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Top 5 Questions about Hot-Air Catheter Tip Forming

The current medical device industry trend towards reduced manufacturing costs has catalyzed new business opportunities for innovative suppliers. Equipment using technologies designed to replace expensive manufacturing processes is generating new interest, as latest statistics reveal.

In the catheter manufacturing sector, more targeted, cost cutting solutions are replacing older overly engineered technologies. Hot air tip forming is one such alternative gaining traction in today's competitive business environment. Beahm Designs, a supplier of catheter manufacturing equipment, has developed a leading edge solution to address this emerging trend. Beahm Designs Auto-Tipper 510-A was designed as an easy-to-operate, low-cost alternative to RF tipping that works with both glass and metallic dies.

As with any new process, hot-air thermal tipping brings up some common questions among end users. Here, Beahm Designs CEO Anita Beahm addresses some of the most frequently asked questions received during presentations and workshops. 

Glass mold tipping
The above image shows glass-mold tip forming. The use of glass allows the user to see the materials forming within the mold and provides visibility for process control.

Five Commonly Asked Questions about Hot Air Tipping

Question 1: What ranges of temperature will the Hot Air Technology accommodate and what is the average cycle time?

Both the 510-A, and the two-up system, 512-A system accommodates temperatures ranging between 250° F-650°F. The average cycle time is 20 seconds.


Question 2: How do you address "flash" or material that leaks from the mold?

This is the greatest tipping challenge. With metallic dies the mandrel can be integrated or welded to the die with glass a tapered mandrel can be used to seal the gaps but each of these methods has it's own challenges.


Question 3: What types of mold releases are available?

70/30 IPA/Water works for most materials and does not have biocompatibility issues. Otherwise pure silicone or a silicone based solution can be used but is difficult to clean from the finished product.


Question 4: What types of materials does the 510-A accommodate?

Virtually all thermoplastics but not all thermo-formable materials can be formed into any geometry.


Question 5: How can I determine whether hot air tipping is a viable alternative to my current process?

Companies like Beahm Designs will sign your NDA, then using your supplied materials, run trials in our applications lab. At Beahm Designs, we identify and document parameter settings, cycle time and photograph the session for review and testing, and guarantee results.

Hot Air Tip Forming Video Demonstration: 

Anita Beahm is available to answer questions on the hot-air tipping via email.

Harvard Professor Blasts CDRH for Failure to Protect LASIK Patients

Harvard Professor Blasts CDRH for Failure to Protect LASIK Patients

by: Jim Dickinson

Harvard Medical School assistant clinical professor Perry Rosenthal lashed out in August at what he alleges is FDA’s continuing failure to protect the public from LASIK surgeries performed for “non-medical reasons on a healthy organ critical to our ability to function” - surgeries that he says should, but don’t, have a zero risk of serious, permanent complications.

Rosenthal 
In a statement on the Web site for the Boston Eyepain Foundation, of which Rosenthal is a founder, he says that as a former practicing eye doctor at the Boston Foundation for Sight, “I have a confession to make. Despite my having been aware of the many blinding consequences of this surgery, having treated many of them … I too failed to act on my observations that these surgical procedures can destroy the quality of life of these victims.
 
“I did nothing,” the statement continues, “until I became aware of a complication that had not been previously reported; long lasting and in many cases, probably permanent, suicide-provoking eye pain.” Rosenthal speculates that this “devastating complication” probably was not reported because these eyes typically look normal and well-healed – meaning eye doctors were misled and assumed patient complains of pain must be imaginary. Moreover, since the pain can occur years after the surgery it is less likely to be connected with the surgery.
 
What Rosenthal says he didn't expect however was a “coordinated effort to suppress this information.” He lashes out at two peer-reviewed, professional scientific journals which “summarily rejected” a study he conducted on 21 patients detailing the characteristics of this pain disease. “I was confused,” he writes. “So I sent the paper to world-class pain researchers for their opinions. All supported its being published.”
 
Rosenthal says his next step was to send his paper to FDA, despite being warned that the agency would not respond. “I didn’t believe it. I was wrong. I sent the paper twice without it even being acknowledged.”
 
According to Market Scope, a Manchester,MO-based research company for the ophthalmic industry, roughly 800,000 LASIK procedures have been performed every year worldwide since 2000 and the available pool of surgical candidates is growing by 2 million eyes per year. “This is a huge industry with tentacles that appear to reach the bowels of the FDA,”Rosenthal’s statement says. “In the meantime, I think about what will be happening to the vast numbers of the people who will be undergoing these procedures, ignorant of their possible life-destroying complications. Shouldn’t they at least be able to make an informed decision?
 
