January is often a time when we make predictions for the upcoming year. Predictions are fun, if for no other reason than you can speak fairly freely because it’s the rare case when someone goes back after the fact to see if you were right.

Richard Nass

December 28, 2010

5 Min Read
Experts Tell You What to  Expect in 2011

In that vein, I’ve asked some of our advisory board members and a few other trusted folks to provide me with a few predictions. As you might expect, some contributors went a little further out on the limb than others. Maybe next December we can go back and see how accurate our “experts” really were.

From Tim Mohn, a principal at Sparta Systems and a former manager for worldwide quality systems at Ortho-Clinical Diagnostics (a Johnson & Johnson company):

As device companies strive for greater operational efficiencies, they’ll look to the pharma sector for lessons-learned in centralizing regulated companies—especially in processes and technology. And look for more automation in the regulatory affairs space as companies demand efficiencies for things like product registration tracking.

From Jim Fitzgerald, executive vice president at Vesta:

FDA scrutiny of supplier controls will continue to have a direct impact on business relationships, with significantly more time being spent on control plan documentation, process validations, and expectations for higher process capability. Hence, staffing levels will increase to support increasing frequency in customers’ supplier audit programs.

Anticipate double-digit revenue growth driven by strong single-digit growth on existing products.

Investments in dedicated manufacturing operations will significantly increase to support the rapid advancements associated with material property enhancements to deliver therapeutic and antimicrobial benefits.

Expect an increasing amount of mergers/acquisitions to happen at every level of the medical device supply chain, as corporate investment spending increases due to attractive borrowing rates and improving economic trends.

From Nancy Singer, president of the Compliance-Alliance and a former special counsel for AdvaMed:

As the number of recalls for medical devices increases, the FDA will be looking more closely at firms’ design controls, and will issue more warning letters in this area. In addition, the FDA will increase the emphasis on holding specific company officials accountable. During inspections, when investigators find violations, they will ask for the names of individuals who had the responsibility for the product area, the action the individuals took or failed to take, and the length of time the firm took to correct the situation.

Medical device firms will continue to merge. Regulatory and quality officials will need to devote substantial resources to programs that help the acquired firm to accept the compliance culture of the acquiring firm.

From Marlene S. Bobka, vice-president of FOI Services Inc:

In keeping with the government-wide transparency initiative, the FDA’s Division of Freedom of Information is actively developing an automated system for submitting Freedom of Information Act (FOIA) requests, and it will go live in the first half of 2011. This system will offer the industry and consumers new tools to facilitate placing and following FOIA requests, such as immediate FDA confirmation of request receipt and the associated tracking number for later follow-up. This development will lead to smoother processing of FOIA requests.

From John T. Bentivoglio, partner at Skadden Arps and former Associate Deputy Attorney General and Special Counsel for Healthcare Fraud, U.S. Department of Justice:

Healthcare fraud/abuse enforcement actions against medical device makers will increase—beyond the record level of 2010. Prosecutors will expand their use of criminal charges against company employees and executives, including strict liability misdemeanor charges for senior managers under the so-called Park doctrine. We are also likely to see the HHS OIG be more aggressive and creative with its authority to exclude companies and individuals from federal healthcare programs (as the OIG did in forcing Synthes to divest its U.S. operating company as a condition of settling an FDCA investigation). The enforcement actions will continue to focus on off-label promotion, improper payments to physicians, and product quality and manufacturing issues.

From Jonathan Lee, vice-president regulatory, quality, and clinical, for Medtronic Surgical Technologies:

Social media will become more relevant to patient care, therapy decisions, and outcomes.

National healthcare isolation is a thing of the past.

More data will be transferred to/from devices through wireless systems, resulting in data theft of patient information, especially for celebrities or public figures.

These wireless data transfers used to upgrade device features provide a potential path for malicious software uploading.

From Denise Dion, formerly FDA medical device expert investigator and currently senior regulatory consultant for Eduquest:

The FDA’s new group of investigators will continue their training into 2011, meaning that, at times, inspections will have multiple investigators.

The FDA’s Software Forensic group will take a more proactive approach to medical-device software defects.

From Debra Csore, president of Kruse & Company:

The FDA will expand its interpretation of what activities are required to meet design controls. Hence, firms that have bare-bones software development processes will be expected to meet recognized consensus standards such as IEC 62304, Medical device software - Software life cycle processes.

The country's likely budget pressure from the federal debt will lead to attrition of reviewers and increased turnaround times for FDA approval of devices.

From Ryan Kelly, a training specialist at Stryker Medical:

In 2011, companies will be looking to better gage the efficacy of their training programs. Business leaders will dedicate a considerable amount of resources to training and will often fail to quantify the benefit. They will begin to ask how training contributes to the bottom line and how it can do so more effectively.

From Nicole Petty, a senior manager of learning and development at Stryker Instruments:

There will be an increased importance on the role learning plays in the organization. Learning is critical to keep pace with the changes to our products, skills, processes, and strategies that are dictated by the evolving marketplace and regulatory environment.

Do you have any predictions of your own that you’d like to add to the list? Or do you strongly disagree with any of our experts? Let us know.


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