How do you ensure you give your medical device the best chance for success? Jessica Urban, Director of Program Management at Stratos Product Development suggests five factors to success in product development:
1. Wait Until the Technology is Really Ready
2. Choose the Right Team
3. Use a Systems Approach
4. Use a Risk-Based Approach
5. Dedicated Project Management
For an in depth look at Jessica’s strategies, check out her article Five Factors To Success In Product Development.
Did you ever stop to consider the color of your medical device and how it may appeal to your consumer? I know it sounds a bit crazy, but perhaps it is worth considering.
CMF, or color, materials and forecasting design, is a design expertise which is becoming more and more prevalent. As products and markets become more complex the need for specific knowledge about color, materials, surface finish and trends has increased.
Medical devices can be given a personal and sophisticated competitive edge when we work with color pallets beyond navy blue, black and silver and with high quality manufacturing techniques and sophisticated finishes. Thoughtful and careful color, materials and surface design create more accepted, appreciated devices which are a natural part of users’ daily lives.
I actually pulled up a website of a company called Fairings that makes specialized coverings that surround an existing prosthetic leg. The site states:
Fairings infuse the individual’s lifestyle and taste into the design from the start. But to make this an even more personal part of the prosthetic leg, Fairings can be enhanced with patterns, graphics, and materials—including leather, ballistic nylon fabric, chrome plating, and even tattoos. By creating a unique custom form that presents the individual, Bespoke Innovations hopes to change the way the world thinks of prostheses.
Am I suggesting that you take your already stretched budget to go out and hire expensive designers to investigate the recent hip trends and somehow transform your product into the new “it” device? I really don’t think anyone wants leopard print surgical tubing, pastel circuit boards, or even leather prosthetic legs for that matter, but CMF certainly is something to keep in mind if you want your product to stand out in today’s market.
In my quest to understand product development, I thought I would start at the beginning, literally, with startups. I recently did an interview with Tiger Buford. Tiger has over 25 years of medical device product development experience.
What makes a startup successful?
Lise, this is a big question, but I’ll give it a try. There are many many ingredients to a successful Medtech startup. It’s like a complicated gourmet dish. If any one ingredient is wrong it will bring the entire meal down. From my experience, all of the successful startups have practiced some or all of these principles:
What is one piece advice you would give to a startup company?
The most important ingredient is the management team. VCs are known to invest in teams, not technology. The management team should be made up of people who can wear many hats and who thrive in chaos and uncertainty. And also, having startup experience with either a success or failure (it doesn’t matter which), is a big plus.
What are some of the challenges that startups face?
Money and Time. This is a double whammy because they are directly affected by each other. Today, Medtech startups are requiring more money and time to reach value-adding milestones because of longer regulatory pathways, smaller funding increments, and longer horizons to exit. Since the credit constriction in 2008, we have all seen the available investment funding shrivel up. There is less investment available for the same number of Startups. Keep in mind that startups don’t have income, but they have a finite barrel of money. The sole purpose is to reach a value-creating event (e.g.: regulatory approval, First-in-Man, etc) before the barrel is dry. If the event is reached, more incremental funding may be available.
Regulatory approvals. Under this administration, the FDA has become unreasonable, unpredictable and not driven by objective science. This unpredictable behavior by the FDA is challenging the business plans of Medtech startups and VC investors. More years are added to the FDA path each year for the same technology. Experts estimate that a startup must spend $90M to get through PMA approval for a Class III device today. Few VCs have the tolerance for this.
By contrast, the EU Regulatory bodies are reasonable and predictable. Therefore, all startups pursuing Class III devices are going to Europe first for regulatory approvals and clinical studies. Many Class II device startups are going to Europe first also. I really wish someone would document the number of Medtech companies fleeing to Europe, because there is a silent exodus happening right now.
Tell me about some of the startup situations you have been involved with.
I jumped into the startup world in 2008, after a successful career in three large Orthopedic device companies.
