Everyone’s health is his or her own. Everyone’s disease belongs to us all. Health is license; disease is liability…a very-personal liability that impacts humans as an individual, a family, a community, a society.
Bob Worrell (left), Founder & Chairman and Kai Worrell, CEO, Worrell Design, displaying “3D IM” Injection Molding Fixtures on Worrell production floor. The medical device itself is a wireless monitor designed to measure contractions and heart rates for women in labor.
Now, Worrell Design Inc. is rolling out new means to reduce those “liabilities” and extend those “licenses”—patient by patient. Worrell—a family-owned and operated business—has established itself as perhaps the most prominent industrial design firm working in the healthcare sector. Regardless—with roll-outs like its just-introduced “3D IM” (3D-Printed Injection Molding) system in close collaboration with leading 3D-printer manufacturer Stratasys Ltd.—the firm is proving itself to be the most innovative. And—philosophically—among the most human-centric.
As the Additive Manufacturing cognoscenti understand, 3DP technology continues to accelerate in development at an ever-increasing rate. Many traditional manufacturers are still struggling to grasp the commercial implications. Inherently conservative segments—like medical-device makers, constrained by FDA regulators—have been particularly slow in adopting what should look like very-compelling 3DP solutions.
On 30 October, separate sector-leaders Stratasys (3D printers) and Worrell (medical-device design)—near geographic neighbors in metropolitan Minneapolis, MN—proclaimed their collaboration around educating and accessing the medical-device marketplace. Their disruptive tool of choice is new 3DP innovation in the long-established, industrial processes of injection molding. As Stratasys states, “Worrell slashes lead times by a game-changing 95% in comparison to traditional tooling, with costs plummeting 70%.” This while mitigating risk for both practitioner and device manufacturer—via very-early feedback and quick iteration in the product-development cycle.
Use the following link for an easy-to-read PDF of Worrell’s “3D IM” Infographic (“3D Printed Injection Molds: Accelerationg Product Development”): http://nyc3dp.com/?p=3202. This Infographic explains the 3D printing and injection molding process and its benefits as modulated by “3D IM.”
By dint of its dramatic cost reductions, Worrell’s 3D IM will also democratize medical device development. Based on a 2010 study by a Stanford University team—entitled “FDA Impact on U.S. Medical Technology Innovation”—the average cost to bring a high-risk Class III device to market is $94 million. For a Class II device, it is $31 million. 3D IM 3D-printed injection molds empower prototype development—using final production materials—for a fraction of the cost. This process can deliver actual finished parts in a matter of days—compared to the typical eight-week lead-time associated with traditional tooling processes.
In human terms, what is the potential value of this saved time? Ultimately, it is saved lives. Worrell’s innovative 3D IM production system will help get life-saving medical devices to market quicker.
To add perspective to that statement, consider this hypothetical case. For millions of people with severe allergies, ordinary foods and everyday events—such as a bee sting—are life-threatening emergencies. The FDA (in “Food Allergies: What You Need to Know”) estimates that anaphylaxis to food in the U.S. results in 30,000 emergency room visits, 2,000 hospitalizations and 150 deaths each year.
Anaphylaxis can be fatal within minutes. So, fast and effective emergency-medical intervention by the untrained is crucial. An at-hand drug injector—capable of immediately delivering a life-saving dose of the drug epinephrine—can mean the difference between survival and death for allergy sufferers.
Worrell worked with Intelliject (recently renamed Kaleo) to redesign the epinephrine pen. Together, they created a user-friendly, epinephrine delivery system the size and shape of a credit card. At the time of the project, 3D IM was not available to rapid-prototype the product. This meant that longer, traditional tooling methods had to be used to develop the device.
Worrell’s 3D IM would have accelerated the product development process, bringing the device to market sooner. If this device had rolled-out just two months sooner—as a result of the delivery-accelerating 3D IM process—approximately 5,000 emergency room visits, 333 hospitalizations and 25 deaths might have been avoided.
Worrell—with offices in Minneapolis, MN and Shanghai, China—is continuing to buttress its reputation for HC product research, design, development, branding and integrated business-success strategy. The growing list of Worrell’s blue-ribbon/blue-chip, healthcare-industry clients includes Medtronic, Becton Dickenson, Amgen, Johnson & Johnson, Covidien and Thoratec.
Just as important—perhaps more so long-term—is Worrell’s championing of design-modulated solutions for the world’s critical human-health issues. As a thought-leader around people and planet needs, the company has helped to inspire, idea-seed and support many innovating health-technology and medical-device startups. These entrepreneurial firms are introducing products that are redefining the healthcare industry globally.
Even with small parts, 3D IM creates precise prototypes that can be used for testing.
Speaking directly to the Worrell “solution engine” of design modulation for healthcare innovations, McKinsey & Company—arguably the world’s most famous business-consulting firm—released a resonant study entitled “Design to value in medical devices” in 2010.
In its study, McKinsey’s team addresses the healthcare-provider fall-out from the worldwide Great Recession and continued weakness in almost every economy globally. That fall-out is the inability of typical medical-device customers—developed or emerging market-based—to continue to afford high-margin, feature-rich and/or bleeding-edge-tech devices.
McKinsey states that medical device companies need product-design regimens that incorporate new tools and novel thinking. “In particular, they need to be able to do two things effectively. First, they must find ways to understand exactly which product features their customers need and, critically, how much they are willing to pay for them.”
