Posted by James Rudolph on Fri, Jul 09, 2010
The future perfect
By the time you arrive, I will have gone to the hospital.
This sentence is an example of the verb tense the future perfect. The unnerving reality of the future perfect is that it describes two or more independent variable actions that may occur in the future - always with a level of uncertainty. Naturally, we respond to the future perfect with mixed emotions: anxiety, skepticism, fear, perhaps a little excitement. It’s no surprise, then, that we respond to the idea of ethnofuturism (or, if you prefer, Futures Thinking) in much the same way. Ethnofuturism, like the future perfect, is research for the future, and understanding the future is never a perfect science.
Ethnofuturism
Originally, ethnofuturism was a term invented by Estonian authors and artists to describe their intentions to blend old, culturally significant forms with modern technologies made available by their recent sociopolitical liberation. Ethnofuturism, as it’s used today, capitalizes on this idea of blending the old with the new, the locally relevant with the globally significant, to enable a more ideal future. Simply put, it’s ethnography for the future. More specifically, it’s an emerging trend of research strategies aimed at using these cultural and behavioral insights to inform business strategies, product innovations, and service applications.
Applications
The consumer and fashion industries have understood the value of ethnofuturist research techniques for many years (see Jan Chipchase’s aptly named blog The Future Perfect which inspired my inquiry into the subject), employing strategists, technologists, trend forecasters, ethnographers, and other multi-disciplinary futurists to understand how people may behave in five, ten, and fifteen-plus years from now. See, for example, Trendwatching.com. The focus of ethnofuturism is on understanding possible shifts in behavior, preference, and knowledge in order to realize a better future.
Professionals working in this area take advantage of traditional research techniques, such as cultural ethnography, marketing research, and data analysis, and blend them with emerging strategies, such as scenario casting, rapid ethnography, and futures thinking, to inform possible outcomes. Venessa Miemis observes “It's not predicting the future, but rather taking a structured approach to understanding the potential impacts of today's decisions and actions” (see her article on Futures Thinking). For a more comprehensive discussion of emerging research strategies, see Design Research: Methods and Perspectives, edited by Brenda Laurel. The objective is to understand predictable behavioral patterns so that new products and services can accommodate and respond in appropriate, valuable, and meaningful ways. Three prominent factors make ethnofuturist techniques relevant for medical product development: increasing human mobility, globalization, and the maturation of advanced medical technologies such as robotics.
Mobility and Globalization
The rapid growth of human mobility, both physical and digital, has led to an increasingly global level of interaction. People respond to other cultural behaviors in observable ways, often co-opting them for their own. The interactions that occur provide expert researchers insight into people’s likely near future expectations, even if they are not adequately met today. This cross pollination of ideas and behaviors occurs in everyday consumer environments, but it occurs just as readily in hospitals and other healthcare environments. Formally, ideas are exchanged through international initiatives such as Doctor’s Without Borders, but the exchange happens much more rapidly and with far more lasting implications through informal, everyday exchanges. The researcher’s job is to understand these behaviors in order to identify potential future needs and expectations.
Technology
Forecasting will become more important in the medical industry as advanced technologies become more ubiquitous. While current applications take advantage of the more technical strengths of robotics, such as precision, repetition, and reliability (see MAKO Surgical’s partial knee resurfacing), future applications will need to incorporate intelligent systems that can respond appropriately to diverse situations, such as medical emergencies. As technologies (and eventually, markets) mature, new applications will certainly arise. Research professionals will be paramount to answering difficult questions: How can these technologies be used to assist our aging population? What level of artificial intelligence is appropriate in home health care settings? What services should these technologies provide, and which applications will be most readily accepted by consumers? Clearly, many research strategies already exist for probing these types of questions, and more will undoubtedly be developed to improve their effectiveness and efficiency.
Medical Future Perfect
Many of the same research strategies employed by futurists today will play a significant role in the future of user research in medical product development. The future of health care is too important and too near for it not to. Jamais Cascio provides a practical overview for how research professionals can begin thinking about likely medical scenarios. His process outlines four key activities: Asking the Question; Scanning the World; Mapping the Possibilities; and Asking the Next Question. Research strategies that allow us to ask pertinent questions, identify telling challenges, and explore “possible, probable and preferable” solutions provide valuable insight to our medical future. These tools will become increasingly relevant in medical and home health care industries as these markets continue to mature and turn to more intelligent technological solutions as a strategic competitive advantage.