My first startup experience was VC-funded startup called NovaLign Orthopedics in Memphis. NovaLign was spun out of an incubator in Atlanta called The Innovation Factory. I was the 2nd hire and had a large voice in the business. The technology that the company was based on was “dead on arrival”. So, in my first month on the job, with the Board’s blessing, the CEO and I scrapped the technology and started over. 12 months later, I had saved the company with a completely different technology and IP that addressed the same unmet market need. During this 12 months, I also transitioned the company from outsource R&D to insource R&D as hired the engineering talent.
My second startup experience was Angel-funded startup called Active Implants with the corporate offices in Memphis. I was brought into to lead the Israeli-based team from a Research-focus to a Development-focus. They did a great job in bringing a game-changing polymer meniscus replacement from Research, through Development, and into Manuf8acturing and Clinical Studies in Europe. After a CEO change, the company is now moving its headquarters to Europe. I am helping out during the transition.
Thanks for sharing your information and experiences, Tiger. This certainly helps me to better grasp what is involved with “starting up” a medical device company.
Stay tuned for further blogs on the product development subject as I continue my research…
We really liked this blog by Peter Kissinger, so we thought we would share it with you…
Stuck. That’s how many of us feel about commercial life sciences. The venture capitalists have abandoned us. The IPO market is largely closed to us. The momentum is once again with IT and all its apps, games and social networking variants. IT and life sciences both tend to cycle with large amplitudes, as reflected for both in the last four decades. IT has the ball today and is running with it. The energy sector is also energized. Meanwhile, innovation in life sciences is struggling like a mouse in a glue trap—and it’s not pretty.
What is Product Development? This is a question that has nagged at me since I started working for Creo Quality. It certainly seems like something that I should know the answer to, since I am working for a company that deals in product development. Alas, the answer had thus far eluded me. So, I set out on a quest to determine for myself what Product Development actually was. So far, I have talked to someone in the industry, checked out websites such as ehow.co and answers.com, and also looked at detailed papers that had been written by experts on the subject. I learned about something called the Fuzzy Front End, and what the difference between is between breakthrough products as opposed to platform products and incremental products. I was surprised at the wealth of information that existed on the subject.
To start off, I asked Jon Speer, Creo Quality’s founder, a few key questions. He spoke to me about the importance of planning and being able to define your objectives and have a process that is reproducible. He also stressed that although planning is important, you don’t want to overplan and get caught up in the process of planning. You must keep your objectives in mind and remember that every project has a beginning, middle, and end.
One of the papers I read was by Kenneth Crow and reiterated most of what Jon said and, like Jon, stressed the importance of the process being repeatable. An interesting point that he made was that the typical duration of most projects “range from six months to six years. As a result, development personnel don’t have the opportunity to learn from and to refine the development process through repeated use on an individual basis. With the rapid pace of technology evolution, the hiring of many young engineers in some industries, high turn-over rates, it is not unusual to see development personnel with keys roles in a development project, but who have not gone through a full development cycle on a prior project within their companies. In short, many development personnel have little understanding of or practical experience with any standard product development process in their companies”. He uses this concept as one of the reasons the process must be reproducible. “The process must be characterized and documented. Unless it is, it will be difficult to assure understanding and agreement on what the process in fact is, difficult for all development personnel to understand the process in a consistent manner, and difficult to communicate that process to new personnel.”
I plan on continuing my search for the meaning of Product Development. In future blogs, I will share with you what I have learned. If you know any good sources of information, please feel free to contact me and share that knowledge with me. This Product Development newbie could use all the help she can get.
How do you come up with inspiration when it comes to medical device product development? Robert G. Cooper and Angelika Dreher wrote an interesting article dealing with the concept of Voice of Customer (VoC) Ideas for idea generation. One of the techniques they discuss is ethnographic research. Ethnography involves “camping out” with customers or observing customers for extended periods, and watching and probing as they use or misuse products.
