4th Annual Purdue Research Park Kickball Tournament

Last month, MED Institute participated on the ‘Too Many Cooks in the Kitchen’ Kickball team as part of the 4th annual Purdue Research Park Kickball Tournament. 3 other Cook companies participated on the team: Cook Advanced Technologies, Cook Research Incorporated and Cook Regentec. In total, the team played in 4 games throughout the evening scoring a total of 52 runs over the course of the evening! We held our opponents to only 6! This is the second year that the Cook team has won the kickball championship game. It’s really great that so many Cook companies can come together as one for events like this. We are excited and proud to take home the trophy for the second year in a row!

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What Should You Do When a Testing Standard Doesn’t Exist? Part 6: Overcoming Standard Committee Stalemate

In part five of this series, we discussed forming an industry consortium as another means to develop a test method. In this part, we’ll discuss what you can do when the standards community disagrees with your proposed method. omtec-6-image

One course of action available to you is to promote awareness of test methodology by publication in peer-reviewed journals. The development of a publication portfolio can help to validate the methods you have developed and will allow industry peers to confirm your practices. This can help everyone come to a consensus on the best way to move forward.

This concludes our series on what you should do when a testing standard doesn’t exist. To continue the discussion or to answer any questions you may have, please contact MED Institute via our website at http://www.medinstitute.com

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MD&M Minneapolis 2016

We ended our 2016 tradeshow season in Minneapolis, MN at MD&M Minneapolis – September 21 and 22nd. It was a nice change of pace to have this show a little earlier in the fall- no snow or cold weather had hit Minnesota yet! We also had a great two-day show. Once again, we featured a TA ElectroForce 3100 fatigue tester as part of our booth to show off one of our numerous testing capabilities. Last year we completed over 3 billion cycles with our fatigue testers for a single client! We also had opportunities to discuss other capabilities including R&D, simulation, regulatory, feasibility clinical trials and many other services we offer.

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Additionally, Justin Metcalf, our Director of Engineering, gave a Tech Talk while at the show on Design Verification Testing: What Should You Do When a Testing Standard Doesn’t Exist? Justin discussed the importance of being involved with standards committees to establish a new standard test method or modify an existing method. He also discussed developing a new non-standard test method and how to mitigate risk with test method validation. This particular topic was a very popular one- it was standing room only! Over 35 people were in attendance during his presentation! Overall, we were really happy with our booth, project discussions and tech talk success at the show. Feel free to follow up with us if you’re interested in receiving more information on the presentation given. See you next year in Minneapolis!

What Should You Do When a Testing Standard Doesn’t Exist? Part 5: Forming an Industry Consortium

In part four of this series, we talked about employing a third party to build testing equipment to develop a new test method. In this part, we’ll discuss forming an industry consortium as another means to develop a test method.

OMTEC Blog post 5 imageThrough the use of Cooperative Research and Development Agreements, an industry consortium can be formed. This can be a useful means of obtaining and sharing data that are expensive to collect.

Collaboration through an industry consortium can result in test method development, new instrumentation, and innovative approaches to shared problems. The knowledge and data developed in the industry consortium can be used to educate others and to support standard development.

For example, in 2006, SRI International, Stanford University, and a consortium of stent manufacturers teamed together to investigate loads on stents in the superficial femoral artery (SFA) and to improve the durability of peripheral vascular implants. An important outcome of this collaborative effort was the identification of bending, torsion, and axial deformations that would need to be simulated in the in vivo loading experienced by the stents. The results suggested possible fracture mechanisms and also provided important parameters for future stent design.

In the final part of this series, we’ll review the options you have when a testing standard doesn’t exist and discuss your recourse if the standards community disagrees with the testing method that you propose.

For more information, please visit our website at http://www.medinstitute.com

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Meet Bill Voorhees,our Vice President and Chief Science Officer.

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I’m Bill Voorhees.  I have been employed by MED Institute for over 25 years, although I have been associated with the company from its inception, serving on its advisory board from 1983 until being hired on in 1990.  Prior to coming to MED, I spent 14 years at the Biomedical Engineering Center at Purdue (4 years as a doctoral student and 10 years as Research Faculty).

It was a natural progression to come to MED.  At the Biomed Center, we did a lot of practical, applied physiology research.  At MED we take the next step and help bring the fruits of such research to the patient.  Our role in the process comprises all aspects of product validation testing including non‑clinical in vitro and in vivo testing as well as clinical trials.  I have to admit I may be most pleased with being involved in helping conduct the first clinical trial, analyzing the resulting data, and preparing the regulatory submissions that led to FDA’s approval of the first coronary stent available in the U.S., The Gianturco-Roubin Flex‑Stent Coronary Stent.  Those were exciting times, and there are more to come as we offer our expertise in all aspects of new product approval to a new set of clients learning to navigate the medical product approval process.

To learn more about our services, please visit our website medinstitute.com.

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Meet Colleen Tennyson, our Treasurer and Director of Quality Assurance and Quality System.

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I’m Colleen Tennyson and I’ve been with MED for over 31 years!  I feel very blessed for all of the opportunities provided to me and am eternally grateful for the chance to serve in various roles over the years, including finance, quality, HR, and compliance.

Both MED and I have changed a lot since 1984.  I was single, had no children and no degree.  Now I’m married with children, grandchildren and great grandchildren and have a degree in business.  MED did only electronics development and worked primarily for sister Cook companies.  I watched us grow from 4 employees to over 240 and back to 24 as we have branched off in order to provide a full range of services from research to publication to clients other than Cook.

And some things never change.  MED was dedicated then to serving patients first and that is still true.  The message has remained consistent and clear – – quality first – –  always.  Few companies have that privilege.

