Everybody talks about innovation. How many companies can define it, and how many actually do it instead of just talking about it? In this engaging and thought-provoking presentation we explore some of the various definitions of innovation are and some of the surprising drivers and techniques for generating innovation, and tools for approaching innovation, and illuminating historical illustrations.

Ted Kucklick has worked on innovative medical devices for numerous companies including RITA Medical (RITA) acquired by ANGO; AfX, (acquired by Guidant); Somnus (SOMN) acquired by Smith and Nephew; Sleep Solutions (now Novasom) and Starion Instruments (acquired by Pentax). Ted is founder and CEO of Cannuflow, Inc., dedicated to developing innovative technologies for arthroscopic surgery. Ted has a degree in product design from CIA, and a certificate from the UC Berkeley Haas School of Business Global Bio-Entrepreneur program, and is a member of the IEEE/EMBS, AMI, and SME professional societies, two-term board member of the SF Bay Area chapter of the IDSA, and inventor on over 31 patents. Ted is author/editor of The Medical Device Handbook, helped develop the SME video production, Medical Applications of Rapid Prototyping, and is a regular contributor to BoneZone and MD Design magazine Notebook, and a frequently invited speaker on the subject of medical device innovation.

Read more…

Come join Hantel Technologies at MDM West from February 8th – 10th at the Anaheim Convention Center in booth #2176!

MDamp;M West Coupon comparatif site poker

U.S. FDA “Approved Materials” for Medical Device Use

The Center for Devices and Radiological Health (CDRH) does not maintain a list of
ingredients or materials that are certified or approved for use in medical devices. That is
because the appropriateness of a material depends on the application. That is why FDA
approves finished devices and not components or materials which could be used in varied
applications. For skin or open wound contact, only short term tests may be needed, where
as for an implant, long term in vivo tests would be recommended.
The responsibility for biocompatibility of a finished device lies with the manufacturer.
This can be accomplished in several ways, one of which is to assess or characterize all
components of a device according to the ISO 10993 standard. Some testing can be
avoided if biocompatibility data is available from the component supplier. Many
component suppliers are aware of the biocompatibility requirements that finished device
manufacturers must meet and will supply testing data to meet those needs. Use of
previously qualified components with a known safety profile can save the finished device
manufacturer time and money.

It is the responsibility of each device manufacturer or specifications developer to assure
that all ingredients and component materials are suitable for their intended purposes.
The finished medical device must be safe and effective for its intended purposes when
used according to its labeling. In this context, safety and effectiveness include many
parameters such as physical properties, chernical properties, and biological effects,
including the biocompatibility of materials that contact human tissue.

If you have reviewed ISO 10993 and the ASTM methods (F748) you should be able to
develop a rational plan for documenting the biocompatibility of your device. If you are
unsure of the minimum testing requirements contact DSMICA at:

DSMlCA@fda.hhs.gov and advise them of your device and indication for use. They will identify the correct division within the Office of Device Evaluation (ODE) for you to start a dialogue.

Published by FDA for MDamp;M Anaheim 2-8-2011 to 2-10-2011

Dear Friends and Collegues,

Today is the deadline for discounted early registration for the Bay Area Biomedical Device Conference which will be held on March 30, 2011, in the Student Union Building at San Jose State University. More information, including registration information, can be found at the Conference website: roulette flash

Last year’s success has motivated us to plan an even better conference and we have another set of outstanding speakers who will be addressing several aspects that are particularly relevant to the biomedical device industry. We thank our Industry Advisors who have been essential in our selection of the speakers.

We are happy to report that thirteen companies, in addition to the SJSU President’s Office and the national Biomedical Engineering Society, are sponsoring this conference. We take this opportunity to thank our sponsors and co-sponsors. If your company would like to join this elite group of conference sponsors, please do let me know.

Please do register today so that you can take advantage of the reduced early bird registration fee which ends on March 17, 2011. To register please go to:

We would appreciate it very much if you could please forward this announcement to any of your friends or colleagues who you think might be interested as well.

We look forward to seeing you at the Conference on March 30, 2011.


Come join us at the  Heart Rhythm 2011 event at the Moscone Center in San Francisco – May 5th to 7th. For more information visit the Heart Rhythm website.