An example cited in the article is about a company who makes breathalyzer testing devices used by police forces in the U.K. A team from the company actually accompanied police officers on their night-time roadside spot checks and discovered some interesting leads to new product development that might have been missed otherwise. For example, it was determined that the two minute wait time for the breathalyzer to process was resulting in officers being overwhelmed when more than one vehicle was pulled over at a time because carfuls of possibly intoxicated people were forced to wait while the breathalyzer was being used on another car. This put the officers in a potentially dangerous situation. So, the company developed a new breathalyzer with only a 10 second wait time. It was also discovered that because of the dials, the current version of the device could only be used with the right-side drivers in the U.K. Thus, when a left-hand-side driver from France or Germany was pulled over in the U.K., the police could not conduct the test quite as quickly. Because of time pressures, the officers had no option but to simply wave the car through. Therefore, an ambidextrous test instrument was developed. These and several other changes based on observations made in the field made for a new device that delighted police forces.
The article states that “Ethnography provides perhaps the greatest insights into users’ unmet and unarticulated needs, applications and problems.”
When trying to come up with new ideas, perhaps you should get down in the trenches with your customer in order to discover what their needs really are. Maybe you will come across something you never even considered before.
Moving quickly and moving deliberately might seem like antithetical concepts, but in the world of medical device development, they are inextricably linked. Given the emphasis placed on releasing products as soon as possible, it’s easy to imagine OEMs throwing caution to the wind in a mad dash to market, but in truth, the realities of the device industry mean that the best way to speed up the process is to carefully plan it out.
“What we really have to understand is what the customer needs, [and] what the market will need,” Barry Craner, vice president of quality assurance and regulatory affairs at Stellartech Research Corp. (Amherst, NY) says. “That’s why it’s important for companies to be fully aware of the market for any potential products, to know exactly what the product would be used for and whether there is any interest in that use. Companies that develop a tight specification for a product early in the design process have “a pretty good chance at a much faster development process,” he says.
I am reminded of the old Aesop’s fable about the tortoise and the hare with the moral “Slow and steady wins the race.” Perhaps in the case of medical device development, the “tortare” would win the race.
As if the medical device industry doesn’t have enough to worry about with the 2010 Health Care Reform and the ensuing medical device tax, there appears to be more gloom and doom for the industry…
Medical device makers as a whole will lose 10 percent of their current revenue by 2015, according to Deloitte analysts Sanjay Behl, Terry Hisey and Ralph Marcello. That’s because indirect changes in the health care marketplace are going to shift market power from producers of medical products to hospitals and large physician groups, which will be under tremendous financial pressure from health plans and consumers to save costs.
Now that hospitals are employing more and more physicians, they are no longer allowing, say, each orthopedic surgeon to chose his or her favorite implants. Instead, those purchasing decisions are made as a group, allowing hospitals to command lower prices and often shutting out some brands of implants entirely. The same goes for stents, pacemakers and other kinds of devices.
The Deloitte analysts suggest one strategy for medical device makers: pitch not merely products, but solutions, by bundling all manner of support services into a contract to supply devices to a hospital. The only problem with that, however, is that services profit margins run about 40 percent, compared with the 90-percent margins of most medical devices themselves.
What is a device maker to do in these trying times? I guess the same thing we always do, adapt and find new ways to be profitable. I am reminded of the old gospel hymn my grandma used to sing, “We Shall Overcome.”
I blogged last week about programmable bandages, and now yet another wound healing material is being developed.
Researchers at Purdue University are developing a scaffold-like material that could be used to facilitate healing of wounds. Once injected into the body, the material hardens and binds to the wound, facilitating recovery time. It can also fill space as needed for applications requiring tissue rebuilding. “Because the material starts out as a thickened liquid, it rapidly can be injected into almost any part of the human anatomy and quickly fills in the gaps between severely damaged and or missing tissues,” Panitch explained in a release.