Rosenthal’s statement came 31 months after former CDRH branch chief for diagnostic and surgical devices Morris Waxler petitioned FDA to reverse his approval of ophthalmic devices for LASIK, complaining about the industry’s promotion of an injury rate of less than 1%, upon which the approvals were based. Waxler alleged that “Manufacturers and their collaborators withheld more than 10% of the adverse event data from 13 of the 25 studies, more than 20% from 12 studies, and more than 40% from seven studies.”
 
FDA has not responded to the petition.

Auto Product Could Boost Medical Imaging

A new device could increase the speed of medical imaging for a low cost, according to researchers at the University of California, Berkeley. By using molybdenum disulfide, a product sold at automotive stores, engineers were able to create a high-speed photodetector. Most traditional photodetectors make use of amorphous silicon due to its favorable properties. In particular, this compound carries a low price tag and absorbs light very well. However, there are several significant issues with this form of silicon. Due to defects, amorphous silicon may prevent the ordered movement of electrons. During imaging procedures, this can lead to lower operating speeds and can increase patient radiation exposure. To ensure better performance, imaging centers have to use high-temperature, high-cost processing. To remedy this issue, researchers paired a thin film of molybdenum disulfide with a very thin sheet of amorphous silicon. Since molybdenum disulfide has a molecular structure that differs from amorphous silicon, photo-generated electrons can move through a molybdenum disulfide-infused sheet faster than a sheet made of amorphous silicon on its own. Since molybdenum disulfide is inexpensive, adding this material to photodetectors wouldn't increase the cost of medical devices. Unlike traditional silicon semiconductors, molybdenum disulfide comprises individual nanosheets. With this type of nanotechnology, researchers can create novel electronic devices. "Our discovery could bring transformational changes in applications from biomedical imaging to solar cells in energy-efficient transistors," note researchers.

Managing Software Risk in Medical Electronics

To mitigate or reduce risk, device manufacturers need to put controls in place to minimize the probability of the occurrence of harm and also limit its consequences. This sounds simple. In reality, the effectiveness of controlling risk is also a function of cost, which device manufacturers must consider in their efforts to successfully compete in the market.
 
With the 3rd edition of IEC 60601-1 now in enforcement in Europe and soon to be in the United States and Canada, there is significant momentum and progress toward improving the overall safety and effectiveness of medical devices. However, for those device manufacturers new to the standard or those that are developing devices certified to the second edition, there are significant changes in place that require dramatically more time and energy for certification.
 
In the large part, risk management now plays a major role in the overall process for ensuring medical device safety. The scope of IEC 60601-1 risk management is large; in fact, more than 10% of the requirements under this new edition pertain to risk management alone. And risk management is specifically called out in IEC 62304, which specifies the life cycle requirements for the development of medical device software. The medical device industry is relying on the guidance of a collection of industry standards, some of which are specific to medical device development and manufacturing and some that are even more specific to the type of device and its intended use.
 
 
Software is a Primary Contributor to Risk
 
There is no question that medical devices are becoming more complex. The industry and regulatory authorities are driving the requirements for devices to provide more connectivity and mobility, operate at lower power, and ensure increased safety and security. All these pressures, functional requirements, regulatory requirements, and time-to-market windows are forcing device manufacturers to find new ways of developing safe and effective systems faster and at lower cost. Software gives device manufacturers flexibility in adapting to new functional requirements and new hardware platforms. At the same time, however, more complexity in software applications increases risk. As a result, cost-effective development, verification, and risk management of software is essential. Ultimately, device manufacturers that are deploying best practices look to more efficient processes and automation to help mitigate risk and reduce costs.
 
Standards for Managing Software Risk
 
For the medical device industry, there are numerous standards now in play that guide the product development cycle. Of course, IEC 60601-1 serves as the primary standard to achieve medical device safety and basic performance. Related to and working in conjunction with this standard, the internationally recognized IEC 62304 standard prescribes the software development processes, activities, and tasks for effective medical device software development. IEC 62304 specifically calls out that the manufacturer shall apply a risk management process complying with ISO 14971. Both IEC 60601-1 and IEC 62304 specify the use of ISO 14971. Under IEC 62304, the manufacturer must specify a safety classification to each software system according to the possible effects on the patient, operator, or others resulting from a hazard to which the software system can contribute.
 