Posted by Chris Loughnane on Mon, Jun 07, 2010
Kaiser Permanente is raising the bar for it's suppliers.
From Fast Company:
We [Kaiser Permanente] evaluated the four major players and found that clinical performance and pricing were comparable, but there were big differences in terms of sustainability performance," explained Robert Gotto, the executive director in Kaiser Permanente's Procurement & Supply group. "One supplier had the foresight to develop a camera that doesn't need to be sterilized with chemicals. It uses steam instead, and can cut down chemicals in operating room by half." So the steam-sterilized endoscope provider ended up getting the five-year, $100 million contract.
Four OEMs. Each one indistinguishable from the next on the basis of cost and performance, but only one lands the $100M contract by virtue of its sustainability.
I was pumped to hear the news. Finally, a product selected on its sustainable merit. Surely this will lend credibility to the not-so-new green movement in the medical sector.
Much to my dismay, I found nothing regarding bioplastics, compostable materials, PCB reduction, or even alternative power. In fact, it seemed as though the only sustainable feature of the product was that it was able to be steam sterilized.
Steam sterilized? Well that's not terribly impressive.
Or maybe it is.
As much as sustainabiliphiles like myself tend to worship the latest widget on the front page of TreeHugger, Kaiser realizes it won't make any hay by demanding top-flight sustainable innovations from OEMs. Not yet anyway.
No, for now Kaiser has deemed it prudent to encourage device firms to test the water rather than push them into the deep end, and their Sustainability Scorecard is as simple and straightforward as you could ask for. At 13 line items deep, it's worth the 30 seconds to garner the insight into Kaiser's new strategy.
If you've got a few more minutes (or are wondering what Polybrominated Bipheyls are),
check out the breakdown of some key scorecard line items.
Is it a NICU Product?
Kaiser doesn't elaborate on why it cares if it's a NICU product. However, it's a good bet that if your product is going into the NICU, the importance of sustainable, healthy materials (especially with regard to RoHS, below) will be exaggerated.
Why?
Children are generally more susceptible to certain substances (such as lead), so allowing them to exist in products used on (or in) fragile infants would likely incline Kaiser to look elsewhere.
Is it a PICU Product?
Likewise.
Is it Latex Free?
The CDC estimates that anywhere from 1% to 6% of the general population, and 8%-12% of healthcare workers, are sensitized to latex.
That's not news... Latex has been a touchy subject for quite a while, and most medical device companies take precautions to avoid its use wherever possible. The result is that there are whole organizations dedicated to cataloging both consumer and medical latex-free alternatives.
Is it RoHS Compliant?
Although Kaiser Permanente fails to mention the EU's RoHS regulation by name, the prohibitions listed in the Sustainability Scorecard are identical to what has been banned in Europe for years.
Like latex, there aren't any surprises here. In fact, it's likely that the last time you heard the name of any of the substances listed below, it was followed by the word "poisoning."
The following substances can exist in quantities <0.1%
Lead (why it's bad)
Mercury (why it's bad)
Hexavalent Chromium (of Erin Brockovich fame)
PolyBrominated Biphenyls (PBBs) (why it's bad)
PolyBrominated DiPheynyl Ethers (PBDEs) (why it's bad)
The following substances can exist in quantities <0.01%
Cadmium (why it's bad)
The good news about all these restrictions? Printed circuit board manufacturers and custom polymer compounders (whose products are some of the biggest potential RoHS offenders) have been dealing with RoHS for years, and can help you with compliance.
Is it PVC + DEHP Free?
Polyvinyl Chloride (PVC) and Diethylhexyl Phthalate (DEHP) are bad news.
With countless advocacy groups sternly cautioning against the use of PVC and DEHP (DEHP is used to make PVC more flexible) in everday products like shower curtains, flooring, and credit cards, it's no surprise that Kaiser is pushing to eliminate it from products people have a much closer relationship with, such as tubing and catheters.
