Publications

Articles  ~ Patents  ~ White Papers

Articles

 

Challenges to International Device Reimbursement

Link to Medical Device and Diagnostic Industry online article: Challenges to International Device Reimbursement
As the world grows smaller, national politics increasingly affect global healthcare economics. Although the medical device industry has boosted its international harmonization efforts, wide variation still exists with respect to healthcare reimbursement. Therefore, device companies must understand reimbursement schemes in their relevant geographic markets before making any significant investment in product development.

The goal of this article is to provide foundational knowledge for U.S. device companies for selecting markets in which product reimbursement will most likely be secured. It also aims to help OEMs craft a unified approach to international product marketing that addresses differing national requirements, particularly in Canada and within the European Union (EU).

 

Convergence, Collaboration, Commercialization

Link to Medical Device and Diagnostic Industry online article: Convergence, Collaboration, Commercialization
Technology convergence and corporate collaboration are propelling rapid changes in today’s medical device industry. Technology convergence is emerging from often disparate disciplines in order to address a wide array of clinical disorders that biologics, devices, or pharmaceuticals cannot resolve independently.

Meanwhile, corporate partnerships are enabling manufacturers to collaborate on such common goals while maximizing the strengths and minimizing the weaknesses of each partner. Partnering across the biotechnology, medical device, and pharmaceutical fields represents an excellent method of creating better, smarter products, and achieving mutual growth.

 

Development of an Automated Manufacturing Course with Lab for Undergraduates

Link to 6-page PDF: Development of an Automated Manufacturing Course with Lab for Undergraduates
At her prior university, Dr. Munro resurrected and enhanced a hands-on advanced CAD and automated manufacturing course that introduces students to advanced solid modeling techniques in CAD, such as sweeps, lofts, and surfacing methods. In addition, students learn manual machining and vacuum forming in our machine shop, along with learning how to create tool paths for CNC machining their designed CAD parts out of wax on various three axis end mills, a 3D printer, and a 3D laser scanner.

 

Hands-on Biomechanics Lab for Undergraduate Universities

Link to 6-page PDF: Hands-On Biomechanics Lab for Undergraduate Universities
This paper discusses the development of a biomechanics lab course suitable for use at undergraduate engineering institutions who wish to expand their elective offerings or move towards developing a bioengineering degree program. The labs are designed to be low cost and feasible in a teaching environment with groups of students rotating through stationary lab setups.

 

Learn to Incorporate Sensors Into Your Next Design Idea

Link to 2-page PDF: BONEZONE, December 4, 2017
The future of orthopaedic medical devices is small — microscopically small. Micro Electro Mechanical Systems, referred to as MEMS devices or sensors, are already used in a host of medical devices, doing tasks that were previously only conceived of in science fiction.

Sensors the size of a flea can now measure strain, temperature or resistivity. They can measure acceleration, frequency and electrical impulses.

 

Putting a Charge in Healing: Electrical Stimulators Show Great Promise, Especially for Spinal Fusions

Link to 3-page PDF: Putting a Charge in Healing: Electrical Stimulators Show Great Promise, Especially for Spinal Fusions
Spinal fusion is the latest application of electrical stimulation as a fracture healing. This exciting new application has been proven over 30 years of use, and the market is now poised for rapid growth. Patent activity shows an increased interest in this technology, and both start-up companies and orthopedic giants can thus benefit from introducing new products in this field.

 

Start With the Problem: The Entrepreneurial Approach to Engineering

Link to 52-page PDF: BONEZONE, Volume 16, Issue 3, August 2017. Link will open on page 45: Start With the Problem: The Entrepreneurial Approach to Engineering
We’ve all been there—the boss, the sales rep, the customer, or someone from another department rushes in with a problem they need solved stat. They tell you what they want you to do and ask how soon you can get it done. The temptation to just implement their idea into a fully-fledged solution is enormous. And why not? It gets the job done, makes them happy, and lets you move on to other problems that need solving. I’ve succumbed to this kind of thinking many times, and the results are always the same—an adequate design that leaves me and everyone else feeling flat. This article presents ideas on how to produce your best work. Link to publication online: BONEZONEpub.com, August 2017.

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Patents

 

IC Chip to PC Board Connector System

Link to 13-page PDF: IC Chip to PC Board Connector System, US Patent 5,288,238
US 5,288,238 IC Chip to PC Board Connector System. An apparatus is described for connecting rows of contact pads on a leadless integrated circuit (IC) chip to rows of traces on a circuit board, which facilitates the connection. Each interface device has a row of compressible conductors each having an upper end engaging a contact pad on the IC chip and a lower end engaging a conductive trace on the circuit board. Each interface device can have contacts at a finer pitch than the contacts on the IC chip or the circuit board, to reduce the precision required in mounting the interface devices on the socket. The result is a zero insertion force connector for rapidly testing IC chips during programming.

 

Strain Monitoring System and Apparatus

Link to 43-page PDF: Strain Monitoring System and Apparatus, US Patent 8,066,650
US 8,066,650 Strain Monitoring System and Apparatus is a system for monitoring strain as an indicator of biological conditions, such as spinal fusion. The system includes an interdigitated capacitive sensor, RF transmitter, and an associated antenna, all of which are microscopic in size and can be implanted in a human or animal. An inductively coupled power supply is employed to eliminate the need for implantation of a battery. Power is provided to the sensor from the external transceiver. The implanted sensor system is left in place permanently.

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White Papers

 

Clinical Literature Reviews: Changes in the European Union’s Medical Device Directive Require Manufacturers to Take Immediate Steps to Comply

Link to 9-page PDF: Clinical Literature Reviews: Changes in the European Union’s Medical Device Directive Require Manufacturers to Take Immediate Steps to Comply
This white paper, written in 2008, advises that manufacturers, now faced with an enormous amount of work to complete in a short period of time (2010 deadline), take immediate steps to deal with the coming changes. At stake is maintaining or increasing share in the growing $86 billion market that accounts for a significant percentage of most U.S. medical device companies’ profits. With nearly 8,000 devices on the EU market, it is possible that a backlog of applications as the deadline approaches could bottleneck approvals, with serious implications for sales and profits.

 

The Power of Meta-Analysis: How Smart Companies are Using a Statistical Methodology to Drive Breakthroughs

Link to 7-page PDF: The Power of Meta-Analysis: How Smart Companies are Using a Statistical Methodology to Drive Breakthroughs
Often, businesses find that they cannot perform a clinical study with enough patients to provide statistical significance to the results, so they must combine their results with those of others to determine safety and efficacy. Other businesses feel their products are far superior to others currently on the market, but to gain market share, they need to demonstrate the benefits of their products across a large cross-section of the population. Whatever the reason, meta-analyses are powerful tools that the medical device industry can use to promote and gain approval for innovative new products.

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