At the next level of detail, ISO 14971 specifies a process to:
 
  • Identify hazards associated with the device
  • Estimate and evaluate the risks associated with these hazards
  • Control these risks
  • Monitor the effectiveness of those controls
  • Risk Management requires bidirectional traceability throughout the software development life cycle.

 
 
Requirements Engineering
 
Requirments engineering is one of the fundamental areas for process improvement and automation . Today, there are products available that not only help elicit high- and low-level requirements but trace those requirements throughout the software development life cycle down into the design, code, and verification procedures and artifacts. With respect to IEC 60601-1 and IEC 62304, requirements engineering offers a clear opportunity to identify and document hazards and trace those hazards back to requirements and into the software development and verification process and the resulting artifacts. Similarly, risk control measures can be easily traced into the software design, implementation, and verification process. Requirements engineering, when linked to other activities in the software lifecycle, can reduce risk and save money by automating the process of determining the effects of changes to requirements, code, test cases, and procedures.
 
Static Analysis
 
Static analysis, although not a panacea, is widely recognized by device manufacturers and the regulatory authorities as a useful tool for identifying and solving a particular class of software problems. Static analysis checks the syntactic quality of high-level source code and can be used to predict run-time or dynamic behavior without having to execute code. For medical device software developers, static analysis can automate the code-review process by automating the analysis of source code and highlighting potential flaws. This enables inspection early and often, which can save tremendous time, energy, and money associated with the equivalent manual process. In addition, static analysis can be used to ensure that the development team adheres to either a specific industry standard such as MISRA-C:2004 or a corporate standard by quickly analyzing the code for discrepancies between the standard and the code as written. This improves consistency, reusability, and code quality.
 
However, not all static analysis tools are alike. Many differ in their level of depth of analysis. Some of the lighter-weight tools are capable of quickly skimming large code bases for the “easy to find” problems, whereas others are more rigorous and perform in-depth analysis for more difficult boundary conditions. The recommendation here is to be careful of tool vendors who claim to use common commercial parsing technology. This likely causes the vendor to lose development control and constrains product advancement. If the parser is not sufficient, what choice do they have to move their overall technology forward to address developers’ specific need?
 
Dynamic Analysis
 
Dynamic analysis uses compilation and execution to perform analysis on the executable code, either on the host platform in a simulated environment or down on the target platform when it is available. Dynamic analysis enables execution traces to be captured and presented back at the source code levels as well as at higher levels of abstraction, such as control and dataflow graphics where it is easy to understand the behavior of the application at a higher level. When combined with static analysis, dynamic analysis can be used for unit, integration, and system-level testing with execution tracing. Test harnesses, procedure/function stubs, and regression suites can be automatically generated and executed. Combined with the trace history, it is very easy to understand the effectiveness of the generated test cases. With strong static and dynamic analysis, it is possible to analyze the code and automatically generate and execute a high-quality test environment that produces comprehensive code coverage analysis. This ultimately reduces risk associated with the use of the medical device itself.
 
Assurance Case Development
 
To gain regulatory approval, medical device manufacturers must document their quality process and the resulting development and verification artifacts to help support the argument that their device is safe and effective. This is particularly true in those areas under scrutiny, such as the infusion pump industry. Regulatory authorities such as FDA are encouraging manufacturers to develop and produce an assurance case – or, more specifically, a safety case – which presents a defensible argument that a device is acceptably safe to use in a particular context. The safety case presents the argument, any assumptions, and the development and verification artifacts as evidence to support and defend the argument. Integrated requirements engineering and static and dynamic analysis capability – combined with automatic and traceable documentation – supports safety case development. It also mitigates risk with the ability to clearly state the objectives of the safety case, document the evidence where the objectives have been met, support the argument linking the evidence to the objectives, and document any assumptions, justifications, and the context. Furthermore, this integrated solution, as part of the argument for the safety case, enables the documentation of the identified hazards and the tracing of those hazards into the engineering control measures to show how the risks have been mitigated.
 
Managing and mitigating risk in medical device software development is no question a complex problem, and new requirements in the 3rd edition of IEC 60601-1 make this more important than ever. With solid, well-defined processes and the latest in requirements engineering and static and dynamic analysis solutions, medical device manufacturers can expedite their approval process as well as reduce their overall development and verification costs through automation and high-quality processes.
 
 
 
Jim McElroy is vice president of marketing at LDRA Technology andis focused on expanding LDRA business in the embedded software verification market by improving developer productivity and software quality in critical application development. Before joining LDRA, McElroy held executive-level marketing and business development positions with Green Hills Software, Telelogic North America, and I-Logix as well as holding industry-level software development positions at Lockheed Martin and Raytheon. McElroy has a MS in computer science from Fitchburg State College and a BS in computer science from the University of Massachusetts.