Purdue associate professor Alyssa Panitch, who heads the research team developing the material, discovered the material during the course of years of clinical testing. Potential applications include treatment of burn victims, damaged bones, spinal cord fusions, and arterial reattachment.
The material also could be used in conjunction with medicine such as antibiotics or pain medication. In the latter case, it could be applied directly to nerve endings.
Once again, I am truly impressed and amazed by the technology we have developed today. This brings to mind the 1966 movie Fantastic Voyage in which a diplomat is nearly assassinated, causing a blood clot to form in his brain. In order to save him, a submarine is shrunken to microscopic size and injected into his blood stream with a small crew. The crew has one hour to get in his brain, remove the clot and get out. Luckily for us, it has proven easier to develop an injectable material that can facilitate the healing of wounds than to come up with a way to shrink down an entire submarine and its crew in order to inject them into someone’s body and have them handle it.
In the quest to integrate biological molecules with nanotechnology, a group of researchers at the University of Pennsylvania (Philadelphia), University of Miami, University of Illinois at Urbana-Champaign, Princeton University (Princeton, NJ), the Monell Chemical Senses Center (Philadelphia), Evolved Machines (Palo Alto, CA), and Nanosense Inc. (Redwood City, CA) have developed a carbon nanotube–based transistor that incorporates olfactory receptor proteins (ORs). Seeking to create electronic devices with a sense of smell that could eventually replace the use of animals to sniff out drugs or bombs, the scientists also hope to develop olfactory electronic devices for performing disease diagnosis.
The scientists were interested in fabricating bioelectronic hybrids that exhibit a carefully designed chemical linkage between the OR and the nanotube device and an engineered membrane-like environment for the OR. These more-complex strategies for housing the OR and coupling it to the nanotube transistor enabled the researchers to demonstrate nanotube-OR hybrids with vapor responses that show strong agreement with the responses measured in another cell system.
I am currently reading a book called Hybrids in which aliens have worked with humans to create human/alien/electronic hybrids. The hybrids, which have been programmed to have super intelligence and physical powers are now attempting to take over the world from their inferior human creators. I’m not normally a science-fiction reader, and throughout the book, I find myself thinking “Sure, like that could really happen…” Perhaps it could…
No matter how great you think your medical device is, I don’t care if you believe it will revolutionize the industry, if people can’t use it effectively, it doesn’t do much good.
Introduced in 2010, the new set of human factors standards (ANSI/AAMI HE75 and IEC 62366) aims to address the high number of medical device incidents that involve usability issues. By requiring companies to track user feedback and justify proposed use-error mitigation approaches, regulators are emphasizing the important role usability plays in product safety. These new regulations are also a response to the transition of device use away from clinical environments. Many medical devices are increasingly being used by patients who have less experience and training.
In addition to promoting safety and user compliance, integrating usability into a product development program is good design practice. Manufacturers should take a holistic view of usability, incorporate it as a key component of every product development program, and make sure that the specific market demands for each new product are understood from the onset.
If the patient is involved in using a product, human factors should be at the core of the development process. Integrating usability into this process is good design practice and ensures that a product is usable. If a product is user-friendly and designed appropriately, it is more likely to be used regularly and as intended, which ultimately leads to increased compliance and improved clinical outcomes. When usability is not properly considered, there is greater potential for incorrect usage, and clinical outcomes could be affected.
The typical goal of a product development program is to ensure that a product works effectively, meets end-use objectives, and achieves target commercial return. Usability is often sidelined, delayed, or considered an add-on to technical development, but this notion is a mistake. Integrating human factors engineering can support all three elements of this goal. It provides essential insight that can balance, challenge, inform, and direct technical decisions throughout the development life cycle.
It certainly seems like common sense. Even restaurants have customer satisfaction surveys. I’m not suggesting that you offer your customers a free order of cheese fries if they go to your website and complete an evaluation, but it’s certainly important to keep the human factor in mind.