This concern has been around for a while as well, and though PVC-free alternatives do exist, PVC is such a great material otherwise that, although declining, use is still broad.
In any case, Kaiser has seen the danger in PVC for a while, and now they aren't buying it.
It will be interesting to see where sustainability in the medical field goes from here. My bet? It's only a matter of time before RoHS (or something similar) becomes law; and even if it doesn't, the great BPA backlash of 2008 exposed the kind of brand damage (Nalgene anybody?) that can occur when short-term thinking results in the use of controversial chemicals.
But regardless of what I think, the fact is that Kaiser Permanente wants you to be sustainable.
Right now that means complying with the Scorecard.
We should all be prepared for what it might mean tomorrow.
Posted by Joe Civiello on Fri, May 21, 2010
Speculation in the medical device industry continues to build as the industry waits for the FDA to unveil changes to its premarket notification submission process, also referred to as the 510(k) process.
Transparency, consistency, and predictability seem to be a few of the FDA buzz words mentioned when describing what is hoped to be the result of positive changes to the FDA submission process. Over the last couple of years, the 510(k) review process has been under scrutiny by the Senate and House and critics within the FDA. Growing concerns cite that the priority to ensure public safety and efficacy of approved medical devices has been minimized in the name of innovation, and device approval fast-track processes have been without enough comparisons to their substantial equivalents or predicate devices.
In an effort to strengthen its approval standards and scientific review rigor, the FDA has commissioned the Institute of Medicine (IOM) to conduct an independent review of the 510(k) program and recommend changes as they see fit. The IOM findings and report is due out early 2011.
In the meantime, the FDA has also opened an internal audit through its own medical devices arm-Center for Devices and Radiological Health (CDRH). The CDRH has established a working group whose efforts kicked off with public meetings held earlier this year in February entitled, "Strengthening the Center for Device and Radiological Health's 510(k) Review Process." These meetings focused on strengthening the 510(k) program in four specific areas:
- Issues related to predicate devices (device creep/redefining substantial equivalence/indications versus intended use)
- New technologies and scientific evidence
- CDRH handling of increased volumes of 510(k) submissions
- Post-market surveillance and new information about marketed devices
Just recently CDRH director, Jeffery Shuren M.D., addressed one of these areas (CDRH handling of 510(k) submissions) by announcing changes in the process for its Medical Device Advisory Committee. The function of this committee serves as a technical panel to discuss and review data for medical devices under premarket review.
Previously, panel members were FDA employees, but effective May 1, 2010, panel members will now be independent professionals from the private sector. These new reviewers will provide expertise and technical assistance from their related field specific to the appropriate medical device that is under review. "These changes are expected to empower the agency to make more effective decisions that are informed by more clear and focused discussion by panel experts," said CDRH Director Jeffrey Shuren.
So what might these changes mean for medical device companies moving forward? It may be too early to tell or understand. It is thought that the current FDA environment has gone too far with a current zero risk tolerance policy in order to satisfy reviewers. New reviewers have little experience with the 510(k) process, which has left medical device companies feeling the pain of a lengthy review process and unpredictable requests and submission guidelines.
Longer approval times and unclear submission requirements can result in costly development overruns. This is a concern for not only the medical device community but for the investment community as well. Recently Massachusetts Medical Device Journal (MassDevice) surveyed a group of New England med-tech investors and found that the FDA changes were the primary concern for investors when considering investment into the med tech sector.
Transparency, consistency, and predictability...These attributes are needed and necessary, but will the additional requirements to see these attributes through result in an improved process? Changes are coming and it will be interesting to see how the 510(k) process evolves.
Posted by Tristan Sedgwick on Wed, May 12, 2010
A case study was recently published in Ergonomics in Design magazine-a publication affiliated with the Human Factors and Ergonomics Society-titled, "User Research Improves Laparoscopic Instruments," co-written by Farm's Director of Research & Usability, Beth Loring, and Industrial Designer, Erin Lemieux. The case study features a development project that Farm worked on for Cardinal Health's Diamond Line of laparoscopic instruments. The case study discusses how Farm's multi-disciplinary team conducted human factors and user research to design a new handle with improved ergonomics, resulting in improved comfort and usability by utilizing a user-centered development process.
