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Kay Hagan Backs Legislation for Management Review Board at FDA

Sweeping new legislation drafted by Senator Kay Hagan (D-NC) in collaboration with the Biotechnology Industry Organization would establish a powerful internal management review board at FDA. The board would be charged with reporting to the HHS secretary on determining “optimal allocation of responsibilities and to improve the efficiency and effectiveness of each office, center, and division in achieving individual and overall missions” of FDA, according to a draft of the legislation.
Hagan’s bill, called “Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT),” would authorize the board to reach out to internal and external entities, including venture capital firms and patient representa-tives. Up to nine of its 22 members would be appointed from within FDA and the remainder would be chosen from outside HHS based on expertise, including at least one each from the medical device, food, drug, and biotech industries. TREAT would require the appointment of a chief innovation officer within the office of the commissioner to, among other things, identify and integrate into the review process “promising new scientific and regulatory approaches to ensure the rapid development, testing, and review of new drugs and devices,” according to the draft.
CDRH and FDA’s drugs and biologics centers would each be required to accept the placement of chief medical policy officers appointed by the HHS secretary to work with the chief innovation officer and the center directors in implement-ing the bill’s objectives.
TREAT would also establish a fixed six-year term for the FDA commissioner, but permit unlimited reappointments.
Former FDA deputy commissioner Peter Pitts writes on his blog,, that under the bill, “drugs would be eligible for ‘progressive’ or ‘exceptional’ approval if they provide meaningful advances in treating an unmet serious or life-threatening condition.” The agency, he writes, “could also approve drugs based on approval in the EU as well as in Australia, Canada, or some other countries.”

CDRH Report Includes Promises to Improve Culture

As if to preempt external examination of its internal workings, CDRH included in a report on its premarket review programs a promise that it is going to “create a culture change toward greater transparency, interaction, collaboration, and the appropriate balancing of benefits and risks.”

In the l0,000-word report released in October, the agency lists improving its culture as a top priority. It writes that it will accomplish this through “better engagement with industry; greater use of external experts; implementing flexible, risk-based policies that appropriately balance benefits and risks and apply a more patient-centric approach; establish-ing new ways of doing business that add value; and setting clear expectations for CDRH staff.”

The report gives little insight into why the center allowed its culture to reach the point in which it needs to be changed; neither does it indicate what the cost of such change will be. Obliquely, it hints that improvements can come about through the smarter use of existing resources and through unspecified additional assistance from the user fees that are currently being negotiated.

Asserting that the agency’s diverse scientific staff is “dedicated to protecting and promoting the public health,” the report says CDRH’s employees also “share(s) industry’s desire to bring safe and effective devices to market quickly.”

Given the rapid advance of technology and science, the increasing attention being paid to evidence-based medicine, and increasing patient involvement, “all members of the medical device ecosystem must refocus,” the report reads. Interestingly, the report mentions that because many devices come from “small, entrepreneurial companies that are flexible, dynamic, nimble and quick,” CDRH should “become more entrepreneurial.”

Industry is perpetually complaining about the unpredictability and inconsistency in the review process. Perhaps as an answer to those complaints, CDRH says it will work to address those issues by taking the following steps:

  • Provide adequate management oversight and staffing.
  • Enhance training.
  • Improve internal processes.
  • Adopt “smarter” policies and issue more guidance.
  • Develop new communication tools.

The report says CDRH should try to maintain a level of flexibility that will enable it to adjust and improve as needed. It also says the center should collaborate with companies to improve the quality of submissions and work to ensure it has the necessary resources to perform its functions. Each of the actions described in the document has either already been implemented or will be implemented, at least in part, within the first half of 2012.

FDA Needs to Examine Its Institutional Culture

The institutional culture at FDA has been gingerly discussed (if at all) for decades. As a major election year gets

underway, the agency and its regulated industries may be forced to confront questions about how FDA does business. “There needs to be more discussion between the regulatory agencies and the industry,” said Senator Al Franken (D-MN, as quoted by the Minneapolis Star Tribune while speaking to Medtronic employees in November. He discussed legislation that would speed the approval process for devices meant to treat rare diseases. “There is a real difference in the culture,” Franken said.

