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The Importance of Outsourcing in Medtech

  
  
  

The latest edition of Medical Product Outsourcing Magazine featured an article that discussed the importance of outsourcing and collaborative partnerships in research and development, a key topic in the current medical technology industry.

Medical Product Outsourcing Magazine

Recognizing Fallbrook Engineering’s 33 years of consulting to the Life Sciences industry, Medical Product Outsourcing reached out to President/CEO Richard Meyst to provide insight into the current and anticipated direction of the medtech industry.

While the challenges companies face today in our industry have changed, the decision making process a company uses to decide if it needs outside resources has remained largely the same.

For example:

Does the company have the appropriate resources for the project?
Do the duration and/or economics of the project warrant hiring people?
How does the project fit into the strategic plans of the company?

The medical device market is rapidly changing with increasing regulatory requirements, a focus on patient outcomes as well as the efficacy of the product, and the impact of the changes to product reimbursement levels. As a result, outsourcing partnerships have become even more instrumental to successful product development through targeting efforts in the areas where companies need the immediate support, but do not want nor need a full staff for the purpose. Fallbrook Engineering specializes in providing the resources to the life sciences community for these situations. As the challenges and needs shift, Fallbrook Engineering shifts to meet those needs.

As Mr. Meyst said in the article,

“The days of technology for technology’s sake are gone. The economics of [Product Development] have become an overriding factor. We have doctors or people associated with startups come to us with great ideas born out of an identified need in the market—a doctor may invent something, for example, because he can’t find a good product to help him do his job. For those kinds of ideas to be successful, there has to be a reimbursement path that ultimately will allow the product to be funded. People don’t think of that. You have to consider how [health] insurance companies are going to look at the innovation. And you have to have a [business] model that allows people to make money selling it.”

Fallbrook Engineering assists Life Sciences companies and inventor/startups to expand their development research efforts by providing expert personnel and manufacturing resources. This offers our clients a variety of pathways for accomplishing their R&D goals, now and in the future.

With operations running for the past 33 years, Fallbrook Engineering has successfully navigated through the significant changes in the industry that started with the 1976 device act. We would like to be your outsource resource, so please contact us today for a confidential consultation.

CONNECT Nearsourcing Initiative: Managing Sourcing Successfully

  
  
  

Fallbrook Engineering will participate in CONNECT's next Nearsourcing Initiative event: Managing Sourcing Successfully.

Fallbrook Engineering's Vice President Bill Atkinson will join a panel of experts to discuss how to successfully manage a business relationship with an outsourcing partner. Topics will include different types of contract agreements, responsibilities of client versus contract provider, how to manage one's expectations, defining metrics of success, and why communication and trust are key.

The event will be held on April 22 at Sheppard Mullin Richter & Hampton in Del Mar.

For more details and registration information, please visit CONNECT's event page.

 

CONNECT.org

Associate Spotlight: New Biotech Senior Associate

  
  
  

Fallbrook Engineering would like to welcome our newest associate, Sylvia Norman, PhD. 

Dr. Norman brings her extensive background in the Biotech and Life Sciences areas to Fallbrook Engineering’s portfolio of Outsourcing Services. Her many years of experience providing molecular diagnostic product development and cross-functional team leadership include developing oncology and infectious disease-related diagnostic products such as HPV, Influenza, Melanoma, West Nile Virus, Non-Small Cell Lung Cancer and Glioma.

Sylvia A. Norman, PhD

“Sylvia’s background and experience significantly expand the services and offerings that Fallbrook Engineering can provide to our clients,” stated Fallbrook CEO Richard Meyst. “We are delighted to begin our collaboration with Sylvia.”

During the course of her career, Dr. Norman has honed her Molecular Biology and Biochemistry Technical Skills, including: multiplex PCR assay design, real-time PCR, digital PCR, genotyping/CNV data analysis, sequence analysis, design/optimization of primers & probes for PCR assays, clinical specimen sample processing, clinical specimen procurement, cloning techniques, ELISA assays and in-situ hybridization techniques. 

