it can be difficult if the job is too big.

OrthoKinetic is a superior spinal device testing lab.

Strengths: Lisa works closely with ASTM and FDA and is well plugged into the intricacies of spinal device testing. She is well published and a recognized expert in spinal biomechanics.

Needs to improve: While her lab equipment is somewhat limited, she has a great network of labs that allow her to accommodate testing programs of even pretty large sizes.

DSM recently changed manufacturing facilities. This process went relatively smoothly, but was still somewhat disruptive to their customers.

Strengths: DSM's Dyneema is an amazing product that will greatly increase the strength of your suture or other fiber product. To their credit, they have done the work to get their UHMWPE master file into the FDA.

Needs to improve: DSM has a virtual monopoly on this product and they know it. You will pay *dearly* for Dyneema.

It looks like they have a huge number of capabilities, but I only have used them for mechanical testing (in their Boston office).

Strengths: Altran has really great employees with a wide variety of knowledge-bases. They have a small number of load frames for mechanical testing at the Boston office, but are very good at specialty-type mechanical testing. They are located very close to Boston Logan, making trips to their office very convenient from out of town.

Needs to improve: They are very pricy.

They have truly deep knowledge of regulatory affairs and are great people with whom to work.

Strengths: Floyd knows an incredible amount about the regulatory world for medical devices. He is heavily involved in ASTM and ISO, who set these standards.

Needs to improve: The pricing structure can be high, even for medical devices. However, this more than made up by the knowledge and speed to market that Paxmed brings.

It has been great dealing with Dynamet over the years.

Strengths: Stan was there at the beginning (of Ti6Al4V)--so if you want to know anything about the use of Titanium in modern materials, he is the source. He literally wrote the book on it.

Needs to improve: This is a smallish shop, with limits on what they can supply.

Things have slipped a little under current management, but still a good place to go if you need it done today and for a low price.

Strengths: Tom will go the extra mile for you. Cost is very competitive.

Needs to improve: Fireball uses the old-school, heat treat like your gut tells you to, rather than worrying so much about modern methods. They absolutely can get your product close to what you want, but maybe with a higher reject rate than other heat treaters.

If you are looking for access to a great textile solution, then Secant is a great place to look. It may just take a little while and cost you a bunch.

Strengths: Secant has some great product managers and depth of knowledge of how to get the most out of their textiles.

Needs to improve: They can be a bit slow to react and spendy, even in the field of medical devices.

This test lab has slipped a little since its former glory days under Helmut. They are still quite competent, but they no longer specialize in hard-to-do, test-here-because-no-one-else-can-do-it projects.

Strengths: Staff are very hard working and willing to go the extra mile. Very good for basic mechanical testing when you want to follow an ASTM standard.

Needs to improve: Huge turn-over in staff. Somewhat dodgy management since Helmut kicked-off several years ago. Not great at custom testing projects.

Empirical has lots of different types of machines and rows and rows of test frames. They can usually fit you in well within your timeframe.

Strengths: Dawn is a powerhouse. She and her staff know the various mechanical testing standards inside and out (sitting on the ASTM committees that write the standards certainly helps). Empirical is strongly focused on quality and has the 17025 system in place.

Needs to improve: This knowledge comes at a price--usually not an issue in the world of medical devices, but still steep for start-ups.

Sawbones is a great company to deal with and the breadth of their product line is vastly under-represented by their catalog or even their website.

Strengths: While there is at least one competitor (worldwide) that offers urethane foams for mechanical testing of medical devices, Sawbones has more options and better customer support (open early, close late despite being all the way on the west coast. Their engineering support staff can give you mechanical specifications for their products and they can custom build test foams to whatever spec you can dream up.

Needs to improve: Their trainers and joint models are functional, but not particularly biofidelic. If you want to feel like you are actually performing the operation using a model, better to go with a custom shop, like Chamberlin Group.

Chamberlain started out making props for slasher films. They take this deep knowledge of human anatomy and combine it with model-making. It is like Sawbones, only more realistic.

Strengths: Very hand's on up front with being certain that they will address all of your specs. They have done many different models of the body and can use this vast knowledge to get started on your design. They are very friendly and go out of their way to ensure that you are happy.

Needs to improve: They will definitely work with you some on price, but all of this expertise and technology is not cheap.

Work can either be kept confidential or submitted for publication.

Ask for the cajun chicken pizza at lunchtime!

Strengths: Good staff. Deep understanding of the spine, knee, and shoulder. Excellent access to local clinicians, but very willing to have you bring your own. Super fast turn-around if needed. Good access to tissue.

Needs to improve: So-so access from far away (via TF Green Airport).

Really work with management to ensure that there are bounds on expenses and the scope of the project is tightly defined.

Strengths: IMDS has a deep history in medical device design with lots of patents and expertise in this area. They can generate a large number of ideas to address your problem statements.

Needs to improve: IMDS doesn't seem particularly hungry to get the job done--lots of time sharpening the ax, not enough time chopping wood. The technical lead was fresh out of school and was difficult to rein in.

I have used Valco for prototyping and small-run machining and recommend them at least for these activities.

Strengths: Valco is a small machine shop that does a great job with small, quick-turnaround orders. They are familiar with the needs of the medical device industry.

Needs to improve: I have not used them for large orders so I don't know what sort of capacity restraints they might have.