To invoke another societal analogy, the Occupy Wall Street movement, it should be remembered that FDA’s cultural problems adversely effect only about 1% of its constituent relationships; the agency operates as it should 99% of the time. Of course, the problems should still be fixed.

Few in industry seem to understand the FDA culture, which in many respects is like that of any other institution prone to dysfunction. Those in a position to make changes are blindly loyal to the organization. The inevitable consequence of that loyalty is that when problems arise, the tendency of the leadership will be to cover up those problems or deny that they exist rather than attempt to solve them. 

In FDA’s case, upper management has had a “circle the wagons” reflex for years. This has repeatedly enabled mis-guided or ill-informed elements in the lower ranks to hurt small businesses. Initial erroneous or destructive decisions are automatically endorsed and defended at each successively higher level when challenged.

Take the case of Utah Medical Products. Ill-trained and poorly supervised FDA employees tried to shut the company down before ultimately being overruled by a federal judge in 2005. Though the courts spared the firm, the decision, which agency lawyers continue to privately call “aberrational,” did not fix the broader issue of cultural dysfunction at FDA.

Or consider the case of TMJ Implants. Agency employees’ anonymous interpretations of the law subsumed legitimate scientific questions, blocking approval or clearance of the company’s key product. The company tried to fight back but was twice defeated in federal court and filed for bankruptcy in 2010. At numerous points in its five-year run, the dispute could have taken a different course, but FDA’s cultural dysfunction kept things on a steady downhill trajectory.

The agency covered up the fact that it had “lost” the company’s written request for appeal for eight months. It lied about substantively reviewing the appeal before denying it, and ambushed the firm with civil money penalties before it even received the appeal denial letter. FDA administrative law judge Daniel Davidson rubber-stamped the agency’s conduct and deceit, as did the HHS departmental appeals board upon reviewing the case. This administrative record was then rubber-stamped by the courts.

Neither company’s complaints about FDA’s culture or conduct were ever reviewed by any member of the judiciary. In both cases, the commissioner in power at the time (Lester Crawford in Utah Medical’s case and Andrew von Eschenbach in TMJ’s) personally promised fixes that never came. Both companies complained vigorously (Utah Medical even sued) but both ran out of money to fund their efforts in court. Both say they didn’t find CDRH’s ombudsman to be of much help.
The record is littered with examples of FDA’s culture negatively affecting small medical device companies. In all of these cases, evidence of the agency’s misconduct remained hidden, thanks to the agency’s efforts as well as companies’ reluctance to face the consequences seeing the fight through.

FDA‘s dysfunction affects internal relationships as well. It is rumored that employee complaints of supervisor favorit-ism, misconduct, and illegal discrimination have been ignored, enabling such destructive behavior to continue without relief.
I am aware that it is not possible for anything meaningful to happen in a courtroom (or the court of public opinion) without hard evidence that those allegations are true. But for a variety of reasons—chiefly the fear of consequences among the aggrieved—such evidence is hard to come by.

Enter the media, which can shine the public spotlight on the kinds of murky details that do not meet the standards of the courtroom. Journalists have yet to do this on a broad level when it comes to the problems companies report having with FDA, but they must do so for things to change. Institutions tend not to be automatically self-cleansing; they need to be prodded, in public. As long as the culture at FDA remains undisturbed, so too will the news media’s attention—newly hamstrung by HHS access restrictions—be integral to any remedy.

The access restrictions, which have been slowly infiltrating communications between the media and FDA on an infor-mal basis since 1997, were formally put into place in October with the issuance of HHS-wide guidelines. These guidelines restrict all media communications to each HHS agency’s press office, obviously hampering the confidential information gathering that penetration of management cover-ups would require.

FDA’s “transparency initiative” has fallen far short of President Obama’s promises to produce “the most open government in history.” If anything, the agency has become more secretive, interpreting “transparency” as improved Web access to the materials it elects to make public, doubtless with some prodding from user fee–paying industry.
As is true elsewhere, institutional culture awaits change; it does not seek it out. In FDA’s case, change is something that is likely to be fought tooth and nail.

Ultrafast Laser Research Could Lead to New Diagnostic Applications

Researchers at Purdue University are exploring the use of ultrafast laser pulses that could be used for new applications in biosensors, diagnostics, and manufacturing. The technology could be used to create novel features and surface textures in a variety of materials including metals and ceramics. The technology could also be used to evaporate cutaneous lesions with minimal peripheral damage. 