Posted by James Rudolph on Fri, Apr 30, 2010
A recent article in the Boston Globe sheds light on a dangerous, often overlooked, and in this case deadly, problem. To summarize, the Boston Globe reported that "alarm fatigue'' was found to be a contributing factor in the death of a heart patient at Massachusetts General Hospital. Safety officials believe this case is not an isolated incident, but a national problem in which device alarms are often ignored, unheard, accidentally turned off, or purposely disabled due to the annoying effect they have on staff.
Unfortunately, auditory fatigue, or auditory desensitization, occurs in many working environments where auditory perceptual needs go unmet. Poor auditory environments challenge our ability to understand a situation, make appropriate decisions, and respond in a timely manner. Fortunately these challenges can and should be addressed through appropriate auditory system design. A brief introduction to the auditory system will enable us to better understand our perceptual needs.
The Auditory System
Sounds play a profound and pervasive role in our experience of reality, yet most of our experiences with sound go largely unnoticed. We respond to sounds quickly, intuitively, and instinctively, and still, few spaces fully consider the implications of our auditory environment. Why? The answer may lie in the simple fact that much of our experience with sound is pre-attentive, and our understanding of auditory environments primarily unconscious. Clearly opportunities have been missed.
Structure of our Auditory Environment
While there are many similarities between our perception of visual and auditory information, there are a few fundamental differences. One key difference is that auditory events are dynamic-they're experienced over time (Stevens, 1938). Researchers refer to this fact as auditory streaming. An auditory stream is the perceptual unit of sound, much like the object is the perceptual unit of vision (Bregman, 1990). For example, an auditory stream could be the low hum of a heating fan or a quiet group of people conversing in the background. Our ability to separate auditory streams into appropriate regions or groups is referred to as auditory scene analysis (Bregman, 1990).
Given an auditory scene, auditory objects can be integrated to form a perceptual stream in one of two ways: sequentially or simultaneously. Sequential integration means that auditory events are connected over time, while simultaneous integration means that auditory events share spectral qualities, such as frequency, at the same moment in time (Darwin, 1997).
Auditory Relationships
Researchers in the perceptual sciences have often used the Gestalt principles of visual grouping as a heuristic launching pad from which to conduct studies about preattentive auditory grouping (Aksentijevic, A., Elliot, M.A., & Barber, P.J., 2001). For example, auditory streams with similar frequencies are said to have similarity because they have physically similar wavelengths. An important strength of our auditory system is its ability to segregate streams with speed and relative accuracy. This has important implications for the design of any hospital environment, where misinterpreting auditory data can cost time and cause serious health risks.
Sequential Grouping
It's fairly easy to segregate auditory streams through spectral qualities; however, it's much more challenging to address concerns such as auditory fatigue or desensitization. The solution, as we'll see, lies in sequential grouping.
Sequential grouping allows us to experience the dynamic nature of sound by locating auditory sources and identifying auditory streams over time (Cusack, Deeks, Aikman, & Carlyon, 2004). One of the keys to identifying the source of an auditory stream is our physiological interaural time differences, or ITDs. ITDs refer to our neurological ability to understand the time difference between sounds entering the ear closer to the event, versus sounds entering the ear farther away from the event, and calculate a sense of spatial location (Stevens, 1938; Wickens, 2004). Unfortunately interference of auditory events and special auditory illusions, such as binding, greatly inhibit our ability to understand the source of streams. It is important that alarms are shut off manually, and at the source, to ensure that they are not overlooked or forgotten during interference.
Design Implications
Emergency rooms are rich auditory environments inundated with complex sounds and interferences. The context of our auditory environment greatly affects our perception of spectral and temporal auditory properties, and as a result, our ability to group and understand our auditory scene. Below I list several solutions to improve scene analysis and decision making. The list is far from comprehensive, and I welcome readers to add to it.
- Monitors with similar alarm frequencies should be spread out so that their auditory streams are clearly segregated, and so that different alarms are correctly identified during an emergency.
- Monitoring should also be decentralized and ubiquitous so that important auditory events, such as onset time, are perceived as distinct and better understood.