Dr. Norman holds 10 patents and has written 14 scientific publications on topics such as molecular diagnostic assays, Type 2 Diabetes and developmental genetics. She received her PhD (specializing in Genetics) from Arizona State University, Tempe, and completed her Project Management Professional certification in 2010.

Fallbrook is pleased to include Dr. Norman in our expanding network of expert associates.  Fallbrook VP Bill Atkinson said, “Sylvia brings excellent skills that will be of great benefit to our clients.”

To speak with Dr. Norman or to speak with any of our team, please contact us to schedule a complementary consultation.

Find FEI in the 2014 Medical Product Outsourcing Directory

  
  
  
MPO

Fallbrook Engineering is pleased to be included in Medical Product Outsourcing's 2014 Company Capabilities and Outsourcing Directory.

In addition to publishing regular editions of relevant medical device industry news, marketing information, and regulatory and legislative updates from the US and abroad, MPO provides a comprehensive listing of manufacturers, products, and services for medical device companies. Their annual directory highlights the capabilities of a variety of companies in the medical device industry, from manufacturers and material suppliers to expert design and development firms like Fallbrook Engineering.

Click here to view a PDF version of our company profile.


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Call for Entries - 2014 Medical Design Excellence Awards

  
  
  
Medical Design Excellence Awards 2014

Tomorrow is the deadline for standard entry in the 2014 Medical Design Excellence Awards. Please see the MDEA Program Overview and UBM's Call for Entries for more information regarding eligibility requirements, deadlines, and entry fees.

The Medical Design Excellence Awards (MDEA) program recognizes achievements in the design and development of medical products. Medical product manufacturers, suppliers, engineers, scientists, designers, and clinicians are celebrated each year for their contribution in creating the groundbreaking products that are improving outcomes, saving lives and changing the face of MedTech. Fallbrook Engineering's President/CEO Richard Meyst will serve his 2nd three year term as a juror at these awards, and encourages any company that has an appropriate medical device to enter the competition. The final entry deadline for the competition is January 22, 2014.

Richard Meyst To Participate In 2014 Medical Design Excellence Awards

  
  
  

Medical Design Excellence Awards

Fallbrook Engineering's CEO Richard Meyst has once again been invited to participate as a juror at the 2014 Medical Design Excellence Awards competition. This will be Richard's 2nd three year term as a juror.

The Medical Design Excellence Awards (MDEA) program recognizes achievements in the design and development of medical products. Medical product manufacturers, suppliers, engineers, scientists, designers, and clinicians are celebrated each year for their contribution in creating the groundbreaking products that are improving outcomes, saving lives and changing the face of MedTech. As a close observer of these awards from the years Richard has participated as a juror, Fallbrook Engineering recognizes the value of this program and encourages any company that has an appropriate medical device to enter the competition. And, as Meyst says, “If you don’t enter, you can’t win."

From the MDEA website:

"The MDEA competition is a prestigious, publicity-charged program that fosters innovation by honoring the highest caliber medical devices on the market today. Both winners and finalists enjoy year-round opportunities to increase the market visibility of their company and its award worthy products among MedTech and healthcare professionals. Each year finalists are announced in the April issue of MD+DI (Medical Device and Diagnostic Industry) magazine. Winners are announced in June during a special ceremony held in conjunction with MD&M East."

For more information and registration entry details, please click here. All entries must be submitted by January 22, 2014, so don’t delay!  And, to learn more about the competition, enjoy the following video that was created to celebrate the 2013 15th Anniversary of the MDEA.

Find Fallbrook Engineering at the CONNECT Nearsourcing Tradeshow

  
  
  

Fallbrook Engineering is excited to participate in the “Connect with CONNECT” networking event in San Diego on October 30th. CONNECT is a regional program that links San Diego County’s life sciences inventors and entrepreneurs with the resources they need for success. Their "Connect with CONNECT" series of events is offered every season to maximize the connections and business opportunities of local entrepreneurs, innovators, researchers, capital providers, industry executives and professional service providers. This season, Fallbrook Engineering and other local businesses will have the opportunity to showcase their services at the Nearsourcing Tradeshow that will take place alongside the networking event.