“A lot of times, what happens in biological research is that researchers use plasma coming out of a target to do analysis,” explained Yung Shin, PhD, a professor of mechanical engineering and director of Purdue University's Center for Laser-Based Manufacturing. “This technique that we have developed can be used potentially to amplify the plasma field and to get a much stronger signal. And, that way, you can do more accurate analysis.” Shin added that that the technique also could be used to “get a much better time resolution” than what other researchers have been able to get. “And you can actually get detailed motion analysis of, say, electrons and ions, and a much finer time resolution.” Shin said that the technology could be potentially used for a variety of applications in life sciences.

Plasma research
Doctoral student Wenqian Hu works on a complex optical setup that is part of research intended to reveal new information on the behavior of ultrafast laser pulses. (Yung Shin, Purdue University School of Mechanical Engineering)

The lasers used in the research pulse at durations of 100 femtoseconds of a second, leading electrons to temporarily reach temperatures exceeding 60,000°C. When imaged with a high-speed camera, the pulses are found to cause tiny mushroom clouds similar to those caused by nuclear explosion. The high-speed images are helpful in understanding how plasma expands when a material is exposed to ultrafast laser pulses. One of the findings of the research is that a cloud forms immediately before the mushroom cloud, which interferes with the laser pulses. Discovering how to eliminate this interference could enable the technology to be used for a variety of industrial applications including materials and chemical processing and machining. In addition, the technology could be potentially used to monitor chemical and atomic reactions at an unprecedented scale. To learn more about the early plasma changes, the scientists tracked the movement of millions of individual atoms in the plasma. 

The research was detailed in a paper published online on December 6 in Applied Physics Letters and in September in the journal Physics of Plasmas. "We found the formation of early plasma has very significant bearing on the use of ultrashort pulse lasers because it partially blocks the laser beam," Shin said in a press release. "The early plasma changes the optical properties of air, but the mechanism is still largely unknown."

The Shin’s team has been working on this research for approximately four of five years.

These high-speed images shows how plasma expands when a material is exposed to ultrafast laser pulses. (Yung Shin, Purdue University School of Mechanical Engineering) 

Think Product Design Consequences Through to Conclusion

By Joe Pustka
Staying one step ahead of the market by coming out with new design iterations consumers want proves to be a winning strategy for most.
Change the color to one that market research shows has more appeal? Why not!
Use a newer composite material that will significantly lower the device weight? Why not!
However, based on my experience developing leak detection systems for medical devices, considerable fat can be trimmed from new product development if more upfront consideration of every detail of full-scale production is made even at the earliest stages of prototype development. This could be that added lean manufacturing boost that so many seek in these economic times.

"Considerable fat can be trimmed from new product development..."

When product design considerations of newer models have had a large aesthetic component as a driver, there sometimes seems to be a lack of forethought that impacts testing. Whenever there is a change in the materials the device is made of or even the color of the device you have to think through modifications in the manufacturing process in far greater detail. 
Even the slightest change of shade of a device will have an impact on how it dissipates heat. That means that a leak detector will not “see” a device of one color the way it sees another. Usually, this means knowing that you are going to need to change settings in the leak detection equipment to account for that color’s intrinsic characteristics for heat absorption, reflection, or dissipation. Creating a new signature for the new color device is readily doable, but those designing assembly lines need to know that these alterations will need to be done if more than one color device is being manufactured on one line.
Does the new material being used for the device have different flexibility and stretch? Even mild modifications in those characteristics may require entirely new test fixture designs.
Best practices for prototype development mean calling in medical device test experts like Uson at the earliest stages of device development for no-cost consultations---even if it is considered a minor design change such as altering the hue a shade or two. Lower production costs, faster time to market, faster production lines---it’s a win, win, win. 
Putska (pictured on the left) is a medical device leak testing technical support manager for Uson, which first developed high accuracy leak testing methods for NASA, and since 1963 has specialized in leak detection, leak testing, and non-destructive testing for the medical device and medical packaging industries, among others. Putska works with medical device companies throughout North and Central America and has worked with Uson in various technical capacities since 1980.


