Until recently producers of medical devices have largely, and perhaps understandably, taken an engineering -led approach to the technologically complex challenge of designing and manufacturing their products.
Now, however, with the global medical device market worth in the region of $250bn and a much more mature market, it makes sense to revaluate the way that medical devices are produced, says Michael Drues, president of medical device and biotechnology consultancy firm Vascular Sciences, to ensure that they are designed and manufactured with their ultimate destination – the human body – more in mind.
Focusing on the body
Drues' approach is essentially a take on "begin with the end in mind", one of author and speaker Steven Covey's habits, from his bestselling book The Seven Habits of Highly Effective People. "My biological spin on this is: "begin with the body in mind"," says Drues, who is also adjunct professor of Medicine & Biotechnology at Northeastern University, Boston, US.
"In my 15 years or so working in this industry, I have realised that, while a lot of very talented engineers and scientists really understand how their medical device is supposed to work, they don't understand to the same degree about the environment that device is supposed to function in. The human body, in other words."
Look at the way most medical devices come into being. Somebody gets an idea, they build a prototype, they test it on an animal, or sometimes on a patient, and only then do they ask the question "what is going to happen next?". Surely, argues Drues, this is approaching the challenge of manufacturing the best devices backwards. It is the antithesis of what the device developers really want to achieve.
"What we really want to do is try to understand how the body is designed to work, and then try to design and manufacture our medical device, or for that matter our drug or biological or combination product, to work with the body, not against it," he says. Unfortunately, when you look at the mechanism of action of many medical devices, including some of the most commonly used devices, they are designed to work in the opposite of the way the body is designed to work. When these devices are put into patients, and less than stellar efficacy rates are achieved, everybody is surprised. But we shouldn't be surprised, because the process did not start out with the body in mind.
One reason that medical devices are not produced with the body in mind is evident from looking at those working in the industry. Many of the people designing the devices are traditional mechanical, electrical and chemical engineers, with very little, if any, knowledge or appreciation of the human body.
Although there are a growing number of biomedical engineers, "biomedical engineering" is a nebulous phrase. Many biomedical students at the graduate level do a lot of engineering, but much less biology and associated sciences. "Engineers can learn so much, if they just open their eyes and ask the question: 'How is the body designed to work?'," says Drues. "As opposed to, as many people in this industry do, approaching the issue from the perspective of forcing the body to work the way you want it to."
It is an issue not only of design but also of the materials that are used. These materials were often never designed to go inside the human body. We use the phrase biocompatible, but that is not a very high place to set the bar, Drues points out. Biocompatible does not mean that the body likes a particular material. Perhaps a better approach would be the idea of biofriendly materials: materials that the body actually likes.
"I spend about half of my time working with medical device companies, and about half my time working with biotech companies," says Drues. "When I go into a biotech company, I don't have to work hard to emphasise the importance of biology.
In biotechnology, everybody knows that biology is important. So why is it that when I walk into a medical device company, I have to work much harder to impress on them that, while engineering is important, biology is also important? I find this a huge problem."
While initially the body and mind concept is directed towards R&D and design, there is also a relationship with manufacturing. "Fifteen or so years ago, when I was starting out in research and development, I was very naïve," Drues explains. "My attitude was that if I built three or four widgets that worked, it was somebody else's job to make three or four million that worked.
"As you might appreciate, that is not a very popular attitude to have in this industry; the concept of just throwing a product over the wall that separates R&D from manufacturing. But the smarter product development teams, the smarter companies, realise that it is simply not enough to be able to come up with a revolutionary product that you can build a few of. You have to be able to make enough to supply market demand."
It is important, therefore, to involve manufacturing people early in the process, preferably from day one. If you are developing a product from the very beginning, it makes sense to have a manufacturing person on the team, providing oversight and contributing to the development process from a manufacturing perspective.
Input from manufacturers is becoming more common as people realise that manufacturing involvement from the early stages is vital. Otherwise, companies are risking developing a product that is effective, but when they get to the point of manufacturing it in a quantity that can meet anticipated market demand, they find out there are real problems.
Manufacturing involvement can be a challenge. The high incidence of outsourcing may make involving the manufacturers in the design process more difficult, especially if the medical device company is focused on driving down costs through outsourcing, rather than how easy the device is to manufacture.
"Outsourcing certainly can complicate the relationship, although it does not make it impossible," says Drues. "It just means that logistically it might be a bit more cumbersome. One challenge might be with smaller start-up kinds of companies. If you have a very small company or start up company, with venture funding, some entrepreneurs and some technology innovators, often this type of company will be much more focused on coming up with an innovative product that works."
Venture capitalists, or other early-stage investors, may have an exit strategy that involves acquisition or licensing, long before the product gets onto the market. There may also be issues for companies acquiring technology. Technology acquisition will often take place in a situation where all or most of the development work is done, and the firm will then take the product to its manufacturing engineers and ask them to scale up manufacturing to commercial levels. There may not be the option to go back at that point and work with the designers of the product, as they are probably not around any longer.
"If it turns out that they can't manufacture the acquired product, or it turns out to be too expensive or difficult to manufacture, they might need to go back and reverse engineer it, and start changing the design slightly to make it more able to be manufactured," says Drues.
"But if you do that you run the risk of opening up a regulatory quagmire. The US FDA, as you might imagine, does not take too kindly to people changing designs after a product has been approved or cleared. You might be opening up a legal quandary as well, over issues of intellectual property. If you tweak your design you might be infringing on somebody else's patent."
The manufacturing challenge is not a theoretical problem either. Take the example of Cordis, part of Johnson & Johnson. When the company introduced the first drug eluting-stent combination product onto the market in 2003, it could not manufacture enough to meet the high demand for the product. In this case an inability to meet market demand allowed Boston Scientific, also an early pioneer of DES technology, to gain a significant foothold in the market.
A new philosophy
In the future, as technologies such as nanotechnology progress, medical devices are going to grow much more complex. The relationship between R&D and manufacturing will then be even more important.
Medical device technology has come a long way in the decades since Dr Charles A Hufnagel implanted the first artificial heart valves into patients back in the early 1950s. Yet it has come much less further in its overall philosophy. Now it is time that medical device producers began to approach device design and manufacture not just as technical engineering challenge, but with the patients –and their bodies – in mind throughout the entire process.