McKinsey—like all successful consulting houses working for the Fortune 100—has created a brand-package and managerial mantra to showcase their whole suite of interlocking, actionable concepts. Voila: McKinsey’s “Design to Value” or DtV.
McKinsey’s DtV system sounds a lot like an older Producer/Client regime: the Value Proposition build. But, regardless of the terminology, an innovative hybrid-capabilities firm like Worrell is the obvious engine to drive a conceptual-frame like DtV to reality in the marketplace. Worrell’s “Health By (3DP) Design”—evidenced via a disruptive system like its 3D IM—changes McKinsey’s “givens” by drastically altering the number-assumptions around medical devices. Further, Worrell is already practicing novel and sophisticated field study via Ethnographic Research (see below). Plus, Worrell addresses time-to-market as the key multivariate element in its own 3d IM mix.
In 2010, McKinsey made no mention of 3DP in its “DtV in Medical Devices” debut. In the five years since McKinsey developed DtV, the famous consultancy has indeed discovered 3DP. And, Worrell may be the perfect, packaged solution for the delivery of many of McKinsey’s DtV tenets.
Using a Stratasys PolyJet printer and an injection molding press, Worrell can create production-level parts in hours.
Since the gestation of humanity, each ill person has had to accept the generic answers to their disease. For most of our common history, that is all our crude “medical science” could afford us at the time of healing need. A kind of undifferentiated hope—usually dashed. Only the gentling comfort of palliative care—the concerned touch and stroke and whispered “there there” of the nurse laying on soft hand and voice—could tender the hurt…a little.
The all-too-revealing word—or state—of “patient” described both halves of the bedside equation. Individual person—doctor, nurse, hospice care-giver—to individual person was as patient-specific as our ignorant healthcare system could enable. The body had to mostly cure itself—“PATIENT heal thyself”— or s/he didn’t and died.
These days, physicians CAN indeed heal. In fact, they’re expected to. Even to the modern anticipation that the doctor will cure death itself—or at least fend it off for the foreseeable (personal) future.
Kai Worrell, CEO of his family’s eponymous firm, thinks that medicine has now become too physician-centric. As a human stance, corporate mission AND most-effective, long-term business strategy, Kai wants to put “patient needs first”—once again. This would be a canny drive to redress what Worrell sees as an unhealthy imbalance in power and perspective. CEO Worrell goes on to state, “Our focus is on improving the provision of care [to the individual] through empathy and technology.”
“Empathy” is not the typical watchword of hard-nosed business leaders. This is despite the fact that every client who signs a purchase order, or customer who pulls out a credit card, has made a personal or emotional decision to purchase something. That decision is mostly based on a relationship with the seller, the product or the expectation. The most certain basis of that relationship IS empathy.
Worrell Design invests scientific method and professional study in human relationships in its healthcare-marketplace environment. Consonant with its humanistic basis for its design and technology decisions, the company engages in high-caliber, field-grounded ethnographic research. To design effective, tech-driven people-solutions in healthcare, Worrell studies human groups in holistic response to the complex healthcare environments in question. E.g., patients in hospitals interacting with medical devices.
Kai’s leadership includes oversight of Worrell’s Ethnographic Research function—an innovation in operational design-management. Worrell researchers conduct user-studies in hospitals, clinics, and patient’s homes in developed and emerging markets around the world. From research proceeds, CEO Worrell also oversees the company’s continued efforts in offering the best device development processes, which now include the new 3D IM 3D-printed tooling and injection-molding capabilities.
As Kai Worrell says, “Our ethnographic methods are a hybrid between anthropology and investigative journalism.” By combining ethnographic research methods with a designer’s arsenal of ideation and visualization tools, Worrell “sheds light on unmet, often unspoken needs, translating these into strategic insights and opportunities. We call it ‘Pivotal Thinking’—a 360º approach to exploring and extrapolating insights from all angles while staying grounded in the stated problem.”
Worrell’s injection molding technician removes a polycarbonate part from a 3D printed injection mold.
Forward-looking Worrell is also “designing-in” innovations in other ancillary fields around its core medical-devices segment:
(1) Care Delivery—
This includes the larger issues of successful, integrated patient Care Delivery driven by the medical-devices it designs.
(2) Systems & Services—
To present effective, over-arching solutions, the company has assured its ethnographic research and design-strategy expertise applies as much to Systems and Services as it does to individual products.
(3) Wireless Health—
Worrell is deeply engaged in Wireless Health via active participation in the wireless life-science industry; the firm is a sponsor of the seminal, eight-year-old “Body Computing Conference” at the University of Southern California.
(4) Wellness —
Finally, Worrell advocates for proactive Wellness as the ultimate “cure” for disease. Treating illnesses is a reactive stance that wastes resources of every kind on a grand scale—not the least of which is the life-enjoying value of each individual’s natural good-health “resource.” The company is designing solutions to prevent illness and promote wellness, from functional foods to consumer technology.
For decades, practically the only patient-specific offering in the medical-device cabinet was the plaster cast. Now—in just the last few years—3DP has been begun to provide more and more solutions in the form of individual patient-tailored exo-devices and implantables
Worrell Design’s new 3D IM—an innovation in 3D-printed injection molding— delivers health by (3DP) design. Its novel deliverables are small-batch prototyping and final-product runs of 10 to 200 units. Thus, Worrell is helping span the gap between patient-generic and patient-specific—through new solutions at the sweetspot of intersecting 3DP and injection molding.