FDA, ABIA to Collaborate on Medical Device Polymer Development

In what is being billed as FDA's first polymer collaboration, the federal agency and the Austen BioInnovation Institute in Akron (ABIA; Akron, OH) have begun working together to support and develop regulatory science for the safe and effective use of biomaterials in medical devices. According to a memorandum of understanding, FDA will draw upon ABIA's resources--including a library of test methods for crystalline polymers and advanced methods of nanoparticle-based surface defect detection--to develop combinatorial and high-throughput methods to support FDA's safety review of biomaterials used in medical device applications. Consisting of Akron Children's Hospital, Akron General Health System, Northeast Ohio Medical University, Summa Health System, the University of Akron, and The John S. and James L. Knight Foundation, ABIA is a collaborative venture focused on innovation and commercialization of biomaterials and medicine.

The FDA and ABIA established the partnership to develop the necessary research protocols and techniques for standardizing ways to evaluate existing or new materials, hybrids, composites, and polymer-centric devices. These materials are anticipated to increase in the regulatory pipeline in the next few years. As part of the collaboration, ABIA will convene a steering committee to guide a process for scientific and intellectual collaborations, outreach, and educational initiatives. This steering committee will also create a path for joint education and research meetings and support research collaborations in applied biomaterials, promoting ways to share unique facilities and equipment specific to the review of biomaterials.

"The FDA can better fulfill its commitment to protect and promote public health if it draws upon the intellectual resources, laboratory capacity and research capabilities that reside in academic centers such as ABIA," remarks Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health. "Our partnership with ABIA will advance regulatory science by augmenting our capacity to examine and better understand engineered tissues, polymers, and coatings and to detect nanoparticle surface defects."

"Given the rapid advances in the technology and development of biomaterials, we anticipate that ABIA will be able to bring sophisticated technologies to the FDA, enhancing the agency's knowledge and expertise in regulatory science as it applies to characterizing and predicting the performance of novel materials in biomedical devices," notes Frank L. Douglas, ABIA's president and CEO.  

The two groups say that they expect to enhance the knowledge of materials development and behaviors, while increasing the capabilities that will aid regulatory agencies that classify, evaluate, and monitor the safety and performance of new and existing products. The partnership is expected to generate polymer libraries in physical/structural properties; develop methods for characterizing and predicting solubility and degradation of polymers; and characterize the presence of bioactive bindings. The partnership will also investigate the short- and long-term durability of flexible implantable devices to determine how coatings impact medical device performance.


Negotiate for Value: Reengineer Your Purchasing

Negotiate for Value: Reengineer Your Purchasing

Considering the current challenging economy, getting the best deal in business transactions has become increasingly difficult. Professionals involved in design, manufacturing, or quality at medical device OEMs face mounting pressure to reap the best value for dollars spent on equipment or product development.

Whether the negotiations involve infusion pumps, rotary valves, or other products and systems, it is crucial not to focus only on dollars and cents. Value is more important than ever, even as the economy begins to recover, and should always be a priority.

Today’s economic climate demands that OEMs carefully value products and services. Consider all the suppliers that have been forced to cut prices and are struggling to deal with eroding margins. If the economy continues improving, those suppliers will be looking to raise prices. OEMs will need to know how to respond, so they can accurately value suppliers’ products and get what they need in the most cost-efficient way.

Negotiations must go beyond simple persuasion tactics, which can take up valuable time without giving either side the desired results. For example, while an OEM may be able to persuade a supplier to agree to a short-term price de-crease on a new manufacturing system, the OEM may lose out on additional service. A seller, on the other hand, may feel satisfied after persuading an OEM to pay 10% more for a system, but may lose out with only a short-term commitment.
In effective negotiations, both sides need to consider variables that are sometimes hard to value or aren’t typically seen as sources of leverage, such as product wear, performance, and service contracts. These are all part of the total value chain.

Considering the Total Cost of Ownership

When approaching negotiations with the total cost of ownership in mind, OEMs should consider the hard and soft costs of a purchase. Hard costs are tangible and easily accounted for. For example, the hard costs of thermally bonded tubing would include the purchase price, installation, maintenance contracts, and spare parts. Soft costs, on the other hand, are related to training, support, downtime, and other variables. Because they aren’t incurred at ac-quisition time, soft costs are often overlooked by buyers when developing budgets and underleveraged by suppliers when trading against hard-dollar variables. The failure to account for such costs can result in projects being delivered late, over budget, or with serious quality issues.