- Auditory systems must be supported by other sensory input, such as visualization, so that information is received effectively by everyone. Our visual perception is a much stronger system for understanding more complex information.
- The challenge of auditory fatigue must be addressed by a larger, overarching system that has input from many different sources, and more importantly, has the intelligence to distribute this information appropriately and effectively.
- Dyanamic displays that allow users to understand the general auditory scene, such as the source of different monitoring devices, will greatly reduce their cognitive workload and enable them to respond more appropriately and efficiently.
References
Aksentijevic, A., Elliot, M.A., & Barber, P.J. (2001). "Dynamics of Perceptual Grouping: Similarities in the Organization of Visual and Auditory Groups." Visual Cognition, 8(5), 349-358.
Cusack, R., Deeks, J., Aikman, G., & Carlyon, R.P. (2004). "Effects of location, frequency region, and time course of selective attention on auditory scene analysis." Journal of Experimental Psychology: Human Perception and Performance, 30(4), 643-656. Retrieved from http://labrosa.ee.columbia.edu/Montreal2004/papers/cusack_et_al-attentionstream2_published.pdf
Darwin, C.J. (1997). "Auditory Grouping." Trends in Cognitive Sciences, 1(9), 327-333. Retrieved from http://web.mit.edu/hst.723/www/ThemePapers/ASA/Darwin97.pdf
Stevens, S.S., & Davis, H.D. (1938). Hearing: Its Psychology and Physiology. New York: John Wiley & Sons, Inc.
Wickens, C.D., Lee, J.D., Liu, Y., Becker, S.E. (2004). An Introduction to Human Factors Engineering. (2nd ed.). Upper Saddle River, New Jersey: Pearson Prentice Hall.
Posted by Beth Loring on Tue, Mar 30, 2010
A couple of weeks ago, I attended the Human Factors Committee meeting of the Association for the Advancement of Medical Instrumentation (AAMI) in Nashville, TN. If you aren't already familiar, AAMI is "a nonprofit organization comprised of nearly 6,000 members from around the world with a variety of different backgrounds unified by their commitment to increasing the understanding and beneficial use of medical instrumentation through effective standards and educational programs, and publications."
The Human Factors Committee convenes several times a year, and its members are responsible for writing the Human Factors standards that are adopted by AAMI and ANSI (the American National Standards Institute) and become best practices that the U.S. FDA expects device manufacturers to follow. This committee worked long and hard to develop the forthcoming ANSI/AAMI HE75:2010, "Human Factors Engineering-Design of Medical Devices." This nearly 500-page document will provide detailed Human Factors engineering design guidance, examples, checklists, and case studies. There is a delay in publication due to the fact that the publisher needs to obtain permissions for some of the figures it contains. It should be available for purchase shortly, but because it's so big, you won't be able to download it.
Another important development to be aware of is the FDA has officially endorsed the international standard IEC/ISO 62366:2007, "Medical Devices-Application of Usability Engineering to Medical Devices." IEC/ISO 62366:2007 calls for manufacturers to follow good Human Factors processes when designing medical devices, but does not provide detailed design guidance. Interestingly, Annex D in 62366 is almost a direct replica of ANSI/AAMI HE74, the document developed by this committee.
The meeting ended with discussions of diverse topics, such as post-market surveillance, user interface design for medical software, and guidelines for observational field research. The group is deciding which initiatives to pursue next.
In addition to hearing about these developments, it was a great opportunity to get a behind-the-scenes glimpse at the work that goes into creating, editing, and approving Human Factors standards. It was an insightful experience and a pleasure to finally meet some of the members that make up this influential group of thought leaders. I highly recommend attending if you're interested in Human Factors standards.
Posted by Tristan Sedgwick on Mon, Mar 15, 2010
Achieving ISO certification is a tedious, time consuming, often difficult and complex process BUT there are a multitude of reasons why you're doing it.
Farm has been going through the lengthy process and although we are not "required" to be ISO certified since we are a medical product development consultancy, we know that our business can benefit dramatically by obtaining ISO certification and so can our clients.
If you're in the process of becoming ISO 13485 certified and you're starting to rip your hair out - keep the following in mind...