It has been a wild ride, and a lot of fun!  I’m looking forward to the future.

To learn about our services, please visit our website www.medinstitute.com

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What Should You Do When a Testing Standard Doesn’t Exist? Part 4: Employ a third party to build testing equipment

In part three of this series, we talked about validating your own test method and gaining FDA approval. In this part, we’ll discuss another option to consider when a testing standard doesn’t exist: Employ a third party to build testing equipment to allow the standardization of the test method.

OMTEC Part 4 ImageMedical device technology combines engineering, science, and medicine to provide technical solutions to medical problems. The design of a new medical device presents a number of engineering challenges throughout the design process. A device can only be considered safe after undergoing tests that prove its safety. Demonstrating that a device is safe starts by devising the right tests.

For example, in the case of vascular stents, there was not a suitable method, nor was the appropriate equipment available to measure radial force.

The American Society for Testing and Materials (ASTM) attempted to develop a standardized method to measure radial force for over ten years without success. It wasn’t until Machine Solutions Incorporated developed new equipment that ASTM was able to standardize a test method capable of measuring stent radial force in a highly repeatable way. This equipment has become the industry standard and has been in use for many years.

This work led to the publication of ASTM F3067, “Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents”, in 2014. It is a guide that covers in vitro bench testing methods and equipment that can be used to measure the radial force, or collapse pressure, of vascular stents.

In the next part of this series, we’ll look at a final option to consider when a testing standard doesn’t exist.

For more information, please visit our website at http://www.medinstitute.com

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Intern Culture Connect

The Co-ops of MED Institute traveled to the heart of Indiana for Cook’s “Intern Culture Connect”. The event lasted two days during which interns from all over Cook learned about the history of the company, exciting new technologies, and the emotional story of one resort selling sulfur water as a laxative.

Day one was held at the impressive corporate headquarters located in Bloomington, Indiana. The day was filled with several activities and presentations.   Throughout the event, products from various business divisions were displayed and interns could see some devices being operated.  Some interns even got to perform the minimally invasive Seldinger technique on several brave grapefruit.  The president of Cook Medical, Pete Yonkman, was also in attendance and participated in a Q&A session.

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Day two was held at the beautiful French Lick Resort.  The historical land mark was purchased by Bill Cook and eventually restored with a small initial investment of 31 million dollars.  A tour of the facility was completed with an in-depth look into the history of the sulfur springs.  A delicious lunch was prepared for the interns and a luau theme was selected for the occasion.  During the lunch several fully restored cars were presented and many pictures were taken with the cars. Eyewitness reports indicate that the MED Institute co-ops were overheard saying they were “too cool to smile in a picture.”

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Overall the Intern Culture Connect was a huge success.  The event was a great opportunity to learn more about the industry and to network with fellow interns. Additionally, everyone in attendance received not one but two biographies of Bill Cook.

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Clinical Trials and Tribulations

MedOur President, Matthew Waninger, was cordially asked to speak at the February 2016 Cavendish Global Health Impact Forum on the topic of Clinical Trials and Tribulations, Lessons for early stage companies.

Cavendish Global helps businesses obtain discrete, peer-to-peer knowledge expansion and a relationship building environment, combined with the innovative resources required to help develop and implement their individual pro-social impact investment, grant making and sustainable philanthropy programs.1

Cavendish Global’s areas of focus include:1

Tying in nicely to Cavendish principles and objectives, Matt shared MED Institute’s principles, history and expertise.  For more than 30 years, MED has provided thoughtful guidance and quality product development services, including clinical trial services, to clients who require expertise in the efficient development of novel medical products and therapies.

At MED Institute we strive to:

  • Channel our creative power into society by providing services to develop products that save and/or improve lives
  • Solve hard problems that matter to patients, physicians and the people with whom we work
  • Collaborate with people who feel as much excitement and possibility in new product ideas as we do

The focus of the talk was early-stage clinical trial decisions and how those decisions can impact trial results negatively or positively.  Knowing when to collect human clinical data, knowing what type of trial to run and having the wisdom to know what questions to ask prospectively are key components to clinical trial success.  Conversely, running the wrong trial, collecting the wrong data, and the inability to enroll patients are just some of the items that can lead to clinical trial tribulations such as wasted time, wasted resources, and even failed trials.

In addition to those considerations, MED believes that clinical trials are given the greatest chance at success by working to truly understand the needs of the client and the clinical site personnel.  Communication and collaborative relationships with clients and clinical site personnel are critically important and are at the forefront of our Clinical Trial Services offering.

To learn more about our Clinical Trial Services and to avoid Clinical Trial tribulations, please contact us at MED Institute Inc. and let us help you run the right trial the right way.

1 Description from the Cavendish Global website, http://cavendishglobal.com/, accessed 5 April 2016.

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Another Audit Celebration

Passing an audit by an accreditation body has become fairly routine for MED Institute; we’ve been audited to ISO 17025 for 12 years now, ISO 14155 for 11, ISO 13485 for 15 years and ISO 9001 for 7 years before that. In addition to accreditation audits, MED undergoes client audits on a regular basis. Client audits provide another way for us to show off our robust system and also a way to improve our quality system with different perspectives. We pride ourselves on maintaining a flexible system and enjoy celebrating meeting our customers’ needs through the audit process. One way we like to celebrate is with cotton candy, because who doesn’t enjoy fresh, made from scratch sugar? Our Director of Engineering Services, Justin Metcalf, brings his own cotton candy machine, so we always have access to sweet treats when celebration calls!

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To learn more about our services, please visit our website.

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