"When approaching negotiations with the total cost of ownership in mind, OEMs should consider the hard and soft costs of a purchase."

To analyze the total cost of ownership, buyers should interview the internal users (the project engineering staff devel-oping a new product for the market) and weigh the importance of all soft costs. The findings should reveal the users’ priorities, which could include high levels of performance, the availability of an extended service contract, or ready access to replacement parts. This will also enable the buyer to compare the competitive advantages of different suppliers. Answering these questions can increase an OEM’s power and leverage and should help lead to the correct purchasing decisions.

When to Involve the Procurement Department

The increasing complexity of negotiation strategies and the growing attention being paid to them underscores the im-portance of getting the procurement or purchasing departments involved early in the process. These departments serve a more vital function than ever, helping the buyer maximize value.

Procurement personnel should always be viewed as a resource rather than an impediment. OEMs shouldn’t make the mistake of viewing them as workers who simply issue purchase orders. Whether they are brought into the process ear-ly or late, they will put pressure on the supplier to extract savings, even if the deal is all but done. If procurement per-sonnel are brought in too late—if, for example, nearly all variables have already been decided—the demands of the procurement department may compel one or both sides to engage in persuasion or haggling—which can lead to a dead end.
As soon as the scope of work or specifications is discussed between the OEM and the supplier, the procurement de-partment should be involved. This will ensure that multiple variables are addressed early in the game. Well-informed procurement personnel can play a vital role in getting a deal done by raising key issues, asking pertinent questions that can move negotiations forward, and expediting the process once the order is placed. But if the procurement team is kept in the dark until a request for purchase dropped on its desk, they will not have time to help—and they may not view the project favorably. For these reasons, some sophisticated suppliers will request that the OEM’s procurement department be involved early in the process.

Sharing Information Helps

Contrary to popular belief, disclosing information during the negotiation process doesn’t weaken either side. OEMs that share the right information with suppliers early in the discussion will earn their respect and trust and better understand the other side’s position. It is especially important for OEMs to be candid with bad news, such as having to dramatically reduce the size of an order. Hiding key information forces the supplier to guess, which could lead to erroneous assumptions, arguments, distrust, and other conflicts. Withholding information can lengthen the negotiation process, running counter to what every OEM’s goal should be—completing deals as soon as possible.

OEMs should first determine what information should be disclosed to the supplier. With regard to sensitive informa-tion that could weaken the OEM’s position, plausible answers or explanations should be prepared that are sufficiently vague, so as not to arouse the supplier’s suspicion or reveal anything proprietary.

OEMs should be prepared to disclose any nonsensitive information that may help them achieve their goals. Informa-tion that may lower, minimize, or change the other party’s expectations gives the OEM power and should be revealed early on, even if it’s not requested. The supplier may be reluctant to share; OEMs should be prepared to trade infor-mation if necessary.

OEMs will need to know what questions to ask to move the negotiation forward. To do this effectively, they should consider information from the other party’s vantage point. This will enable OEMs to develop open-ended questions that will elicit answers beyond the standard yes-no responses and secure the needed information.

Depending on the OEM’s situation and its relationship with the supplier, the OEM may want to send the supplier a list of prioritized variables (such as price, service, and deadlines) before the negotiations begin. It could help the seller better understand the OEM and may lead to shorter negotiations with a better outcome. For example, if price is a low priority for an OEM, the supplier may be willing to accommodate the OEM with regard to its high-priority variables in exchange for a price increase. Although it ends up paying more, the OEM may achieve other goals that it considers far more valuable.
In a competitive bidding process, OEMs should make any request for proposal (RFP) or request for quotation (RFQ) as explicit as possible. Once negotiations are underway, OEMs should express what they want. If the supplier is left to guess, the OEM may wind up trying to pursue a “pin the tail on the donkey” strategy, where it is hesitant to ask for something and merely hopes the seller offers more than requested. If the supplier is given the chance to make the first proposal, it will likely favor the supplier disproportionately.