- You are doing this because you want to offer your clients a high level of customer satisfaction. A certified quality system establishes your company's credibility and commitment to quality, helping you earn your client's trust and confidence.
- You want to comply with statutory and regulatory requirements to assure clients that you are committed to developing products that are safe and effective.
- You want to unlock doors that were previously closed since many medical device companies won't even speak to a development company that is not certified.
- You want to experience financial growth by gaining access to a larger market share that operates in a highly regulated medical sector.
- You want to motivate your staff and increase productivity. This is achieved through proper training, a documented, straightforward communication of the quality management system and evaluation process in order to create a work environment that embraces accountability.
- You realize the importance of mitigating risks in all stages of the product development process in order to detect and prevent errors in all stages of a product's lifecycle.
- You want the ability to identify when processes are obsolete or inefficient so you can reassess and correct them.
The process of achieving ISO 13485 certification shouldn't be feared, it should be embraced. It's a chance for a company to create a quality management system that works for them, not against them. It's an opportunity to develop a system that will offer a competitive advantage and help your business be the best that it can be.
If you reach your goal in obtaining ISO certification and are thanking your lucky stars that it's finally over - you're missing the point! Certification and the process in and of itself NEVER ends. Your quality system must continue to be audited and improved, tracked and reviewed, trained and understood by everyone in your business. It's not a course you've completed and will soon forget but instead a promise you've made to your business, employees, clients, suppliers and industry liaisons. If you want to be successful as a business, you must realize there is always room for performance improvement and by changing your perception you will not just raise the bar but go above it.
Posted by Marc Dubreuil on Fri, Mar 05, 2010
"Cautiously optimistic" is what one person is calling the outlook for venture capital funding. It's not news to anyone that this industry has fallen on hard times, and it will likely remain troubled for a few years. It is hard to believe how much money was flowing into the VC world when, just two years ago, it was actually considered to be an "asset class." At a recent conference the speaker suggested it was always a niche investment instrument and it will return to that category until the next predicted cycle (roughly ten years) brings the money back to the excitement and heroic returns that drove the IPO markets.
The good news from PriceWaterhouseCoopers indicates that the last quarter of 2009 saw significant funding gains over the prior quarters and over 2008, and Life Sciences funding is leading that comeback. Although the funding is still at its lowest point in six years, the good news for us in the product development business is that the population is aging and we will demand more diagnostics, therapeutics, and procedures/devices.
We heard about two big strategy shifts with investors last year.
In this brave new world everyone involved in start-up funding is practicing "capital efficiency." We used to call it belt tightening, but it's more about higher ROI on your early investment rounds. For us in the product development outsourcing business, it means becoming smarter, more nimble, and more effective at bringing safe and competent solutions much earlier in the game. We use analysis, prototyping, and testing in quick iterative steps to confirm our concepts and ideas, but the pressure is on to get to animal, cadaver, and human trials as major milestones in the validation of products and investments.
Another major speculation was regarding the shift from early-stage investment to later stage opportunities. The prognosticators were suggesting that later stage investments may compromise equity positions, but they also reduced risk and shortened the time to an exit event. Interestingly enough early stage funding grew to $1 billion in the fourth quarter of 2009 vs $649 million in the same quarter of 2008 while late stage funding declined over the same period in almost identical numbers.
The best news probably came from reports and blogs from the annual JP Morgan event recently held in San Francisco. The news is that private investors are getting back into the game and that VCs are back to raising funds. It all sounds so hopeful, and then you read about the FDA overhauling the 510K process. Just when we thought the money was coming back and the healthcare reform bill was dying to give us a hint of hope, the FDA turns on the warning lights to all of us in Life Sciences product development. Stay tuned.
Posted by Matt Harkins on Mon, Mar 01, 2010
Due to the buzz surrounding social media, it seems people have shifted their focus away from traditional networking events. While social media and online networking provide added value, you cannot abandon the traditional networking events that foster growth, collaboration, and innovation in the medical device community. I'm a business development manager here at Farm and can testify to the benefits received from attending medical device networking events. Networking has not only contributed directly to top-line growth by bringing in new projects and prospects, it has also helped us build brand recognition as a leader in medical product development.
