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Medical Device Companies are Looking for Professionals with Improved "Soft" Skills

Home / Master of Science in Health Sciences in Regulatory Affairs / Resource / Medical Device Companies are Looking for Professionals with Improved "Soft" Skills

This article is republished from the original at http://www.mpo-mag.com/contents/view_online-exclusives/2015-10-20/build-employee-loyalty-with-training-and-education/

After spending 47 years in the medical device industry, Bob Yocher has seen it all. If you ask him to name one particular issue that still irks him after all this time, it would be dealing with inadequate writing and communication skills. This requires too much editing and rewriting, and has the potential to cause significant problems for companies.

"It's amazing to me that many people in industry cannot write effectively," said Yocher, senior vice president of regulatory affairs for Framingham, Mass.-based medical device firm Heartware. “They can't put a cogent thought together."

Soft skills—active listening, critical thinking, effective writing and influential speaking—are of extreme importance to Yocher. After all, it can take only one slipup to tarnish a manufacturer's hard-earned reputation or negatively affect its bottom line.

“To advance in our company, scientific skills are not enough. To be truly successful, you must have good soft skills. This requirement isn't just in my company. It prevails industry-wide. Everything we do in our regulated business is dependent on documentation," the longtime regulatory professional pointed out.

An industry survey conducted by David Locke and Frances Richmond, Ph.D., from the University of Southern California School of Pharmacy found that companies value a prospective employee’s soft skills more than ever before. A whopping 77 percent (117 of the 152 respondents) said they're looking for regulatory and quality candidates with good writing skills. In addition, 68 percent said they need employees who can speak well.

Universities Incorporate Soft Skills

Academic programs in regulatory and quality are available that provide opportunities for students to develop soft skills in addition to learning the traditional curriculum.

For example, communication is one of the key competencies of the master's degree program in regulatory affairs at George Washington University (GW)—"and I know a number of other universities have also placed a similar emphasis on soft skills," said Daniela Drago, Ph.D., assistant professor and director of the regulatory affairs program at GW.

“The feedback we receive from our graduates is that the knowledge and skills they acquired in the program enabled them to advance in their careers," Drago said. "We have had almost no evidence of unemployment. My colleagues at other universities have seen similar results.”

A Compliance-Alliance survey of 332 device industry professionals revealed that 60 percent of respondents indicated that their firms would help pay for a bachelor's degree, while 65 percent said their company would pay for a master's degree. In addition, 40 percent indicated that their firm would provide funds to help an employee earn a doctorate.

"Most regulatory programs educate people who are already working in industry whose companies are willing to help with tuition reimbursement. However, I'm aware that some companies are reluctant to invest in their employees' education," Drago said. "Some firms might argue, 'What happens if we invest in developing employees and then they leave us?' Well, I think a good counterpoint to that argument is, 'What happens if you don't invest and then they stay?' Employers that are recognized globally as the best places to work put strong emphasis on employee development and education. They also encourage their employees to enroll in graduate education programs, and provide financial support and time off, when needed."

Organizations Bring In-House Training

To improve his employees’ writing skills, HeartWare's Yocher decided trian his entire staff. He teamed up with Compliance-Alliance President Nancy Singer, a former U.S. Department of Justice prosecutor and defense lawyer, to create and present a unique educational course titled "Clear and Effective Writing."

"We really needed to train people on this technical type of writing. It was impractical for senior officials like the general counsel and me to review all of our documentation, and be the editors too," he said.

To create "Clear and Effective Writing," Singer and Yocher customized an already-offered Compliance-Alliance training course called "Writing Under Pressure: Making It Easy."

During this class, Singer and Yocher taught Heartware employees how to write documents that would answer a reader's questions before they were asked, organize documents in less than a minute, and employ the appropriate tone when writing to managers, colleagues, and subordinates.

Yocher noted that he has already seen employees using some of the writing tools that were taught during the course.

At the Stryker Instruments division of Kalamazoo, Mich.-based Stryker Corp., Nicole Petty, the company’s director of learning and development, makes sure that employees have the training and skills they need to grow—an investment that helps ensure that only high-quality devices are sent to market.

A few years ago Stryker Instruments conducted learning-needs assessments for its employees and found that many of them struggled with communication skills.

"We discovered that they needed to be more effective when they communicated with decision-makers and more persuasive to influence others to gain buy-in," Petty said.

That's when the manufacturer looked to Compliance-Alliance's Singer for help. Singer taught two communication-related courses to Stryker employees: "Talking to Decision-Makers: What to Say and How to Say it" and "Overcoming Communication Barriers."

Petty was impressed with a technique Singer taught in which an employee could describe a particular issue or problem within half a minute.

"That concept has been extremely useful and helps our staff outline their thoughts before a presentation so they can be concise and focused when they speak in a meeting, to a senior leader, or during a presentation," Petty said.

"I've received feedback from participants who say, 'I've already started to use the method to prepare for presentations and meetings. Now before I talk to my manager, I organize my thoughts and am able to effectively convey the necessary information in a succinct and professional manner," she said.

While it's important for employees in device firms to ensure that they communicate properly, this skill is essential for U.S. Food and Drug Administration (FDA) officials.

Several years ago, Virginia Connelly, a former director of investigations in FDA's Cincinnati, Ohio, district office, arranged for Singer to teach writing skills to agency investigators. Connelly wanted to make sure that documents—such as FDA-483 inspection observation forms and Establishment Inspection Reports—were clear and could not be misinterpreted.

In a high-energy, interactive session, Singer used case studies to remind investigators that they should write as indicated in FDA's Investigations Operations Manual, and to write in first-person while using an active voice.

Cincinnati isn't the only district office to use Compliance-Alliance courses. In fact, Singer has taught classes to the investigators and compliance officers in ten FDA district offices, as well as many other agency employees in FDA Staff Colleges.

An attractive salary, generous benefits, and time off are strong motivators for people to stay with a particular company. But those incentives can take an employer-employee relationship only so far.

That's why continuing education is essential. "Employees want a company that wants to help them grow and support their progress. I view a company as a family, and employees want a company that is interested in career development so they can give back to the company what they've learned," Compliance-Alliance's Singer said.

While it's common to hear “people are our most important asset,” organizations that believe this must act accordingly. "They want to retain the best talent. Employees want to improve their skills so they can be more productive. An obvious answer is to support education and training," Singer said.

"People are one of the most critical—if not the most critical—assets a company has. And it's because of people that a company will achieve its goals, whether it's maintaining compliance, increasing revenue, or improving products and services," Stryker Instruments’ Petty said. "If you're investing in your people, they're going to be more confident, more productive, and more effective in what they're doing."

A pervasive commitment to education and training signals to employees that the organization backs them and means it.

The Bottom Line?

Organizations need a wakeup call. They want to get and keep the best talent, yet the professionals they hire want to improve their set of knowledge and skills so they can be more productive. In the future, organizations that support education and training will prosper, while those that don’t might not be around to explain why.

Mitzi Perdue writes for the Academy of Women’s Health, and Genetic Engineering & Biotechnology News. She is a member of the advisory board for the master's program in regulatory affairs at the School of Medicine and Health Sciences at George Washington University and serves on the board of the Institute of International Education. She holds degrees from Harvard University and George Washington University.

See more at: http://www.mpo-mag.com/contents/view_online-exclusives/2015-10-20/build-employee-loyalty-with-training-and-education/#sthash.w9E3qkfR.dpuf