The Balance of Power: Wish and Concession Lists

A critical part of negotiating is the power balance analysis, which should be a robust and creative process. The OEM’s representatives should start by comparing the OEM’s strengths and weaknesses with the supplier’s and listing what each side will likely want.

The OEM’s wish list should include items that would be nice to have but which are not the primary points being nego-tiated. The OEM should also create a flexible concession list that includes items such as deadlines for low-priority products, payment terms, and length-of-service contracts.

This process will enable the OEM’s representatives to develop their objectives, opening statement, and strategy. It also enables more flexibility between the OEM and the supplier with regard to negotiating terms and fees. For example, if maintaining the upfront asking price of an injection-molding system is more important to the seller than the cost of service, the purchasing OEM may be able to negotiate a highly favorable service contract—thus raising its overall standing in the total cost of analysis.

"Packaging a proposal, by adjusting variables to make the deal more palatable to a supplier, is one way to increase the chances of closing a deal without substantially increasing the price."

Follow Negotiating Best Practices

Negotiation is a multiphase process requiring a strategic approach. To get the most out of negotiations, there are some basic tips for OEMs to follow.

Watch for Signals. Be alert for both verbal and nonverbal signals. Nonverbal signals, such as gestures and changes in posture, may reveal a negotiating partner’s true feelings. Verbal signals are typically words such as like, want, or need. If a supplier says, “I would like a 10% price increase,” it may be settle for less than that figure. Also, since 10% is an estimate, the actual number may be lower.

Signals can also take the form of questions about a stated position. For example, if the supplier’s representative asks a question about a proposal put forth by the OEM, the supplier is likely interested in it. Such signals convey flexibility and should be rewarded, not punished. They indicate flexibility because the party hearing them—the OEM—recognizes that the supplier is not yet at its limit. So the OEM should use these signals to move the process forward. For example, the OEM can say, “Thank you for saying you would ‘like’ a price increase of 5%. Would you settle for 4.5%?”

Know When to Make a Proposal. The proposal sets the agenda for the negotiation. OEMs should be sure they address the key issues, is supported by facts, and doesn’t go beyond what is believed to be the supplier’s limit, which they should have determined in preparation.  The proposal should be preceded by a brief introduction and followed with an explanation and summary. Negotiators can then invite a response by posing the following questions to the supplier:

  • Is the proposal acceptable to you?

  • Which aspect of the proposal are you unhappy with?

  • What can I do to make this proposal acceptable?

  • Under what circumstances would you accept the proposal?

  • If this proposal isn’t acceptable, then what do you propose?

Package the Proposal. Packaging a proposal, by adjusting variables to make the deal more palatable to a supplier, is one way to increase the chances of closing a deal without substantially increasing the price. If the proposal is rejected because the supplier feels it fails to meet its needs, the package can be modified. If they say the proposal isn’t enough, it’s a bargaining issue, indicating that the value—not the shape—of the package needs to be modified.

Bargain Throughout the Negotiation Process. Bargaining is the trading activity that occurs throughout the negotiation process. Negotiators bargain for information, concessions, signals, time, and, ultimately, the final terms of the deal. OEMs should attach conditions to offers. Instead of asking questions when requesting a concession or making an offer, representatives should make statements such as, “If you agree to cut prices 15%, we’ll sign an extended two-year contract.”

OEMs should be prepared to make concessions. A price should always be assigned to demands (even unreasonable demands; these should simply be assigned unreasonable prices), and nothing should be given away without some-thing being offered in return.

Close Effectively. Subtly hinting that it is time to close can draw out any undiscovered issues. For example, a negotia-tor could ask the other party if it would be satisfied if the negotiator agreed to all its conditions.

The most common opportunity to close is when the other party asks a question about a minor aspect of a proposal, such as whether delivery is included or whether legal costs are covered. Instead of replying with a simple yes or no, a negotiator could answer in a way that transitions into an attempt to close. For example, the negotiator could say something like, “If you agree to our proposal, we’ll refer three other companies likely to be interested in your product.”
Closing conditions should be specific and small. When closing, negotiators must avoid getting greedy and snatching defeat from the jaws of victory.

Clarify All Agreements. It’s much easier to clear up ambiguities during negotiations than after. OEMs should confirm agreements in an acceptable form and ensure that all parties are comfortable with and ready to implement them. OEMs should avoid the phenomenon known as “deal creep,” in which the other party’s notes are ambiguous and the OEM interprets them for its benefit.