The New England region has a number of valuable medical device specialty interest groups that are great venues for networking with industry professionals and promoting your services to prospects. It would be overwhelming to attend them all, so it is important to identify the meetings where you can add the most value and gain access to the right group of prospects. Here are some groups in the medical device industry that I have found to be valuable:
Medical Development Group (MDG)
MDG holds networking meetings in Waltham, MA on the first Wednesday of each month. MDG combines networking meetings with a forum session where industry experts are brought together to discuss different topics of interest in the medical device industry. Past topics have included healthcare reform and its affect on medical technology usage, the emergence of drug delivery and combination products, future trends in women's health products, trends in medical devices, and why devices fail and how to prevent it from happening. Farm has been an MDG sponsor for five years now. We have gained excellent visibility and brand recognition due to our affiliation with its networking sessions and forum meetings.
MassMEDIC
MassMEDIC provides a number of different networking opportunities throughout the year. In addition to its annual Investors Conference in the fall, MassMEDIC hosts smaller networking sessions with a range of relevant topics from the Massachusetts Gift Ban Law to best practices in the 510K process. MassMEDIC has also started MedTechIGNITE to help foster medical device companies through their early stages of conceptualization, formation, and product development. MedTechIGNITE offers its own networking sessions geared toward medical device startups and entrepreneurs seeking advice in Massachusetts.
Merrimack Valley Venture Forum (MVVF)
MVVF provides a variety of valuable events for the technology and scientific industries. It is important to identify the meetings that fit with your networking needs. The MVVF provides multiple sessions for medical device startups to pitch their business plans to an audience of potential investors, service providers, and business partners. In the past these events have attracted a number of startups from the orthopedics, urology, women's health, cardiology, and biotech markets.
Tradeshows
In addition to networking groups, tradeshows offer another great venue for networking with industry professionals. Throughout the year Farm exhibits at a number of tradeshows that are geared specifically to the medical device design and manufacturing community. We recently exhibited at MD&M West in Anaheim, CA. It was our first time exhibiting on the west coast and we were overwhelmed by the positive response we received. In addition to meeting new prospects in need of development services, we were able to reconnect with a number of former colleagues. Exhibiting at the show served as a powerful reminder of how important it is to get out and promote our services to our target audience.
It is important to remember that you won't walk away from every networking event with an opportunity. Networking is a cumulative effort where persistence pays off. You'll benefit from being a regular attendee and finding additional ways to get involved. Establishing more visibility in your industry will help you build brand recognition and increase the chance that your prospects will know of you when you reach out to them.
Posted by Jack Harkins on Thu, Feb 18, 2010
Have you seen the recent Verizon FiOS ad on television? The one where a focus group is being conducted on high-speed fiber optic service? After the users weigh in, the technician (cable guy) asks why they are talking to users anyway. The Verizon tech (smart guy) only needs to say "oh boy" to make the point that the competition just doesn't get it.
I've been in the product development business for forty years and the industry has come a long way since the early '90s. Back then there was marketing and there was engineering. One was focused on the competition and the other was focused on the technology. We in the design community talked about the importance of user needs research, but it was serious missionary work back then.
Today companies are acutely aware of the importance in understanding the end-consumer's needs but have been slow to adopt a rigorous process to meet those needs, even those companies in the medical device industry. Over the last five years, the FDA has strengthened its emphasis on usability and human factors guidelines. This requires companies to demonstrate best practices, including field research to learn user needs, preference testing of early concepts with customers, and usability testing of both prototypes and pre-production units for verification and validation. Rather than testing individual devices for safety and efficacy, there is a renewed focus basically saying- there's a right way to do this and we will evaluate your process to make sure you did it that way.
This is a blessing in disguise for device manufacturers due to the fact that it can provide many competitive advantages such as significant cost reductions, including the prevention of expensive device modifications. Medical device manufacturers are also able to minimize risk on liability and recall expenses. User research and validation ultimately yields a product that is easier to use, quicker to adopt, and improves patient treatment.
With user needs research lives have been saved and accidents associated with improper usage are now being avoided. With all of these positive aspects, it's still confusing to me why companies don't leverage the user research benefit earlier into the development process. Why do you think companies are so reluctant?