Google Glass Makes Its Orthopedics Debut

Google Glass makes its splash in orthopedics.
A surgeon uses Google Glass to send live video of a knee surgery. Image from Ohio State University.

Are Google Glass and head-mounted displays in general overhyped? The answer depends on who you ask. Interest in Google Glass from the medical field, however, is certainly high. Surgeons in particular see the technology as a game changer for the operating room. Surgeon advocates see the technology as having the potential to give them the ability to have Terminator-like vision, helping to analyze surgical objects and overlay medical scans over the patients' anatomy, giving them near x-ray vision. Glass can also help with quality control by giving surgeons access to relevant clinical information and enabling them to scroll through checklists without using their hands.  

Google Glass recently was used by orthopedic surgeon Christopher Kaeding to take and relay live video of a surgery to a colleague and a group of remote medical students. Kaeding said that, during use, Glass fades into the background; Kaeding forgot he was wearing it several times during surgery, he acknowledged. 

"It's hands-free and voice-activated, so I can keep my hands sterile as a surgeon," Kaeding was quoted as saying

Kaeding likes the idea of using Google Glass to look through CT or MRI scans during the surgery--all without having to leave the operating table. It could also be used to keep an eye on vital signs, he says.   

App developers are already developing medical software for Google Glass. Shown here is an app designed to help facilitate CPR and the location of a nearby external defibrillator. 

For more on Google Glass:

Should You Consider a Career in Regulatory Affairs?

Should You Consider a Career in Regulatory Affairs?

As director of the regulatory affairs program at The George Washington University, Daniela Drago oversees the university's certificate and master's degree programs in regulatory affairs. She has held managerial positions in global regulatory affairs for small and medium-sized companies as well as at multinational life science companies. Here, she offers advice for those considering a career in regulatory affairs.

Will I find regulatory affairs/science interesting?

Interested in regulatory affairs? Register for the Quality Control, Risk Management, and Regulations conference track at MD&M Chicago, September 10–12, 2013.

The work of a regulatory professional is diversified and dynamic. The profession offers a unique perspective of various aspects of the development and commercialization of healthcare products (i.e., medicines, medical devices, cosmetics, and nutritionals). For example, in a typical week a regulatory professional working in industry might interact with colleagues from sales, marketing, research and development, and production. The regulatory professional will sit on a crossfunctional team that reviews carcinogenicity results, clinical protocols, manufacturing batch records, and promotional material. The team’s activities will make an impact on patients, public health, and the company’s bottom line.


Will I get a job?

Companies, governmental agencies, clinics, hospitals, and universities seek candidates who understand the regulatory world. Jobs in regulatory affairs/science are available in the United States and internationally. Generally there are more vacancies than qualified applicants. Highly sought-after candidates are team players. They can combine strategic thinking with effective negotiation and communication skills. Talented regulatory professionals don’t stay long on the job market.


Will I see a growth in demand?

The healthcare industry is expected to grow, especially in emerging markets. This will result in an increased demand for skilled regulatory professionals. Currently harmonization efforts are underway to streamline regulatory requirements and processes (e.g., ICH and IMDRF). However, there is still a high variation across national borders and between segments of the industry. Therefore the need for well-trained regulatory professionals is likely to increase. This will occur not only in the United States and western Europe, but in Latin America, Asia, and other “pharmerging” markets. Undoubtedly, those with a broad knowledge of global regulations who can work effectively in an international environment will have a competitive advantage.


What challenges can I expect?

Keeping your knowledge up-to-date, especially in such a broad and diverse function, can be challenging. Professionals in this field must closely follow changes in regulations and effectively interpret and communicate their implications. They must also establish and maintain collaborative relationships with regulatory bodies in order to be able to provide safe and effective quality products to consumers and patients.


How do I transition into a regulatory role?


Traditionally, regulatory affairs has been a field in which individuals would enter from related areas and get on-the-job training. In the past few years, however, academic and certification programs in regulatory affairs have flourished. State-of-the-art online programs, designed to meet the needs of busy professionals, can be a useful way for individuals to enter or advance in the field. People considering higher education should seek out a program that has a good reputation. The program also must have an academically rigorous curriculum that meets the constantly changing needs of a dynamic profession.

Daniela Drago is an assistant professor of clinical research and leadership at the School of Medicine and Health Sciences at The George Washington University.