Hantel Booth Number: 2041


1. MEDevice Forum- San Diego- Sep 13th and 14th. Booth # 408

2. MDM- BIOMEDevice 2011- San Jose – Dec 6th and 7th. Booth # 214

3. MDM West in Anaheim – February 14th to 16th, 2012. Booth # 2170


Come join Hantel Technologies at Sacramento Med Tech Showcase on May 6th 2011 at Sacramento State University. For more details and registration visit their WEBSITE.

Gaining a Competitive Advantage with Strategic

Medical Device Operational Outsourcing

Hantel Technologies, Inc., May 13, 2011

In recent years, the outsourcing of medical device design and manufacturing activities to contract firms has become more and more common. This has largely been due to pressure to keep product pricing down, manage rising costs, and maintain a competitive edge in the marketplace. Consulting Engineering and Contract Manufacturing firms can streamline the product lifecycle and greatly reduce the time to market and total cost of product development. In particular, they can help companies operate efficiently and allocate resources appropriately when market conditions are difficult, such as those we face in the current economic climate. Some of the advantages offered by consulting firms include decreased time and cost of product development, increased flexibility in timing of development efforts, reduced fixed overhead and capital equipment costs, greater access to expert engineering and manufacturing resources, and increased leverage of infrastructure.

Consulting firms are uniquely structured to quickly get a project up and running thanks to several unique factors. First, contract firms that specialize in an array of medical device technologies have an outstanding depth and breadth of talent available from which to choose for each project. Thus, the right resources can be tailored to each project, bringing with them the expertise to get the work started quickly. Second, because contract firms are service oriented, the work environment rewards not only excellence in device development and manufacture but also timeliness in delivery and adherence to project budget. This not only allows projects to start quickly but also decreases the time to market, an essential factor to ensure strong company positioning in a competitive market environment.

Because contract firms already have the equipment needed to design, test, and manufacture medical devices, a client may avoid incurring substantial overhead costs involved in purchasing and maintaining machinery. Contract firms also typically have established infrastructures that can be readily leveraged, including document control and complete quality systems. Though frequently taken for granted, the time and effort involved in creating this infrastructure is substantial; utilizing the systems in place at the contract firm can greatly reduce the total project cost and reduce the time to market. These systems are tried and true; this is a great advantage for startup companies that might otherwise lose valuable time and money when a flaw in a newly established quality or document control system is discovered.

Perhaps the greatest value in a contract firm is the flexibility it provides. Projects may be started and stopped on a dime. As a result, when the project needs to be frozen due to economic constraints or the need to rethink the next steps for product development, the client does not incur the overhead costs of keeping employees and facilities running, with the exception of their own core staff. Conversely, project phases that are under enormous deadline pressure may receive the benefit of resources that can be quickly and easily added, without the expense and hassle of hiring and training new employees.

Selecting a Contract Firm

Several factors must be taken into account in order to select the contract firm that will best meet your needs. Numerous contract firms are available from which to choose. This is a testament to their utility as cost effective and time efficient organizations. Each brings unique strengths to the table, and it is therefore crucial to think critically about your product development and/or manufacturing needs before selecting a contract firm.

Questions for you to ask include:

General: What is the nature of the device? Is it complex, with multiple parts or components? Does it involve novel processes or technology? Does it require specialized expertise for difficult‐to‐perform processes such as tip forming? Does it interface with other devices or equipment? Rigorously assessing your product’s key features will help you determine whether you need a firm with specific technical expertise, or one that has more diverse expertise. Most firms will offer a fairly broad array of expertise; however some have specific areas in which their knowledge and experience is particularly deep.

Engineering: What experience do engineers at the contract firm bring to the table? Can the firm help with product conceptualization in addition to design? Can they help with design for manufacturing once the product is nearing readiness for market? What is their experience with guiding verification and validation testing? Can they rapidly produce prototypes, solid models, and CAD? Do they have the resources available to meet your needs, both in terms of expertise and in terms of project timelines? Can they add or remove engineering resources easily? Finally, what is the contract firm’s experience with similar devices? Questions like these will allow you to establish whether or not a contract firm has the engineering resources and expertise to meet your needs.

