PM360 JUNE 2010

THINK TANK

MEDICAL DEVICE MARKETING INNOVATIONS

Where has med device marketing led the field? PM360 consulted the experts for their thoughts about new developments and opportunities.

DAVID WEST
Vice President
Medical Device Development
Quintiles Consulting
david.west@quintiles.com

The business of healthcare has changed—cost pressures, increased regulatory scrutiny, and a shift of stakeholders has created a complex environment that is stalling innovation. In this new health landscape, biopharma and device companies need to find greater efficiencies and new approaches to development that not only meet the needs of the market but allow them to deliver higher-quality and safe products for patients.

Since the late 1990s, FDA’s Quality System Regulation, 21 CFR Part 820, has required that devices be developed under a systematic and documented design control process as a means to assure device safety and effectiveness and minimize the incidence of post-market device malfunctions that can lead to patient injury. The internationally recognized device quality standard, ISO 13485, dating from 2003, also specifies design control elements. Yet today, many medical device manufacturers still struggle with conformance to design control requirements, often unnecessarily complicating the product development process and thwarting advances in technology. By embedding leading class design controls in the product development process, a manufacturer can more readily identify and focus on necessary and sufficient product development activities, thereby avoiding waste of time and resources.

Manufacturers must optimize their product development lifecycle by embedding leading class design controls and underlying risk management approaches that accelerate time to market and reduce the post-market incidence of device malfunctions. Integrating leading edge design controls into product lifecycle management results in shorter, more predictable device development with reduced costs and safer and higher-quality devices. This approach also provides documented development activities compliant with FDA requirements and international standards for global acceptance, and fewer field corrective actions.

Both small and large device manufacturers can benefit from optimized product development processes with embedded leading class design controls. Being able to “right-size” the product development process is particularly advantageous for start-up and small companies racing to launch their first device. For established or large companies, optimized product development processes with embedded leading edge design controls can reduce the complexity of existing product development processes while maintaining compliance with regulatory or international standards requirements. Moreover, optimized processes can provide appropriate linkage of design control and underlying risk management activities to other quality system elements.

Manufacturers can benefit from applying enhanced capabilities, methodologies, and process improvement tools, such as Six Sigma, process mapping, and gap analysis. The value to the device manufacturer is faster time to market, decreased development and manufacturing costs, and improved operational efficiency for safer and more effective devices.

YALE GRAVES
VP of Marketing
Aesculap
yale.graves@aesculap.com

Before I offer a short example of a “marketing innovation” implemented by Jay Schrader, Product Manager at Aesculap, I would like to offer my interpretation of innovation. I like the one found in Wikipedia that describes innovation as “the practical application of inspired creative thinking to create something better.”

Jay has “created something better” by combining several marketing tools to address the growing need by patients and their guardians to better understand not just the clinical side of their illnesses but the device technological side as well. Jay’s program enables this information and education exchange to take place at walkathons nationwide. Participants have access to expertly trained representatives who are available on site to demonstrate the technology, answer questions or concerns, and direct people to the numerous resources of additional information available to them both electronically and in print.

Marketing teams need to clearly understand when the modern advanced ways of communicating need to be augmented or even replaced with trusted face-to-face human interaction. We must not underestimate the value of combining “new with old” to improve effectiveness.

Education, relationship building, sharing of expertise —all serve to provide better understanding by patients, family members, and company to create long-lasting loyalties in a relaxed, personal, team-building environment. Now that’s innovative!

NANCY FINIGAN
Executive Vice President
Group Account Director
Goble & Associates
nfinigan@goble-assoc.com

For years, promoting medical devices to hospitals was focused on personal selling, and messages were shrouded in “est”—fewest, easiest, smallest, safest, fastest. The more “ests” you could apply to a product, the better.

Personal selling is still critically important in driving product adoption within the complex environment of acute care, but today, hospital device marketing has advanced beyond promoting just features and benefits. Marketers are investing more than ever in customer research, seeking critical insights that create emotional connections to the devices they need and the companies that build them. This is a far cry from the days of simply testing concepts and messages to drive creative strategy and communications.

Today’s savvy hospital marketers realize that competing based on product features is a slippery slope. Continuing quality initiatives like improving patient outcomes, lowering infection rates, and reducing length of stay require that medical devices continually evolve. Innovation is the price of admission for every medical device manufacturer that aspires to stay relevant beyond the initial sale. Subsequently, it’s virtually guaranteed that a new product feature or upgrade will soon be trumped. Thus, the question arises, “If a product’s communication platform is not based on features and their impact, how do medical device marketers win?”

Winning requires what marketers outside of healthcare have embraced for some time—as explained by Al Ries and Jack Trout in The 22 Immutable Laws of Marketing—it’s not the best products that win, it’s what customers think about them.

As healthcare evolves, hospital resources will no doubt continue to be stretched and costly decisions regarding medical devices will continue to be complicated by the multitude of decision makers and influencers involved in device selection. Understanding what these customers think about themselves, feel about their professions, and perceive about products can ultimately lead to communication strategy that can change minds and markets.

JOHN MCDONOUGH
CEO
T2 Biosystems
info@t2biosystems.com

In the early stages of development, a medical device company with a true platform technology must determine a go-to-market strategy with an initial portfolio of applications that will create significant corporate value while also validating the broad capabilities of the platform. The firm must also consider carefully how its activities will foster partnering opportunities. With minimal funds and staff, choosing markets that meet these goals is critical for the company’s success. At T2 Biosystems, we focused first on developing a deep understanding of the competitive advantages of our unique diagnostic platform and then developed a strategy to create significant shareholder value through both internal product development and with partners who are well positioned to leverage our unique technological capabilities.