[image courtesy of DAVID CASTILLO/FREEDIGITALPHOTOS.NET] 

How to Land a Job in Medtech

How to Land a Job in Medtech

Bob Jeffers founded Allen-Jeffers Associates, a medical device and pharmaceutical industry recruitment company in Irvine, CA, in 1978, after working his way up the ladder to become a technical superintendent of manufacturing for American Hospital Supply Corp. in Glendale, CA, and serving as a plant manager at C.R. Bard. He’s helped companies including Edwards (before it was Edwards Lifesciences), GE, and Philips, as well as numerous start-ups, find medtech employees to suit their needs.

Looking for a job in medtech? Attend the MEDevice San Diego conference September 26–27, 2013, for valuable networking opportunities.

Jeffers recently spoke with with MD+DI about which medtech jobs are in demand, which areas of the country offer the most opportunity for job seekers, start-ups vs. established firms, and which positions are paying well.

MD+DI: Are there any general qualities that a good medtech candidate should have?

Jeffers: If I were to pull down one, aside from the obvious technical competence in their field, I would say just communications skills. You’ve got to be able to write reports; you’ve got to be able to give reports. You have to be able to make a presentation, particularly in medtech because FDA requires that you communicate well. You’ve got SOPs, you’ve got all the documentation, you’ve got the standards that have to be met that FDA has promulgated. And there are those that the individual manufacturers have that are probably even more stringent than FDA’s.

When you’re talking about some of the technical product here, you definitely have to have communication skills. That goes all the way down to even the individual that’s sitting on the line assembling these things. They’ve got to understand how to put these things together or whatever it is that they’re doing.

MD+DI: Does social media help or a hinder a medtech job search?

Jeffers: Social media is a good thing, but it shouldn’t be overestimated as to what it can do for an individual—or a company for that matter. In the olden days, you used to have newspapers, and I subscribed to a whole lot of them. You’d look in the business section, the Wall Street Journal, you’d see all these classified ads, you’d say, “Hey, I know somebody over there, I should call that person and see if I can get the job.” You can do that now. You can put a Web site together, and you get people calling you. That’s never really changed; it’s just that you have more avenues now.

MD+DI: Can you walk us through how you work with applicants to match them with a medtech employer?

Jeffers: It starts long before we have a job description. Because you have to get to know the client—and by the client I mean not just who they are and what they make, but what kind of personality the company itself has, and what kind the department has, and what they’re looking for [with] the soft skills. And then you work back from there. You look for the individuals who have the technical capability, and then you start asking the questions [to see] if they have the personality that would match. That’s really what it comes down to.

MD+DI: Other than working with a recruiter, what advice can you offer to medtech candidates looking for a suitable position, even to start?

Jeffers: That hasn’t changed in 40 years, probably even longer than that. Network with your people. People you know, who you deal with. [Work] your contacts, whether they’re coworkers or people in school if you’re getting an MBA. Definitely get to know people, and don’t lose that contact, because they are invaluable. That’s how we work, frankly. We network all the time.

John Conroy is a frequent contributor to MD+DI. Reach him at johnconroy@roadrunner.com.

[image courtesy of STOCKIMAGES/FREEDIGITALPHOTOS.NET]
 

Want to Get Paid Well? Get One of These Medtech Jobs

Want to Get Paid Well? Get One of These Medtech Jobs

Bob Jeffers founded Allen-Jeffers Associates, a medical device and pharmaceutical industry recruitment company in Irvine, CA, in 1978, after working his way up the ladder to become a technical superintendent of manufacturing for American Hospital Supply Corp. in Glendale, CA, and serving as a plant manager at C.R. Bard. He’s helped companies including Edwards (before it was Edwards Lifesciences), GE, and Philips, as well as numerous start-ups, find medtech employees to suit their needs.

Looking for a job in medtech? Attend the MEDevice San Diego conference September 26–27, 2013, for valuable networking opportunities.

Jeffers recently spoke with with MD+DI about which medtech jobs are in demand, which areas of the country offer the most opportunity for job seekers, start-ups vs. established firms, and how to land a job in the industry.

MD+DI: Which positions in medtech are paying well?

Jeffers: Regulatory affairs professionals are in need. Naturally, your marketing people. Some of the top sales people. Engineering across the board is doing pretty good. Even some of your sales reps are making some pretty good money, although that is being challenged now, too. With all of the mergers and acquisitions, among the first things to go were duplicate efforts in sales, marketing, and the financial side. They’ve become expendable just like the manufacturing people.