The Nearsourcing Tradeshow will be preceded by a Nearsourcing Workshop featuring an expert panel that will discuss how to effectively utilize newly designed nearsourcing programs to create a shortened supply chain, accelerate time to market and increase quality and innovation.

Please visit CONNECT's website to register for both portions of the event, and be sure to stop by the Fallbrook Engineering booth on October 30th!

Connect With Connect

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FEI Project Engineer Now A Certified SolidWorks Professional

  
  
  
Scott Thompson, a Certified SolidWorks Professional

Congratulations to Fallbrook Engineering's Project Engineer Scott Thompson for completing the training courses and exam required to become a Certified SolidWorks Professional (CSWP).

SolidWorks 3D CAD software is an essential part of Fallbrook’s design and development process and is used in nearly every project. Certifications are used as a benchmark to measure knowledge and competency with SolidWorks software. Exams focus on the fundamental skills necessary to ensure a company’s overall success using SolidWorks, such as creating a part from a drawing, using linked dimensions and equations to aid in modeling, using equations to relate dimensions, updating parameters and dimension sizes, modifying geometry on an initial part to create a more complex part, and mass property analysis, among many more.

As stated on the SolidWorks certification webpage, each CSWP has established his or her ability to design and analyze parametric parts and movable assemblies using a variety of complex features in SolidWorks software. Fallbrook is proud to have another Certified SolidWorks Professional on our uniquely talented staff of engineers.


C.ideas Exhibits the Amazing Possibilities of 3D Printing

  
  
  
C.ideas Miller 91 Race Car

The advancing technology of additive manufacturing, often criticized as an inferior alternative to traditional manufacturing methods, is given a stunning display in this video from C.ideas, a rapid prototyping service based in Crystal Lake, Illinois. C.ideas took a computer model of a 1927 Miller 91 race car and entirely used 3D printing processes to create a 40% scale model replica.

The CAD model was created with SolidWorks software by Bill Gould, one of Fallbrook Engineering’s most talented Senior Associates. With over 40 years of professional experience in the medical device and consumer product industries, Bill Gould’s work has been essential to Fallbrook Engineering’s efforts and we are excited to see his talent used to demonstrate such remarkable manufacturing technology.

Check out the video below from C.ideas for a detailed look at the state of the art in 3D printing process.  You won’t believe your eyes!  Fallbrook uses Bill’s SolidWorks designs and similar fabrication technologies to create prototypes for our clients for many purposes.

Another Successful Event from BIOCOM

  
  
  
DeviceFest 2013 Booth

Congratulations to all who participated in BIOCOM’s DeviceFest Conference and Medical Device Expo earlier this week.

This year’s event included a conference with speakers and panelists from FDA and such companies as Johnson & Johnson, Medtronic, Covidien and CareFusion, among many more.

The expo portion of the event consisted of a “Contract Alley” feature of San Diego firms that provide design and contract manufacturing services for device and diagnostic companies, offering a special opportunity for attendees to preview the exceptional local services that are available to assist with bringing a medical product to market.

The expo also showcased a select group of local companies that displayed an innovative medical technology or product that is under development or has initially gone to market within the last two years. Fallbrook Engineering was honored to be included in both expo categories this year and welcomed all the people who visited with us.

“Once again, BIOCOM put together an outstanding program for the recent DeviceFest and Expo 2013,” said Fallbrook Engineering’s Vice President Bill Atkinson. “The expert speakers and panelists provided attendees with excellent overviews and insights on the current status and the future directions of our industry and community.”

Many thanks to BIOCOM for hosting this event, to the distinguished companies and speakers who participated and to all who attended!

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