Because I have young children, I found the following tidbit interesting…
Stanmore Implants won FDA clearance for an extendible femur implant that can “grow” as the patient does, without the need for surgery, anesthesia or sedation.
Anything that can decrease discomfort to children and therefore make parent’s lives easier is definitely a great advancement in my book.
In May, the UCLA School of Nursing along with the UCLA Wireless Health Institute published a study on a system to remotely monitor for symptoms indicative of CHF (Congestive Heart Failure) related decompensation. Dubbed WANDA, the system uses wireless devices to track weight, blood pressure, activity levels, and the Heart Failure Somatic Awareness Scale (HFSAS). The goal and idea are simple enough – catch early signs of an exacerbation, intervene, and keep patients at home.
WANDA is a customizable mobile platform that integrates seamlessly into patients lives and uses automated data analysis to allow for easy physician review. So when the system catches a slow increased in weight, blood pressures above goal, or dropping activity levels – all warning signs for decompensated heart failure – physicians can intervene before the patient ends up in the hospital.
My dad suffered from CHF among other things before he passed away and it seems like he was forever being taken back to the hospital to be “monitored” every time he had any suspicious symptoms. It certainly would have saved him and my mom a lot of time and effort if he could’ve done some of the monitoring at home. Of course, my dad, who was born in 1917, wasn’t a big believer in computer “gadgets”, so convincing him he needed a mobile platform to monitor his health may have been a bigger obstacle to overcome.
There’s been a lot of talk lately about how the FDA clearance process is doing, and whether it is working or not, depending on who you talk to.
Emergo Group did a study in which they found that application times jumped 37% from 2006 to 2010. In 2006 510(k) applications cleared by the FDA took about 96 days, but that number soared to 132 days in 2010.
But, why are the reviews at FDA taking longer? As part of the MDUFMA/FDAAA reauthorization in 2007, FDA made a promise for interactive review process in a commitment letter to Congress. The Agency stated that it “will continue to incorporate an interactive review process to provide for, and encourage, informal communication between FDA and sponsors to facilitate timely completion of the review process based on accurate and complete information.” The purpose of the interactive review process is to prevent unnecessary delays in the completion of the review, to avoid surprises to the sponsor at the end of the review, and to minimize the number of review cycles. This process would benefit both FDA and 510(k) sponsors, but are reviewers using this process? According to a presentation made by FDA in March 2011, FDA reviewers utilized the interactive review process less in 2010 than they had in previous years.
Technology is rapidly changing – and diverging further from current technology, thus making SE (Substantially Equivalent)decisions harder to prove and review. As new technology becomes more ever more divergent from the predicate device, it becomes all the more difficult for the FDA reviewer to agree with the sponsor’s proposed SE strategy, resulting in longer review times. Quite often the 510(k) submitters aren’t providing FDA with adequate scientific data (performance data) and/or SE strategies (appropriate predicate devices). The bottom line result of these trends is longer review times.
Sen. Al Franken (D-Minn.) sent a letter to Dr. Jeffrey Shuren, director at the Center for Devices & Radiological Health at the U.S. Food & Drug Administration, that urged the agency to include industry input on any recommendations the Institute of Medicine makes about changes to the 510(k) process.
CDRH director Jeffrey Shuren said seven new guidelines are now in preparation, covering the following subjects:
I, for one, will be interested to see where the whole process leads us.
I’m just getting started with a new client medical device product development engagement. The project schedule is a 300+ line item MS Project file with a very firm due date. However, the product requirements have not been fully defined and approved yet. Also, the client mentioned project scope continues to creep. The client said regardless of the scope creep, the due date MUST be met.
I know, this happens ALL the time. Every time, I ask why? How can the project schedule be defined when the project scope is not completely known? How can the project schedule be defined when resources have not been completely determined? When developing a new medical device, there are so many unknowns, not the least of which is regulatory clearances.
I know there is a better way. Hell, everyone involved with medical device product development knows there is a better way. Yet, no one seems to have the ability to try a better way.