MD+DI: Which positions do not pay as well?

Jeffers: Probably operations [jobs] are not paying as well. Getting solid people who have the experience that the companies are looking for is always a difficult challenge.

MD+DI: What are the salary ranges you’re seeing?

Jeffers: We typically don’t deal with anything less than $75,000. I haven’t done anything less than $100,000 for I don’t know how long. These are typically engineering positions and individual contributor positions. I don’t remember the last time we placed an individual at less than $100,000, to be honest with you.

MD+DI: And that’s for every region in the United States?

Jeffers: Yes. The old days, when you used to have a significantly higher salary here in California, don’t seem to hold up much anymore. The salaries that I’ve seen in Boston and the East Coast are pretty consistent with what you see out here, level for level.

John Conroy is a frequent contributor to MD+DI. Reach him at johnconroy@roadrunner.com.

[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET] 

Oasys Occipito-Cervico-Thoracic System by Stryker Faces Class I Recall

Stryker initiated a recall of its Oasys Occipito-Cervico-Thoracic System. FDA regulators assigned the recall Class I status, indicating a serious risk of patient injury or death.

The Oasys Occipito-Cervico-Thoracic System is designed to stabilize the junction between a patient's vertebrae and occipital bone. Both of these anatomical features are found in the cervical spine. The company received reports that the pin that links the plate body and the tulip head can fracture under some conditions. This can lead to nerve injury or blood loss. In some cases, revision surgery may be needed to correct the fracture.

The company first initiated a recall of the device in May of this year. At that time, Stryker warned customers to stop using impacted lots. The company requested that all impacted lots be shipped back to the company for replacement. Two months ago, the company sent out another notice warning surgeons to conduct post-op evaluations for patients who received the implants.

In its latest notice, the company provided further detail on the recall timeline. However, Stryker has not yet stated the total number of impacted devices. The company has also declined to share the impact of the recall on its bottom line.

Stryker has a colorful history of recall costs associated with implants. Last year, the company recalled its ABG II and Rejuvenate hip implants. In total, the company paid out $400 million revision surgeries and lawsuits for the devices. This is $10 million more than the company predicted in January. That being said, the company has managed profit gains for the last three quarters.

Medtech Start-Ups vs. Established Firms: Which Offers the Most Opportunity for Employees?

Medtech Start-Ups vs. Established Firms: Which Offers the Most Opportunity for Employees?

Here's a hypothetical question: A medtech job seeker finds himself or herself with two job offers—one with an established company and another with a start-up. Which should he or she take?

Looking for a job in medtech? Attend the MEDevice San Diego conference September 26–27, 2013, for valuable networking opportunities.

MD+DI posed this question to medtech recruiter Bob Jeffers, founder and president of Allen-Jeffers Associates, an Irvine, CA-based recuriting firm specializing in medtech. He says the difference between start-ups and established firms isn't as great as it was in the past.

Employees used to choose to work for established medtech firms because they thought they offered greater job stability, Jeffers says. But job stability isn't a given no matter what company you work for these days.

"With the mergers and acquisitions, we’ve all seen some of the large companies acquired and moved out of that area, so that stability is pretty much gone," Jeffers says. "All you have to do is take a look at Hudson RCI or at the old American Hospital Supply Corp., which was gobbled up by a smaller company, Baxter. All of those companies have been folded up, have disappeared, or been sold. In the case of McGaw Laboratories, it was sold about six or seven times. I lost count after six. That kind of stability isn’t there anymore."

Employees who work for start-ups are often required to wear more than one hat and keep a close eye on costs. But in today's business environment, established medtech firms are also demanding the same.

"The upside of a start-up company is typically you do receive stock," Jeffers says. "Depending on the level you’re at, you could become a millionaire. That’s something that you’re probably not going to get if you’re with a large company."

Still, he says, not every start-up will end up making its employees rich. 

In the end, Jeffers says in today's climate, no medtech jobs are entirely safe.

"They’re all having layoffs," he says. "You can pick up the newspaper and trade magazines and see that. They all have had or will have layoffs for whatever reason. Part of it is the economy, and part of it is Obamacare and the tax. They can blame it on anything and everything they want. The bottom line is there are mergers and acquisitions, and the trend is consolidation."

Note: This article was based on an interview with Bob Jeffers conducted for MD+DI by John Conroy.

Jamie Hartford, managing editor, MD+DI
jamie.hartford@ubm.com

[image courtesy of JSCREATIONZS/FREEDIGITALPHOTOS.NET]