In any early-stage company, the real breakthroughs are created by the scientists and engineers who innovate solutions that can make a difference in the market. Once you launch product and establish partnerships, it’s all about realizing revenue growth and driving to profitability. Initially, it can be a real challenge to find the balance between internal development and pursuing partnerships.

We achieve this balance by developing one instrument to meet the needs of all markets and through separately funded, focused project teams that allow us to avoid pulling resources from one project to another. Weekly technical reviews and monthly program reviews ensure that efforts and insights are coordinated across all teams, while reinforcing the importance of each team’s project.

The specific market choices we have made demonstrate the value of our technology when its advantages are applied systematically to clinical care. Importantly, we have chosen markets to fall within a set of boundaries that minimizes competition between us and our current and future partners.

Each milestone that T2 Biosystems targets and achieves is aligned to ensure that success moves the company closer to our objectives. The end result of this strategy is that we have developed a pipeline of unique opportunities that we believe increase our ability to realize the company’s vision of a single, easy-to-use instrument that can run molecular and immunodiagnostic tests fast and cost effectively in decentralized settings.

ROBERT J. DESIMONE
President
MediComm Consultants, Inc.
rjd@medicomminc.com

Device companies are constantly challenged to hold the line on costs as their customers deal with shrinking reimbursement. Each cost component of a product is scrutinized, tweaked, and trimmed to drive the product to lowest overall cost.

One such component is post sales support, specifically in-service training. Recently, we had a client transitioning from a history of warm body training programs to more self-paced, computer-based training that could be delivered over the web. Their products were highly configurable, and they required that the training be equally configurable. After extensive analysis of their situation, we proposed a model that included three main components—a configuration tool, an authoring methodology, and a stand-alone player. Customers who did not have web access and still required a CD-based version of the training would use the stand-alone player.

The configuration tool allows an education manager to customize a training program for her unique installation. By answering questions about the course, the manager generates a course for her trainees.

A key component of our approach was to develop a course authoring methodology that made extensive use of dynamic content. This way, instead of creating hundreds of different courses to cover the product’s different configurations, the course consisted of a blank canvas that was dynamically presented to the student, based on the predetermined configuration created by the configuration tool. From the student’s perspective, she was viewing a unique course.

An additional project involved the creation of a content authoring tool that permits the client’s clinical education team to create highly configurable courses that routinely cost upwards of six figures for a fraction of the cost. The result is cost savings both in a reduction in warm body training costs and the substantially reduced cost for self-paced content development.

RAMIRO ROMAN
Marketing Manager
Solutions Marketing
GE Healthcare
rroman7@gmail.com

THE NEW NORMAL
According to the American College of Healthcare Executives, “financial challenges” continue to be top of mind for the fifth year in a row. Beyond economic softness, healthcare reform will have a significant impact on the medical device industry, both in taxes and decreased reimbursement. Companies are presently evaluating different scenarios in order to position themselves for success. The key marketing strategy determinant: product mix.

STRATEGIC PORTFOLIO MANAGEMENT
The legislative changes are forcing companies to seriously consider their strategic options. Marketers are shifting their product/investment matrixes to decide which products to prioritize.

Products that serve the anticipated influx of 35 million younger and healthier patients and are less impacted by reimbursement will be prioritized. Companies will increase advertising, distribution, and product development budgets for these products. Traditional commercial marketing will be key to driving expansion and differentiation. Those products that are negatively impacted by reimbursement will be defocused. Long gone are the “replacement” strategies that had become a common business practice. Services for this type of equipment will grow. What companies will also need to evaluate are gaps in product portfolio and adjacent markets.

A FOCUS ON PARTNERSHIPS
Last year’s economic downtown has inflated corporate cash reserves. Look for companies to use this cash prudently by acquiring products or companies that will immediately improve their competitive position in the new market scenario. However, this is not a heavy spending market, look to CFOs to continue expanding their influence and make investments ever more wisely.

Business development will not be all about M&A, partnerships will be the primary strategy as a way to mitigate risks and prove out business cases. Creative partnerships that increase customer value propositions should flourish and perhaps lead to M&A, but not necessarily. It’s a new game and bigger is not better. Good marketing!

NANCY BUNDEK, PhD
Senior Vice President
Aprexis Health Solutions
nancy.bundek@aprexis.com

Technology advances have resulted in the recent introduction and use of a wide range of medical devices. Regardless of whether the device is fairly simple or highly complex in terms of design and use, the patient-user is often faced with significant adjustments to incorporate the device into his or her daily life. The extent to which patients successfully adapt determines the adherence and correct device utilization over time. While pharmaceutical firms typically initiate and sustain adherence programs, device manufacturers have only recently initiated similar efforts. Because of the unique characteristics of each device, the typical “one size fits all” adherence program isn’t practical.

Aprexis Health Solutions creates and implements successful adherence programs for medical devices. Its approach to marketing these programs is centered on its ability to offer a custom program for each device. A flexible technology platform enables Aprexis to craft uniquely meaningful clinical components into its adherence solution. In doing so, each program meets the specific needs of every unique patient population. The end result is a customized adherence program that features:

• Identification of major challenges a patient will face
• Delivery of relevant coaching to help patients overcome those barriers
• When possible, first contact with the patient prior to device installation or implementation
• A focus on evidence-based clinical device benefits
• Reinforcement with web-based tools that deliver patient education about the device and its benefits

Device manufacturers are responsive to the clinical focus for several reasons. First, Aprexis understands the device and the challenges faced by patients. By delivering effective coaching that directly addresses the patient challenges, patients are able to properly use the device and remain adherent, resulting in improved clinical outcomes for the patient and higher levels of satisfaction. Better outcomes, in turn, reinforce the prescribing physician’s assessment of the value of the device.

The opinions expressed by the authors in the Think Tank section are their own and do not necessarily reflect those of their affiliated companies or organizations.