With the economy continuing to represent a huge unknown, it is important for OEMs to thoroughly understand the value of their products, systems, or contracts—from their perspective as well as that of their suppliers. Having such an understanding puts a company in a good position to maximize results after negotiations are completed. It will also make it easier for individual representatives to defend their decisions within the firm. A representative who, for ex-ample, knows that securing a significant discount on a service contract from a supplier will more than compensate for a 10% price increase can confidently explain this to any colleagues who question the decision to pay more in the short term. The best outcome of a negotiation is for both sides to walk away feeling victorious.

Tom Governale is vice president of business development and strategy at Scotwork (NA) Inc. (Parsippany, NJ).

When Reason Meets the Absurd: A Quick Look at FDA and CDRH in 2011

When Reason Meets the Absurd: A Quick Look at FDA and CDRH in 2011

FDA logoWhile FDA (CDRH) and the medical device industry have a long history of antagonism, the relationship seemed to become especially sour in 2011. The agency has acknowledged it is facing real problems with staff turnover and tight funding. Both of these issues are leading to inconsistent reviews in the CDRH Office of Device Evaulations and, yes, some degree of incompetency—because many of its new reviewers are recent college grads with no relevant work experience.

But many of the decisions the agency makes are fair and rational. Sure, it doesn't help when, for instance, Jeffrey Shuren, MD, blames most of 510(k) clearance delays on the industry, when high CDRH staff turnover is at least part of the reason. But it's hard, for instance, to argue against the use of computational modeling, to beef up regulatory science. And, of course, the agency's reliance on statistics to justify its reviews does make sense. And it is a good idea to require manufacturers to show equivalence in safety and efficacy for products that represent incremental improvements to existing products. It is also a sound idea to opt for randomized clinical data when possible.

But sometimes the push for randomized trials is not always reasonable. At times, the agency itself has trouble with risk–benefit analysis. I recently spoke with a medical device entrepreneur who provided an example of this. His company had developed an implantable device that was approved and commercialized in Europe. "We went to the FDA with a trial design and they came back and said 'it has to be randomized,'” he explained. "They are invoking this randomization in absurd situations."

In this example, FDA told the manufacturer that the clinical trial has to have two groups. In one, the device is implanted to assess its effectiveness. In other—the control group, the device is implanted but not switched on. "Which patient in their right mind would subject themselves to be implanted and not have the device turned on?" the entrepreneur asks. This is where FDA's logic become irrational: where a formulaic notion (randomization) that makes sense on paper doesn't make sense in a specific instance. 

"Randomization is a great idea," the entrepreneur acknowledged. "It takes the placebo effect out; it takes the biases out of the trial. But randomization cannot be done when surgery is involved. Or when the patient knows that he is getting a dud."

—Brian Buntz

Medtech Attorney Pilot Urges Third Party Device Reviews

Larry PilotThird-party medical device reviews by qualified third-party experts were recommended in 1970 by the Cooper Committee and embraced by the European Union but never enacted into U.S. law. As Pilot explains, such reviews would “reduce CDRH workload and resources; eliminate the need for costly user fees; limit the need for redundant higher pay grade personnel; enable the CDRH to complete PMA review within 180 days; and retain appropriate and efficient use of independent statutory advisory panels.” The Cooper Committee “was emphatic in its belief that external advisory experts were essential to the expected success of the PMA process.”

Today’s advisory panels are a far cry from their forerunners introduced by the 1976 Medical Device Amendments, he argues. They worked well for many years, but “beginning in the 1980s and continuing to today, there have been complaints about the qualifications of the members and FDA management of the advisory panels,” Pilot writes. “These complaints, in part, relate to overly strict application of ‘conflict of interest’ criteria depriving qualified experts from panel membership and possible FDA manipulation of the panels by concealing from PMA applicants information shared with panel members.”  

Weekly Vitals: Reflecting on 2011, Looking Ahead to 2012, and More

As we inch toward the holidays and into a new year, UBM Canon's medical device editorial teams have been deeply entrenched in end-of-year list mania. Check out our various reflections on the past 12 months and what's to come for 2012.