Quality and Regulatory Affairs: Do you have a quality system? A document control system? A regulatory affairs manager or consultant? If not, you will need to ensure that the contract firm has these services. Are they ISO 13485 certified? Are they registered with the FDA and with the California FDB? Have they passed all of their FDA and ISO audits? Have they passed all customer audits? Do they have strong relationships with other service providers for activities such as shipping validation, sterilization validation, biocompatibility testing, etc? Product realization from concept to production is a thrilling process, and it can be easy to overlook the fact that every step along the way must be performed with impeccable adherence to quality control systems, and that regulatory activities must be performed appropriately and in a timely manner. A good contract firm can help you with all of these services. Even if you do have your own quality and regulatory affairs systems in place, it is important for the contract firm to have their own as well, so that you know that all activities are conducted in accordance with federal and state regulation and that any potential quality issues are recognized and addressed early.

Manufacturing: What are the manufacturing and machining capabilities of the contract firm? Does the machine shop have both manual mills and lathes and CNC machining? Do they offer quick turnaround on prototype and custom parts? Is there a clean room (and what class is the clean room)? Is there a shipping and receiving system in place? Is there a supply chain system and do they provide warehousing services? Is there a regulated materials control system? Are there highly trained and skilled assembly workers who have experience with the materials used in your device?

Contract Firm Policies and Management: Does the contract firm retain any of the intellectual property for the devices it helps design and build? Does it make any of its own products that might compete with your device? Does it have a strong accounting system such that purchase orders are closely tracked and billable hours tightly controlled? Does it have a well structured management system? Is the company structured such that the departments work cross functionally and as a team to meet your needs? Selecting a Contract Firm Summary: Prospective clients must do their due diligence prior to selecting a contract firm. However, selecting the right firm can make all the difference in a successful and productive partnership.

Successful Management of the Contract Relationship

Outsourcing is not without its challenges. Regular and open communications are essential for smooth project coordination and execution. Because the contract firm and client teams are separated geographically, the casual yet critical conversations that occur throughout the day in the office place are absent between these two groups. Though taken for granted, this constant communication is essential for identifying and addressing challenges, both small and large, that invariably arise throughout the course of the product lifecycle. Something that is considered to be “common knowledge” in one location may be completely unknown to another. Hence, a more formal and regular meeting structure is highly recommended in order to ensure that all parties are kept informed and up‐to‐date regarding issues and even slight changes in project direction.

Another challenge that is magnified in the outsourcing environment is scope creep. The scope of a project will naturally expand to accommodate unforeseen challenges in design, manufacturing, test results, etc. In‐house, this creep may go unnoticed, or be more generally accepted as a normal part of product development. However, a contract firm is working under a much more specifically defined and tightly controlled timeline and budget, and is under contract to fulfill this obligation. Therefore, even a seemingly small change in design or process, or the identification of a previously unforeseen risk, may have a significant impact on the timeline and budget of the project, especially in light of the project scope as defined in the original contract. Thus, it is essential to constantly review the project status and projected activities in light of the existing contract, and update it as necessary in order to accommodate changes in scope. This allows both parties to operate with complete transparency, forces them to think more critically about changes to the project (thus contributing to project streamlining), and prevents surprises and miscommunication on the part of both parties.


Outsourcing medical device development and manufacturing activities to an established and respected contract design and manufacturing firm can greatly reduce the time to market and total cost of development of medical devices. Outsourcing can also allow a company to gain access to engineering, manufacturing, and quality expertise that it otherwise might not have in‐house or on an as‐needed basis. Finally, outsourcing also provides the flexibility crucial for product development in a competitive market, allowing projects to start, stop, or change direction quickly. In a competitive market environment, key business decisions such as the choice to use a contract firm can greatly improve your company’s chances for success.

Hantel Technologies Customer Survey 2011


We would greatly appreciate if you took a moment to rate our customer services.

Did we provide valuable engineering and product design service?

Did we provide valuable sterilization and packaging validation test services?

Did our production personnel demonstrate process understanding and product knowledge?

Did we meet our contract commitments using prompt billing methods and sufficient invoice information?

Would you recommend Hantel Technologies to other companies for design and manufacturing of Medical Devices?

Be our Guest at San Diego’s very own medical device conference & supplier showcase:

MEDevice Forum 2011 - San Diego

MEDevice Forum – San Diego
September 13th amp; 14th, 2011

San Diego Convention Center
Upper Level Ballroom
San Diego, CA

Register for FREE supplier showcase admission at – MEDeviceforum.com